Beechams Venos Cough Mixture


1. Name Of The Medicinal Product

Beechams Veno's Cough Mixture

Veno's Cough Syrup

2. Qualitative And Quantitative Composition

Glucose liquid 3.18 g, Treacle 1.35 g

For excipients, see 6.1.

3. Pharmaceutical Form

Syrup

4. Clinical Particulars 4.1 Therapeutic Indications

Recommended for the symptomatic relief of sore throat and unproductive cough in minor respiratory tract infections.

4.2 Posology And Method Of Administration

Adults and children over the age of 12: Take one 5 ml or 10 ml dose (one or two 5 ml spoonfuls). Repeat the dose every 2 or 3 hours.

Children aged 3 to under 12 years: Take one 5 ml dose (one 5 ml spoonful) and give every 2 to 3 hours. Do not give to children under 3 years except on medical advice.

Route of Administration

Oral

4.3 Contraindications

Hypersensitivity to glucose, treacle or any other of the ingredients.

4.4 Special Warnings And Precautions For Use

Special Label Warnings

Keep all medicines out of the sight and reach of children.

If symptoms persist consult your doctor.

Total sugars content 3.6 g per 5 ml.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

Use in pregnancy and lactation is not contraindicated. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Immune system disorders

Hypersensitivity reactions e.g. skin rash

4.9 Overdose

The product does not contain any ingredient in a high enough concentration to cause toxic effects; therefore no specific symptoms of overdosage would be anticipated and no antidotes would be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Treacle and glucose liquid are demulcents, which will help relieve an unproductive cough and will soothe a sore throat.

5.2 Pharmacokinetic Properties

None Stated.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Capsicum tincture, aniseed oil, xanthan gum, camphor racemic, glacial acetic acid, sodium benzoate, sodium metabisulphite (E223), levomenthol, water and colour caramel (E150).

6.2 Incompatibilities

None

6.3 Shelf Life

Unopened: Three years

Opened: Six months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Clear glass bottle with a roll-on, pilfer proof, aluminium cap containing a melinex-coated aluminium-faced pulp-board wad. The bottle is contained in a boxboard carton.

Pack sizes: 100 ml, 160 ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data 7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as:

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0157R

9. Date Of First Authorisation/Renewal Of The Authorisation

28 September 1988 / 9 November 1993

10. Date Of Revision Of The Text

01/12/2010


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Beechams Max Strength Sore Throat Relief Blackberry Lozenges


1. Name Of The Medicinal Product

Beechams Max Strength Sore Throat Relief Blackberry Lozenges.

2. Qualitative And Quantitative Composition

Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg

3. Pharmaceutical Form

Lozenge

4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic relief of sore throat, the associated pain and pharyngitis.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over the age of 12: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours.

Children aged 7 to 12 years: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or excipients.

Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance

4.4 Special Warnings And Precautions For Use

Keep out of the reach and sight of children

If symptoms persist consult your doctor.

Do not exceed the stated dose

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 2.5 g of total glucose and sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There is a lack of evidence of safety of the product in human pregnancy and in animals, but both hexylresorcinol and benzalkonium chloride have been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat.

4.9 Overdose

The oral toxic dose of benzalkonium chloride is between 1 and 3g, symptoms of overdose are unlikely with a product containing such a low level.

An overdose of hexylresorcinol may cause minor gastrointestinal irritation.

After withdrawal of the product, treatment is symptomatic.

Theoretically symptoms are possible in children if at least 50 lozenges are consumed in a short space of time. In such extreme overdose related to menthol ingestion, symptoms may include nausea, vomiting, diarrhoea, profuse sweating and intense thirst.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Hexylresorcinol is a local anaesthetic effective for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

Benzalkonium chloride is a quaternary ammonium compound with antiseptic activity typical of this group.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric acid monohydrate, sucrose, liquid glucose, propylene glycol, blackberry flavour, levomenthol, Ponceau Red E124, Brilliant Black E151

6.2 Incompatibilities

Benzalkonium chloride is incompatible with other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, tartrates and alkalis. Incompatibilities have also been reported with other substances including aluminium, hydrogen peroxide, kaolin and some sulphonamides.

Hexylresorcinol is also incompatible with alkalis and oxidising agents.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Blisters (PVC 250 microns/PVdC 60 microns/Aluminium 20 microns)

Pack sizes 10, 12, 20.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Beecham Group Plc

908 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, Middlesex, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0386

9. Date Of First Authorisation/Renewal Of The Authorisation

26 April 2002

10. Date Of Revision Of The Text

26/01/2011


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Heliox



Dosage Form: gas
COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 20) LABEL

COMPRESSED GAS, N.O.S. (HELIUM, OXYGEN) NON-FLAMMABLE GAS 2 UN 1956

MEDICAL GAS MIXTURE   BALANCE HELIUM, USP  CAS:   7440-59-7  20.0%OXYGEN, USP   CAS:   7782-44-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: HIGH PRESSURE GAS. MAY ACCELERATE COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.

FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.

SERIAL NUMBER:  0000000   LOT NO:  0000000 - VOLUME: 204.1 - EXP. DATE: 1/1/2015 VER. 3.11

FOR MEDICAL USE ONLY   DO NOT REMOVE THIS PRODUCT LABEL

COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 25) LABEL

COMPRESSED GAS, OXIDIZING, N.O.S. (OXYGEN, HELIUM) NON-FLAMMABLE GAS 2 OXIDIZER 5.1 UN 3156

MEDICAL GAS MIXTURE  25.0% OXYGEN USP   CAS:  7782-44-7  BALANCE HELIUM, USP   CAS:   7440-59-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.
FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.
SERIAL NUMBER: 0000000   LOT NO:0000000 - VOLUME: 200 - EXP. DATE: 1/1/2015 VER. 3.11
FOR MEDICAL USE ONLY. DO NOT REMOVE THIS PRODUCT LABEL.

COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 30) LABEL

COMPRESSED GAS, OXIDIZING, N.O.S. (HELIUM, OXYGEN) NON-FLAMMABLE GAS 2  OXIDIZER 5.1  UN 3156

MEDICAL GAS MIXTURE  BALANCE HELIUM, USP   CAS:   7440-59-7  30.0% OXYGEN, USP   CAS:   7782-44-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.
FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.
SERIAL NUMBER:  00000000   LOT NO.:0000000 - VOLUME: 204.1 - EXP. DATE: 1/1/2013 VER. 3.11
FOR MEDICAL USE ONLY.  DO NOT REMOVE THIS PRODUCT LABEL.







Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-009 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 20 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 80 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-009-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-010 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 25 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 75 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-010-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-011 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 30 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 70 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-011-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Labeler - Acetylene Oxygen Company (008110181) Registrant - Acetylene Oxygen Company (008110181) Establishment Name Address ID/FEI Operations Acetylene Oxygen Company 809889033 manufacture Revised: 04/2011Acetylene Oxygen Company
More Heliox resources Heliox Drug Interactions Heliox Support Group 0 Reviews · Be the first to review/rate this drug


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Carbon Dioxide Oxygen Mixture


Dosage Form: gas
Carbon Dioxide Oxygen Mixture

COMPRESSED GAS, OXIDIZING, N.O.S.
(  % CARBON DIOXIDE USP,    %OXYGEN USP) UN 3156 NON-FLAMMABLE 2    OXIDIZER 5.1   30460D (06/02)
OXYGEN CONTENT OVER 23.5% Rx only. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindication and side effects, and the precautions to be taken. CAUTION: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  CARBON DIOXIDE CAS: 124-38-9 OXYGEN CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
FILLED and INSPECTED BY GENERAL AIR SERVICE and SUPPLY DENVER, CO 80204

COMPRESSED GAS, OXIDIZING, N.O.S.
(  % CARBON DIOXIDE USP,    %OXYGEN USP) UN 3156 NON-FLAMMABLE 2    OXIDIZER 5.1   30460D (06/02)
OXYGEN CONTENT OVER 23.5% Rx only. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindication and side effects, and the precautions to be taken. CAUTION: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  CARBON DIOXIDE CAS: 124-38-9 OXYGEN CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
FILLED and INSPECTED BY GENERAL AIR SERVICE and SUPPLY DENVER, CO 80204


Carbon Dioxide Oxygen Mixture 
Carbon Dioxide Oxygen Mixture  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 21220-129 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 200 mL  in 1 L Oxygen (Oxygen) Oxygen 800 mL  in 1 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21220-129-01 7101 L In 1 CYLINDER None 2 21220-129-02 707 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1975
Labeler - General Air Service & Supply Co (151227338) Establishment Name Address ID/FEI Operations General Air Service & Supply Co 006686091 manufacture Revised: 10/2010General Air Service & Supply Co


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Magnesium Trisilicate Mixture BP


1. Name Of The Medicinal Product

Magnesium Trisilicate Mixture BP or Indigestion Mixture.

2. Qualitative And Quantitative Composition

Magnesium carbonate light

250mg/5ml

Magnesium trisilicate

250mg/5ml

Sodium hydrogen carbonate

250mg/5ml

For full list of excipients see section 6.1

3. Pharmaceutical Form

Mixture

4. Clinical Particulars 4.1 Therapeutic Indications

For relief of the symptoms of indigestion, heartburn and dyspepsia.

4.2 Posology And Method Of Administration

Oral.

RECOMMENDED DOSE

Adults and children over 12 years: two to four 5ml spoonfuls.

Children 5 to 12 years: one to two 5ml spoonfuls.

Directions for use: shake the bottle.

Take in a little water.

DOSAGE SCHEDULE

To be taken three times a day or as required.

4.3 Contraindications

Contraindicated in severe renal failure and hypophosphataemia.

Should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The product should be used with caution in patients with fluid retention. In view of the sodium hydrogen carbonate content the product should also be administered extremely cautiously to patients with congestive heart failure, renal impairment, cirrhosis of the liver, hypertension and to patients receiving corticosteroids.

If renal function is impaired hypermagnesaemia may result giving the symptoms described under (9) overdose.

The following warnings and precautions appear on the labels:

Keep all medicines away from children

Discard any unused mixture one month after opening.

If symptoms persist consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids may interact with a number of other drugs by altering their absorption and, sometimes, their elimination. Examples include diflunisal, phenytoin, cimetidine, mexiletine, chlorpromazine, isoniazid, allopurinol, iron preparations, tetracyclines, phenothiazines, penicillamine, pivampicillin, atenolol, diclofenac, digitoxin, ibuprofen, indomethacin, ketoprofen, levodopa, metoprolol, metronidazole, ketoconazole, itraconazole, prednisolone, quinidine, tolfenamic acid, ciprofloxacin, ofloxacin, norfloxacin, rifampicin, azithromycin aspirin, fosinopril, dipyridamole, hydroxychloroquine, chloroquine, diazepam, bisphosphonates, warfarin and lithium.

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Magnesium salts may cause diarrhoea in some patients. Magnesium carbonate and sodium hydrogen carbonate may cause stomach cramps and flatulence as a result of excess carbon dioxide production.

4.9 Overdose

Overdose, or excessive or prolonged intake of magnesium containing antacids may give rise to hypermagnesaemia, and excessive administration of sodium hydrogen carbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with renal insufficiency.

Symptoms of hypermagnesaemia include nausea, vomiting, flushing of the skin, thirst, drowsiness, hypotension, confusion, muscle weakness, CNS and respiratory depression, hyporeflexia, peripheral vasodilatation, bradycardia, cardiac arrhythmias, coma and cardiac arrest. Treatment of mild hypermagnesaemia is usually limited to restricting magnesium intake. In severe hypermagnesaemia, ventilatory and circulatory support may be required.

Treatment should consist of the intravenous administration of calcium gluconate injection 100% at a dose of 10 – 20ml, to counteract respiratory depression or heart block. If renal function is normal, adequate fluids should be given to assist magnesium removal from the body. Haemodialysis may be necessary in patients with renal impairment or for whom other methods prove ineffective. Metabolic alkalosis and hypernatraemia can be treated by appropriate correction of fluid and electrolyte balance.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Magnesium trisilicate mixture is an antacid with slow neutralising action and mild laxative action.

5.2 Pharmacokinetic Properties

Magnesium chloride and hydrated silica gel are formed during the neutralisation. About 5% of magnesium is absorbed and traces of liberated silica may be absorbed and excreted in the urine.

Any sodium hydrogen carbonate not neutralised in the stomach is absorbed and excreted as bicarbonate and sodium ions in the urine in the absence of a plasma deficit.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium nipasept, peppermint oil, chloroform, polysorbate 20, purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

200ml: 18 months unopened, 1 month after first opening.

500ml: 18 months unopened, 1 month after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

200ml: amber glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE/Saranex liner.

500ml: amber glass bottle with plastic lined cap or white 28mm cap with tamper evident band and EPE/Saranex liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0025

9. Date Of First Authorisation/Renewal Of The Authorisation

10th May 1994 / 10th May 1999

10. Date Of Revision Of The Text

10/10/2011


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Vicks Cough Lozenges with Honey


Vicks Cough Lozenges with Honey

Dextromethorphan 7.33mg per Lozenge

In this leaflet: 1. What Vicks Cough Lozenges with Honey are and what they are used for 2. Before you take Vicks Cough Lozenges with Honey 3. How to take Vicks Cough Lozenges with Honey 4. Possible side effects 5. How to store Vicks Cough Lozenges with Honey 6. Further information Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Vicks Cough Lozenges with Honey carefully to get the best results from them.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. What Vicks Cough Lozenges with Honey are and what they are used for

Vicks Cough Lozenges with Honey contain the active ingredient Dextromethorphan which suppresses a cough by acting on the cough centre of the brain. These lozenges relieve dry coughs associated with colds and flu.

Before you take Vicks Cough Lozenges with Honey Do not take Vicks Cough Lozenges with Honey if you: are allergic to dextromethorphan or other ingredients (see section 6) have severe liver disease have a productive cough - (coughing produces mucus/phlegm). are taking medicines called monoamine oxidase inhibitors (MAOIs – a type of antidepressant) or have taken them in the last 14 days.

Do not give Vicks cough lozenges with honey to children under 12 years of age.

Take special care with Vicks Cough Lozenges with Honey

Talk to your doctor or pharmacist before taking this medicine if you:

have asthma you have ever had liver problems are diabetic or have difficulty digesting some sugars you have any long standing problems with your lungs Taking other medicines

Do not take Vicks Cough Lozenges with Honey if you are taking medicine
for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) or have done so in the last 14 days.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this product if you are pregnant or breast feeding.

Driving and using machines

If you feel dizzy, experience confusion or have symptoms of excitation (rapid pulse, hyperactivity or excessive sweating) do not drive or operate machinery.

Important information about some of the ingredients of Vicks Cough Lozenges with Honey:

Each lozenge contains 3.3g of sugar (as sucrose and glucose syrup). This should be taken into account if you are diabetic. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

How to take Vicks Cough Lozenges with Honey

Always use Vicks Cough Lozenges with Honey exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Adults and children over 12 years : 2 lozenges, sucked one after the other.

Repeat the dose every 6 hours if required. Do not take more than 8 lozenges in 24 hours.

Do not give this medicine to children under 12 years of age.

Do not exceed the recommended dose.

If symptoms persist, speak to your pharmacist or doctor.

If you take more Vicks Cough Lozenges with Honey than you should

Seek medical advice immediately if you accidentally take more lozenges than you should.

If you forget to take Vicks Cough Lozenges with Honey

If you accidentally miss a dose, do not take a double dose; just take the next dose as normal.

Possible side effects

Like all medicines, Vicks Cough Lozenges with Honey can cause side effects, although not everyone gets them.

These may include: Dizziness Excitation (rapid pulse, hyperactivity or excessive sweating). Mental confusion Stomach upsets

If any side effects you experience become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Vicks Cough Lozenges with Honey

Keep out of the reach and sight of children.

Store below 25°C. Store in original packaging.

Do not take Vicks Cough Lozenges with Honey after the expiry date which is printed on the carton.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Vicks Cough Lozenges with Honey contain:

Active ingredient: 7.33 mg Dextromethorphan base per lozenge. Other ingredients: Sucrose, glucose syrup, honey, levomenthol, honey flavour, caramel flavour.

This pack contains 12 lozenges in a blister foil.

Marketing Authorisation Holder Procter & Gamble (Health & Beauty Care) Limited Weybridge Surrey KT13 0XP UK

(send all enquiries to this address).

Manufacturer: Procter & Gamble Manufacturing GmbH Procter & Gamble Strasse 1 64521, Gross Gerau Germany

PL 0129/0129

Text Revised: 04/2009

98873922


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ElixSure Cough Gel Syrup


Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: ElixSure Cough
ElixSure Cough Gel Syrup is used for:

Temporarily relieving cough due to the common cold, hay fever, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

ElixSure Cough Gel Syrup is a cough suppressant. It works in the cough center of the brain to reduce a dry or nonproductive cough.

Do NOT use ElixSure Cough Gel Syrup if: you are allergic to any ingredient in ElixSure Cough Gel Syrup you are taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using ElixSure Cough Gel Syrup:

Some medical conditions may interact with ElixSure Cough Gel Syrup. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have chronic cough, chronic bronchitis, asthma, emphysema, chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with ElixSure Cough Gel Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of toxic side effects may be increased by ElixSure Cough Gel Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if ElixSure Cough Gel Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ElixSure Cough Gel Syrup:

Use ElixSure Cough Gel Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

ElixSure Cough Gel Syrup may be taken with or without food. Take with food if stomach upset occurs. Shake well before using. Use the teaspoon provided with ElixSure Cough Gel Syrup to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of ElixSure Cough Gel Syrup and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ElixSure Cough Gel Syrup.

Important safety information: ElixSure Cough Gel Syrup may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to ElixSure Cough Gel Syrup. Using ElixSure Cough Gel Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition. ElixSure Cough Gel Syrup contains dextromethorphan. Before you being taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your health care provider or pharmacist. Diabetes patients - Some brands of ElixSure Cough Gel Syrup may contain sugar and affect your blood sugar level. Read the label carefully before using ElixSure Cough Gel Syrup. ElixSure Cough Gel Syrup is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: It is unknown if ElixSure Cough Gel Syrup can cause harm to the fetus. If you become pregnant while taking ElixSure Cough Gel Syrup, discuss with your doctor the benefits and risks of using ElixSure Cough Gel Syrup during pregnancy. It is unknown if ElixSure Cough Gel Syrup is excreted in breast milk. Do not breast-feed while taking ElixSure Cough Gel Syrup. Possible side effects of ElixSure Cough Gel Syrup:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: ElixSure Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of ElixSure Cough Gel Syrup:

Store ElixSure Cough Gel Syrup between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep ElixSure Cough Gel Syrup out of the reach of children and away from pets.

General information: If you have any questions about ElixSure Cough Gel Syrup, please talk with your doctor, pharmacist, or other health care provider. ElixSure Cough Gel Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about ElixSure Cough Gel Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More ElixSure Cough resources ElixSure Cough Side Effects (in more detail) ElixSure Cough Use in Pregnancy & Breastfeeding ElixSure Cough Drug Interactions ElixSure Cough Support Group 0 Reviews for ElixSure Cough - Add your own review/rating Compare ElixSure Cough with other medications Cough


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Scot-Tussin Expectorant SF Cough


guaifenesin
Dosage Form: oral liquid
Scot-Tussin Expectorant SF Cough Active Ingredient: 

Each teaspoonful (5 ml) contains:

Guaifenesin 100mg

Purpose

Expectorant

Uses Helps loosen phlegm (mucus) to make coughs more productive thereby relieving chest congestion. Warnings Do not exceed recommended dosage.
*Phenylketonurics: Contains Phenylalanine. When using this product Do not exceed recommended dosage. Ask a doctor before use if you have a Cough that occurs with too much phlegm (mucus).
a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Stop use and ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding,

Do Not Use.

Keep out of reach of children.

In case of overdose get medical help or contact a Poison Control Center right away.

Directions: Follow Dosage Chart.
Do not exceed six doses in any 24 hour period. Adults 2-4 teaspoonfuls (10-20 ml)
every 4 hours Children 12 years
and older Consult a Doctor Children Under
12 years old DO NOT USE Other Information Store at 20? – 25? C (68? – 77? F). Inactive Ingredients

Aspartame* (see warning) Benzoic Acid, Citric Acid, Clear Grape Flavor, Glycerin, Hydroxypropylmethylcellulose, Menthol, Methyl-Paraben, Propyl-Paraben, Propylene Glycol, Purified Water, *Phenylketonurics: Contains Phenylalanine.

PRINCIPAL DISPLAY PANEL

NDC 0372-0006-04

SCOT-TUSSIN

EXPECTORANT

COUGH

For DIABETICS since 1956

SUGAR-FREE

LOOSENS &

RELIEVES

CHEST

CONGESTION

100%

SUGAR-FREE
HIGH BLOOD PRESSURE SAFE
LACTOSE-FREE
ALCOHOL-FREE
SODIUM-FREE
CLEAR
GLUTEN-FREE

Scot-Tussin

STRIVING FOR PERFECTION

4 FL OZ (118 ml)


Scot-Tussin Expectorant SF Cough 
guaifenesin  liquid Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0372-0006 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME   BENZOIC ACID   CITRIC ACID MONOHYDRATE   GLYCERIN   HYPROMELLOSE   MENTHOL   METHYLPARABEN   PROPYLPARABEN   PROPYLENE GLYCOL   WATER   Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0372-0006-04 118 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/1974
Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918) Revised: 04/2009SCOT-TUSSIN Pharmacal Co., Inc.
More Scot-Tussin Expectorant SF Cough resources Scot-Tussin Expectorant SF Cough Side Effects (in more detail) Scot-Tussin Expectorant SF Cough Dosage Scot-Tussin Expectorant SF Cough Use in Pregnancy & Breastfeeding Scot-Tussin Expectorant SF Cough Support Group 0 Reviews for Scot-Tussin Expectorant SF Cough - Add your own review/rating Compare Scot-Tussin Expectorant SF Cough with other medications Bronchitis Cough


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Sucrets 4-Hour Cough Drops Lozenges


Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: Examples include Hold and Sucrets 4-Hour Cough Drops
Sucrets 4-Hour Cough Drops Lozenges are used for:

Temporarily relieving cough due to the common cold, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

Sucrets 4-Hour Cough Drops Lozenges are a cough suppressant. It works by loosening mucus and lung secretions in the chest and making coughs more productive.

Do NOT use Sucrets 4-Hour Cough Drops Lozenges if: you are allergic to any ingredient in Sucrets 4-Hour Cough Drops Lozenges you are taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sucrets 4-Hour Cough Drops Lozenges:

Some medical conditions may interact with Sucrets 4-Hour Cough Drops Lozenges. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have chronic cough, chronic bronchitis or any breathing problems, such as asthma, emphysema, chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with Sucrets 4-Hour Cough Drops Lozenges. Tell your health care provider if you are taking any other medicines, especially any of the following:

Furazolidone or MAO inhibitors (eg, phenelzine ) because the risk of toxic side effects may be increased by Sucrets 4-Hour Cough Drops Lozenges

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sucrets 4-Hour Cough Drops Lozenges may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sucrets 4-Hour Cough Drops Lozenges:

Use Sucrets 4-Hour Cough Drops Lozenges as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sucrets 4-Hour Cough Drops Lozenges may be taken with or without food. Take with food if stomach upset occurs. Dissolve the medicine slowly in the mouth. Do not swallow whole. If you miss a dose of Sucrets 4-Hour Cough Drops Lozenges and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sucrets 4-Hour Cough Drops Lozenges.

Important safety information: Sucrets 4-Hour Cough Drops Lozenges may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sucrets 4-Hour Cough Drops Lozenges. Using Sucrets 4-Hour Cough Drops Lozenges alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition. Sucrets 4-Hour Cough Drops Lozenges contains dextromethorphan. Before you being taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your health care provider or pharmacist. Phenylketonuria patients - Sucrets 4-Hour Cough Drops Lozenges contains phenylalanine. Sucrets 4-Hour Cough Drops Lozenges are not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Sucrets 4-Hour Cough Drops Lozenges during pregnancy. It is unknown if Sucrets 4-Hour Cough Drops Lozenges are excreted in breast milk. Do not breast-feed while taking Sucrets 4-Hour Cough Drops Lozenges. Possible side effects of Sucrets 4-Hour Cough Drops Lozenges:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sucrets 4-Hour Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of Sucrets 4-Hour Cough Drops Lozenges:

Store Sucrets 4-Hour Cough Drops Lozenges between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep Sucrets 4-Hour Cough Drops Lozenges out of the reach of children and away from pets.

General information: If you have any questions about Sucrets 4-Hour Cough Drops Lozenges, please talk with your doctor, pharmacist, or other health care provider. Sucrets 4-Hour Cough Drops Lozenges are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sucrets 4-Hour Cough Drops Lozenges. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sucrets 4-Hour Cough Drops resources Sucrets 4-Hour Cough Drops Side Effects (in more detail) Sucrets 4-Hour Cough Drops Use in Pregnancy & Breastfeeding Sucrets 4-Hour Cough Drops Drug Interactions Sucrets 4-Hour Cough Drops Support Group 0 Reviews for Sucrets 4-Hour Cough - Add your own review/rating Compare Sucrets 4-Hour Cough Drops with other medications Cough


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PediaCare Long-Acting Cough Freezer Pops


Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: PediaCare Long-Acting Cough
PediaCare Long-Acting Cough Freezer Pops are used for:

Temporarily relieving cough due to the common cold, hay fever, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

PediaCare Long-Acting Cough Freezer Pops are a cough suppressant. It works in the cough center of the brain to reduce a dry or nonproductive cough.

Do NOT use PediaCare Long-Acting Cough Freezer Pops if: you are allergic to any ingredient in PediaCare Long-Acting Cough Freezer Pops you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using PediaCare Long-Acting Cough Freezer Pops:

Some medical conditions may interact with PediaCare Long-Acting Cough Freezer Pops. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of chronic cough, asthma, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with PediaCare Long-Acting Cough Freezer Pops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of serious side effects, such as severe low blood pressure, fever, severe muscle problems, and possibly death, may be increased by PediaCare Long-Acting Cough Freezer Pops

This may not be a complete list of all interactions that may occur. Ask your health care provider if PediaCare Long-Acting Cough Freezer Pops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use PediaCare Long-Acting Cough Freezer Pops:

Use PediaCare Long-Acting Cough Freezer Pops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

PediaCare Long-Acting Cough Freezer Pops may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation. To use, cut off the top of the freezer pop sleeve and push freezer pop up from the bottom. PediaCare Long-Acting Cough Freezer Pops may be eaten frozen or the contents of 1 unfrozen sleeve may be poured into a cup or glass to drink. Immediately throw away any unused portion of the opened medicine. If you miss a dose of PediaCare Long-Acting Cough Freezer Pops and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PediaCare Long-Acting Cough Freezer Pops.

Important safety information: PediaCare Long-Acting Cough Freezer Pops may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to PediaCare Long-Acting Cough Freezer Pops. Using PediaCare Long-Acting Cough Freezer Pops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your doctor. A persistent cough could be a sign of a serious condition. PediaCare Long-Acting Cough Freezer Pops contains dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your doctor or pharmacist. Diabetes patients - Some brands of PediaCare Long-Acting Cough Freezer Pops may contain sugar and affect your blood sugar level. Read the label carefully before using PediaCare Long-Acting Cough Freezer Pops. PediaCare Long-Acting Cough Freezer Pops are not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: It is unknown if PediaCare Long-Acting Cough Freezer Pops can cause harm to the fetus. If you become pregnant while taking PediaCare Long-Acting Cough Freezer Pops, discuss with your doctor the benefits and risks of using PediaCare Long-Acting Cough Freezer Pops during pregnancy. It is unknown if PediaCare Long-Acting Cough Freezer Pops are excreted in breast milk. Do not breast-feed while taking PediaCare Long-Acting Cough Freezer Pops. Possible side effects of PediaCare Long-Acting Cough Freezer Pops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: PediaCare Long-Acting Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of PediaCare Long-Acting Cough Freezer Pops:

Store PediaCare Long-Acting Cough Freezer Pops at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PediaCare Long-Acting Cough Freezer Pops out of the reach of children and away from pets.

General information: If you have any questions about PediaCare Long-Acting Cough Freezer Pops, please talk with your doctor, pharmacist, or other health care provider. PediaCare Long-Acting Cough Freezer Pops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about PediaCare Long-Acting Cough Freezer Pops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More PediaCare Long-Acting Cough resources PediaCare Long-Acting Cough Side Effects (in more detail) PediaCare Long-Acting Cough Use in Pregnancy & Breastfeeding PediaCare Long-Acting Cough Drug Interactions 0 Reviews for PediaCare Long-Acting Cough - Add your own review/rating Compare PediaCare Long-Acting Cough with other medications Cough


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Covonia Chesty Cough Mixture Mentholated


1. Name Of The Medicinal Product

Covonia Chesty Cough Mixture Mentholated

2. Qualitative And Quantitative Composition

Levomenthol

4.0mg/5ml

Squill Tincture

0.6ml/5ml

Liquorice Liquid Extract

0.125ml/5ml

For excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

A brown, viscous, opaque liquid

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of productive (chesty) coughs and sore throats.

4.2 Posology And Method Of Administration

Oral.

Recommended Doses

Adults, the elderly and children over 12 years: One or two 5ml spoonfuls.

Children 5-12 years: One 5ml spoonful.

Dosage Schedule

The dose to be taken every four hours if required.

4.3 Contraindications

Contraindicated in patients with known hypersensitivity to any of the ingredients. Also Contraindicated in patients with cardiac disorders.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen consult your doctor.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine as it contains sucrose and glucose.

This medicine contains up to 600mg ethanol per 10ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy.

May cause allergic reactions, possibly delayed as this medicine contains sodium methyl, ethyl and propyl hydroxybenzoates (E219, E215 and E217)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Toxicity of squill glycosides may be increased when given in combination with thiazides or loop diuretics, as these may cause hypokalaemia and hypomagnesaemia, which may lead to cardiac arrhythmias.

When used with carbenoxolone it may produce sodium and water retention and hypokalaemia. and may give rise to greater toxicity of squill.

4.6 Pregnancy And Lactation

There are no adverse reports when used in recommended doses.

However, as with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

No adverse effects have been reported with this product, however, a few cases of hypersensitivity reactions to menthol have been reported. These include generalised urticaria and flushing, menthol may give rise to contact dermatitis.

Liquorice may cause sodium and water retention, and hypokalaemia.

4.9 Overdose

Ingestion of large doses of the active ingredients has been reported to cause the following effects: Gastrointestinal disturbances such as abdominal pain, nausea, vomiting and diarrhoea would be expected to occur with the menthol and squill.

Common symptoms of digoxin overdosage include headache, facial pain, fatigue, weakness, dizziness, drowsiness, disorientation, mental confusion, bad dreams and more rarely delirium, acute psychoses, and hallucinations. Convulsions have been reported. Visual disturbances including blurred vision may occur. Colour vision may be affected with objects appearing yellow or less frequently green, red, brown, blue or white.

Adverse effects on the heart may result from the cardiac glycosides in squill. Toxic doses may cause or aggravate heart failure. Supraventricular or ventricular arrhythmias and defects of conduction are common and may be an early indication of excessive dosage.

In addition CNS effects such as vertigo, ataxia and drowsiness have been reported after ingestion of large quantities of menthol; reported adverse effects following excessive ingestion of liquorice include hypertension, congestive heart failure, cardiac arrest, headache, muscle weakness, myopathy, myoglobinuria, paralysis, hyperprolactinaemia and amenorrhoea.

In the unlikely event of overdosage with this preparation, gastric lavage and / or symptomatic treatment together with supportive measures should be employed. Treatment of acute digoxin poisoning consists of emptying the stomach by emesis or lavage. Activated charcoal may be given. Cardiac toxicity should be treated under ECG control and serum electrolytes should be monitored. Anti-arrhythmic treatment may be necessary and should be determined by the specific arrhythmia present. Atropine may be given intravenously to control bradycardia and in patients with heart block; cardiac pacing may be necessary if atropine is not effective. Colestyramine or colestipol may be of use in increasing the elimination of cardiac glycosides.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

R05C – Cough and cold preparations, expectorants, excl. combinations with cough suppressants

Menthol dilates the blood vessels causing a sensation of coldness followed by analgesic effect. It is used to relieve the symptoms of bronchitis, sinusitis and similar conditions.

Squill has an irritant effect on the gastric mucosa, it has a reflex expectorant action.

Liquorice is a demulcent and mild expectorant.

5.2 Pharmacokinetic Properties

After absorption menthol is excreted in the bile and urine as a glucuronide.

Squill glycosides are poorly absorbed from the gastro-intestinal tract, they are of short acting duration and are not cumulative, they are excreted in the urine and faeces.

No information is available on the pharmacokinetics of liquorice.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Peppermint oil, anise oil, capsicum tincture capsicum oleoresin, ethanol), sucrose, liquid glucose, magnesium aluminium silicate, sodium nipasept (E215, E217, E219), glycerol (E422), caramel (E150) and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

50ml : 36 months unopened.

150ml: 36 months unopened.

180ml: 36 months unopened.

200ml: 36 months unopened.

300ml: 36 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

50ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.

150ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.

180ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.

200ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.

300ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0047

9. Date Of First Authorisation/Renewal Of The Authorisation

12/09/2007

10. Date Of Revision Of The Text

15/02/2011


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Thioguanine Tabloid


Generic Name: Thioguanine
Class: Antineoplastic Agents
VA Class: AN300
CAS Number: 154-42-7

Introduction

Antineoplastic agent; antimetabolite, synthetic purine antagonist.103 b

Uses for Thioguanine Tabloid Acute Myeloid Leukemia (AML)

Remission induction (in combination with other antineoplastic agents) in acute myeloid (myelogenous, nonlymphocytic) leukemia (AML, ANLL).103 104 115 116

Has been used with other antineoplastic agents in regimens of consolidation therapy for AML following induction of a complete remission; optimal regimen of such therapy in prolonging remissions remains to be established but is typically administered short-term.115 b

Not recommended for maintenance or long-term continuous therapy.103 (See Hepatic Effects under Cautions.)

Thioguanine Tabloid Dosage and Administration General

Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.103 b

Individualize dosage according to clinical and hematologic response and tolerance of the patient.103

Administration Oral Administration

Calculate total daily dose to the nearest multiple of 20 mg and administer orally once daily.b

Dosage

Consult currently published protocols for dosages used in combination regimens and method and sequence of administration.103

Dosage reduction may be necessary if used concomitantly with other myelosuppressive agents.103 (See Specific Drugs under Interactions.)

When initiating thioguanine therapy, patients with inherited deficiency of thiopurine S-methyl transferase (TPMT) activity are at increased risk of life-threatening myelotoxicity; substantial dosage reduction may be required.103 (See Hematologic Effects under Cautions.)

Pediatric Patients Acute Myeloid Leukemia Induction and Consolidation Therapy Oral

If monotherapy is appropriate, initially, approximately 2 mg/kg daily.103 If there is no clinical improvement and no leukocyte or platelet count depression after 4 weeks on initial dosage, dosage may be cautiously increased to 3 mg/kg daily.103

Thioguanine should not be part of maintenance therapy.103 (See Hepatic Effects under Cautions.)

Adults Acute Myeloid Leukemia Induction and Consolidation Therapy Oral

If monotherapy is appropriate, initially, approximately 2 mg/kg daily.103 If there is no clinical improvement and no leukocyte or platelet count depression after 4 weeks on initial dosage, dosage may be cautiously increased to 3 mg/kg daily.103

Thioguanine should not be part of maintenance therapy.103 (See Hepatic Effects under Cautions.)

Special Populations Hepatic Impairment

Consider dosage reduction; however, no specific dosage recommendations at this time.103 (See Hepatic Effects under Cautions.)

Renal Impairment

Consider dosage reduction; however, no specific dosage recommendations at this time.103

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.103

Cautions for Thioguanine Tabloid Contraindications

If a diagnosis of AML has not been adequately established and there is no responsible clinician knowledgeable in assessing response to chemotherapy.103

Patients whose disease was resistant to prior therapy with the drug.103 Consider that there is complete cross-resistance between thioguanine and mercaptopurine.103

Warnings/Precautions Warnings Toxicity

Highly toxic; low therapeutic index; therapeutic response is unlikely without some evidence of toxicity.b Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy.103 b

Hepatic Effects

Risk of hepatotoxicity associated with vascular endothelial damage; usually manifested as hepatic veno-occlusive disease (e.g., hyperbilirubinemia, hepatomegaly, ascites) or portal hypertension (e.g., splenomegaly, thrombocytopenia out of proportion with neutropenia, esophageal varices).103

Possible jaundice and increases in serum aminotransferases (AST, ALT), alkaline phosphatase, and ? glutamyl transferase concentrations.103 Hepatoportal sclerosis, nodular regenerative hyperplasia, peliosis hepatitis, and periportal fibrosis reported.103

Discontinue immediately if evidence of hepatotoxicity (e.g., jaundice) occurs; signs and symptoms generally reversible after discontinuance of the drug.103

Hepatic function must be carefully monitored.103 Serum transaminase, alkaline phosphatase, and bilirubin concentrations should be determined weekly during initiation of therapy and monthly thereafter.103 More frequent testing in patients with preexisting liver disease and in those receiving other hepatotoxic drugs.103

Hematologic Effects

Risk of myelosuppression (manifested as anemia, leukopenia, and/or thrombocytopenia); usually dose related.103 Hematologic status must be carefully monitored.103

Discontinue temporarily at the first sign of an abnormally large or rapid decrease in leukocytes, platelets, or hemoglobin concentration or abnormal depression of bone marrow, unless induction of bone marrow hypoplasia is desired.103 b Bone marrow examination (aspiration and/or biopsy) may be helpful in distinguishing between progression of leukemia, resistance to therapy, and marrow hypoplasia induced by therapy.103 b

Perform CBC, including platelet count and leukocyte differential, at least once weekly during therapy; more frequent blood counts may be required, particularly during remission induction therapy and with concomitant therapy with other antineoplastic agents.103 b

When initiating thioguanine therapy, patients with inherited deficiency of thiopurine S-methyl transferase (TPMT) activity are at increased risk for life-threatening myelotoxicity; substantial dosage reduction may be required.103 Concomitant use with drugs that inhibit TPMT (e.g., olsalazine, mesalamine, sulfasalazine) may exacerbate such toxicity.103 Consider testing for TPMT deficiency prior to initiating therapy.103

Infectious Complications and Hemorrhagic Complications

Life-threatening infections due to granulocytopenia may occur.103 Anti-infectives or granulocyte transfusions may be needed.103

Bleeding due to thrombocytopenia may occur.103 Platelet transfusions may be needed.103

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity demonstrated in animals.103

Avoid pregnancy during therapy.103 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.103

Major Toxicities GI Effects

Possible nausea, vomiting, anorexia, and stomatitis.103

General Precautions Hyperuricemia

Hyperuricemia occurs frequently because of extensive purine catabolism accompanying rapid cellular destruction.103 Hyperuricemia may be minimized or prevented by adequate hydration, alkalinization of urine, and/or administration of allopurinol.103

Immunization

Effects of thioguanine on immunocompetence are unknown.103 Avoid live virus vaccines in immunocompromised patients.103

Specific Populations Pregnancy

Category D.103 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether thioguanine is distributed into milk.103 Discontinue nursing or the drug.103

Geriatric Use

Clinical studies did not include sufficient numbers of patients ?65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.103

Common Adverse Effects

Myelosuppression, hyperuricemia, hepatotoxicity.103

Interactions for Thioguanine Tabloid Specific Drugs

Drug

Interaction

Comments

Allopurinol

Pharmacokinetic interactions not expected103

Dosage adjustments not required103

Aminosalicylates (e.g., olsalazine, mesalamine, sulfasalazine)

Potential pharmacokinetic interaction; increased risk of thioguanine myelotoxicity103 (see Hematologic Effects under Cautions)

Use concomitantly with caution103

Myelosuppressive agents

Possible additive myelosuppressive effects103

Reduced thioguanine dosage may be necessary with concomitant therapy103

Thioguanine Tabloid Pharmacokinetics Absorption Bioavailability

Absorption from GI tract is variable and incomplete; approximately 30% of an oral dose may be absorbed.103

Distribution Extent

Incorporated into the DNA and RNA of bone marrow cells.103

Does not reach therapeutic concentrations in the CSF.103

Thioguanine crosses the placenta; not known whether distributed into milk.103

Elimination Metabolism

Rapidly and extensively metabolized in the liver and other tissues, principally to the less toxic and less active methylated derivative 2-amino-6-methylthiopurine.103

Elimination Route

Excreted principally in urine as metabolites.103 b

Half-life

Biphasic; terminal half-life averages 11 hours.b

Stability Storage Oral Tablets

15–25°C.103

ActionsActions

Converted intracellularly to ribonucleotides that result in a sequential blockade of the synthesis and utilization of purine and guanine nucleotides.103 b

Thioguanine ribonucleotides incorporate into DNA and RNA; cytotoxic effects may be related primarily to substitution of ribonucleotides into DNA.103 b

Usually complete cross-resistance between thioguanine and mercaptopurine.103 b

Advice to Patients

Advise patients that the major toxicities of the drug are related to myelosuppression, hepatotoxicity, and GI toxicity.103

Importance of taking the drug only under medical supervision.103

Importance of patients informing their clinicians if fever, sore throat, jaundice, nausea, vomiting, signs of local infection, bleeding from any site, or symptoms suggestive of anemia occur.103

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to the fetus.103

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Thioguanine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

40 mg

Thioguanine Tabloid (scored)

GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Tabloid 40MG Tablets (GLAXO SMITH KLINE): 25/$235.91 or 50/$466.57

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Griner PF, Elbadawi A, Packman CH. Veno-occlusive disease of the liver after chemotherapy of acute leukemia. Ann Intern Med. 1976; 85:578-82. [IDIS 65468] [PubMed 1068643]

101. Gill RA, Onstad GR, Cardamone JM et al. Hepatic veno-occlusive disease caused by 6-thioguanine. Ann Intern Med. 1982; 96:58-60. [IDIS 142618] [PubMed 7053705]

102. Krivoy N, Raz R, Carter A et al. Reversible hepatic veno-occlusive disease and 6-thioguanine. Ann Intern Med. 1982; 96:788. [IDIS 152653] [PubMed 7091946]

103. GlaxoSmithKline. Tabloid brand thioguanine 40-mg scored tablets prescribing information. Research Triangle Park, NC; 2004 Dec.

104. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 Aug 22.

105. Thiersch JB. Effect of 2-6 diaminopurine (2-6 DP): 6 chlorpurine (CIP) and thioguanine (ThG) on rat litter in utero. Proc Soc Exp Biol Med. 1957; 94:40-3. [PubMed 13400865]

107. Key NS, Kelly PMA, Emerson PM et al. Oesophageal varices associated with busulphan-thioguanine combination therapy for chronic myeloid leukaemia. Lancet. 1987; 2:1050-2. [IDIS 235711] [PubMed 2889964]

109. Shepherd PC, Fooks J, Gray R et al. Thioguanine used in maintenance therapy of chronic myeloid leukaemia causes non-cirrhotic portal hypertension. Br J Haematol. 1991; 79:185-92. [PubMed 1958475]

110. McCauley DL. Treatment of adult acute leukemia. Clin Pharm. 1992; 11:767-96. [IDIS 300402] [PubMed 1521402]

111. Arlin Z, Case DC Jr, Moore J et al. Randomized multicenter trial of cytosine arabinoside with mitoxantrone or daunorubicin in previously untreated adult patients with acute nonlymphocytic leukemia (ANLL). Leukemia. 1990; 4:177-83. [PubMed 2179638]

112. Feldman EJ. Acute myelogenous leukemia in the older patient. Semin Oncol. 1995; 22(Suppl 1):21-4. [PubMed 7532322]

113. Pavlovsky S, Gonzalez Llaven J, Garcia Martinez MA et al. A randomized study of mitoxantrone plus cytarabine versus daunomycin plus cytarabine in the treatment of previously untreated adult patients with acute nonlymphocytic leukemia. Ann Hematol. 1994; 69:11-5. [PubMed 8061102]

114. Wahlin A, Hornsten P, Hedenus M et al. Mitoxantrone and cytarabine versus daunorubicin and cytarabine in previously untreated patients with acute myeloid leukemia. Cancer Chemother Pharmacol. 1991; 28:480-3. [PubMed 1934252]

115. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 Jul 17.

116. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.

b. AHFS drug information 2008. McEvoy GK, ed. Thioguanine. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2008:1232-3.

More Thioguanine Tabloid resources Thioguanine Tabloid Side Effects (in more detail) Thioguanine Tabloid Use in Pregnancy & Breastfeeding Drug Images Thioguanine Tabloid Drug Interactions Thioguanine Tabloid Support Group 0 Reviews for Thioguanine Tabloid - Add your own review/rating Compare Thioguanine Tabloid with other medications Acute Nonlymphocytic Leukemia


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Little Colds Decongestant/Cough Drops


Pronunciation: DEX-troe-meth-OR-fan/FEN-il-EF-rin
Generic Name: Dextromethorphan/Phenylephrine
Brand Name: Examples include Albatussin Pediatric Drops and Little Colds Decongestant/Cough
Little Colds Decongestant/Cough Drops are used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Little Colds Decongestant/Cough Drops are a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you to breathe more easily. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Little Colds Decongestant/Cough Drops if: you are allergic to any ingredient in Little Colds Decongestant/Cough Drops you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease) you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Little Colds Decongestant/Cough Drops:

Some medical conditions may interact with Little Colds Decongestant/Cough Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke if you have a history of chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Little Colds Decongestant/Cough Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Little Colds Decongestant/Cough Drops's side effects Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased Bromocriptine because the risk of its side effects may be increased by Little Colds Decongestant/Cough Drops Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Little Colds Decongestant/Cough Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Little Colds Decongestant/Cough Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Little Colds Decongestant/Cough Drops:

Use Little Colds Decongestant/Cough Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Little Colds Decongestant/Cough Drops by mouth with or without food. Use the dropper that comes with Little Colds Decongestant/Cough Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Little Colds Decongestant/Cough Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Little Colds Decongestant/Cough Drops.

Important safety information: Little Colds Decongestant/Cough Drops may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Little Colds Decongestant/Cough Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not take appetite suppressants while you are taking Little Colds Decongestant/Cough Drops without checking with your doctor. Little Colds Decongestant/Cough Drops has dextromethorphan and phenylephrine in it. Before you start any new medicine, check the label to see if it has dextromethorphan or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor. Little Colds Decongestant/Cough Drops may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Little Colds Decongestant/Cough Drops. Tell your doctor or dentist that you take Little Colds Decongestant/Cough Drops before you receive any medical or dental care, emergency care, or surgery. Use Little Colds Decongestant/Cough Drops with caution in the ELDERLY; they may be more sensitive to its effects. Caution is advised when using Little Colds Decongestant/Cough Drops in CHILDREN; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Little Colds Decongestant/Cough Drops while you are pregnant. It is not known if Little Colds Decongestant/Cough Drops are found in breast milk. If you are or will be breast-feeding while you use Little Colds Decongestant/Cough Drops, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Little Colds Decongestant/Cough Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Little Colds Decongestant/Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Little Colds Decongestant/Cough Drops:

Store Little Colds Decongestant/Cough Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Little Colds Decongestant/Cough Drops out of the reach of children and away from pets.

General information: If you have any questions about Little Colds Decongestant/Cough Drops, please talk with your doctor, pharmacist, or other health care provider. Little Colds Decongestant/Cough Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Little Colds Decongestant/Cough Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Little Colds Decongestant/Cough resources Little Colds Decongestant/Cough Side Effects (in more detail) Little Colds Decongestant/Cough Use in Pregnancy & Breastfeeding Little Colds Decongestant/Cough Drug Interactions 0 Reviews for Little Colds Decongestant/Cough - Add your own review/rating Compare Little Colds Decongestant/Cough with other medications Cough and Nasal Congestion


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Beechams Cold and Flu Hot Blackcurrant


1. Name Of The Medicinal Product

Beechams Cold & Flu Hot Blackcurrant

2. Qualitative And Quantitative Composition

Active Constituents

mg / 6 g powder

Paracetamol

600.00

Ascorbic Acid

40.00

Phenylephrine Hydrochloride

10.00

3. Pharmaceutical Form

Powder

4. Clinical Particulars 4.1 Therapeutic Indications

The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.

4.2 Posology And Method Of Administration

Directions for use

Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.

Do not take continuously for more than 7 days without medical advice.

Not to be given to children under 12 years of age except on medical advice

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Closed angle glaucomaHypertensive patients or those taking or have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5).

Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Medical advice should be sought before taking this product in patients with these conditions:

• An enlargement of the prostate gland

• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing or other cold, flu or decongestant products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Special label warnings

Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported

Monoamine oxidase inhibitors

(including moclobemide)

Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).

Sympathomimetic amines

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)

Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.

Tricyclic antidepressants (e.g. amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine.

Ergot alkaloids

(ergotamine and methylsergide) increased risk of ergotism

Digoxin and cardiac glycosides

Increase the risk of irregular heartbeat or heart attack

4.6 Pregnancy And Lactation

Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable Effects

Paracetamol

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

These are not necessarily causally related to paracetamol

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bromchospasm *

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System

Undesirable effect

Psychiatric disorders

Nervousness, irritability, restlessness, and excitability

Nervous system disorders

Headache, dizziness, insomnia

Cardiac disorders

Increased blood pressure

Gastrointestinal disorders

Nausea, Vomiting

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Eye disorders

Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma

Cardiac disorders

Tachycardia, palpitations

Skin and subcutaneous disorders

Allergic reactions (e.g. rash, urticaria, allergic dermatitis).

Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics

Renal and urinary disorders

Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under advserse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Ascorbic acid

Symptoms and signs

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol: Provides the analgesic and antipyretic actions.

Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.

Ascorbic Acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.

5.2 Pharmacokinetic Properties

Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Ascorbic Acid - Is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sucrose Ph Eur, Sodium citrate Ph Eur, Citric acid Ph Eur, Sodium cyclamate NF, Saccharin sodium BP, Blackcurrant Juice, Blackcurrant Polvaromas, Blackcurrant Flavour, Natural Grapeskin (E163).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9GS

U.K.

8. Marketing Authorisation Number(S)

PL 00079/0282

9. Date Of First Authorisation/Renewal Of The Authorisation

21.11.91 / 10.11.97

10. Date Of Revision Of The Text

June 2010.


More




Beechams Flu-Plus Hot Berry Fruits


1. Name Of The Medicinal Product

Beechams Flu-Plus Hot Berry Fruits

2. Qualitative And Quantitative Composition

Active Constituents

mg / 6.427 g powder

Paracetamol

1000

Ascorbic Acid

70

Phenylephrine Hydrochloride

10

3. Pharmaceutical Form

Powder

4. Clinical Particulars 4.1 Therapeutic Indications

Short term symptomatic relief of symptoms of influenza, feverishness, chills and colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.

4.2 Posology And Method Of Administration

Directions for use

Empty contents of sachet into a beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

The contents of one sachet to be taken every four to six hours as necessary, up to a maximum of four sachets in any 24 hours.

The product should not be used continuously for more than seven days without medical advice.

Not to be given to children under 12 years of age, except on medical advice.

4.3 Contraindications

Known hypersensitivity to paracetamol or any of the other constituents.

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Closed angle glaucoma

Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease. Patients taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken within the last two weeks, monoamine oxidase inhibitors (see section 4.5).

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Medical advice should be sought before taking this product in patients with these conditions:

• An enlargement of the prostate gland

• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)

• Cardiovascular disease

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Do not exceed the stated dose.

Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.

Keep out of the reach and sight of children.

If symptoms persist consult your doctor.

Consult your doctor if you are taking warfarin.

Special label warnings

Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported

Monoamine oxidase inhibitors

(including moclobemide)

Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).

Sympathomimetic amines

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)

Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.

Tricyclic antidepressants (e.g. amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine.

Ergot alkaloids

(ergotamine and methylsergide) increased risk of ergotism

Digoxin and cardiac glycosides

Increase the risk of irregular heartbeat or heart attack

4.6 Pregnancy And Lactation

Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable Effects

Paracetamol

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

These are not necessarily casually related to paracetamol.

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bromchospasm*

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System

Undesirable effect

Psychiatric disorders

Nervousness, irritability, restlessness, and excitability

Nervous system disorders

Headache, dizziness, insomnia

Cardiac disorders

Increased blood pressure

Gastrointestinal disorders

Nausea, Vomiting, diarrhoea

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Eye disorders

Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma

Cardiac disorders

Tachycardia, palpitations

Skin and subcutaneous disorders

Allergic reactions (e.g. rash, urticaria, allergic dermatitis).

Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics

Renal and urinary disorders

Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

or

b) Regularly consumes ethanol in excess of recommended amounts.

or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Ascorbic acid

Symptoms and signs

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol: An analgesic and antipyretic.

Ascorbic acid: a common ingredient of cold and influenza combination products included to compensate for Vitamin C losses which may occur in the initial stages of acute viral infections.

Phenylephrine hydrochloride: a sympathomimetic decongestant.

The active ingredients are not known to cause sedation.

5.2 Pharmacokinetic Properties

Paracetamol: is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucoronide and sulphate conjugates.

Ascorbic Acid: is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic Acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine Hydrochloride: is readily absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tartaric acid, Sodium citrate, Aspartame (E951), Euroblend blackcurrant, Berry fruit flavourburst, Sucrose and colours carmoisine (E122) and sunset yellow (E110) , green S (E142) with sodium chloride and sodium sulphate.

6.2 Incompatibilities

None known

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

The product is packed in laminate sachets comprising paper/polythene/aluminium foil/polythene. Five or ten sachets may be contained in a box board carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0336

9. Date Of First Authorisation/Renewal Of The Authorisation

July 1996

10. Date Of Revision Of The Text

June 2010


More




Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour Powder for Oral Solution


1. Name Of The Medicinal Product

Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour powder for oral solution

2. Qualitative And Quantitative Composition

Active Constituents

mg / 6 g powder

Paracetamol

600.00

Phenylephrine Hydrochloride

10.00

Excipients

 

Vitamin C (Ascorbic Acid)

40.00

Sucrose

3802

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for Oral Solution.

Off-white to beige, free-flowing, heterogeneous powder with an odour of honey, lemon and menthol.

4. Clinical Particulars 4.1 Therapeutic Indications

The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.

4.2 Posology And Method Of Administration

Directions for use

Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.

Do not take continuously for more than 7 days without medical advice.

Not to be given to children under 12 years of age except on medical advice.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Concomitant use of other sympathomimetic decongestants.

Phaeochromocytoma.

Closed angle glaucoma.

Hypertensive patients or those taking of have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5). Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Medical advice should be sought before taking this product in patients with these conditions:

• An enlargement of the prostate gland

• Occlusive Vascular disease (e.g. Raynaud's Phenomenon)

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing or any other cold, flu or decongestant products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Special label warnings

Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.

Monoamine oxidase inhibitors (including moclobemide)

Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).

Sympathomimetic amines

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)

Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.

Tricyclic antidepressants (e.g. amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine.

Ergot alkaloids

(ergotamine and methylsergide) increased risk of ergotism

Digoxin and cardiac glycosides

Increase the risk of irregular heartbeat or heart attack

4.6 Pregnancy And Lactation

Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable Effects

Paracetamol

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

These are not necessarily causally related to paracetamol

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/ toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bromchospasm*

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System

Undesirable effect

Psychiatric disorders

Nervousness, irritability, restlessness, and excitability

Nervous system disorders

Headache, dizziness, insomnia

Cardiac disorders

Increased blood pressure

Gastrointestinal disorders

Nausea, Vomiting.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Eye disorders

Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma

Cardiac disorders

Tachycardia, palpitations

Skin and subcutaneous disorders

Allergic reactions (e.g. rash, urticaria, allergic dermatitis).

Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics

Renal and urinary disorders

Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors:

If the patient

a. Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

OR

b. Regularly consumes ethanol in excess of recommended amounts.

OR

c. Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management:

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine Hydrochloride

Symptoms and signs:

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Ascorbic Acid

Symptoms and signs

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol provides the analgesic and antipyretic actions.

Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.

Ascorbic Acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.

5.2 Pharmacokinetic Properties

Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Ascorbic Acid - Is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ascorbic acid, Sucrose, Sodium citrate, Citric acid, Maize starch, Menthol, Honey flavour, Honey Flav-o-lok, Lemon flavour, Caramel SCS (E 150), aspartame, saccharin sodium.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9GS

U.K.

8. Marketing Authorisation Number(S)

PL 00079/0674

9. Date Of First Authorisation/Renewal Of The Authorisation

29/07/2011

10. Date Of Revision Of The Text

29/07/2011


More




Tylenol Infants Plus Cold/Cough Drops


Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Pseudoephedrine
Brand Name: Tylenol Infants Plus Cold/Cough
Tylenol Infants Plus Cold/Cough Drops are used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tylenol Infants Plus Cold/Cough Drops are an analgesic, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex.

Do NOT use Tylenol Infants Plus Cold/Cough Drops if: you are allergic to any ingredient in Tylenol Infants Plus Cold/Cough Drops you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease) you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Infants Plus Cold/Cough Drops:

Some medical conditions may interact with Tylenol Infants Plus Cold/Cough Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Tylenol Infants Plus Cold/Cough Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Tylenol Infants Plus Cold/Cough Drops may be increased Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased Bromocriptine because the risk of side effects may be increased by Tylenol Infants Plus Cold/Cough Drops Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Tylenol Infants Plus Cold/Cough Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Infants Plus Cold/Cough Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Infants Plus Cold/Cough Drops:

Use Tylenol Infants Plus Cold/Cough Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tylenol Infants Plus Cold/Cough Drops may be taken with or without food. Use the dropper that comes with Tylenol Infants Plus Cold/Cough Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Tylenol Infants Plus Cold/Cough Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Infants Plus Cold/Cough Drops.

Important safety information: Tylenol Infants Plus Cold/Cough Drops may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol Infants Plus Cold/Cough Drops. Using Tylenol Infants Plus Cold/Cough Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Do not take appetite suppressants while you are taking Tylenol Infants Plus Cold/Cough Drops without checking with your doctor. Tylenol Infants Plus Cold/Cough Drops contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist. Do NOT exceed the recommended dose or take Tylenol Infants Plus Cold/Cough Drops for longer than prescribed without checking with your doctor. If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor. Tylenol Infants Plus Cold/Cough Drops may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol Infants Plus Cold/Cough Drops or other pain relievers/fever reducers. Alcohol use combined with Tylenol Infants Plus Cold/Cough Drops may increase your risk for liver damage. Tylenol Infants Plus Cold/Cough Drops may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Tylenol Infants Plus Cold/Cough Drops. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol Infants Plus Cold/Cough Drops. Use Tylenol Infants Plus Cold/Cough Drops with caution in the ELDERLY because they may be more sensitive to its effects. Caution is advised when using Tylenol Infants Plus Cold/Cough Drops in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol Infants Plus Cold/Cough Drops, discuss with your doctor the benefits and risks of using Tylenol Infants Plus Cold/Cough Drops during pregnancy. It is unknown if Tylenol Infants Plus Cold/Cough Drops are excreted in breast milk. Do not breast-feed while taking Tylenol Infants Plus Cold/Cough Drops. Possible side effects of Tylenol Infants Plus Cold/Cough Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tylenol Infants Plus Cold/Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Tylenol Infants Plus Cold/Cough Drops:

Store Tylenol Infants Plus Cold/Cough Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Infants Plus Cold/Cough Drops out of the reach of children and away from pets.

General information: If you have any questions about Tylenol Infants Plus Cold/Cough Drops, please talk with your doctor, pharmacist, or other health care provider. Tylenol Infants Plus Cold/Cough Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tylenol Infants Plus Cold/Cough Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tylenol Infants Plus Cold/Cough resources Tylenol Infants Plus Cold/Cough Side Effects (in more detail) Tylenol Infants Plus Cold/Cough Use in Pregnancy & Breastfeeding Tylenol Infants Plus Cold/Cough Drug Interactions Tylenol Infants Plus Cold/Cough Support Group 1 Review for Tylenol Infants Plus Cold/Cough - Add your own review/rating Compare Tylenol Infants Plus Cold/Cough with other medications Cold Symptoms


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Comtrex Cold and Cough Maximum Strength


Pronunciation: a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/FEN-il-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Phenylephrine
Brand Name: Examples include Comtrex Cold and Cough Maximum Strength and Vicks DayQuil Multi-Symptom Cold/Flu Relief
Comtrex Cold and Cough Maximum Strength is used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Comtrex Cold and Cough Maximum Strength is an analgesic, cough suppressant, and decongestant combination. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily.

Do NOT use Comtrex Cold and Cough Maximum Strength if: you are allergic to any ingredient in Comtrex Cold and Cough Maximum Strength you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease) you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Comtrex Cold and Cough Maximum Strength:

Some medical conditions may interact with Comtrex Cold and Cough Maximum Strength. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, liver problems (eg, hepatitis), or severe kidney problems, or if you drink more than 3 alcohol-containing drinks per day if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Comtrex Cold and Cough Maximum Strength. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Comtrex Cold and Cough Maximum Strength's side effects. Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects, such as bleeding, irregular heartbeat, or heart attack, may be increased Bromocriptine because the risk of its side effects may be increased by Comtrex Cold and Cough Maximum Strength Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Comtrex Cold and Cough Maximum Strength

This may not be a complete list of all interactions that may occur. Ask your health care provider if Comtrex Cold and Cough Maximum Strength may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Comtrex Cold and Cough Maximum Strength:

Use Comtrex Cold and Cough Maximum Strength as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Comtrex Cold and Cough Maximum Strength by mouth with or without food. If you miss a dose of Comtrex Cold and Cough Maximum Strength, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Comtrex Cold and Cough Maximum Strength.

Important safety information: Comtrex Cold and Cough Maximum Strength may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Comtrex Cold and Cough Maximum Strength with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not take diet or appetite control medicines while you are taking Comtrex Cold and Cough Maximum Strength without checking with your doctor. Comtrex Cold and Cough Maximum Strength has acetaminophen, dextromethorphan, and phenylephrine in it. Before you start any new medicine, check the label to see if it has acetaminophen, dextromethorphan, or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do not use Comtrex Cold and Cough Maximum Strength for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 5 to 7 days or if they become worse, check with your doctor. Comtrex Cold and Cough Maximum Strength may harm your liver. Your risk may be greater if you drink alcohol while you are using Comtrex Cold and Cough Maximum Strength. Talk to your doctor before you take Comtrex Cold and Cough Maximum Strength or other fever reducers if you drink more than 3 drinks with alcohol per day. Comtrex Cold and Cough Maximum Strength may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Comtrex Cold and Cough Maximum Strength. Tell your doctor or dentist that you take Comtrex Cold and Cough Maximum Strength before you receive any medical or dental care, emergency care, or surgery. Use Comtrex Cold and Cough Maximum Strength with caution in the ELDERLY; they may be more sensitive to its effects. Comtrex Cold and Cough Maximum Strength should be used with extreme caution in CHILDREN; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Comtrex Cold and Cough Maximum Strength while you are pregnant. It is not known if Comtrex Cold and Cough Maximum Strength is found in breast milk. Do not breast-feed while taking Comtrex Cold and Cough Maximum Strength. Possible side effects of Comtrex Cold and Cough Maximum Strength:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Comtrex Cold and Cough Maximum Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Comtrex Cold and Cough Maximum Strength:

Store Comtrex Cold and Cough Maximum Strength between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Comtrex Cold and Cough Maximum Strength out of the reach of children and away from pets.

General information: If you have any questions about Comtrex Cold and Cough Maximum Strength, please talk with your doctor, pharmacist, or other health care provider. Comtrex Cold and Cough Maximum Strength is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Comtrex Cold and Cough Maximum Strength. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Comtrex Cold and Cough Maximum Strength resources Comtrex Cold and Cough Maximum Strength Side Effects (in more detail) Comtrex Cold and Cough Maximum Strength Use in Pregnancy & Breastfeeding Comtrex Cold and Cough Maximum Strength Drug Interactions 0 Reviews for Comtrex Cold and Cough Maximum Strength - Add your own review/rating Compare Comtrex Cold and Cough Maximum Strength with other medications Cold Symptoms Cough Cough and Nasal Congestion Nasal Congestion Pain/Fever Sinus Symptoms Tonsillitis/Pharyngitis


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Tylenol Cough/Sore Throat Liquid


Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/dox-IL-a-meen
Generic Name: Acetaminophen/Dextromethorphan/Doxylamine
Brand Name: Clear Cough PM Multi-Symptom and Tylenol Cough/Sore Throat
Tylenol Cough/Sore Throat Liquid is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tylenol Cough/Sore Throat Liquid is an analgesic, cough suppressant, and antihistamine combination. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing.

Do NOT use Tylenol Cough/Sore Throat Liquid if: you are allergic to any ingredient in Tylenol Cough/Sore Throat Liquid you are unable to urinate or are having an asthma attack you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Cough/Sore Throat Liquid:

Some medical conditions may interact with Tylenol Cough/Sore Throat Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a fast, slow, or irregular heartbeat if you have a history of heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; liver problems; severe kidney problems; or if you consume more than 3 alcohol-containing drinks per day if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tylenol Cough/Sore Throat Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), furazolidone, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol Cough/Sore Throat Liquid may be increased Anticoagulants (eg, warfarin) because risk of bleeding, irregular heartbeat or heart attack may be increased Hydantoins (eg, phenytoin) because side effects may be increased by Tylenol Cough/Sore Throat Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Cough/Sore Throat Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Cough/Sore Throat Liquid:

Use Tylenol Cough/Sore Throat Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tylenol Cough/Sore Throat Liquid may be taken with or without food. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Tylenol Cough/Sore Throat Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Cough/Sore Throat Liquid.

Important safety information: Tylenol Cough/Sore Throat Liquid may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol Cough/Sore Throat Liquid. Using Tylenol Cough/Sore Throat Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Do not take diet or appetite control medicines while you are taking Tylenol Cough/Sore Throat Liquid without checking with your doctor. Tylenol Cough/Sore Throat Liquid contains acetaminophen, doxylamine, and dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, doxylamine, or dextromethorphan. If it does or if you are uncertain, contact your doctor or pharmacist. Do NOT exceed the recommended dose or take Tylenol Cough/Sore Throat Liquid for longer than prescribed without checking with your doctor. If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor. Tylenol Cough/Sore Throat Liquid may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tylenol Cough/Sore Throat Liquid. Use a sunscreen or protective clothing if you must be outside for a prolonged period. Tylenol Cough/Sore Throat Liquid may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol Cough/Sore Throat Liquid or other pain relievers/fever reducers. Alcohol use combined with Tylenol Cough/Sore Throat Liquid may increase your risk for liver damage. If you are scheduled for allergy skin testing, do not take Tylenol Cough/Sore Throat Liquid for several days before the test because it may decrease your response to the skin tests. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol Cough/Sore Throat Liquid. Use Tylenol Cough/Sore Throat Liquid with caution in the ELDERLY because they may be more sensitive to its effects. Caution is advised when using Tylenol Cough/Sore Throat Liquid in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol Cough/Sore Throat Liquid, discuss with your doctor the benefits and risks of using Tylenol Cough/Sore Throat Liquid during pregnancy. It is unknown if Tylenol Cough/Sore Throat Liquid is excreted in breast milk. Do not breast-feed while taking Tylenol Cough/Sore Throat Liquid. Possible side effects of Tylenol Cough/Sore Throat Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tylenol Cough/Sore Throat side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; and vomiting.

Proper storage of Tylenol Cough/Sore Throat Liquid:

Store Tylenol Cough/Sore Throat Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Cough/Sore Throat Liquid out of the reach of children and away from pets.

General information: If you have any questions about Tylenol Cough/Sore Throat Liquid, please talk with your doctor, pharmacist, or other health care provider. Tylenol Cough/Sore Throat Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tylenol Cough/Sore Throat Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tylenol Cough/Sore Throat resources Tylenol Cough/Sore Throat Side Effects (in more detail) Tylenol Cough/Sore Throat Use in Pregnancy & Breastfeeding Tylenol Cough/Sore Throat Drug Interactions 0 Reviews for Tylenol Cough/Sore Throat - Add your own review/rating Compare Tylenol Cough/Sore Throat with other medications Cough Pain


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Arcalyst


Generic Name: rilonacept (Subcutaneous route)

ril-ON-a-sept

Commonly used brand name(s)

In the U.S.

Arcalyst

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interleukin-1 Inhibitor

Uses For Arcalyst

Rilonacept is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Rilonacept can help lessen the signs and symptoms of CAPS, such as rash, joint pain, fever, and tiredness .

This medicine is available only with your doctor's prescription .

Before Using Arcalyst

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rilonacept in children below 12 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rilonacept in the elderly. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of rilonacept .

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adalimumab Adenovirus Vaccine Type 4, Live Adenovirus Vaccine Type 7, Live Anakinra Bacillus of Calmette and Guerin Vaccine, Live Etanercept Infliximab Influenza Virus Vaccine, Live Measles Virus Vaccine, Live Mumps Virus Vaccine, Live Poliovirus Vaccine, Live Rotavirus Vaccine, Live Rubella Virus Vaccine, Live Smallpox Vaccine Typhoid Vaccine Varicella Virus Vaccine Yellow Fever Vaccine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Diabetes or Immune system problems—Patients with these conditions will have an increased risk of infection . Serious infections (e.g., HIV, hepatitis B or C, tuberculosis)—Rilonacept may decrease the body's ability to fight infection . Proper Use of Arcalyst

This medicine is given as a shot under your skin. Rilonacept may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected .

This medicine comes with a patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions .

Use a new needle and syringe each time you inject your medicine .

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bruised, red, tender, or hard .

This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not use if it is cloudy or has specks floating in it .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (vial): For cryopyrin-associated periodic syndromes: Adults—At first, 320 milligrams (mg) given as two, 2-milliliter (mL) doses of 160 mg injected under the skin on the same day at two different sites. Your dose will be adjusted to 160 mg once a week, given as a single, 2 mL injection. Children and teenagers 12 to 17 years of age—At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2-milliliter (mL) doses injected under the skin. Your dose will be adjusted to 2.2 mg per kg of body weight up to 160 mg once a week, given as a single, 2 mL injection. Children below 12 years of age—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Once the powder medicine has been mixed with the liquid, this mixture may be stored at room temperature, away from direct light. You must use this mixture within 3 hours. Throw away any leftover mixture .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using Arcalyst

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects (e.g., increased amount of cholesterol or fats in the blood) .

Your body's ability to fight infection may be reduced while you are being treated with rilonacept. It is very important that you call your doctor at the first signs of any infection (such as fever or chills; cough or hoarseness; lower back or side pain; or painful or difficult urination) .

While you are being treated with rilonacept, do not have any immunizations (vaccinations) without your doctor's approval. Rilonacept may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Tell your doctor about any vaccinations you have received in the past. Ask your doctor whether you should receive any vaccinations, including pneumonia and flu shots, before receiving rilonacept .

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test .

Using this medicine may increase your risk of certain types of cancer. Talk with your doctor about this risk .

Rilonacept may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection .

Do not take adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), or infliximab (Remicade®) while you are being treated with this medicine, unless your doctor says it is okay .

Arcalyst Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site body aches or pain chills cough difficulty in breathing ear congestion fever headache loss of voice nasal congestion runny nose sneezing sore throat unusual tiredness or weakness Incidence not known Bloody or black, tarry stools constipation cough producing mucus lower back or side pain pain or tenderness around eyes and cheekbones painful or difficult urination severe stomach pain shortness of breath or troubled breathing tenderness tightness of chest or wheezing vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings Less common Stomach discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Arcalyst side effects (in more detail)

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The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Arcalyst resources Arcalyst Side Effects (in more detail) Arcalyst Use in Pregnancy & Breastfeeding Arcalyst Drug Interactions Arcalyst Support Group 1 Review for Arcalyst - Add your own review/rating Arcalyst Prescribing Information (FDA) Arcalyst Consumer Overview Arcalyst Monograph (AHFS DI) Arcalyst MedFacts Consumer Leaflet (Wolters Kluwer) Rilonacept Professional Patient Advice (Wolters Kluwer) Compare Arcalyst with other medications Cryopyrin-Associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle Wells Syndrome


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