1. Name Of The Medicinal Product

HEPARIN (MUCOUS) INJECTION BP

2. Qualitative And Quantitative Composition

Heparin (Mucous) Injection BP 1000 Units/ml: each ml contains Heparin Sodium 1,000 IU

Heparin (Mucous) Injection BP 5000 Units/ml: each ml contains Heparin Sodium 5,000 IU

Heparin (Mucous) Injection BP 25000 Units/ml: each ml contains Heparin Sodium 25,000 IU

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of thrombo-embolic disorders such as deep vein thrombosis, acute arterial embolism or thrombosis, thrombophlebitis, pulmonary embolism and fat embolism.

For prophylaxis against deep vein thrombosis and thrombo-embolic events in susceptible patients.

4.2 Posology And Method Of Administration

For intravenous or subcutaneous injection.

Treatment Dosage:

Intravenous administration

5,000 - 10,000 IU every 4 hours or 500 IU/kg bodyweight daily as a continuous infusion in sodium chloride injection or dextrose injection. Doses should be individually adjusted according to coagulation tests.

Subcutaneous administration

The initial dose is 250 IU/kg bodyweight. Further doses should be given every 12 hours and individually adjusted according to coagulation tests.

Dosage adjustment

It is recommended that dosages be adjusted to maintain a thrombin clotting time, whole blood clotting time or activated partial thromboplastin time 1.5 to 2 times that of control on blood withdrawn 4 - 6 hours after the first injection or commencement of infusion and at similar intervals until the patient is stabilised.

Prophylactic Dosage:

Administration is by subcutaneous injection.

Patients undergoing major elective surgery:

5,000 IU should be given 2 hours pre-operatively and then every 8 - 12 hours post-operatively for 10 - 14 days or until the patient is ambulant, whichever is the longer.

Following myocardial infarction:

5,000 IU should be given twice daily for 10 days or until the patient is mobile.

Other patients:

5,000 IU should be given every 8 - 12 hours.

These standard prophylactic regimens do not require routine control.

Dosage in Children

Treatment Dosage:

Standard treatment dosages should be given initially. Subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.

Dosage in the Elderly

Treatment Dosage:

Lower treatment dosages may be required. However, standard treatment dosages should be given initially and then subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.

Prophylactic Dosage:

Dosage alterations are unnecessary for prophylaxis in the elderly.

Pregnancy

This heparin formulation contains the preservative benzyl alcohol. As benzyl alcohol may cross the placenta the use of this formulation should be avoided in pregnancy. If use is considered essential, the dosage recommendations given in this section should be followed.

Treatment Dosage:

Standard treatment dosages should be given initially by continuous intravenous infusion, or every 12 hours by subcutaneous injection. Intermittent intravenous injections are not advised. Subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.

Prophylactic Dosage:

It is recommended that plasma heparin levels be maintained below 0.4 IU/ml as determined by specific anti-Xa assay. A suggested dosage is 5,000 IU every 12 hours in early pregnancy increasing to 10,000 IU every 12 hours in the last trimester. The dosage should be reduced during labour and the standard prophylactic dosage is suitable in the puerperium.

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin-induced thrombocytopenia.

Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.

Heparin (Mucous) Injection contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates (see Section 4.6).

An epidural anaesthesia during birth in pregnant women treated with heparin is contraindicated (see Section 4.6).

In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special Warnings And Precautions For Use

Heparin should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Care should be taken when heparin is administered to patients with increased risk of bleeding complications, hypertension, renal or hepatic insufficiency.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with heparin (see Section 4.5).

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

Heparin should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk, care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin (Mucous) Injection contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic reactions and allergic reactions (anaphylactoid) in this age group.

Heparin (Mucous) Injection contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anticoagulant effect of heparin may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C. Where such combination cannot be avoided, careful clinical and biological monitoring is required.

Combined use with ACE inhibitors or angiotensin II antagonists may increase the risk of hyperkalaemia.

Use of glyceryl trinitrate infusion may reduce the anticoagulant effect of heparin.

4.6 Pregnancy And Lactation

Because of the known haemorrhagic effect, heparin should be used with caution in pregnant women and only if the benefits outweigh the risks according to the physician's judgement. Precaution is particularly required because of uteroplacental haemorrhage, especially at the time of delivery. If epidural anaesthesia is envisaged, heparin treatment should be suspended, whenever possible.

Heparin (Mucous) Injection contains 10 mg/ml of the preservative benzyl alcohol. Cases of “Gasping Syndrome” have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/kg/day). Therefore the use of this formulation in newborns (especially in preterm babies) is contraindicated (see Section 4.3).

As benzyl alcohol may cross the placenta, the use of this formulation should be avoided during pregnancy.

The use of heparin in women with abortus imminens is contraindicated (see Section 4.3).

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

Very common

>1/10

Common

>1/100 and <1/10

Uncommon

>1/1,000 and <1/100

Rare

>1/10,000 and <1/1,000

Very rare

<1/10,000

The most frequently reported undesirable effects are bleeding events, reversible increase in liver enzymes, reversible thrombocytopenia and various skin reactions. Isolated reports of generalised allergic reactions, skin necrosis and priapism have been reported.

Blood and lymphatic system disorders

Heparin can cause thrombocytopenia either through a direct effect or through an immune effect producing a platelet-aggregating antibody (see Section 4.4). Reversible after drug withdrawal.

Common:

Thrombocytopenia type I

Rare:

Thrombocytopenia type II, probably of an immunoallergic nature (see section 4.4)

In some cases thrombocytopenia type II has been accompanied by venous or arterial thrombi.

Immune system disorders

Rare:

Allergic reactions of all types and severities, with various manifestations

Very rare:

Anaphylactoid reactions and anaphylactic shock

Metabolism and nutrition disorders

Rare:

Hypoaldosteronism. Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. Rarely, clinically significant hyperkalaemia may occur particularly in patients with chronic renal failure and diabetes mellitus (see Section 4.4).

Vascular disorders

Common:

Haemorrhage

Haemorrhages may affect any organ, particularly inconnection with high doses.

In some cases haemorrhage has resulted in death or permanent disability.

Very rare cases of epidural and spinal haematoma have been reported in patients receiving heparin for prophylaxis undergoing spinal or epidural anaesthesia or spinal puncture (see Section 4.4).

Hepatobiliary disorders

Common:

Raised transaminases, gamma-GT, LDH and lipase levels. They are reversible after drug withdrawal.

Skin and subcutaneous tissue disorder

Uncommon:

Rash (various types of rash such as erythematous and maculopapular), urticaria, pruritus.

Rare:

Skin necrosis. If this occurs treatment must be withdrawn immediately.

One case of erythema multiforme was also reported.

Musculoskeletal and connective tissue disorders

Uncommon:

Osteoporosis has been reported in connection with long-term heparin treatment.

Reproductive system and breast disorders

Very rare:

Priapism

General disorders and administration site conditions

Common:

Injection site reactions; local irritation may occur when injected subcutaneously

4.9 Overdose

Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic Properties

The increase in clotting time provided by heparin becomes apparent immediately after administration and lasts for four to six hours after intravenous injection and for about eight hours after subcutaneous injection.

5.3 Preclinical Safety Data

There are no preclinical 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

Heparin (Mucous) Injection BP 1000 Units/ml and Heparin (Mucous) Injection BP 5000 Units/ml: Benzyl alcohol, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium citrate dihydrate, Sodium chloride and Water for Injections.

Heparin (Mucous) Injection BP 25000 Units/ml: Benzyl alcohol, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium citrate dihydrate and Water for Injections.

6.2 Incompatibilities

Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and some antihistamines.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Heparin (Mucous) Injection BP 1000 Units/ml: 10 x 5 ml vials.

Heparin (Mucous) Injection BP 5000 Units/ml: 10 x 5ml vials.

Heparin (Mucous) Injection BP 25000 Units/ml: 5 x 5ml vials.

6.6 Special Precautions For Disposal And Other Handling

From a microbiological point of view, once opened, the product may be stored for a maximum of 14 days below 25°C. Other in use storage times and conditions are the responsibility of the user.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

Heparin (Mucous) Injection BP 1000 Units/ml - PL 0043/0041R.

Heparin (Mucous) Injection BP 5000 Units/ml - PL 0043/0038R

Heparin (Mucous) Injection BP 25000 Units/ml - PL 0043/0039R.

9. Date Of First Authorisation/Renewal Of The Authorisation

Heparin (Mucous) Injection BP 1000 Units/ml - 3 December 1975.

Heparin (Mucous) Injection BP 5000 Units/ml and Heparin (Mucous)

Injection BP 25000 Units/ml - 4 December 1975.

10. Date Of Revision Of The Text

April 2007

LEGAL CATEGORY

POM



minoxidil



Generic Name: hydralazine/hydrochlorothiazide/reserpine (hye DRAL a zeen/hye droe klor oh THYE a zide/re SER peen)



Pronunciation: IN-su-lin



Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin)



Generic Name: hydrochlorothiazide and metoprolol (HYE droe klor oh THYE a zide and me TOE proe lole)



Pronunciation: hye-DROX-i-zeen



Generic Name: crataegus fruit, arnica montana, potassium phosphate, dibasic and calcium fluoride granule



Pronunciation: kar-bi-NOX-a-meen



1. Name Of The Medicinal Product

HYDROMOL EMOLLIENT

2. Qualitative And Quantitative Composition

Light Liquid Paraffin BP 37.80% w/w

Isopropyl Myristate BP 13.00% w/w

3. Pharmaceutical Form

Hydromol Emollient is a clear, colourless bath additive.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of dry skin conditions such as eczema, ichthyosis and senile pruritus.

4.2 Posology And Method Of Administration

Route of administration

Hydromol Emollient should be used topically and is either added to water or applied to wet skin.

1. For use in the bath

a) Adults/Children and the Elderly:

Add 1–3 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ? to 2 capfuls to a small bath of water.

2. For application to the skin as a sponge bath or in the shower.

Adults and Children and the Elderly:

Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.

4.3 Contraindications

Known sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from eyes. Take care to avoid slipping in the bath/shower. If there is aggravation of the condition consult the doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Hydromol Emollient is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Patients should be advised to take care to avoid slipping in the bath.

4.9 Overdose

Not applicable. Hydromol Emollient is for topical use only.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The combination of oils used in Hydromol Emollient are deposited on the skin surface during bathing and thus reduce moisture loss, provide anti-pruritic action, lubricate and soften the skin.

Hydromol Emollient is particularly suitable for infant bathing. The preparation can also be used as a cleanser where soaps are best avoided.

5.2 Pharmacokinetic Properties

Hydromol Emollient is a water-dispersible bath additive resulting in an emulsion of dispersed oils together with an homogenised film on the surface.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

C12-C14 Alcohol with 3 molecules of Ethylene Oxide, Polyol Fatty Acid Ester, Iso-octyl Stearate.

6.2 Incompatibilities

Not applicable. Hydromol Emollient is for topical use only.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Hydromol Emollient should be stored in a dry place avoiding extremes of temperature ie above 30°C or below 5°C.

6.5 Nature And Contents Of Container

Hydromol Emollient is packed in printed polyethylene bottles of 25 ml, 150 ml, 200 ml, 350 ml and 1 litre capacity.

6.6 Special Precautions For Disposal And Other Handling

Hydromol Emollient should be used topically and is either added to water or applied to wet skin.

1. For use in the bath

a) Adults/Children and the Elderly:

Add 1–3 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ? to 2 capfuls to a small bath of water.

2. For application to the skin as a sponge bath or in the shower.

Adults and Children and the Elderly:

Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.

7. Marketing Authorisation Holder

Adams Healthcare

Lotherton Way

Garforth

Leeds LS25 2JY

United Kingdom

8. Marketing Authorisation Number(S)

PL 16108/0043

9. Date Of First Authorisation/Renewal Of The Authorisation

31 August 2001

10. Date Of Revision Of The Text





Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)



Generic Name: haloperidol (Oral route)

hal-oh-PER-i-dol

Oral route(Tablet)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

Haldol

In Canada

Alti-Haloperidol Apo-Haloperidol Novo-Peridol Peridol Pms-Haloperidol Ratio-Haloperidol

Available Dosage Forms:

Tablet Solution

Therapeutic Class: Antipsychotic

Pharmacologic Class: Dopamine Antagonist

Chemical Class: Butyrophenone

Uses For Haldol

Haloperidol is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It is also used to control the symptoms of Tourette's disorder. This medicine should not be used to treat behavior problems in older adult patients who have dementia.

Haloperidol is also used to treat severe behavioral problems (e.g., aggressive, impulsive behavior) or hyperactivity in children who have already been treated with psychotherapy or other medicines that did not work well.

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

Before Using Haldol

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 haloperidol in children younger than 3 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of haloperidol in the elderly. However, elderly women are more likely to have a side effect called tardive dyskinesia, and elderly patients are more likely to have age-related heart problems, which may require an adjustment in the dose for patients receiving haloperidol.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil Cisapride Dronedarone Levomethadyl Mesoridazine Metoclopramide Pimozide Sparfloxacin Terfenadine Thioridazine

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.

Acecainide Ajmaline Alfuzosin Amiodarone Amisulpride Amitriptyline Amoxapine Apomorphine Aprindine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bretylium Chloral Hydrate Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dalfopristin Dasatinib Desipramine Dibenzepin Disopyramide Dofetilide Dolasetron Doxepin Droperidol Encainide Enflurane Erythromycin Flecainide Fluconazole Fluoxetine Foscarnet Gatifloxacin Gemifloxacin Granisetron Halofantrine Halothane Hydromorphone Hydroquinidine Ibutilide Imipramine Isoflurane Isradipine Ketoconazole Lapatinib Levofloxacin Lidoflazine Lithium Lopinavir Lorcainide Lumefantrine Mefloquine Methadone Milnacipran Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Paroxetine Pazopanib Pentamidine Perflutren Lipid Microsphere Pirmenol Posaconazole Prajmaline Probucol Procainamide Prochlorperazine Promethazine Propafenone Propranolol Protriptyline Quetiapine Quinidine Quinine Quinupristin Ranolazine Risperidone Salmeterol Saquinavir Sematilide Sertindole Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Spiramycin Sulfamethoxazole Sultopride Sunitinib Tedisamil Telavancin Telithromycin Tetrabenazine Toremifene Tramadol Trazodone Trifluoperazine Trimethoprim Trimipramine Vandetanib Vardenafil Vasopressin Vemurafenib Venlafaxine Voriconazole Ziprasidone Zolmitriptan Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Benztropine Betel Nut Bupropion Buspirone Carbamazepine Dextromethorphan Fluvoxamine Methyldopa Nefazodone Olanzapine Procyclidine Rifampin Rifapentine Tacrine Trihexyphenidyl 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:

Breast cancer, history of or Chest pain or Heart or blood vessel disease, severe or Hyperprolactinemia (high prolactin in the blood) or Hypotension (low blood pressure) or Mania or Neuroleptic malignant syndrome, history of or Seizures or epilepsy, history of—Use with caution. May make these conditions worse. Central nervous system depression, severe or Coma or Dementia in elderly or Parkinson's disease—Should not be used in patients with these conditions. Heart rhythm problems (e.g., familial long QT-syndrome), history of or Hypokalemia (low potassium in the blood) or Hypomagnesemia (low magnesium in the blood) or Hypothyroidism (underactive thyroid) or Thyrotoxicosis (overactive thyroid)—May increase risk for more serious side effects. Proper Use of haloperidol

This section provides information on the proper use of a number of products that contain haloperidol. It may not be specific to Haldol. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is particularly important for elderly patients, since they may react very strongly to this medicine.

For patients taking the liquid form of this medicine:

This medicine is to be taken by mouth and it comes in a dropper bottle. Each dose is to be measured with the specially marked dropper provided with your bottle. Do not use other droppers since they may not deliver the correct amount of medicine. This medicine should be mixed with water or a beverage, such as orange juice, apple juice, tomato juice, or cola, and taken immediately after mixing.

Continue taking this medicine for the full time of treatment. Sometimes haloperidol must be taken for several days to several weeks before its full effect is reached.

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 oral dosage forms (solution and tablets): For nervous, emotional, or mental conditions: Adults and teenagers—At first, 0.5 to 5 milligrams (mg) two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day. Older adults—At first, 0.5 to 2 milligrams (mg) two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day. Children 3 to 12 years of age or weighing 15 to 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 150 micrograms per kg per day, given in divided doses two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 6 mg per day. Children below 3 years of age—Use and dose must be determined by the 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 the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using Haldol

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. The amount of haloperidol you take may be changed to meet the needs of your condition and to prevent side effects.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This will allow your body time to adjust and help avoid a worsening of your medical condition.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally, especially as the amount of medicine is increased. Even if you take haloperidol at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are using this medicine.

Haloperidol may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Wear protective clothing, including a hat or sunglasses. Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor. Apply a sun block lipstick that has an SPF of at least 15 to protect your lips. Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Haloperidol may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Contact your doctor as soon as possible if you have chest pain or discomfort, a fast heartbeat, trouble breathing, or fever and chills. These can be symptoms of a very serious problem with your heart.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Haldol 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 Difficulty with speaking or swallowing inability to move the eyes loss of balance control mask-like face muscle spasms, especially of the neck and back restlessness or need to keep moving (severe) shuffling walk stiffness of the arms and legs trembling and shaking of the fingers and hands twisting movements of the body weakness of the arms and legs Less common Decreased thirst difficulty in urination dizziness, lightheadedness, or fainting hallucinations (seeing or hearing things that are not there) lip smacking or puckering puffing of the cheeks rapid or worm-like movements of the tongue skin rash uncontrolled chewing movements uncontrolled movements of the arms and legs Rare Confusion convulsions (seizures) difficult or fast breathing fast heartbeat or irregular pulse fever (high) high or low blood pressure hot, dry skin, or lack of sweating increased blinking or spasms of the eyelid increased sweating loss of bladder control muscle stiffness (severe) muscle weakness sore throat and fever uncontrolled twisting movements of the neck, trunk, arms, or legs unusual bleeding or bruising unusual facial expressions or body positions unusual tiredness or weakness unusually pale skin yellow eyes or skin Incidence not known Continuing nausea or vomiting increase in the frequency of seizures loss of appetite swelling of the face tiredness and weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Difficulty with breathing (severe) dizziness (severe) drowsiness (severe) muscle trembling, jerking, stiffness, or uncontrolled movements (severe) unusual tiredness or weakness (severe)

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 Blurred vision changes in menstrual period constipation dryness of the mouth swelling or pain in the breasts (in females) unusual secretion of milk weight gain Less common Decreased sexual ability drowsiness increased sensitivity of the skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn) nausea or vomiting

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: Haldol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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 Haldol resources Haldol Side Effects (in more detail) Haldol Use in Pregnancy & Breastfeeding Drug Images Haldol Drug Interactions Haldol Support Group 9 Reviews for Haldol - Add your own review/rating Haldol Prescribing Information (FDA) Haldol MedFacts Consumer Leaflet (Wolters Kluwer) Haldol Concise Consumer Information (Cerner Multum) Haloperidol Monograph (AHFS DI) Haloperidol Professional Patient Advice (Wolters Kluwer) Haloperidol Prescribing Information (FDA) Haldol Decanoate MedFacts Consumer Leaflet (Wolters Kluwer) Haldol Decanoate Prescribing Information (FDA) Compare Haldol with other medications Dementia ICU Agitation Mania Nausea/Vomiting Psychosis Tourette's Syndrome



Definition of Hemolytic Anemia: Hemolytic anemia is a condition of an inadequate number of circulating red blood cells (anemia), caused by premature destruction of red blood cells. There are a number of specific types of hemolytic anemia which are described individually.

Drugs associated with Hemolytic Anemia

The following drugs and medications are in some way related to, or used in the treatment of Hemolytic Anemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Hemolytic Anemia Autoimmune Hemolytic Anemia (4 drugs) G-6-PD Deficiency (0 drugs) Learn more about Hemolytic Anemia

Micromedex Care Notes:

Erythroblastosis Fetalis Hemolytic Anemia Jaundice In Newborns Rh Factor Incompatibility

Medical Encyclopedia:

Congenital spherocytic anemia Drug-induced immune hemolytic anemia Hemolytic anemia Hemolytic anemia caused by chemicals and toxins Iron deficiency anemia Newborn jaundice Rh incompatibility

Harvard Health Guide:

Symptoms and treatment for Hemolytic Anemia



Pronunciation: dox-ehr-kal-SIFF-eh-role



Generic Name: hydrochlorothiazide and aliskiren (HYE droe KLOR oh THYE a zide and a LIS ke rin)



1. Name Of The Medicinal Product

HEPARIN SODIUM 100 IU/ml I.V. FLUSH SOLUTION

2. Qualitative And Quantitative Composition

Heparin sodium Ph. Eur. 100 IU/ml

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

4.2 Posology And Method Of Administration

For routine use, 2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required.

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin induced thrombocytopenia.

Heparin Sodium 100 IU/ml i.v. flush solution contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

4.4 Special Warnings And Precautions For Use

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin Sodium 100 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Heparin Sodium 100 IU/ml i.v. flush solution contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic and allergic reactions (anaphylactoid) in this age group (see also section 4.3 for premature babies or neonates).

Heparin Sodium 100 IU/ml i.v. flush solution contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For incompatibilities with other medicinal products see Section 6.2.

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter the results of the tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken.

4.6 Pregnancy And Lactation

The dose of heparin used would not be expected to constitute a hazard. However, as benzyl alcohol may cross the placenta, the use of Heparin Sodium 100 IU/ml i.v. flush solution containing benzyl alcohol should be avoided during pregnancy.

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

When used as recommended, the low dose of heparin reaching the blood is unlikely to have any systemic effects. However, heparin may cause thrombocytopenia and hypersensitivity reactions.

Local irritation may occur if inadvertently injected subcutaneously.

4.9 Overdose

An overdose is unlikely to occur. Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine sulphate itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine sulphate may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol,

Methylparahydroxybenzoate,

Propylparahydroxybenzoate,

Sodium citrate,

Sodium chloride,

Water for Injections.

6.2 Incompatibilities

This product is compatible with normal saline. Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

10 x 2 ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0057

9. Date Of First Authorisation/Renewal Of The Authorisation

23 October 1978/16 January 1995

10. Date Of Revision Of The Text

November 2007

LEGAL CATEGORY

POM



Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)



1. Name Of The Medicinal Product

Multiparin 25,000 I.U./ml solution for injection or concentrate for solution for infusion or Heparin sodium 25,000 I.U./ml solution for injection or concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Heparin sodium 25,000 I.U./ml (125,000 I.U. in 5ml)

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection or concentrate for solution for infusion

A colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of deep vein thrombosis and pulmonary embolism

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

Prophylaxis of mural thrombosis following myocardial infarction.

In extracorporeal circulation and haemodialysis.

4.2 Posology And Method Of Administration

Route of administration

By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection.

The intravenous injection volume of heparin injection should not exceed 15ml.

As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.

Recommended dosage

Prophylaxis of deep vein thrombosis and pulmonary embolism:

Adults:

2 hours pre-operatively:

5,000 units subcutaneously

followed by:

5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant.

No laboratory monitoring should be necessary during low dose heparin prophylaxis. If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged.

During pregnancy:

5,000 - 10,000 units every 12 hours, subcutaneously, adjusted according to APTT or anti-Xa assay.

Elderly:

Dosage reduction and monitoring of APTT may be advisable.

Children:

No dosage recommendations.

Treatment of deep vein thrombosis and pulmonary embolism:

Adults:

Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism)

Maintenance:

1,000-2,000 units/hour by intravenous infusion,

or 10,000-20,000 units 12 hourly subcutaneously,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously

Maintenance:

15-25 units/kg/hour by intravenous infusion,

or 250 units/kg 12 hourly subcutaneously

or 100 units/kg 4-hourly by intravenous injection

Treatment of unstable angina pectoris and acute peripheral arterial occlusion:

Adults:

Loading dose: 5,000 units intravenously

Maintenance:

1,000-2,000 units/hour by intravenous infusion,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously

Maintenance:

15-25 units/kg/hour by intravenous infusion,

or 100 units/kg 4-hourly by intravenous injection

Daily laboratory monitoring (ideally at the same time each day, starting 4-6 hours after initiation of treatment) is essential during full-dose heparin treatment, with adjustment of dosage to maintain an APTT value 1.5-2.5 x midpoint of normal range or control value.

Prophylaxis of mural thrombosis following myocardial infarction

Adults:

12,500 units 12 hourly subcutaneously for at least 10 days.

Elderly:

Dosage reduction may be advisable

In extracorporeal circulation and haemodialysis

Adults:

Cardiopulmonary bypass:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.

Haemodialysis and haemofiltration:

Initially 1-5,000 units,

Maintenance: 1-2,000 units/hour, adjusted to maintain clotting time >40 minutes.

Heparin resistance

Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect. Also refer to section 4.4, Special warnings and precautions for use.

4.3 Contraindications

Known hypersensitivity to heparin or any of the other ingredients.

Must not be given to premature babies or neonates (contains benzyl alcohol).

Patients who consume large amounts of alcohol, who are sensitive to the drug, who are actively bleeding or who have haemophilia or other bleeding disorders, severe liver disease (including oesophageal varices), purpura, severe hypertension, active tuberculosis or increased capillary permeability.

Patients with present or previous thrombocytopenia. The rare occurrence of skin necrosis in patients receiving heparin contra-indicates the further use of heparin either by subcutaneous or intravenous routes because of the risk of thrombocytopenia. Because of the special hazard of post-operative haemorrhage heparin is contra-indicated during surgery of the brain, spinal cord and eye, in procedures at sites where there is a risk of bleeding, in patients that have had recent surgery, and in patients undergoing lumbar puncture or regional anaesthetic block.

The relative risks and benefits of heparin should be carefully assessed in patients with a bleeding tendency or those patients with an actual or potential bleeding site eg. hiatus hernia, peptic ulcer, neoplasm, bacterial endocarditis, retinopathy, bleeding haemorrhoids, suspected intracranial haemorrhage, cerebral thrombosis or threatened abortion.

Menstruation is not a contra-indication.

4.4 Special Warnings And Precautions For Use

Platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

In patients with advanced renal or hepatic disease, a reduction in dosage may be necessary. The risk of bleeding is increased with severe renal impairment and in the elderly (particularly elderly women).

Although heparin hypersensitivity is rare, it is advisable to give a trial dose of 1,000 I.U. in patients with a history of allergy. Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins.

Heparin injection contains benzyl alcohol (10mg/ml) and methyl parahydroxybenzoate as preservatives. Caution should be used if prescribing Heparin injection to susceptible patients. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to three years old. Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm.

In most patients, the recommended low-dose regimen produces no alteration in clotting time. However, patients show an individual response to heparin, and it is therefore essential that the effect of therapy on coagulation time should be monitored in patients undergoing major surgery.

Caution is recommended in spinal or epidural anaesthesia (risk of spinal haematoma).

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium, or taking potassium sparing drugs. The risk of hyperkalemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and in all patients treated for more than 7 days.

Heparin resistance

There is considerable variation in individual anticoagulant responses to heparin.

Heparin resistance, defined as an inadequate response to heparin at a standard dose for achieving a therapeutic goal occurs in approximately 5 to 30% of patients.

Factors predisposing to the development of heparin resistance, include:

• Antithrombin III activity less than 60% of normal (antithrombin III-dependent heparin resistance):

Reduced antithrombin III activity may be hereditary or more commonly, acquired (secondary to preoperative heparin therapy in the main, chronic liver disease, nephrotic syndrome, cardiopulmonary bypass, low grade disseminated intravascular coagulation or drug induced, e.g. by aprotinin, oestrogen or possibly nitroglycerin)

• Patients with normal or supranormal antithrombin III levels (antithrombin III-independent heparin resistance)

 

• Thromboembolic disorders

 

• Increased heparin clearance

• Elevated levels of heparin binding proteins, factor VIII, von Willebrand factor, fibrinogen, platelet factor 4 or histidine-rich glycoprotein

 

• Active infection (sepsis or endocarditis)

• Preoperative intra-aortic balloon counterpulsation

• Thrombocytopenia

• Thrombocytosis

• Advanced age

• Plasma albumin concentration

• Relative hypovolaemia

Heparin resistance is also often encountered in acutely ill patients,in patients with malignancy and during pregnancy or the post-partum period.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and other NSAIDs should be used with care. Increased risk of haemorrhage with ketorolac (avoid concomitant use even with low-dose heparin).

Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase, dipyridamole, dextran solutions, or any other drug which may interfere with coagulation.

Cephalosporins: Some cephalosporins, e.g. cefaclor, cefixime and ceftriaxone, can affect the coagulation process and may therefore increase the risk of haemorrhage when used concurrently with heparin.

ACE inhibitors: Hyperkalaemia may occur with concomitant use.

Nitrates: Reduced activity of heparin has been reported with simultaneous intravenous glyceryl trinitrate infusion.

Probenecid: May increase the anticoagulant effects of heparin.

Tobacco smoke: Nicotine may partially counteract the anticoagulant effect of heparin. Increased heparin dosage may be required in smokers.

Interference with diagnostic tests may be associated with pseudo-hypocalcaemia (in haemodialysis patients), artefactual increases in total thyroxine and triiodothyronine, simulated metabolic acidosis and inhibition of the chromogenic lysate assay for endotoxin. Heparin may interfere with the determination of aminoglycosides by immunoassays.

4.6 Pregnancy And Lactation

Heparin is not contraindicated in pregnancy. Heparin does not cross the placenta or appear in breast milk. The decision to use heparin in pregnancy should be taken after evaluation of the risk/benefit in any particular circumstances.

Reduced bone density has been reported with prolonged heparin treatment during pregnancy.

Haemorrhage may be a problem during pregnancy or after delivery.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Haemorrhage (see also Special Warnings and Precautions and Overdosage Information).

Adrenal insufficiency secondary to adrenal haemorrhage has been associated with heparin (rarely).

Thrombocytopenia has been observed occasionally (see also Special Precautions and Warnings). Two types of heparin-induced thrombocytopenia have been defined. Type I is frequent, mild (usually >50 x 109/L) and transient, occurring within 1-5 days of heparin administration. Type II is less frequent but often associated with severe thrombocytopenia (usually <50 x 109/L). It is immune-mediated and occurs after a week or more (earlier in patients previously exposed to heparin). It is associated with the production of a platelet-aggregating antibody and thromboembolic complications which may precede the onset of thrombocytopenia. Heparin should be discontinued immediately.

There is some evidence that prolonged dosing with heparin (ie. over many months) may cause alopecia and osteoporosis. Significant bone demineralisation has been reported in women taking more than 10,000 I.U. per day of heparin for at least 6 months.

Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. Rarely, clinically significant hyperkalemia may occur particularly in patients with chronic renal failure and diabetes mellitus (see Warnings and Precautions).

Hypersensitivity reactions to heparin are rare. They include urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock. In some instances the precipitating agent will prove to be the preservative rather than the heparin itself.

Local irritation and skin necrosis may occur but are rare. Erythematous nodules, or infiltrated and sometimes eczema-like plaques, at the site of subcutaneous injections are common, occurring 3-21 days after starting heparin treatment.

Priapism has been reported. Increased serum transaminase values may occur but usually resolve on discontinuation of heparin. Heparin administration is associated with release of lipoprotein lipase into the plasma; rebound hyperlipidaemia may follow heparin withdrawal.

4.9 Overdose

A potential hazard of heparin therapy is haemorrhage, but this is usually due to overdosage and the risk is minimised by strict laboratory control. Slight haemorrhage can usually be treated by withdrawing the drug. If bleeding is more severe, clotting time and platelet count should be determined. Prolonged clotting time will indicate the presence of an excessive anticoagulant effect requiring neutralisation by intravenous protamine sulphate, at a dosage of 1 mg for every 100 I.U. of heparin to be neutralised. The bolus dose of protamine sulphate should be given slowly over about 10 minutes and not exceed 50 mg. If more than 15 minutes have elapsed since the injection of heparin, lower doses of protamine will be necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is an anticoagulant and acts by inhibiting thrombin and by potentiating the naturally occurring inhibitors of activated Factor X (Xa).

5.2 Pharmacokinetic Properties

As heparin is not absorbed from the gastrointestinal tract and sublingual sites it is administered by injection. After injection heparin extensively binds to plasma proteins.

Heparin is metabolised in the liver and the inactive metabolic products are excreted in the urine.

The half life of heparin is dependent on the dose.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Methyl parahydroxybenzoate (E218)

Water for injections

Sodium hydroxide solution

Hydrochloric acid

6.2 Incompatibilities

Heparin is incompatible with many injectable preparations e.g. some antibiotics, opioid analgesics and antihistamines.

The following drugs are incompatible with heparin;

Alteplase, amikacin sulphate, amiodarone hydrochloride, ampicillin sodium, aprotinin, benzylpenicillin potassium or sodium, cefalotin sodium, chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin sodium, methotrimeprazine, netilmicin sulphate, nicardipine hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride, polymyxin B sulphate, promethazine hydrochloride, streptomycin sulphate, tobramycin sulphate, triflupromazine hydrochloride, vancomycin hydrochloride and vinblastine sulphate.

Dobutamine hydrochloride and heparin should not be mixed or infused through the same intravenous line, as this causes precipitation.

Heparin and reteplase are incompatible when combined in solution.

If reteplase and heparin are to be given through the same line this, together with any Y-lines, must be thoroughly flushed with a 0.9% saline or a 5% glucose solution prior to and following the reteplase injection.

6.3 Shelf Life

36 months

Following the withdrawal of the first dose the remainder should be used within 28 days. After this period, any unused material should be discarded.

6.4 Special Precautions For Storage

Do not store above 25°C

Store in the original package

Chemical and physical in use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton containing 10 vials.

6.6 Special Precautions For Disposal And Other Handling

Each multidose vial should be restricted to use in a single patient.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK.

8. Marketing Authorisation Number(S)

PL 29831/0108

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 15 October 2007

10. Date Of Revision Of The Text

04 /03/2011



Humira

40 mg solution for injection in pre-filled syringe

Adalimumab

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira. Keep this Patient Alert Card with you. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Humira is and what it is used for



1
2 3 4 5 6 7 8 9 10 Next →