1. Name Of The Medicinal Product

Zenalb®20, a 200 g/L of human albumin solution for infusion (20% Solution).

2. Qualitative And Quantitative Composition

Zenalb®20 contains 200 g/L and is a solution containing 200 g/L (20%) of total protein of which at least 95% is human albumin.

A vial of 100 mL contains 20 g of human albumin

Zenalb®20 has a mildly hyperoncotic effect.

For excipients see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

A clear, slightly viscous liquid, it is almost colourless, yellow, amber or green.

4. Clinical Particulars 4.1 Therapeutic Indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

4.2 Posology And Method Of Administration

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the patient, based on official recommendations.

Posology

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

- arterial blood pressure and pulse rate

- central venous pressure

- pulmonary artery wedge pressure

- urine output

- electrolyte

- haematocrit/haemoglobin

Method of administration

Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).

The infusion rate should be adjusted according to the individual circumstances and the indication.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Suspicion of allergic or anaphylactic-type reactions requires immediate discontinuation of the injection. In the case of shock, the standard medical standards treatment for shock should be implemented.

Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:

- Decompensated cardiac insufficiency

- Hypertension

- Oesophageal varices

- Pulmonary oedema

- Haemorrhagic diathesis

- Severe anaemia

- Renal and post-renal anuria

The colloid-osmotic effect of human albumin 200 g/L is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

200 g/L human albumin solutions are relatively low in electrolytes compared to 40-50 g/L human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived human albumin solutions.

It is strongly recommended that every time that Zenalb®20 is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interactions of human albumin with other medicinal products are known.

4.6 Pregnancy And Lactation

The safety of Zenalb®20 for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected.

No animal reproduction studies have been conducted with Zenalb®20.

Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri and postnatal development. However, human albumin is a normal constituent of human blood.

4.7 Effects On Ability To Drive And Use Machines

No effects on the ability to drive and use machines have been observed.

4.8 Undesirable Effects

Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and appropriate treatment should be initiated.

Post-marketing experience:

Additional side effects reported spontaneously include rigors, hypertension, hypotension, feeling cold, tachycardia, tremor, bronchospasm, dyspnoea, chest tightness, stridor and dizziness.

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code: B05AA01

Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.

Physicochemical data: Zenalb®20, human albumin 200 g/L has a corresponding hyperoncotic effect.

The most important physiological functions result from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier for hormones, enzymes, medicinal products and toxins.

5.2 Pharmacokinetic Properties

Under normal conditions the total exchangeable albumin pool is 4-5 g/kg bodyweight, of which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.

Under normal conditions the half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.

In healthy people, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

5.3 Preclinical Safety Data

Human albumin is a normal constituent of plasma and acts like physiological albumin.

In animals, single dose toxicity testing is of little relevance and does not permit the estimation of toxic or lethal doses or of a dose-effect relationship. Repeated dose toxicity testing is impracticable due to the development of antibodies to heterologous protein in animal models.

To date, human albumin has not been reported to be associated with embryo-foetal toxicity, oncogenic or mutagenic potential.

No signs of acute toxicity have been described in animal models.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium 50-120 mmol/L

Potassium

Chloride

Citrate

Sodium n-octanoate

Zenalb® 20 contains not more than 200 µg/L of aluminium

6.2 Incompatibilities

Human albumin should not be mixed with other medicinal products (except those mentioned in 6.6), whole blood and packed red cells.

6.3 Shelf Life

50 mL and 100 mL size

Unopened

36 months

Opened

3 hours

6.4 Special Precautions For Storage

Zenalb®20 should be stored between 2°C and 25°C. DO NOT FREEZE.

The expiry date of the product is stated on the label.

Store in the original container. Keep container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

The solution is contained in glass bottles stoppered with a rubber bung. The bung is over-sealed with a tamper evident cap.

6.6 Special Precautions For Disposal And Other Handling

The solution can be directly administered by the intravenous route or it can be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room temperature before use.

Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated.

Once the infusion container has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

This product is manufactured and marketed by

Bio Products Laboratory

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom.

8. Marketing Authorisation Number(S)

PL 08801/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

27th April 1993 / June 2000

10. Date Of Revision Of The Text

September 2008

Version Code: ABS8

POM

 

 



Pronunciation: DOX-e-pin



Generic Name: bupropion (byoo PRO pee on)



1. Name Of The Medicinal Product

Zelapar 1.25 mg Oral Lyophilisate.

2. Qualitative And Quantitative Composition

Each Zelapar Oral Lyophilisate contains 1.25 mg of selegiline hydrochloride, equivalent to 1.05 mg selegiline free base.

Each tablet contains 1.25mg of aspartame (source of Phenylalanine)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral lyophilisate.

A pale yellow round tablet with the letter A on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

Adjunctive therapy in combination with levodopa (with a peripheral decarboxylase inhibitor) in the treatment of Parkinson's disease. Zelapar in combination with maximal levodopa therapy is indicated particularly in patients who experience fluctuations in their condition such as 'end-dose' type fluctuations, 'on-off' symptoms or other dyskinesias.

Zelapar may be used alone in early Parkinson's disease for symptomatic relief and/or to delay the need for levodopa.

4.2 Posology And Method Of Administration

Posology

When prescribed as monotherapy for the first time in the early stage of Parkinson's disease or as an adjuvant to levodopa, the dose of Zelapar is one 1.25 mg unit.

When Zelapar adjunctive therapy is prescribed a reduction (10 to 30%) in the dose of levodopa is usually required. Reduction of the levodopa dose should be gradual in steps of 10% every 3 to 4 days.

No dosage adjustment is required for patients with renal or hepatic impairment.

Method of administration

The unit should be placed on the tongue in the morning, at least five minutes before breakfast and allowed to dissolve.

The unit will dissolve rapidly (in less than 10 seconds) in the mouth. The patient should not eat, drink, rinse or wash-out out their mouth for five minutes after taking their medicine to enable selegiline to be absorbed pre-gastrically.

Do not push the Zelapar tablet through the foil blister. Peel back the foil and carefully remove the unit.

Unused tablets must be disposed of after three months of a sachet opening.

4.3 Contraindications

Hypersentitivity to the active substance or to any of the excipients.

Patients receiving treatment with serotonin-agonists (e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan).

Patients with phenylketonuria due to the content of aspartame, a source of phenylalanine.

Concomitant use with pethidine and other opioids.

Patients with other extrapyramidal disorders not related to dopamine deficiency.

Patients with active duodenal or gastric ulcer.

Patients who are being treated with antidepressant drugs, including MAO inhibitors and selective serotonin reuptake inhibitors (e.g citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline and venlafaxine. See section 4.5 interactions).

Concomitant use with other drugs which are also monoamine oxidase inhibitors, e.g. linezolid.

Combination with levodopa is contra-indicated in severe cardiovascular disease, arterial hypertension, hyperthyroidism, phaeochromocytoma, narrow-angle glaucoma, prostatic adenoma with appearance of residual urine, tachycardia, arrhythmias, severe angina pectoris, psychoses, advanced dementia and thyrotoxicosis.

4.4 Special Warnings And Precautions For Use

One unit of Zelapar contains 1.25 mg selegiline. It is recommended that patients be warned that the correct dose of Zelapar is one oral lyophilisate.

Special care should be taken when administering selegiline to patients who have labile hypertension, cardiac arrhythmias, severe angina pectoris, psychosis or a history of peptic ulceration.

Although serious hepatic toxicity has not been observed, caution is recommended in patients with a history of hepatic dysfunction. Transient or continuing abnormalities with a tendency for elevated plasma concentrations of liver enzymes have been described during long-term therapy with conventional tablets of selegiline.

The selectivity for MAO

Concomitant treatment with medicines which inhibit MAO

Since selegiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased. When selegiline is added to the maximum tolerated dose of levodopa, involuntary movements and agitation may occur. Levodopa should be reduced by about 10 to 30% when selegiline is added to the treatment (see section 4.2 Posology and Method of Administration). When an optimum dose of levodopa is reached, adverse effects from the combination are less than those observed with levodopa on its own.

Although conventional tablets of selegiline, at doses of 5 to 10 mg/day, have been in widespread use for many years, the full spectrum of possible responses to Zelapar may not have been observed to date. Therefore patients should be observed closely for atypical responses.

Mouth ulcers may occur during treatment with Zelapar 1.25 mg oral lyophilisate.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Selegiline should not be administered with any type of antidepressant.

When selegiline is used at its recommended dose, it selectively inhibits MAO-B. The combined use of the SSRI, fluoxetine and Zelapar, should only be used under clinical supervision. Use of Zelapar beyond the recommended dose could lead to non-selectivity and serious adverse effects.

Serious reactions with signs and symptoms that may include diaphoresis, flushing, ataxia, tremor, hyperthermia, hyper/hypotension, seizures, palpitation, dizziness and mental changes that include agitation, confusion and hallucinations progressing to delirium and coma have been reported in some patients receiving a combination of selegiline and fluoxetine. Similar experience has been reported in patients receiving selegiline and two other serotonin reuptake inhibitors, sertraline and paroxetine. There is a potential risk of interaction with fluvoxamine and venlafaxine.

Death has been reported to occur following the initiation of therapy with non

At least 14 days should lapse between the discontinuation of selegiline and initiation of treatment with any drug known to interact with selegiline.

A time interval of 24 hours is recommended between the discontinuation of selegiline and initiation of serotonin agonists.

Patients being treated with selegiline currently or within the past 2 weeks should receive dopamine only after careful risk-benefit assessment, as this combination enhances the risk of hypertensive reactions.

Selegiline should not be given in conjunction with non

Severe CNS toxicity has been reported in patients with the combination of tricyclic antidepressants and selegiline. In one patient receiving amitriptyline and selegiline this included hyperpyrexia and death, and another patient receiving protriptyline and selegiline experienced tremor, agitation, and restlessness followed by unresponsiveness and death two weeks after selegiline was added.

Other adverse reactions occasionally reported in patients receiving a combination of selegiline with various tricyclic antidepressants include hyper/hypotension, dizziness, diaphoresis, tremor, seizures and changes in behavioural and mental status.

Concomitant use of sympathomimetics, nasal decongestants, hypertensive agents, anti-hypertensives, psychostimulants, central suppressant drugs (sedatives, hypnotics) and alcohol should be avoided.

The combination of selegiline and oral contraceptives or drugs for hormone replacement therapy, should be avoided, as this combination may multiply the bioavailability of selegiline.

Foodstuffs containing tyramine have not been found to cause hypertensive reactions during therapy with conventional selegiline tablets at dosages recommended for the treatment of Parkinson's disease. As the selectivity of action of Zelapar for MAO

Concomitant administration of amantadine and anticholinergic drugs can lead to an increased occurrence of side-effects.

In view of the high degree of binding to plasma proteins by selegiline particular attention must be given to patients who are being treated with medicines with a narrow therapeutic margin such as digitalis and/or anticoagulants.

Four patients receiving altretamine and a monamine oxidase inhibitor experienced symptomatic hypotension after four to seven days of concomitant therapy.

Interactions between non-selective MAO

4.6 Pregnancy And Lactation

Selegiline is indicated for the treatment of Parkinson's disease which, in most cases, is a disease occurring after childbearing age. As no work has been done to assess the effects of selegiline on pregnancy and lactation, it should not be used in such cases.

Selegiline should not be used by mothers when breastfeeding as information is lacking concerning whether selegiline passes into breast milk.

4.7 Effects On Ability To Drive And Use Machines

Zelapar has major influence on the ability to drive and use machines, therefore patients should avoid these activities.

4.8 Undesirable Effects

The following undesirable effects have been reported with Zelapar during clinical trials and/or post-marketing use. They are listed below as MedDRA preferred term by system organ class and frequency. Frequencies are defined as: undesirable effects very common (>1/10), common (

System Organ Class

Frequency

Undesirable effects

Psychiatric disorders

common

Confusion, depression, hallucinations, insomnia,

 

uncommon

abnormal dreams, agitation, anxiety, psychoses

Nervous system disorders

common

Dizziness, dyskinesia (including akinesia, bradykinesia), headache, impaired balance, tremor,

Ear and labyrinth disorders

common

vertigo

Cardiac disorders

uncommon

angina pectoris

Vascular disorders

common

Hypertension, hypotension

Respiratory, thoracic and mediastinal disorders

common

nasal congestion, sore throat

uncommon

dyspnoea

 

Gastrointestinal disorders

very common

stomatitis

 

common

constipation, diarrhoea, dry mouth, mouth ulceration, nausea

Skin and subcutaneous tissue disorders

common

sweating increased

Musculoskeletal and connective tissue disorders

common

arthralgia, back pain, muscle cramps

General disorders and administration site conditions

common

fatigue

uncommon

chest pain, irritability

 

Injury, poisoning and procedural complications

common

fall

The following undesirable effects have been reported with selegiline, with an uncommon frequency (

System Organ Class

Undesirable effects

Infections and infestations

pharyngitis

Blood and lymphatic system disorders

Leucocytopenia, thrombocytopenia

Metabolism and nutrition disorders

loss of appetite

Eye disorders

blurred vision

Cardiac disorders

Arrhythmias, palpitations

Vascular disorders

orthostatic hypotension

Skin and subcutaneous tissue disorders

hair loss, skin eruptions

Musculoskeletal and connective tissue disorders

myopathy

Renal and urinary disorders

micturition disorders

General disorders and administration site conditions

ankle oedema

Investigations

transient transaminase increase (ALAT), transient increase in liver enzyme values

In the first 5 years of marketing experience with Zelapar,the following adverse reactions were reported: nausea, confusional state, dizziness, hallucinations and vertigo.

As selegiline potentiates the effect of levodopa, the side-effects of levodopa may be emphasised unless the dosage of levodopa is reduced. The most common undesirable effect reported for conventional tablets is dyskinesia (4% of patients). Once the optimum levodopa dose level has been established, the side-effects produced by the combination will usually be less than those caused by the levodopa therapy on its own.

4.9 Overdose

Zelapar is rapidly metabolised and the metabolites rapidly excreted. In cases of suspected overdosage the patient should be kept under observation for 24 to 48 hours.

No specific information is available about clinically significant overdoses with Zelapar. However, experience gained in use of conventional tablets of selegiline reveals that some individuals exposed to doses of 60 mg/day suffered severe hypotension and psychomotor agitation.

Since the selective inhibition of MAO

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Monoamine oxidase B inhibitors, ATC Code: N04B D01

Zelapar selectively inhibits MAO?

The magnitude of increase in the urinary excretion of ???

Combined with levodopa therapy selegiline reduces, in particular, fluctuation in the condition of patients who suffer from parkinsonism, e.g. on-off symptoms or end

In a clinical trial where patients were switched from 10 mg conventional selegiline tablets to 1.25 mg Zelapar oral lyophilisate, control of motor symptoms was maintained.

Zelapar may be useful in those patients with Parkinson's disease who experience difficulties in swallowing.

5.2 Pharmacokinetic Properties

Zelapar dissolves completely within 10 seconds of placing on the tongue and, in contrast to conventional tablets, selegiline is absorbed primarily pregastrically.

The plasma concentrations of selegiline following single doses of Zelapar 1.25 mg are of the same order as those obtained with conventional 10 mg tablets of selegiline, but are much less variable. The range of AUCs for plasma selegiline is 0.22 to 2.82 ng.h/ml for Zelapar 1.25 mg and 0.05 to 23.64 ng.h/ml for conventional 10 mg tablets. The Cmax ranges are 0.32 to 4.58 ng/ml and 0.07 to 16.0 ng/ml respectively.

After Zelapar 1.25 mg, plasma concentrations of selegiline metabolites, Ndesmethylselegiline, llamphetamine, were reduced by between 88% and 92% in comparison with the concentrations reached after conventional selegiline tablets 10 mg.

Ninety-four per cent of plasma selegiline is reversibly bound to plasma protein. Selegiline is mainly eliminated by metabolism. It is excreted mainly in the urine as metabolites (mainly l

5.3 Preclinical Safety Data

Selegiline has not been sufficiently tested for reproductive toxicity. Studies with selegiline revealed no evidence of mutagenic or carcinogenic effects. The only safety concerns for human use derived from animal studies were effects associated with an exaggerated pharmacological action.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Gelatin

Mannitol

Glycine

Aspartame

Citric Acid anhydrous

Grapefruit flavour

Yellow Colouring (yellow iron oxide [E172], hypromellose [E464]).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Sealed sachets - 3 years.

Opened sachets - 3 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PE/PVdC blister packs sealed with aluminium foil enclosed in a paper/PE/aluminium foil/PE sachet. Each pack contains 10, 30, 60 or 100 oral lyophilisates. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

United Kingdom

8. Marketing Authorisation Number(S)

PL 16260/0031

9. Date Of First Authorisation/Renewal Of The Authorisation

04 June 2010

10. Date Of Revision Of The Text

20 June 2010



Generic Name: phenylephrine and zinc ophthalmic (fen ill EFF rin and zink off THAL mick)



Pronunciation: zink/VYE-ta-min



Generic Name: ondansetron (Oral route, Oromucosal route)

on-DAN-se-tron

Commonly used brand name(s)

In the U.S.

Zofran Zofran ODT Zuplenz

Available Dosage Forms:

Film Tablet, Disintegrating Tablet Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Zofran ODT

Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Before Using Zofran ODT

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 ondansetron in children under 4 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 ondansetron in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. 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.

Apomorphine Cisapride Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin 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 Alfuzosin Amiodarone Amitriptyline Amoxapine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bretylium Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enflurane Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Halothane Ibutilide Iloperidone Isoflurane Isradipine Lapatinib Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Paliperidone Pazopanib Perflutren Lipid Microsphere Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Salmeterol Saquinavir Sematilide Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

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.

Cyclophosphamide 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:

Allergy to other selective 5-HT3 receptor antagonists (alosetron Lotronex], dolasetron [Anzemet], granisetron [Kytril], palonosetron [Aloxi])—Use with caution. It is likely you will also be allergic to ondansetron. Bowel blockage or Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems. Heart rhythm problems (e.g., prolonged QT interval)—Use with caution. May make this condition worse. Liver disease—May have an increased chance of side effects. Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse. Proper Use of ondansetron

This section provides information on the proper use of a number of products that contain ondansetron. It may not be specific to Zofran ODT. 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.

To use the oral disintegrating tablet:

Make sure your hands are dry. Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet. Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

To use the oral soluble film:

Make sure your hands are clean and dry before and after using this medicine. Fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the film out from the pouch. Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole. Once the film is dissolved, you may swallow with or without water.

If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 (oral disintegrating tablets, solution, or tablets): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days. Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment. Children younger than 12 years of age—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) one hour before anesthesia is given. Children—Use and dose must be determined by your doctor. For oral dosage form (soluble film): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days. Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—One 8-milligram (mg) film three times a day. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film. Children—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.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. 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.

Precautions While Using Zofran ODT

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

Zofran ODT 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 Confusion dizziness fast heartbeat fever headache shortness of breath weakness Less common Decrease in the frequency of urination decrease in urine volume difficulty with passing urine (dribbling) painful urination Rare Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness convulsions cough decreased urine difficulty with breathing difficulty with swallowing dry mouth fast, pounding, or irregular heartbeat or pulse hives increased thirst itching loss of appetite loss of bladder control loss of consciousness mood changes muscle pain or cramps nausea or vomiting noisy breathing numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash sweating tightness in the chest total body jerking unusual tiredness or weakness wheezing Incidence not known Blurred vision dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fixed position of the eye heart stops hoarseness inability to move the eyes increased blinking or spasms of the eyelid large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs no breathing no pulse or blood pressure noisy breathing pounding heartbeat slow or irregular breathing sticking out of the tongue sweating trouble with breathing, speaking, or swallowing unconscious uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressions

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 Anxiety difficulty having a bowel movement (stool) dry mouth general feeling of discomfort or illness hyperventilation irritability restlessness shaking trouble sleeping Rare Difficulty with speaking drooling loss of balance control muscle trembling, jerking, or stiffness shuffling walk stiffness of the limbs twisting movements of the body uncontrolled movements, especially of the face, neck, and back Incidence not known Feeling of warmth hiccups hives or welts redness of the face, neck, arms, and occasionally, upper chest redness of the skin

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: Zofran ODT Oral, Oromucosal 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 Zofran ODT Oral, Oromucosal resources Zofran ODT Oral, Oromucosal Side Effects (in more detail) Zofran ODT Oral, Oromucosal Use in Pregnancy & Breastfeeding Drug Images Zofran ODT Oral, Oromucosal Drug Interactions Zofran ODT Oral, Oromucosal Support Group 9 Reviews for Zofran ODT Oral, Oromucosal - Add your own review/rating Compare Zofran ODT Oral, Oromucosal with other medications Alcohol Dependence Gastroenteritis Nausea/Vomiting Nausea/Vomiting, Chemotherapy Induced Nausea/Vomiting, Postoperative Nausea/Vomiting, Radiation Induced Obsessive Compulsive Disorder Postanesthetic Shivering Pruritus



Pronunciation: ra-NI-ti-deen



Pronunciation: HYE-droe-KOR-ti-sone AS-e-tate/pram-OX-een



1. Name Of The Medicinal Product

ZAMADOL 24hr 150 (200/300/400) mg prolonged release tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 150 (200/300/400) mg of tramadol hydrochloride

Excipient: Each prolonged-release tablet contains 0.60 (1.00/1.40/1.80) mg lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged release tablet

White film coated tablets marked T 150 (200/300/400)

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

ZAMADOL 24hr tablets should be taken at 24-hourly intervals and must be swallowed whole and not chewed.

As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient. The correct dosage for any individual patient is that which controls the pain with no or tolerable side effects for a full 24 hours. Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the ZAMADOL 24hr range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported. (See Section 4.4 Special Warnings and Precautions for Use).A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.

Adults and children over 12 years: The usual initial dose is one 150 mg tablet daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.

Elderly patients: Dosing as for adults. The elimination half-life of tramadol may be prolonged in patients over 75 years . A starting dose of 150 mg daily is recommended. Dose titration upwards should be carefully monitored.

Patients with renal or hepatic insufficiency: The elimination half-life of tramadol may be prolonged in these patient populations. A starting dose of 150 mg daily is recommended. Dose titration upwards should be carefully monitored. Tramadol is not recommended for patients with severe renal impairment and/or severe hepatic impairment.

As tramadol is only removed very slowly by haemodialysis or by haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.

Children under 12 years: ZAMADOL 24hr has not been studied in children. Safety and efficacy of ZAMADOL 24hr have not been established and the product should not be used in children.

4.3 Contraindications

Hypersensitivity to tramadol or to any of the excipients; acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.

Tramadol must not be used for narcotic withdrawal treatment.

4.4 Special Warnings And Precautions For Use

Warnings

At therapeutic doses withdrawal symptoms have been reported at a frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly.

In patients with a tendency to drug abuse or dependence, treatment should be for short periods and under strict medical supervision.

Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.

Precautions

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold. (See Section 4.5 Interactions with other Medicaments and other forms of Interaction).

Tramadol should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock.

Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent administration of tramadol with other centrally acting drugs, including alcohol, may potentiate CNS depressant effects.

Simultaneous treatment with carbamazepine may shorten the analgesic effect as a result of a reduction in serum levels of tramadol and its active metabolite.

Co-administration with cimetidine is associated with a small prolongation of the half-life of tramadol, but this is not clinically relevant.

Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors (SSRIs), tricyclic anti-depressants (TCAs), anti-psychotics and other seizure threshold lowering drugs to cause convulsions (see Section 4.4 Special Warnings and Special Precautions for Use and 5.2 Pharmacokinetic Properties). Co-administration with SSRIs may lead to an increase of 5HT associated effects.

Co-administered ritonavir may increase serum concentration of tramadol resulting in tramadol toxicity.

Digoxin toxicity has occurred rarely during co-administration of digoxin and tramadol.

MAO inhibitors: A serotoninergic syndrome is likely to occur: diarrhoea, tachycardia, sweating, tremor, confusion, coma. In case of recent treatment with MAOIs, treatment with tramadol should not be started until 15 days after cessation of treatment with MAOIs.

Other morphine derivatives (including anti-tussives, substitution treatments), benzodiazepines, barbiturates: Increased risk of respiratory depression, that may be fatal in overdosage.

Mixed agonists/antagonists (eg buprenorphine, nalbuphine, pentazocine): The analgesic effect of tramadol which is a pure agonist may be reduced, and a withdrawal syndrome may occur.

There have been isolated reports of interaction with coumarin anticoagulants resulting in an increased INR and so care should be taken when commencing treatment with tramadol in patients on anticoagulants.

The analgesic effect of tramadol is in part mediated by inhibition of the re-uptake of norepinephrine and enhancement of the release of serotonin (5-HT). In studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirements of tramadol in patients with postoperative pain.

4.6 Pregnancy And Lactation

There are no adequate data from the use of tramadol in pregnant women. Animal studies have shown reproductive toxicity, but not teratogenic effects (see section 5.3). Tramadol crosses the placental barrier and chronic use during pregnancy can cause withdrawal symptoms in the new-born baby. Therefore, it should not be used during pregnancy.

Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in respiratory rate which are not usually clinically relevant.

During lactation very small amounts of tramadol and its metabolites (approximately 0.1% of an intravenous dose) are found in human breast milk. Therefore tramadol should not be administered during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Tramadol may cause drowsiness, blurred vision and dizziness which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery.

4.8 Undesirable Effects

The following frequency categories form the basis for classification of the undesirable effects:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000) not known (cannot be estimated from the available data)

 

Very Common

Common

Uncommon

Rare

Very Rare

Immune system disorders

 

 

 

 

 

 

Hypersensitivity

Anaphylactic reaction

 

 

Psychiatric disorders

 

 

 

 

 

 

Hallucinations

Nightmare

Mood altered

Elevated mood

Dysphoria

Decreased activity

Illusion

Agitation

Anxiety

Nervousness

Insomnia

Nervous system disorders

Dizziness

 

 

Headache

Paraesthesia

Increased activity

Cognitive disorder

Sensory disturbance

Judgement impaired

Convulsion

Hyperkinesia

Tremor

Eye disorders

 

 

 

 

 

 

Blurred vision

 

 

Cardiac disorders

 

 

 

 

Palpitations

Tachycardia

Bradycardia

 

 

Vascular disorders

 

 

 

 

Orthostatic hypotension

Circulatory collapse

Hypertension

Flushing

 

 

Respiratory, thoracic and mediastinal disorders

 

 

 

 

 

 

Dyspnoea

Asthma

Respiratory depression

Bronchospasm

Wheezing

 

 

Gastro-intestinal disorders

Nausea

Vomiting

Dry mouth

Retching

Constipat-ion

Abdominal discomfort

Anorexia

Diarrhoea

Gastro-intestinal disorder

Hepatobiliary disorders

 

 

 

 

 

 

 

 

Hepatic enzyme increased

Skin and subcutaneous tissue disorders

 

 

Hyperhidrosis

Pruritus

Rash

Urticaria

Angioedema

 

 

Renal and urinary disorders

 

 

 

 

 

 

Micturition disorder

Dysuria

Urinary retention

 

 

Musculoskeletal and connective tissue disorders

 

 

 

 

 

 

Muscular weakness

 

 

General disorders and administration site conditions Investigations

 

 

 

 

 

 

 

 

Drug withdrawal syndrome

4.9 Overdose

Symptoms of overdosage are typical of other opioid analgesics, and include miosis, vomiting, cardiovascular collapse, sedation and coma, seizures and respiratory depression. In severe cases tramadol overdose may result in a fatal outcome.

Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam.

Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with tramadol with haemodialysis or haemofiltration alone is not suitable for detoxification.

Emptying the gastric contents is useful to remove any unabsorbed drug, particularly when a modified release formulation has been taken.

5. Pharmacological Properties

Pharmacotherapeutic group: N02A X02

5.1 Pharmacodynamic Properties

Tramadol is a centrally acting analgesic (N02A X02). It is a non selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms that may contribute to its analgesic effect are inhibition of neuronal re-uptake of noradrenaline and 5HT.

5.2 Pharmacokinetic Properties

Following oral administration of a single dose, tramadol is almost completely absorbed and the absolute bioavailability is approximately 70%. Tramadol is metabolised to O

Following administration of one ZAMADOL 24hr tablet 200 mg in the fasting state, a mean peak plasma concentration (Cmax) of 192 ng.ml-1 was attained. This was associated with a median tmax of 6 hours (range 4-8 hours). The availability of tramadol from the ZAMADOL 24hr tablet 200 mg was complete when compared with an immediate release tramadol solution 100 mg, after dose adjustment. In the presence of food, the availability and controlled release properties of ZAMADOL 24hr tablets were maintained, with no evidence of dose-dumping.

A single dose-proportionality study has confirmed a linear pharmacokinetic response (in relation to tramadol and O-desmethyltramadol) following administration of the 200 mg, 300 mg and 400 mg tablets. A steady state study has confirmed the dose adjusted bioequivalence of the 150 mg and 200 mg tablets administered once-daily. This study also confirmed that the ZAMADOL 24hr tablet 150 mg provided an equivalent peak concentration and extent of availability of tramadol to an immediate release capsule 50 mg administered 8-hourly. On this basis it is recommended that patients receiving immediate release tramadol should be transferred initially to the nearest daily dose of ZAMADOL 24hr tablets. It may be necessary to titrate the dose thereafter.

A further steady state study has demonstrated that immediate release tramadol tablets 50 mg, administered 6-hourly, provided plasma concentrations that were greater than would have been anticipated following administration of a single dose. This observation is consistent with a non-linear elimination of the drug substance. In contrast, the plasma concentrations from ZAMADOL 24hr tablet 200 mg administered once-daily were in line with single dose data, confirming that the controlled delivery of tramadol from ZAMADOL 24hr minimises the non-linearity associated with faster-releasing preparations. The more predictable plasma concentrations may lead to a more manageable dose titration process.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.

Studies in rats and rabbits have revealed no teratogenic effects. However, embryotoxicity was shown in the form of delayed ossification. Fertility, reproductive performance and development of offspring were unaffected.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core

Hydrogenated vegetable oil

Talc

Magnesium stearate

Film coat

Lactose Monohydrate

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol 4000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30oC.

6.5 Nature And Contents Of Container

1) PVC blisters with aluminium backing foil (containing 2, 7, 10, 14, 15, 20, 28, 30, 50,56, 60 or 100 tablets).

2) Polypropylene containers with polyethylene lids (containing 2, 7, 10, 14, 15, 20, 28, 30, 50,56, 60 or 100 tablets).

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

UK

8. Marketing Authorisation Number(S)

PL 16950/0084 (85/86/87)

9. Date Of First Authorisation/Renewal Of The Authorisation

7 November 2001/19 June 2006

10. Date Of Revision Of The Text

August 2009



Generic Name: zinc sulfate (ZINK SUL fate)



1. Name Of The Medicinal Product

Zamadol SR 50 mg prolonged-release hard capsules

Zamadol SR 100 mg prolonged-release hard capsules

Zamadol SR 150 mg prolonged-release hard capsules

Zamadol SR 200 mg prolonged-release hard capsules

2. Qualitative And Quantitative Composition

One capsule contains 50 mg, 100mg, 150mg, 200mg of tramadol hydrochloride

This product contains the excipients sucrose (9.375 18.75 28.125 37.5mg/capsule).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged release hard capsule.

The 50 mg capsules are dark green and marked T50SR.

The 100 mg capsules are white and marked T100SR

The 150 mg capsules are dark green and marked T150SR

The 200 mg capsules are yellow and marked T200SR

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

The capsules are intended for twice daily oral administration and can be taken independently of meal times, swallowed whole with water.

As with all analgesic drugs the dosing of Zamadol SR prolonged-release hard capsules should be adjusted depending on the severity of the pain and the individual clinical response of the patient. The dose used should be the lowest dose that provides pain relief.

Adults:

The usual initial dose is 50-100 mg twice daily, morning and evening. This dose may be titrated up to 150-200 mg twice daily according to pain severity.

If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.

A total oral daily dose of 400 mg should not be exceeded except in special clinical circumstances.

Elderly patients:

Dosing as for adults, however it should be noted that in patients over 75 years there tends to be an increase in absolute bioavailability of tramadol and a 17% increase in the terminal elimination half-life. An adjustment of the dosage or the dose interval may be required.

Patients with renal or hepatic insufficiency:

As the elimination of tramadol may be prolonged in patients with severe renal and/or hepatic impairment, the use of Zamadol SR prolonged-release hard capsulesis not recommended. In moderate cases an adjustment of the dosage interval may be required.

Patients who have difficulty in swallowing:

Zamadol SR prolonged-release hard capsules can be opened, carefully, so that the pellets are deposited on a spoon. The spoon and pellets should be taken into the mouth, followed by a drink of water to rinse the mouth of all pellets. The pellets must not be chewed or crushed.

Children and adolescents :

Over 12 years: Dosage as for adults.

Under 12 years: Zamadol SR prolonged-release hard capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

4.3 Contraindications

Zamadol SR prolonged-release hard capsules should not be given to patients who have previously shown hypersensitivity to the active substance tramadol or to any of the other excipients.

The product should not be administered to patients suffering from acute intoxication with hypnotics, centrally acting analgesics, opioids, psychotropic drugs or alcohol.

Tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within 2 weeks of their withdrawal.

Contra-indicated in patients suffering from uncontrolled epilepsy.

Tramadol must not be used for narcotic withdrawal treatment.

4.4 Special Warnings And Precautions For Use

Warnings:

Tramadol has a low dependence potential. On long-term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment should be for short periods under strict medical supervision. In rare cases at therapeutic doses, tramadol has the potential to cause withdrawal symptoms.

Zamadol SR prolonged-release hard capsules are not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist.

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold (see section 4.5).

This medicinal product contains sucrose and therefore should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Precautions:

Zamadol SR prolonged-release hard capsules should be used with prudence in patients who have shown previous hypersensitivity to opiates, and in patients with severe renal or hepatic impairment, head injury, decreased level of consciousness, increased intracranial pressure, or patients in shock or at risk of convulsions.

At recommended therapeutic doses Zamadol SR prolonged-release hard capsules are unlikely to produce clinically relevant respiratory depression. Care should however be taken when administering Zamadol SR prolonged-release hard capsules to patients with existing respiratory depression or excessive bronchial secretion and in those patients taking concomitant CNS depressant drugs.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients treated with monoamine oxidase inhibitors within 14 days prior to the administration of the opioid pethidine have experienced life-threatening interactions affecting the central nervous system as well as the respiratory and circulatory centres. The possibility of similar interactions occurring between monoamine oxidase inhibitors and tramadol cannot be ruled out.

Tramadol may potentiate the CNS depressant effects of other centrally acting drugs (including alcohol) when administered concomitantly with such drugs.

Tramadol may increase the potential for selective serotonin re-uptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), anti-psychotics and other seizure threshold lowering drugs to cause convulsions (see section 4.4).

Isolated cases of serotonergic syndrome have been reported with the therapeutic use of tramadol in combination with other serotonergic agents such as selective serotonin re-uptake inhibitors (SSRIs). Serotonergic syndrome can be manifested by symptoms such as confusion, restlessness, fever, sweat, ataxia, hyperreflexia, myoclonia and diarrhoea. Withdrawal of the serotonergic agent produces a rapid improvement.

Administration of Zamadol SR prolonged-release hard capsules together with carbamazepine results in markedly decreased serum concentrations of tramadol which may reduce analgesic effectiveness and shorten the duration of action.

Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives (e.g. warfarin) due to reports of increased INR and ecchymoses in some patients.

The combination of mixed agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and tramadol is not recommended because it is theoretically possible that the analgesic effect of a pure agonist is attenuated under these circumstances.

The analgesic effect of tramadol is in part mediated by inhibition of the re-uptake of norepinephrine and enhancement of the release of serotonin (5-HT). In studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirements of tramadol in patients with postoperative pain.

There is no interaction with food.

4.6 Pregnancy And Lactation

Pregnancy:

Zamadol SR prolonged-release hard capsules should not be used during pregnancy as there is inadequate evidence available to assess the safety of tramadol in pregnant women. Tramadol - administered before or during birth - does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant.

Lactation:

Zamadol SR prolonged-release hard capsules should not be administered during breast feeding as tramadol and its metabolites have been detected in breast milk. 0.1% of the dose administered to the mother may be excreted in milk.

4.7 Effects On Ability To Drive And Use Machines

Zamadol SR prolonged-release hard capsules may cause drowsiness and this effect may be potentiated by alcohol, anti-histamines and other CNS depressants. If patients are affected they should be warned not to drive or operate machinery.

4.8 Undesirable Effects

The most commonly reported adverse drug reactions are nausea and dizziness, both occurring in more than 10% of patients.

Immune system disorders:

Rare (

Metabolism and nutrition disorders:

Rare (

Psychiatric disorders:

Rare (1/10,000 to < 1/1,000): psychic side-effects may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders), hallucinations, confusion, sleep disturbances and nightmares.

Prolonged administration of Zamadol SR prolonged-release hard capsules may lead to dependence (see section 4.4). Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

Nervous system disorders:

Very common (1/10) dizziness.

Common (

Rare (

Paraesthesia and tremor.

Very rare (< 1/10,000): vertigo

Eye disorders:

Rare (

Cardiac disorders:

Uncommon (1/1,000 to < 1/100): effects on cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse effects may occur especially on intravenous administration and in patients who are physically stressed.

Rare (1/10,000 to < 1/1,000): bradycardia, increase in blood pressure.

Vascular disorders:

Very rare (< 1/10,000): flushing.

Respiratory disorders:

Worsening of asthma has also been reported, though a causal relationship has not been established.

Respiratory depression has been reported. If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (see section 4.5 "Interaction with other medicinal products and other forms of interaction") respiratory depression may occur.

Gastrointestinal disorders:

Very common (1/10): vomiting, nausea.

Common (1/100 to < 1/10): constipation, dry mouth.

Uncommon (1/1,000 to < 1/100): retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating).

Hepatobiliary disorders:

In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.

Skin and subcutaneous tissue disorders:

Common (1/100 to < 1/10): sweating.

Uncommon (1/1,000 to < 1/100): dermal reactions (e.g. pruritus, rash, urticaria).

Musculoskeletal, connective tissue and bone disorders:

Rare (1/10,000 to < 1/1,000): motorial weakness.

Renal and urinary system disorders:

Rare (1/10,000 to < 1/1,000): micturition disorders (difficulty in passing urine and urinary retention).

General disorders:

Common (

4.9 Overdose

Symptoms of tramadol overdose include vomiting, miosis, sedation, seizures, respiratory depression and hypotension, with circulatory failure and coma. Respiratory failure may also occur. Such symptoms are typical of opioid analgesics.

Treatment of overdose requires the maintenance of the airway and cardiovascular functions. Respiratory depression may be reversed using naloxone and fits controlled with diazepam. Naloxone administration may increase the risk of seizures.

The treatment of acute overdose of tramadol using haemodialysis or haemofiltration alone is not sufficient or suitable due to the slow elimination of tramadol from the serum by these routes.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other opioids, ATC code: N02AX02

Tramadol is a centrally acting analgesic which possesses opioid agonist properties. Tramadol consists of two enantiomers, the (+)-isomer is predominantly active as an opioid with preferential activity for the ?-receptor. The (-)-isomer potentiates the analgesic effect of the (+)-isomer and is active as an inhibitor of noradrenaline and serotoninuptake thereby modifying the transmission of pain impulses.

Tramadol also has an antitussive action. At the recommended dosages, the effects of tramadol given orally on the respiratory and cardiovascular systems appear to be clinically insignificant. The potency of tramadol is reported to be 1/10 to 1/6 of morphine.

5.2 Pharmacokinetic Properties

About 90% of tramadol released from Zamadol SR prolonged-release hard capsules is absorbed after oral administration. The mean absolute bioavailability is approximately 70%, irrespective of concomitant intake of food.

The difference between absorbed and non-metabolised available tramadol is probably due to low first-pass effect. The first pass-effect after oral administration is a maximum of 30%.

Tramadol has a high tissue affinity with an apparent volume of distribution of 203 ± 40 litres after oral dosing in healthy volunteers. Protein binding is limited to 20%.

After single dose administration of Zamadol SR 50 mg prolonged-release hard capsules the peak plasma concentration Cmax 70 ± 16 ng/ml is reached after 5.3 h. After administration of Zamadol SR 100 mg prolonged-release hard capsules Cmax 137 ± 27 ng/ml is reached after 5.9 h. Following administration of Zamadol SR 200 mg prolonged-release hard capsules Cmax 294 ± 82 ng/ml is reached after 6.5 h. The reference product (Tramadol Immediate Release Capsules, given as a total dose of 200 mg tramadol hydrochloride) reached a peak concentration of Cmax 640 ± 143 ng/ml after 2.0 hours.

The relative bioavailability for the slow release formulation after single dose administration is 89% and increases to 100% after multiple dose administration in comparison to the reference product.

Tramadol passes the blood-brain and placenta barriers. Very small amounts of the substance and its O-demethyl derivative are found in the breast-milk (0.1% and 0.02% respectively of the applied dose).

Elimination of half-life t??is approximately 6 h, irrespective of the mode of administration. In patients above 75 years of age it may be prolonged by a factor of 1.4.

In humans tramadol is mainly metabolised by means of N- and O-demethylation and conjugation of the O-demethylation products with glucuronic acid. Only O-desmethyltramadol is pharmacologically active. There are considerable interindividual quantitative differences between the other metabolites. So far, eleven metabolites have been found in the urine. Animal experiments have shown that O-desmethyltramadol is more potent than the parent substance by the factor 2-4. Its half life t?? (6 healthy volunteers) is 7.9 h (range 5.4-9.6 h) and is approximately that of tramadol.

The inhibition of one or both cytochrome P450 isoenzymes, CYP3A4 and CYP2D6 involved in the metabolism of tramadol, may affect the plasma concentration of tramadol or its active metabolite. The clinical consequences of any such interactions are not known.

Tramadol and its metabolites are almost completely excreted via the kidneys. Cumulative urinary excretion is 90% of the total radioactivity of the administered dose. In cases of impaired hepatic and renal function the half-life may be slightly prolonged. In patients with cirrhosis of the liver, elimination half-lives of 13.3 ± 4.9 h (tramadol) and 18.5 ± 9.4 h (O-desmethyltramadol), in an extreme case 22.3 h and 36 h respectively have been determined. In patients with renal insufficiency (creatinine clearance < 5 ml/min) the values were 11 ± 3.2 h and 16.9 ± 3 h, in an extreme case 19.5 h and 43.2 h, respectively.

Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range.

The relationship between serum concentrations and the analgesic effect is dose-dependent, but varies considerably in isolated cases. A serum concentration of 100 - 300 ng/ml is usually effective.

5.3 Preclinical Safety Data

Pre-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. Studies of tramadol in rats and rabbits have revealed no teratogenic effects. However, embryo toxicity was shown in the form of delayed ossification. Fertility, reproductive performance and development of offspring were unaffected.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Capsule Contents: Sugar spheres (sucrose and maize starch), colloidal anhydrous silica, ethylcellulose, shellac, talc.

Capsule Shell: Gelatin, Titanium Dioxide (E171)

The 50 mg and 150 mg capsules also contain Iron Oxide Yellow (E172) and Indigotine (E132).

The 200 mg capsules also contain Iron Oxide Yellow (E172)

Printing ink contains shellac, iron oxide black (E172) and propylene glycol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5 Nature And Contents Of Container

White opaque PVC/PVDC and aluminium foil blisters. Each blister contains 10 capsules.

Each pack contains 10, 20, 30, 50, 60 or 100 capsules per pack.

Not all pack sizes may be marketed in all Member States.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

8. Marketing Authorisation Number(S)

PL 15142/0120

PL 15142/0121

PL 15142/0122

PL 15142/0123

9. Date Of First Authorisation/Renewal Of The Authorisation

September 2007

10. Date Of Revision Of The Text

10 September 2009



Zirtek ALLERGY RELIEF

cetirizine hydrochloride

ONE A DAY

What You Should Know About Your Tablets

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy Relief. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy Relief

Each tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating hydroxypropylmethyl cellulose (E464), titanium dioxide (E171) and polyethylene glycol.

The tablets are small white oblong film-coated tablets, each scored and bearing the code Y/Y. Your medicine is supplied in blister packs of 7 tablets.

Your medicine belongs to the antihistamine group of drugs.

Product licence number: PL 00039 / 0561

This medicine is manufactured and licenced by:

UCB Pharma Ltd 208 Bath Road Slough SL1 3WE When Is Zirtek Allergy Relief Used

This medicine treats people suffering from hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like Zirtek Allergy Relief relieve the unpleasant symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

Before Taking ZirtekAllergy Relief

If you are pregnant or if your doctor has told you that you have kidney problems, you should consult your doctor before taking these tablets. You should not take this medicine if you are breastfeeding or if you have ever had an allergic reaction to any of its constituents (see 'What is in Zirtek Allergy Relief).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

As with all antihistamines, you should avoid excessive alcohol consumption when taking your tablets.

If you have ever had a reaction to an antihistamine in the past consult your doctor or pharmacist before taking these tablets.

How To Take Your Tablets

Adults and children aged 12 years and over should take one tablet daily.

Each dose should be taken with water.

REMEMBER... If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

If you accidentally take a larger dose than recommended consult your doctor immediately.

You may feel drowsy or dizzy, taking half your dose twice a day may reduce this.

Zirtek Allergy Relief tablets are not for use in children under 12 years of age.

If symptoms persist consult your doctor.

After Taking Zirtek Allergy Relief Tablets

These tablets do not cause side-effects in most people. However, as with all medicines, some people can react differently. If you:

have frequent headaches have an upset stomach become agitated have diarrhoea get a dry mouth feel weak and/or unwell experience unusual touch sensation experience fatigue, dizziness or drowsiness experience itchiness and skin rash

Stop taking the tablets and tell your doctor.

Other rare side effects have been reported such as bleeding and bruising easily, rapid heart beat, difficulty focussing, blurred vision, swelling, allergic reaction/shock, changes in liver function, fits, confusion, depression, aggression, weight increase, unusual limb movements, experience a bad taste in the mouth, fainting, hallucination, insomnia, bed wetting, pain and/or difficulty passing water, red and/or blotchy skin rash.

If you notice anything unusual or have these or any other unexpected effects stop taking the tablets and tell you doctor. These tablets do not normally cause drowsiness. However, individuals can react differently to treatment. If you are affected you should not drive or operate machinery, but should persist with the tablets as any drowsiness doesn't usually last very long.

Storing Your Tablets.

Keep your tablets out of reach and sight of children.

Do not use after the expiry date shown under EXP on the end panel of the carton.

LEGAL STATUS: GSL.

Date of preparation of this leaflet: October 2005

© UCB 2004 - UCB logo



Generic Name: acyclovir (Oral route, Intravenous route)

ay-SYE-kloe-vir

Commonly used brand name(s)

In the U.S.

Zovirax

In Canada

Acyclovir

Available Dosage Forms:

Suspension Tablet Capsule Solution Powder for Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Uses For Zovirax

Acyclovir belongs to the family of medicines called antivirals, which are used to treat infections caused by viruses. Usually these medicines work for only one kind or group of virus infections.

Acyclovir is used to treat the symptoms of chickenpox, shingles, herpes virus infections of the genitals (sex organs), the skin, the brain, and mucous membranes (lips and mouth), and widespread herpes virus infections in newborns. Acyclovir is also used to prevent recurrent genital herpes infections. Although acyclovir will not cure herpes, it does help relieve the pain and discomfort and helps the sores (if any) heal faster.

Acyclovir may also be used for other virus infections as determined by your doctor. However, it does not work in treating certain virus infections, such as the common cold.

Acyclovir is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, acyclovir by injection is used in certain patients with the following medical conditions:

Herpes simplex (for prevention of repeated infections) in people with a weak immune system Herpes zoster infections of the eye Shingles (for prevention of repeated infections) in people with a weak immune system Before Using Zovirax

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

A limited number of studies have been done using oral acyclovir in children, and it has not caused different effects or problems in children than it does in adults.

Geriatric

Agitation, confusion, dizziness, and drowsiness may be especially likely to occur in elderly patients who are usually more sensitive than younger adults to the central nervous system effects of acyclovir.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Tizanidine Varicella Virus Vaccine

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.

Fosphenytoin Phenytoin Valproic Acid 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:

Dehydration or Kidney disease—Dehydration or kidney disease may increase blood levels of acyclovir, increasing the chance of side effects. Nervous system problems—Acyclovir may make these problems worse. Proper Use of Zovirax

Patient information about the treatment of herpes, chickenpox, or shingles is available with this medicine. Read it carefully before using this medicine.

Acyclovir is best used as soon as possible after the symptoms of herpes infection or shingles (for example, pain, burning, blisters) begin to appear.

If you are taking acyclovir for the treatment of chickenpox, it is best to start taking acyclovir as soon as possible after the first sign of the chickenpox rash, usually within one day.

Acyclovir capsules, tablets, and oral suspension may be taken with meals or on an empty stomach.

Acyclovir is best taken with a full glass (8 ounces) of water.

If you are using acyclovir oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your herpes infection, chickenpox, or shingles, keep taking acyclovir for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses. However, do not use this medicine more often or for a longer time than your doctor ordered.

If you are taking acyclovir capsules, tablets, or oral suspension, you should drink plenty of water to avoid becoming dehydrated.

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 (capsules, oral suspension, or tablets): For treatment of genital herpes: Adults and children 12 years of age and older—200 milligrams (mg) five times a day for ten days. Children up to 12 years of age—Use and dose must be determined by the doctor. For prevention of recurrent outbreaks of genital herpes infections: Adults and children 12 years of age and older—200 to 400 mg two to five times a day for five days or up to twelve months, depending on how often your outbreaks of infection occur. Children up to 12 years of age—Use and dose must be determined by the doctor. For treatment of chickenpox: Adults and children who weigh over 88 pounds (40 kilograms)—800 mg four times a day for five days. Children 2 years of age and older and weighing 88 pounds (40 kilograms) or less—Dose is based on body weight and must be determined by the doctor. The usual dose is 20 mg per kilogram (kg) of body weight, up to 800 mg, four times a day for five days. Children up to 2 years of age—Use and dose must be determined by the doctor. For treatment of shingles: Adults and children 12 years of age and older—800 mg five times a day for seven to ten days. Children up to 12 years of age—Use and dose must be determined by the doctor. For injection dosage form: For treatment of herpes of the brain, genitals, or mucous membranes, or for the treatment of shingles: Adults and children 12 years of age and older—Dose is based on body weight and must be determined by the doctor. The usual dose is 5 to 10 mg of acyclovir per kg (2.3 to 4.5 mg per pound) of body weight, injected slowly into a vein over at least a one-hour period, and repeated every eight hours for five to ten days. Children up to 12 years of age—Dose is based on body weight and must be determined by the doctor. The usual dose is 10 mg to 20 mg of acyclovir per kg (4.5 mg to 9.1 mg per pound) of body weight, injected slowly into a vein over at least a one-hour period and repeated every eight hours for seven to ten days. For treatment of widespread herpes virus infection in newborns: Infants from birth to 3 months of age—Dose is based on body weight and must be determined by the doctor. The usual dose is 10 mg of acyclovir per kg (4.5 mg per pound) of body weight, injected slowly into a vein over at least a one-hour period and repeated every eight hours for ten days. 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.

Precautions While Using Zovirax

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

The areas affected by herpes, chickenpox, or shingles should be kept as clean and dry as possible. Also, wear loose-fitting clothing to avoid irritating the sores (blisters).

It is important to remember that acyclovir will not keep you from spreading herpes to others.

Herpes infection of the genitals can be caught from or spread to your partner during any sexual activity. Even though you may get herpes if your partner has no symptoms, the infection is more likely to be spread if sores are present. This is true until the sores are completely healed and the scabs have fallen off. Therefore, it is best to avoid any sexual activity if either you or your sexual partner has any symptoms of herpes. The use of a latex condom (“rubber”') may help prevent the spread of herpes. However, spermicidal (sperm-killing) jelly or a diaphragm will probably not help.

Zovirax 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 - For acyclovir injection only Pain, swelling, or redness at place of injection Less common Abdominal or stomach pain decreased frequency of urination or amount of urine increased thirst loss of appetite nausea or vomiting unusual tiredness or weakness Rare Black, tarry stools blood in urine or stools chills, fever, or sore throat confusion convulsions (seizures) hallucinations (seeing, hearing, or feeling things that are not there) hives pinpoint red spots on skin trembling unusual bleeding or bruising Frequency not determined Bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder), continuing blistering, peeling, or loosening of skin bluish coloring, especially of the hands and feet blurred vision bruising at the place of injection changes in facial skin color changes in vision clumsiness coughing decreased consciousness difficulty in breathing or swallowing dizziness or feeling faint, severe fast heartbeat irritability itching or skin rash large hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs mood or mental changes muscle cramps, pain, or weakness pale skin red or irritated eyes sense of agitation or uneasiness shakiness and unsteady walk sores, ulcers, or white spots in mouth or on lips swelling of eyelids, face, feet, hands, lower legs or lips swollen, painful, or tender lymph nodes (glands) in neck, armpit, or groin unsteadiness or other problems with muscle control or coordination yellow eyes or skin

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 - Especially seen with high doses General feeling of discomfort or illness Less common - Especially seen with long-term use or high doses Diarrhea headache Frequency not determined Burning, prickling, or tingling sensations drowsiness loss of hair

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: Zovirax Oral, Intravenous 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 Zovirax Oral, Intravenous resources Zovirax Oral, Intravenous Side Effects (in more detail) Zovirax Oral, Intravenous Use in Pregnancy & Breastfeeding Drug Images Zovirax Oral, Intravenous Drug Interactions Zovirax Oral, Intravenous Support Group 11 Reviews for Zovirax Oral, Intravenous - Add your own review/rating Compare Zovirax Oral, Intravenous with other medications Herpes Simplex Herpes Simplex Encephalitis Herpes Simplex, Mucocutaneous/Immunocompetent Host Herpes Simplex, Mucocutaneous/Immunocompromised Host Herpes Simplex, Suppression Herpes Zoster Varicella-Zoster



Address Zogenix, Inc,



Generic Name: zonisamide (Oral route)

zoe-NIS-a-mide

Commonly used brand name(s)

In the U.S.

Zonegran

Available Dosage Forms:

Capsule Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Sulfonamide

Uses For Zonegran

Zonisamide is used together with other medicines to control partial seizures (convulsions) in the treatment of epilepsy. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

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

Before Using Zonegran

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 zonisamide in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of zonisamide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of zonisamide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving zonisamide.

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.

Ketorolac Metformin Naproxen

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.

Ginkgo 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:

Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia) or Depression, history of—Use with caution. May make these conditions worse. Kidney disease or Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body. Proper Use of Zonegran

Take this medicine only as directed by your doctor to help your condition as much as possible. 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 medicine comes with a medication guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Zonisamide may be taken with or without food, on a full or empty stomach. Swallow the capsule whole. Do not break, crush, or chew it.

It is important that you drink extra water every day while you take zonisamide to help prevent kidney stones.

This medicine will be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

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 form (capsules): For seizures: Adults and teenagers 16 years of age and older—At first, 100 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day. Children and teenagers younger than 16 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 Zonegran

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for pregnant patients taking a seizure medicine.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. 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.

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 medicines or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Contact your doctor immediately if you develop a skin rash, fever, sore throat, sores in your mouth, easy bruising, severe muscle pain or weakness, or worsening of your seizures.

Check with your doctor right away if you have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

This medicine may make you sweat less, which causes your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine. Overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Do not stop taking zonisamide without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount of medicine you are taking before stopping it completely.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

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.

Zonegran 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 Discouragement feeling sad or empty irritability lack of appetite loss of interest or pleasure mood or mental changes shakiness or unsteady walking tiredness trouble with concentrating trouble with sleeping Less common Agitation bruising delusions hallucinations large, flat blue or purplish patches on the skin rash

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

Symptoms of overdose Difficult or labored breathing faintness loss of consciousness slow or irregular heartbeat

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 Abdominal or stomach pain anxiety difficulty with memory dizziness double vision headache loss of appetite nausea restlessness sleepiness sleeplessness unusual drowsiness unusual tiredness or weakness Less common Aching muscles or joints acid or sour stomach bad, unusual, or unpleasant taste in the mouth belching change in taste chills constipation diarrhea difficulty with speaking difficulty with thinking dry mouth fever general ill feeling headache heartburn indigestion mental slowness nervousness runny or stuffy nose sneezing tingling, burning, or prickly feelings on the skin uncontrolled, back and forth, or rolling eye movements weight loss

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: Zonegran 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 Zonegran resources Zonegran Side Effects (in more detail) Zonegran Use in Pregnancy & Breastfeeding Drug Images Zonegran Drug Interactions Zonegran Support Group 18 Reviews for Zonegran - Add your own review/rating Zonegran Prescribing Information (FDA) Zonegran Consumer Overview Zonegran Monograph (AHFS DI) Zonegran MedFacts Consumer Leaflet (Wolters Kluwer) Zonisamide Professional Patient Advice (Wolters Kluwer) Compare Zonegran with other medications Benign Essential Tremor Migraine Prevention Parkinsonian Tremor Seizures



Generic Name: ondansetron (Oral route, Oromucosal route)

on-DAN-se-tron

Commonly used brand name(s)

In the U.S.

Zofran Zofran ODT Zuplenz

Available Dosage Forms:

Film Tablet, Disintegrating Tablet Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Zofran

Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Before Using Zofran

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 ondansetron in children under 4 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 ondansetron in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. 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.

Apomorphine Cisapride Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin 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 Alfuzosin Amiodarone Amitriptyline Amoxapine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bretylium Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enflurane Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Halothane Ibutilide Iloperidone Isoflurane Isradipine Lapatinib Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Paliperidone Pazopanib Perflutren Lipid Microsphere Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Salmeterol Saquinavir Sematilide Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

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.

Cyclophosphamide 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:

Allergy to other selective 5-HT3 receptor antagonists (alosetron Lotronex], dolasetron [Anzemet], granisetron [Kytril], palonosetron [Aloxi])—Use with caution. It is likely you will also be allergic to ondansetron. Bowel blockage or Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems. Heart rhythm problems (e.g., prolonged QT interval)—Use with caution. May make this condition worse. Liver disease—May have an increased chance of side effects. Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse. Proper Use of ondansetron

This section provides information on the proper use of a number of products that contain ondansetron. It may not be specific to Zofran. 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.

To use the oral disintegrating tablet:

Make sure your hands are dry. Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet. Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

To use the oral soluble film:

Make sure your hands are clean and dry before and after using this medicine. Fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the film out from the pouch. Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole. Once the film is dissolved, you may swallow with or without water.

If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 (oral disintegrating tablets, solution, or tablets): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days. Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment. Children younger than 12 years of age—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) one hour before anesthesia is given. Children—Use and dose must be determined by your doctor. For oral dosage form (soluble film): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days. Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—One 8-milligram (mg) film three times a day. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film. Children—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.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. 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.

Precautions While Using Zofran

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

Zofran 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 Confusion dizziness fast heartbeat fever headache shortness of breath weakness Less common Decrease in the frequency of urination decrease in urine volume difficulty with passing urine (dribbling) painful urination Rare Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness convulsions cough decreased urine difficulty with breathing difficulty with swallowing dry mouth fast, pounding, or irregular heartbeat or pulse hives increased thirst itching loss of appetite loss of bladder control loss of consciousness mood changes muscle pain or cramps nausea or vomiting noisy breathing numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash sweating tightness in the chest total body jerking unusual tiredness or weakness wheezing Incidence not known Blurred vision dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fixed position of the eye heart stops hoarseness inability to move the eyes increased blinking or spasms of the eyelid large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs no breathing no pulse or blood pressure noisy breathing pounding heartbeat slow or irregular breathing sticking out of the tongue sweating trouble with breathing, speaking, or swallowing unconscious uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressions

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 Anxiety difficulty having a bowel movement (stool) dry mouth general feeling of discomfort or illness hyperventilation irritability restlessness shaking trouble sleeping Rare Difficulty with speaking drooling loss of balance control muscle trembling, jerking, or stiffness shuffling walk stiffness of the limbs twisting movements of the body uncontrolled movements, especially of the face, neck, and back Incidence not known Feeling of warmth hiccups hives or welts redness of the face, neck, arms, and occasionally, upper chest redness of the skin

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: Zofran Oral, Oromucosal 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 Zofran Oral, Oromucosal resources Zofran Oral, Oromucosal Side Effects (in more detail) Zofran Oral, Oromucosal Use in Pregnancy & Breastfeeding Drug Images Zofran Oral, Oromucosal Drug Interactions Zofran Oral, Oromucosal Support Group 64 Reviews for Zofran Oral, Oromucosal - Add your own review/rating Compare Zofran Oral, Oromucosal with other medications Alcohol Dependence Gastroenteritis Nausea/Vomiting Nausea/Vomiting, Chemotherapy Induced Nausea/Vomiting, Postoperative Nausea/Vomiting, Radiation Induced Obsessive Compulsive Disorder Postanesthetic Shivering Pruritus



loteprednol etabonate and tobramycin



dexamethasone



ZINACEF 1.5 g, 750 mg and 250 mg

cefuroxime sodium powder for injection

Please read this leaflet carefully before starting to take your medicine. Keep it safe, as you may want to read it again. This leaflet contains important information about Zinacef injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is Zinacef?

Zinacef contains cefuroxime, which is an antibiotic belonging to the cephalosporin class. Antibiotics are used to kill the bacteria or “germs” which cause infections.

What Zinacef contains

Each vial contains:

The active ingredient - cefuroxime 250 mg or 750 mg or 1.5 g (as sodium salt).

Other ingredients - none.

Zinacef is supplied in single vials of cefuroxime 250 mg, 750 mg or 1.5 g.

Product licence holder and manufacturer Product licence held by Glaxo Operations UK Ltd. trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Manufactured by GlaxoSmithKline Manufacturing S.p.A. Verona Italy What Zinacef does

This medicine is used to treat infections of the airways; ear, nose and throat; urinary tract; bones and joints; pelvis; blood and wounds; gonorrhoea and meningitis.

Your doctor has decided to give you Zinacef because you have an infection or to protect you from infection before an operation or during dialysis. Sometimes Zinacef is used at the same time as other antibiotics and the correct dose is checked by blood tests.

Before having Zinacef Make sure your doctor knows: if you think you may be pregnant if you are breast-feeding if you have been told that you are allergic to Zinacef, cefuroxime or other antibiotics e.g. penicillin if you have been told that your kidneys are not working as well as they should be if you are taking a diuretic such as furosemide if you are taking an aminoglycoside type antibiotic or any other antibiotics. You and your doctor should also know that: if your urine is tested for sugar, Zinacef does not normally cause a false positive result as occurs with some other cephalosporin antibiotics if you have any blood tests, Zinacef can cause changes to the results.

Like other medicines used to treat meningitis, Zinacef may take a while to clear the body of all the meningitis infection. Because of this, hearing loss caused by meningitis has occurred in a few patients after using Zinacef to treat the disease.

Dosage and administration

The correct dose of Zinacef will be decided by your doctor and depends on the type of infection and your weight and age. Zinacef will usually be given by a doctor or nurse either directly into a vein or into a muscle. In some cases, it may be added to a “drip” intravenous infusion. Zinacef is made up by adding the following amount of sterile water or other recommended diluting solution.

Vial Size 250mg Intramuscular injection (suspension): 1ml Intravenous injection (solution): 2ml Intravenous infusion (solution): - Vial Size 750mg Intramuscular injection (suspension): 3ml Intravenous injection (solution): 6ml Intravenous infusion (solution): - Vial Size 1.5g Intramuscular injection (suspension): - Intravenous injection (solution): 15ml Intravenous infusion (solution): - Vial Size 1.5g infusion Intramuscular injection (suspension): - Intravenous injection (solution): - Intravenous infusion (solution): 50ml

The usual adult dose is from 750 mg to 1.5 g three times a day: bigger or more frequent doses are sometimes needed. The duration of treatment depends on the type of infection. In special cases, just one 1.5 g dose is sufficient.

To treat pneumonia in adults, the usual dose of Zinacef is 1.5 g, twice a day for 2 to 3 days, followed by a 7 day course of the oral form of Zinacef, called Zinnat (cefuroxime axetil).

To treat a sudden worsening of chronic bronchitis, the usual dose of Zinacef is 750 mg, twice a day for 2 to 3 days, followed by a 5 to 7 day course of Zinnat.

The duration of your treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment.

For infants and children, the dose is based on body weight and is usually between 30 mg to 100 mg per kilogram daily divided into three or four separate doses. For newborn children the dose is as for infants and children, but is divided into 2 or 3 doses.

The daily dose depends on whether it is a simple or complicated infection and on whether other antibiotics are being used at the same time.

For patients with kidney problems the dose of Zinacef will be reduced.

Your medication will usually be given to you by a health professional. However if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

Zinacef Side Effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given Zinacef find it causes no problems.

A few people can be allergic to antibiotics, if any of the following rare side effects appear soon after having your injection, tell your doctor immediately:

sudden wheeziness, chest tightness, pain or collapse, as these may be symptoms of an acute allergic reaction to your medicine. The more common side effects of Zinacef that could happen to between in 1 in 10 and 1 in 100 people taking it include: changes to “blood counts” or tests used to measure the functioning of organs in the body such as the liver pain or inflammation at the site of injection (thrombophlebitis). Uncommon side effects that could happen to between 1 in 100 and 1 in 1,000 people taking Zinacef include: skin lumps or hives skin rash (red spots), itchiness diarrhoea or vomiting. Rare side effects that could happen to between 1 in 1,000 and 1 in 10,000 people include: as with other antibiotics after long courses of treatment, thrush in the vagina or mouth can occur easy bruising (thrombocytopenia) fever. Very rare side effects that could happen to less 1 in 10,000 taking Zinacef include: swelling of eyelids, face or lips severe diarrhoea from colitis (lower end of the bowel inflamed) kidney inflammation blistering or peeling skin.

If you feel unwell or have any unusual discomfort you do not understand, tell the doctor as soon as possible.

Storage

If you keep the vials at home, keep them away from heat and light which could spoil them. As with all medicines, keep Zinacef vials safely away from children. Store any unopened vials at room temperature below 25°C (77°F). Store reconstituted vials in a fridge at 2-8°C for no longer than 24 hours. Do not autoclave (a method of sterilization often used in hospitals).

What to do with any unused medication

If you are at home and your doctor stops your treatment, return any unused Zinacef vials to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.

Further information

Remember this medicine is for you. Only a doctor can prescribe it for you.

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.

Leaflet last updated 3 May 2006

The information provided applies only to Zinacef

Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline group of companies

© 2006 GlaxoSmithKline group of companies



1
2 3 4 5 6 Next →