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Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Clopidogrel is generally well tolerated drug.

• Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
• Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.

Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

The recommended oral dose is one tablet daily.

This combination is generally well tolerated.

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.

There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.

It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Clopidogrel is generally well tolerated drug.

• Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
• Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.

Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Topical Antifungal preparations

Ciclopirox Olamine is a synthetic broad spectrum antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox Olamine exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans. The mode of action of Ciclopirox Olamine was studied mainly in Candida albicans. It is presumed that Ciclopirox Olamine mediated growth inhibition or death of fungal cells is primarily caused by in vitro cellular depletion of some essential substrates and/or ions and that such effects are brought about through blockage of their uptake from the medium.In addition to its broad spectrum of antifungal action, Ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. Theanti-inflammatory effects of Ciclopirox have been demonstratedin human polymorphonuclear cells, where Ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.

Ciclopirox Cream should be gently massaged onto the affected and surrounding skin areas twice daily for four weeks. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with Ciclopirox cream, the diagnosis should be redetermined. Patients with Tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Use in children: Safety and effectiveness in children below the age of 10 years have not been established.

Ciclopirox Olamine cream is well tolerated with a low incidence of adverse reactions reported in clinical trials.

Ciclopirox Olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox Olamine cream is not for ophthalmic use.

Pregnancy category B. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine cream or is administered to nursing women.

Store below 25°C, protect from light.Keep out of the reach of children.

Shampoo is indicated in the treatment of Seborrheic dermatitis, Dandruff, Inflammation and Swelling of the scalp.

Topical Antifungal preparations

Ciclopirox Olamine is a synthetic broad spectrum antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox Olamine exhibits fungicidal activity in-vitro against isolates of Trichophyton rubrum,   Trichophyton    mentagrophytes,   Epidermophyton floccosum, Microsporum canis, and Candida albicans. The mode of action of Ciclopirox Olamine was studied mainly in Candida albicans. It is presumed that Ciclopirox Olamine mediated growth inhibition or death of fungal cells is primarily caused by in-vitro cellular depletion of some essential substrates and/or ions and that such effects are brought about through blockage of their uptake from the medium. In addition to its broad spectrum of antifungal action, Ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. The anti-inflammatory effects of Ciclopirox have been demonstrated in human polymorphonuclear cells, where Ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.

Wet hair and apply approximately 1 teaspoon (5 ml) of Ciclopirox Olamine Shampoo to the scalp. Up to 2 teaspoons (10 ml) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications.

Ciclopirox Olamine Shampoo is well tolerated with a low incidence of adverse reactions reported in clinical trials.

This Shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox Olamine Shampoo is not for ophthalmic, oral, or intravaginal use.

Pregnancy category B. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine Shampoo or is administered to nursing women.

No clinical trials have been conducted in subjects younger than 16 years.

Keep away from light and moisture. Store below 30°C. Keep out of the reach of children.

Zuclopenthixol is indicated for the management of the manifestations of schizophrenia. This is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia.

Phenothiazine related drugs

Zuclopenthixol, a thioxanthene derivative, has high affinity for both dopamine D1 receptors and dopamine D2 receptors. Zuclopenthixol also has high affinity for α1 -adrenergic and 5 HT2 receptors. It has weaker histamine H1 receptor blocking activity, and even lower affinity for muscarinic cholinergic and α2 -adrenergic receptors.

Zuclopenthixol Tablets: When initiating treatment with Zuclopenthixol tablets, it is recommended that the drug be given in divided doses (BID or TID). During the maintenance phase of treatment Zuclopenthixol tablets may be given as a single nighttime dose. For acute psychosis, the usual starting dose is 10-50 mg/day, which may be increased by 10-20 mg every 2-3 days, according to the patient’s response. The usual therapeutic range is 20 mg to 60 mg daily. However, as with other antipsychotic drugs, some patients may require lower, while others may require higher dosage in order to obtain optimal benefit. Daily dosage higher than 100 mg is not recommended. For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control. The usual maintenance dose is 20-40 mg/day.

Zuclopenthixol Acuphase: Dosage should be individually adjusted according to the patient’s condition. The usual dose is 50-150 mg (1-3 ml) administered intramuscularly and repeated if necessary, at intervals of 2-3 days. Some patients may need an additional injection 1 or 2 days after the first injection.

Zuclopenthixol Depot: Close supervision is required during the period following initiation of Zuclopenthixol Depot treatment, in order to minimize the risk of over-medication or insufficient suppression of psychotic symptoms. Supplemental oral antipsychotic medication may be required in diminishing dosage during this period. The usual maintenance dose is 150-300 mg intramuscularly, every 2-4 weeks. Some patients may require higher or lower doses, or shorter intervals between doses.

Common side effects are Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations) Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertonia).

Caution should be taken if-

• you have used zuclopenthixol or any other treatment for schizophrenia before and if you had any problems
• you are taking any other prescription or non-prescription medicines
• you are pregnant or thinking of becoming pregnant, or if you are breast-feeding
• you regularly drink a lot of alcohol
• you have any liver problems, Parkinson’s disease or have ever had seizures
• you have dementia
• you have glaucoma
• you have any kidney problems
• you have risk factors for stroke (e.g. smoking, high blood pressure).
• you have hypokalemia or hypomagnesia (too little potassium or magnesium in your blood)
• you have a history of cardiovascular disorders
• you or someone in your family has a history of blood clots
• you are being treated for cancer (applies to zuclopenthixol Depot only)
• you use any other antipsychotic medicine

Drugs that may interact with Zuclopenthixol include:

• tricyclic antidepressant medicines
• guanethidine and similar medicines (used to lower the blood pressure)
• barbiturates and similar medicines
• levodopa and similar medicines (used to treat Parkinson’s disease)
• metoclopramide (used in the treatment of gastro-intestinal disorders)
• other antipsychotic medicines (e.g. thioridazine)
• medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycine, moxifloxacin, lithium)

The safe use of zuclopenthixol during pregnancy has not been established. Zuclopenthixol is excreted in human milk. The safe use of zuclopenthixol during lactation has not been established.

The safety and efficacy of zuclopenthixol in children under the age of 18 years have not been established, therefore its use is not recommended.

Symptoms of overdose may include: somnolence, coma, unusual movements, convulsions, shock, high or low body temperature

Should be stored between 15°C and 25°C. Protect from light.

Zuclopenthixol is indicated for the management of the manifestations of schizophrenia. This is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia.

Phenothiazine related drugs

Zuclopenthixol, a thioxanthene derivative, has high affinity for both dopamine D1 receptors and dopamine D2 receptors. Zuclopenthixol also has high affinity for α1 -adrenergic and 5 HT2 receptors. It has weaker histamine H1 receptor blocking activity, and even lower affinity for muscarinic cholinergic and α2 -adrenergic receptors.

Zuclopenthixol Tablets: When initiating treatment with Zuclopenthixol tablets, it is recommended that the drug be given in divided doses (BID or TID). During the maintenance phase of treatment Zuclopenthixol tablets may be given as a single nighttime dose. For acute psychosis, the usual starting dose is 10-50 mg/day, which may be increased by 10-20 mg every 2-3 days, according to the patient’s response. The usual therapeutic range is 20 mg to 60 mg daily. However, as with other antipsychotic drugs, some patients may require lower, while others may require higher dosage in order to obtain optimal benefit. Daily dosage higher than 100 mg is not recommended. For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control. The usual maintenance dose is 20-40 mg/day.

Zuclopenthixol Acuphase: Dosage should be individually adjusted according to the patient’s condition. The usual dose is 50-150 mg (1-3 ml) administered intramuscularly and repeated if necessary, at intervals of 2-3 days. Some patients may need an additional injection 1 or 2 days after the first injection.

Zuclopenthixol Depot: Close supervision is required during the period following initiation of Zuclopenthixol Depot treatment, in order to minimize the risk of over-medication or insufficient suppression of psychotic symptoms. Supplemental oral antipsychotic medication may be required in diminishing dosage during this period. The usual maintenance dose is 150-300 mg intramuscularly, every 2-4 weeks. Some patients may require higher or lower doses, or shorter intervals between doses.

Common side effects are Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations) Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertonia).

Caution should be taken if-

• you have used zuclopenthixol or any other treatment for schizophrenia before and if you had any problems
• you are taking any other prescription or non-prescription medicines
• you are pregnant or thinking of becoming pregnant, or if you are breast-feeding
• you regularly drink a lot of alcohol
• you have any liver problems, Parkinson’s disease or have ever had seizures
• you have dementia
• you have glaucoma
• you have any kidney problems
• you have risk factors for stroke (e.g. smoking, high blood pressure).
• you have hypokalemia or hypomagnesia (too little potassium or magnesium in your blood)
• you have a history of cardiovascular disorders
• you or someone in your family has a history of blood clots
• you are being treated for cancer (applies to zuclopenthixol Depot only)
• you use any other antipsychotic medicine

Drugs that may interact with Zuclopenthixol include:

• tricyclic antidepressant medicines
• guanethidine and similar medicines (used to lower the blood pressure)
• barbiturates and similar medicines
• levodopa and similar medicines (used to treat Parkinson’s disease)
• metoclopramide (used in the treatment of gastro-intestinal disorders)
• other antipsychotic medicines (e.g. thioridazine)
• medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycine, moxifloxacin, lithium)

The safe use of zuclopenthixol during pregnancy has not been established. Zuclopenthixol is excreted in human milk. The safe use of zuclopenthixol during lactation has not been established.

The safety and efficacy of zuclopenthixol in children under the age of 18 years have not been established, therefore its use is not recommended.

Symptoms of overdose may include: somnolence, coma, unusual movements, convulsions, shock, high or low body temperature

Should be stored between 15°C and 25°C. Protect from light.

Zuclopenthixol is indicated for the management of the manifestations of schizophrenia. This is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia.

Phenothiazine related drugs

Zuclopenthixol, a thioxanthene derivative, has high affinity for both dopamine D1 receptors and dopamine D2 receptors. Zuclopenthixol also has high affinity for α1 -adrenergic and 5 HT2 receptors. It has weaker histamine H1 receptor blocking activity, and even lower affinity for muscarinic cholinergic and α2 -adrenergic receptors.

Zuclopenthixol Tablets: When initiating treatment with Zuclopenthixol tablets, it is recommended that the drug be given in divided doses (BID or TID). During the maintenance phase of treatment Zuclopenthixol tablets may be given as a single nighttime dose. For acute psychosis, the usual starting dose is 10-50 mg/day, which may be increased by 10-20 mg every 2-3 days, according to the patient’s response. The usual therapeutic range is 20 mg to 60 mg daily. However, as with other antipsychotic drugs, some patients may require lower, while others may require higher dosage in order to obtain optimal benefit. Daily dosage higher than 100 mg is not recommended. For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control. The usual maintenance dose is 20-40 mg/day.

Zuclopenthixol Acuphase: Dosage should be individually adjusted according to the patient’s condition. The usual dose is 50-150 mg (1-3 ml) administered intramuscularly and repeated if necessary, at intervals of 2-3 days. Some patients may need an additional injection 1 or 2 days after the first injection.

Zuclopenthixol Depot: Close supervision is required during the period following initiation of Zuclopenthixol Depot treatment, in order to minimize the risk of over-medication or insufficient suppression of psychotic symptoms. Supplemental oral antipsychotic medication may be required in diminishing dosage during this period. The usual maintenance dose is 150-300 mg intramuscularly, every 2-4 weeks. Some patients may require higher or lower doses, or shorter intervals between doses.

Common side effects are Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations) Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertonia).

Caution should be taken if-

• you have used zuclopenthixol or any other treatment for schizophrenia before and if you had any problems
• you are taking any other prescription or non-prescription medicines
• you are pregnant or thinking of becoming pregnant, or if you are breast-feeding
• you regularly drink a lot of alcohol
• you have any liver problems, Parkinson’s disease or have ever had seizures
• you have dementia
• you have glaucoma
• you have any kidney problems
• you have risk factors for stroke (e.g. smoking, high blood pressure).
• you have hypokalemia or hypomagnesia (too little potassium or magnesium in your blood)
• you have a history of cardiovascular disorders
• you or someone in your family has a history of blood clots
• you are being treated for cancer (applies to zuclopenthixol Depot only)
• you use any other antipsychotic medicine

Drugs that may interact with Zuclopenthixol include:

• tricyclic antidepressant medicines
• guanethidine and similar medicines (used to lower the blood pressure)
• barbiturates and similar medicines
• levodopa and similar medicines (used to treat Parkinson’s disease)
• metoclopramide (used in the treatment of gastro-intestinal disorders)
• other antipsychotic medicines (e.g. thioridazine)
• medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycine, moxifloxacin, lithium)

The safe use of zuclopenthixol during pregnancy has not been established. Zuclopenthixol is excreted in human milk. The safe use of zuclopenthixol during lactation has not been established.

The safety and efficacy of zuclopenthixol in children under the age of 18 years have not been established, therefore its use is not recommended.

Symptoms of overdose may include: somnolence, coma, unusual movements, convulsions, shock, high or low body temperature

Should be stored between 15°C and 25°C. Protect from light.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Clopidogrel is generally well tolerated drug.

• Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
• Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.

Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Ophthalmic steroid - antibiotic combined preparations

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

Eye:

• Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
• Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.

The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.

It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.

Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.

Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.

Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.

Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.

Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.

The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.

It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.

Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.

Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.

Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.

Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.

Ophthalmic steroid - antibiotic combined preparations

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

Eye:

• Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
• Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

Chlorpheniramine Maleate is indicated in the following indications-

• Urticaria
• Sensitivity reactions
• Angioneurotic edema
• Vasomotor rhinitis
• Cough
• Common cold
• Motion sickness and
• Other allergic conditions.

Sedating Anti-histamine

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

• 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
• 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
• 1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Clopidogrel is generally well tolerated drug.

• Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
• Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.

Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

The recommended oral dose is one tablet daily.

This combination is generally well tolerated.

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.

There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.

It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

The treatment of fungal infections where co-existing symptoms of inflammation e.g. itching, require rapid relief.

• All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi.
• All dermatomycoses due to yeasts (Candida species).
• Skin diseases showing secondary infection with these fungi
• The treatment of nappy rash where infection due to Candida albicans is present.

Hydrocortisone & Combined preparations

Clotrimazole is a broad-spectrum antifungal agent active on dermatophytes, yeasts and other fungi. Hydrocortisone is a glucocorticoid with both glucocorticoid and to a lesser extent mineralocorticoid activity. Hydrocortisone is used for replacement therapy in adrenocortical insufficiency.

Apply thinly and evenly to the affected area twice daily.

Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.

It is contraindicated in patients with known hypersensitivity to any of the components of this preparation.

In infants, the napkins may act as an occlusive dressing and increase absorption. Treatment should be for a maximum period of seven days.

Keep in a cool and dry place. Keep out of the reach of children.

Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis

Second generation Cephalosporins

Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.

Adult-

• Usual dose: 250 mg 8 hrly.
• Bronchitis & pneumonia: 250 mg tid.
• Sinusitis: 500 mg tid for 10 days.
• Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
• Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.

Children- 

• Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
• Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
• Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.

May be taken with or without food.

Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.

Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.

Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.

The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.

Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.

Store in a cool and dry place. Protect from light.

Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis

Second generation Cephalosporins

Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.

Adult-

• Usual dose: 250 mg 8 hrly.
• Bronchitis & pneumonia: 250 mg tid.
• Sinusitis: 500 mg tid for 10 days.
• Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
• Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.

Children- 

• Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
• Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
• Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.

May be taken with or without food.

Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.

Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.

Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.

The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.

Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.

Store in a cool and dry place. Protect from light.

Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis

Second generation Cephalosporins

Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.

Adult-

• Usual dose: 250 mg 8 hrly.
• Bronchitis & pneumonia: 250 mg tid.
• Sinusitis: 500 mg tid for 10 days.
• Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
• Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.

Children- 

• Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
• Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
• Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.

May be taken with or without food.

Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.

Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.

Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.

The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.

Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.

Store in a cool and dry place. Protect from light.