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Proton Pump Inhibitor

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks. 

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.

• Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
• Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
• Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
• A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
• Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
• There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
• Co-administration of atazanavir with Rabeprazole is not recommended.
• Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human 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.

Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.

The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are  generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Proton Pump Inhibitor

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks. 

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.

• Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
• Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
• Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
• A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
• Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
• There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
• Co-administration of atazanavir with Rabeprazole is not recommended.
• Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human 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.

Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.

The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are  generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.

Oral:

• Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

• The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.

• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.

It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.

Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.

Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.

Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.

Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.

Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.

Oral:

• Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

• The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.

• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.

It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.

Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.

Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.

Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.

Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.

Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Angiotensin-ll receptor blocker

Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).

Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.

Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.

Rare: Chest pain, peripheral edema, arthritis.

Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.

With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.

Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Paediatric use: Safety and effectiveness in paediatric patients have not been established.

Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.

Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.

Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

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

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

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

Second generation Cephalosporins

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Tablet or Suspension-

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

• Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
• Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
• Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
• Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
• Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
• 
  Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
• In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

• Adult: 3 gm IV injection three times daily.
• Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
• Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

• Adult: 1.5 gm IV injection four times daily.
• Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

No potentially hazardous interactions have been reported.

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

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

Cytotoxic Chemotherapy

Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.

Administer Doxorubicin at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution.

• Ovarian cancer: 50 mg/m2 IV every 4 weeks
• AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks
• Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib

Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.

Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.

Elderly, children, hepatic impairment. Monitor blood counts and ECG.

Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Hepatic Impairment-
 
serum-bilirubin: 12-30 mcg/ml: Half the normal dose;
serum-bilirubin: >30 mcg/ml: Quarter of the usual dose.

Acute overdosage may increase the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment includes hospitalisation of the severely myelosuppressed patient, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of haemopoietic growth factor (G-CSF, GM-CSF) may be considered. Cumulative dosage increases risk of cardiomyopathy and resultant congestive heart failure which may be managed with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.

Powder for injection: Store at 15-30°C.
Solution for injection & liposomal formulations: Refrigerate at 2-8°C. Do not freeze.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
• The prophylaxis of Herpes simplex infections in immunocompromised patients

Herpes simplex & Varicella-zoster virus infections

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.
• Children under 2 years: Half of the adult dose.
• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
• Children 1 month-2 years: 200 mg 4 times daily for 5 days.
• Children 2-5 years:400 mg 4 times daily for 5 days.
• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.

Herpes simplex & Varicella-zoster virus infections

Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.

• Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
• Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
• Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
• Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours

Each dose should be administered by slow intravenous infusion over a one-hour period.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.

• Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
• Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)

Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.

Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.

Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.

Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.

Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.

Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.

Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m² (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m² (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:

• CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
• CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
• CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.

Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.

Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.

Herpes simplex & Varicella-zoster virus infections

Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.

• Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
• Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
• Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
• Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours

Each dose should be administered by slow intravenous infusion over a one-hour period.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.

• Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
• Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)

Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.

Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.

Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.

Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.

Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.

Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.

Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m² (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m² (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:

• CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
• CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
• CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.

Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.

It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.

Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.

It is a topical eye antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers)

Ophthalmic Anti-viral Products

This eye gel contains the active ingredient, Ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which acts as an antiviral agent by inhibiting the synthesis of viral DNA in two ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of DNA replication.

The recommended dosing regimen for Ganciclovir eye gel 0.15% is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals and then 1 drop 3 times per day for 7 days.

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

It is contraindicated to the patients with known hypersensitivity to Ganciclovir.

It is indicated for topical eye use only. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with it.

Pregnancy Category C. Ganciclovir has been shown to be embryo toxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption.

Nursing Mothers: It is not known whether topical eye ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when it is administered to nursing mothers.

Pediatric Use: Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdose through local or accidental oral administration is not likely.

Store at 15°C to 30°C in a dry place protected from light. It is desirable that the contents should not be used more than one month after first opening of the tube.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Non opioid analgesics

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

It is contraindicated in known hypersensitivity to Paracetamol.

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

Keep in a dry place away from light and heat. Keep out of the reach of children.