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Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Other Antifungal preparations

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

• At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
• Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

• Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
• Maintenance Dose: 4 mg/kg 12 hourly.

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

Known hypersensitivity to Voriconazole or any other components of this drug-

• Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The efficacy to the children under 12 years of age is not established.

There is no data found about overdose of Voriconazole.

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Pazopanib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). Pazopanib is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR 2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR-β receptors.

Absorption: Pazopanib is absorbed orally with median time to achieve peak concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results in geometric mean AUC and C max of 1,037 mcg/mL and 58.1 mcg/mL (equivalent to 132 µM), respectively. There was no consistent increase in AUC or C max at Pazopanib doses above 800 mg.

Distribution: Binding of Pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro, studies suggest that Pazopanib is a substrate for P-gp and BCRP.

Metabolism: In vitro studies demonstrated that Pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8.

Elimination: Pazopanib has a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg. Elimination is primarily via feces with renal elimination accounting for less than 4% of the administered dose.

The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib should not exceed 800 mg. Tablets should not be crushed due to the potential for increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose. Or, as directed by the registered physicians.

Common side effects of Pazopanib include:

• Hepatic Toxicity and Hepatic Impairment
• QT Prolongation and Torsades de Pointes
• Cardiac Dysfunction
• Hemorrhagic Events
• Arterial and Venous Thromboembolic Events
• Thrombotic Microangiopathy
• Gastrointestinal Perforation and Fistula
• Interstitial Lung Disease/Pneumonitis
• Reversible Posterior Leukoencephalopathy Syndrome
• Hypertension
• Hypothyroidism
• Proteinuria
• Tumor Lysis Syndrome
• Infection
• Increased Toxicity with Other Cancer Therapy

It is contraindicated in patients with known hypersensitivity to Pazopanib or any other components of this product.

Hepatic Toxicity and Hepatic Impairment: In clinical trials with Pazopanib, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase [ALT], aspartate aminotransferase [AST]) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks).

QT Prolongation and Torsades De Pointes: In the RCC trials of Pazopanib, QT prolongation (greater than or equal to 500 msec) was identified on routine electrocardiogram (ECG) monitoring in 2% (11/558) of patients. Torsades de pointes occurred in less than 1% (2/977) of patients who received Pazopanib in the monotherapy trials. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant pre-existing cardiac disease. When using Pazopanib, baseline and periodic monitoring of ECGs and maintenance of electrolytes (e.g., calcium, magnesium, potassium) within the normal range should be performed.

Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes: In vitro studies suggested that the oxidative metabolism of Pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of Pazopanib.

CYP3A4 Inhibitors: Coadministration of Pazopanib with strong inhibitors of CYP3A4 (e.g., Ketoconazole, Ritonavir, Clarithromycin) increases Pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of Pazopanib to 400 mg. Grapefruit or grapefruit juice should be avoided as it inhibits CYP3A4 activity and may also increase plasma concentrations of Pazopanib.

CYP3A4 Inducers: CYP3A4 inducers, such as Rifampin, may decrease plasma Pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.

Drugs that Inhibit Transporters: In vitro studies suggested that Pazopanib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Therefore, absorption and subsequent elimination of Pazopanib may be influenced by products that affect P-gp and BCRP. Concomitant treatment with strong inhibitors of P-gp or BCRP should be avoided due to risk of increased exposure to Pazopanib. Selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP should be considered.

Effects of Pazopanib on CYP Substrates: Results from drug-drug interaction trials conducted in cancer patients suggest that Pazopanib is a weak inhibitor of CYP3A4, CYP2C8, and CYP2D6 in vivo, but had no effect on CYP1A2, CYP2C9, or CYP2C19. Concomitant use of Pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Coadministration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.

Effect of Concomitant Use of Pazopanib and Simvastatin: Concomitant use of Pazopanib and Simvastatin increases the incidence of ALT elevations. Across monotherapy trials with Pazopanib, ALT greater than 3 x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of Simvastatin. If a patient receiving concomitant Simvastatin develops ALT elevations, follow dosing guidelines for Pazopanib or consider alternatives to Pazopanib. Alternatively, consider discontinuing Simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Pazopanib.

Pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of the childbearing potential of the potential risk to a fetus. There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazopanib, a lactating woman should be advised not to breastfeed during treatment with Pazopanib and for 2 weeks after the final dose.

Females: Pazopanib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 2 weeks after the last dose of Pazopanib.

Males: To avoid potential drug exposure to pregnant partners and female partners of reproductive potential, male patients (including those who have had vasectomies) with female partners of reproductive potential should be advised to use condoms during treatment with Pazopanib and for at least 2 weeks after the last dose.

Pediatric Use: The safety and effectiveness of Pazopanib in pediatric patients have not been established.

Pazopanib doses up to 2000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg daily and 1000 mg daily, respectively. Treatment of overdose with Pazopanib should consist of general supportive measures. There is no specific antidote for overdosage of Pazopanib. Hemodialysis is not expected to enhance the elimination of Pazopanib because Pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

Store below 30° C in a cool and dry place, away from sunlight. Keep out of reach of children.

Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Other beta-lactam Antibiotics

The bactericidal activity of ertapenem results from the inhibition of cell wall synthesis and is mediated through ertapenem binding to penicillin binding proteins (PBPs). In Escherichia coli, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preference for PBPs 2 and 3. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. Ertapenem is hydrolyzed by metallo-beta-lactamases.

Ertapenem should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis.

Treatment regimen:

• Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
• Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)
• Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.

Prophylaxis regimen for adults:

• 1 gram single dose given 1 hour prior to elective colorectal surgery.

Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. In the prophylaxis indication, the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.

Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.

Known hypersensitivity to product components or anaphylactic reactions to β-lactams. Due to the use of lidocaine HCl as a diluent, Ertapenem administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide-type.

Pregnancy Category B. There are, however, no adequate and well-controlled trials 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. Ertapenem is excreted in human breast milk. Caution should be exercised when Ertapenem is administered to a nursing woman. Ertapenem should be administered to nursing mothers only when the expected benefit outweighs the risk.

Pediatric Use: Safety and effectiveness of Ertapenem in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled trials in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled trials in pediatric patients 3 months to 17 years of age.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Patients with Renal Impairment: Dosage adjustment is necessary in patients with creatinine clearance 30 mL/min or less.

Patients with Hepatic Impairment: The pharmacokinetics of ertapenem in patients with hepatic impairment have not been established.

No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Ertapenem 1 g single dose should be prepared with diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem should not be frozen.

Anti-coagulants, Oral Anti-coagulants

Warfarin is a [vitamin K] antagonist which acts to inhibit the production of vitamin K by vitamin K epoxide reductase. The reduced form of vitamin K, vitamin KH₂ is a cofactor used in the γ-carboxylation of coagulation factors VII, IX, X, and thrombin. Carboxylation induces a conformational change allowing the factors to bind Ca²⁺ and to phospholipid surfaces. Uncarboxylated factors VII, IX, X, and thrombin are biologically inactive and therefore serve to interrupt the coagulation cascade. The endogenous anticoagulation proteins C and S also require γ-carboxylation to function. This is particularly true in the case of thrombin which must be activated in order to form a thrombus. vitamin KH₂ is converted to vitamin K epoxide as part of the γ-carboxylation reaction catalyzed by γ-glutamyl carboxylase. Vitamin K epoxide is then converted to vitamin K₁ by vitamin K epoxide reductase then back to vitamin KH₂ by vitamin K reductase. Warfarin binds to vitamin K epoxide reductase complex subunit 1 and irreversibly inhibits the enzyme thereby stopping the recycling of vitamin K by preventing the conversion of vitamin K epoxide to vitamin K₁. This process creates a hypercoagulable state for a short time as proteins C and S degrade first with half lives of 8 and 24 hours, with the exception of factor VII which has a half life of 6 hours. Factors IX, X, and finally thrombin degrade later with half lives of 24, 36, and 50 hours resulting in a dominant anticoagulation effect. In order to reverse this anticoagulation vitamin K must be supplied, either exogenously or by removal of the vitamin K epoxide reductase inhibition, and time allowed for new coagulation factors to be synthesized. It takes approximately 2 days for new coagulation factors to be synthesized in the liver. Vitamin K₂, functionally identical to vitamin K₁, is synthesized by gut bacteria leading to interactions with antibiotics as elimination of these bacteria can reduce vitamin K₂

Whenever possible, the baseline prothrombin time should be determined but the initial dose should not be delayed whilst awaiting the result.

Use in adults: The usual adult induction dose of warfarin is 10 mg daily for 2 days. The subsequent maintenance dose depends upon the prothrombin time, reported as INR (international normalized ratio). The daily maintenance dose of warfarin is usually 3 to 9 mg (taken at the same time each day). The maintenance dose is omitted if the prothrombin time is excessively prolonged. Once the maintenance dose is established in the therapeutic range, it is rarely necessary to alter. In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where there is less urgency, as in patients disposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone. Control tests must be made at regular intervals and maintenance dosage further adjusted according to the results obtained.

Use in children: Safety and efficacy in children <18 years old have not been established. However, there is evidence of use and the initial dose is usually 0.1 mg.kg^-1.d^-1 adjusted subsequently to aim for an INR range the same as in adults.

Hemorrhage is the principal adverse effect of oral anticoagulants. Other adverse reactions include nausea, vomiting, diarrhea, hypersensitivity, rash, alopecia, and unexplained drop in haematocrit, "purple toes", skin necrosis, jaundice, and hepatic dysfunction.

Warfarin can not be administered in the following cases;

• Actual or potential hemorrhagic conditions, eg. Peptic ulcer, or to patients with uncontrolled hypertension
• Severe hepatic or renal disease
• Pregnancy
• Known hypersensitivity to warfarin
• Bacterial endocarditis

Its use within 24 hours following surgery or labor should be undertaken with caution, if at all.

Periodic determination of prothrombin time (PT)/international normalized ratio (INR) or other suitable coagulation test is essential. Numerous factors, alone or in combination, including travel, changes in diet, environment, physical state and medication may influence response of the patient to anticoagulants. It is generally good practice to monitor the patient's response with additional PT/INR determination in the period immediately after discharge from the hospital, and whenever other medications are initiated, discontinued or taken irregularly. The following factors may exaggerate the effects of warfarin and necessitate a reduction in dosage; loss of weight, elderly subject, acute illness, deficient renal function, decreased dietary intake of vitamin K, administration of certain drugs (see drug interaction). Factors which may call for an increase in maintenance dosage include weight gain, diarrhea and vomiting, increased intake of vitamin K, fats and oils, and the administration of certain drugs. Careful additional laboratory control is necessary if the patient is to be changed from one formulation to another. Reversal of warfarin anticoagulation by vitamin K takes several days. In emergency situations fresh frozen plasma should be given.

Oral anticoagulants have a greater potential for clinically significant drug interactions. Warn all patients about potential hazards and instruct against taking or withdrawing any drug, including non-prescription products, without the advice of a physician.

Warfarin is contraindicated in the first trimester of pregnancy because of the risk of teratogenicity. It should not be used in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus. Warfarin appears in the milk of nursing mothers in an inactive form. Infants nursed by mothers treated with Warfarin had no change in prothrombin times. Effects in premature infants have not been evaluated.

If hemorrhage occurs or a potential bleeding state arises, excessive depression of the coagulation activity can be corrected by temporary withdrawal of warfarin accompanied, if necessary, by infusion of fresh-frozen plasma or whole blood. Vitamin K, 5 mg to 10 mg orally or intravenously, may be required to supplement specific treatment with co-factor concentrates.

Do not store above 30°C. Keep away from light and out of the reach of children.

Anti-coagulants, Oral Anti-coagulants

Warfarin is a [vitamin K] antagonist which acts to inhibit the production of vitamin K by vitamin K epoxide reductase. The reduced form of vitamin K, vitamin KH₂ is a cofactor used in the γ-carboxylation of coagulation factors VII, IX, X, and thrombin. Carboxylation induces a conformational change allowing the factors to bind Ca²⁺ and to phospholipid surfaces. Uncarboxylated factors VII, IX, X, and thrombin are biologically inactive and therefore serve to interrupt the coagulation cascade. The endogenous anticoagulation proteins C and S also require γ-carboxylation to function. This is particularly true in the case of thrombin which must be activated in order to form a thrombus. vitamin KH₂ is converted to vitamin K epoxide as part of the γ-carboxylation reaction catalyzed by γ-glutamyl carboxylase. Vitamin K epoxide is then converted to vitamin K₁ by vitamin K epoxide reductase then back to vitamin KH₂ by vitamin K reductase. Warfarin binds to vitamin K epoxide reductase complex subunit 1 and irreversibly inhibits the enzyme thereby stopping the recycling of vitamin K by preventing the conversion of vitamin K epoxide to vitamin K₁. This process creates a hypercoagulable state for a short time as proteins C and S degrade first with half lives of 8 and 24 hours, with the exception of factor VII which has a half life of 6 hours. Factors IX, X, and finally thrombin degrade later with half lives of 24, 36, and 50 hours resulting in a dominant anticoagulation effect. In order to reverse this anticoagulation vitamin K must be supplied, either exogenously or by removal of the vitamin K epoxide reductase inhibition, and time allowed for new coagulation factors to be synthesized. It takes approximately 2 days for new coagulation factors to be synthesized in the liver. Vitamin K₂, functionally identical to vitamin K₁, is synthesized by gut bacteria leading to interactions with antibiotics as elimination of these bacteria can reduce vitamin K₂

Whenever possible, the baseline prothrombin time should be determined but the initial dose should not be delayed whilst awaiting the result.

Use in adults: The usual adult induction dose of warfarin is 10 mg daily for 2 days. The subsequent maintenance dose depends upon the prothrombin time, reported as INR (international normalized ratio). The daily maintenance dose of warfarin is usually 3 to 9 mg (taken at the same time each day). The maintenance dose is omitted if the prothrombin time is excessively prolonged. Once the maintenance dose is established in the therapeutic range, it is rarely necessary to alter. In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where there is less urgency, as in patients disposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone. Control tests must be made at regular intervals and maintenance dosage further adjusted according to the results obtained.

Use in children: Safety and efficacy in children <18 years old have not been established. However, there is evidence of use and the initial dose is usually 0.1 mg.kg^-1.d^-1 adjusted subsequently to aim for an INR range the same as in adults.

Hemorrhage is the principal adverse effect of oral anticoagulants. Other adverse reactions include nausea, vomiting, diarrhea, hypersensitivity, rash, alopecia, and unexplained drop in haematocrit, "purple toes", skin necrosis, jaundice, and hepatic dysfunction.

Warfarin can not be administered in the following cases;

• Actual or potential hemorrhagic conditions, eg. Peptic ulcer, or to patients with uncontrolled hypertension
• Severe hepatic or renal disease
• Pregnancy
• Known hypersensitivity to warfarin
• Bacterial endocarditis

Its use within 24 hours following surgery or labor should be undertaken with caution, if at all.

Periodic determination of prothrombin time (PT)/international normalized ratio (INR) or other suitable coagulation test is essential. Numerous factors, alone or in combination, including travel, changes in diet, environment, physical state and medication may influence response of the patient to anticoagulants. It is generally good practice to monitor the patient's response with additional PT/INR determination in the period immediately after discharge from the hospital, and whenever other medications are initiated, discontinued or taken irregularly. The following factors may exaggerate the effects of warfarin and necessitate a reduction in dosage; loss of weight, elderly subject, acute illness, deficient renal function, decreased dietary intake of vitamin K, administration of certain drugs (see drug interaction). Factors which may call for an increase in maintenance dosage include weight gain, diarrhea and vomiting, increased intake of vitamin K, fats and oils, and the administration of certain drugs. Careful additional laboratory control is necessary if the patient is to be changed from one formulation to another. Reversal of warfarin anticoagulation by vitamin K takes several days. In emergency situations fresh frozen plasma should be given.

Oral anticoagulants have a greater potential for clinically significant drug interactions. Warn all patients about potential hazards and instruct against taking or withdrawing any drug, including non-prescription products, without the advice of a physician.

Warfarin is contraindicated in the first trimester of pregnancy because of the risk of teratogenicity. It should not be used in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus. Warfarin appears in the milk of nursing mothers in an inactive form. Infants nursed by mothers treated with Warfarin had no change in prothrombin times. Effects in premature infants have not been evaluated.

If hemorrhage occurs or a potential bleeding state arises, excessive depression of the coagulation activity can be corrected by temporary withdrawal of warfarin accompanied, if necessary, by infusion of fresh-frozen plasma or whole blood. Vitamin K, 5 mg to 10 mg orally or intravenously, may be required to supplement specific treatment with co-factor concentrates.

Do not store above 30°C. Keep away from light and out of the reach of children.

For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures

Chlorhexidine & Chloroxylenol preparations

Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.

Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.

Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.

Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.

Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare

Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.

Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.

Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.

No untoward effects are known

Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.

Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.

Do not store above 25° C.

This hand sanitizer is generally used to decrease infectious agents on the hands and is the most commonly used disinfectant in pharmaceutical industries. The important thing is that only 70% solution of isopropyl alcohol acts as a disinfectant killing all surface microorganisms. It is used to disinfect hands and equipment surface in pharmaceuticals.

Bleaching and Disinfectants

Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.

Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.

Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.

Alcohol-based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting. It is generally more effective at killing microorganisms and better tolerated than soap and water. Alcohol-based hand sanitizer is recommended only if soap and water are not available. Using guideline is given bellow-

1. Apply product to the palm of one hand.
2. Rub hands together.
3. Rub the product over all surfaces of hands and fingers until hands are dry.

Inhaling large amounts of isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty with breathing as coughing can occur making it difficult for you to catch your breath. Isopropyl alcohol may cause burning, stinging, or a cold feeling where the medicine is applied.

Isopropyl Alcohol is contraindicated in patients with known Hypersensitivity.

Isopropyl Alcohol is highly flammable in the presence of heat, sparks, or an open flame. When handling isopropyl alcohol in a work environment (to best to avoid any contact with skin) protective clothing should be always be worn, including safety gloves and goggles. Isopropyl alcohol should be kept away from heat, sparks, flames and other sources of ignition, as well as strong oxidizers, acetaldehyde, chlorine, ethylene oxide, acids, and isocyanates. A flammable safety cabinet is the best storage option.

Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.

They are liquids used primarily as a topical antiseptic. They also have multiple industrial and household uses. The term "rubbing alcohol" has become a general non-specific term for either isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol) rubbing-alcohol products.

Bleaching and Disinfectants

Ethanol and isopropyl alcohol are both members of the alcohol family and have similar disinfectant properties. Ethanol is the type of alcohol present in alcoholic beverages. Isopropyl alcohol is also known as isopropanol, 2-propanol or rubbing alcohol. When used as disinfectants, both are typically at a concentration of 70 percent in water.

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