Tamiflu Capsule

Treatment of Influenza: Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients older than 1 year of age who have been symptomatic for no more than 2 days.

Prophylaxis of Influenza: Tamiflu is indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older.

Oseltamivir is an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, Oseltamivir carboxylate. The proposed mechanism of action of Oseltamivir is via inhibition of influenza virus neuraminidase with the possibility of alteration of virus particle aggregation and release.

Oseltamivir Phosphate may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.

Treatment of Influenza: Adults and Adolescents: The recommended oral dose of Oseltamivir for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza.

Prophylaxis of Influenza: The safety and efficacy of Oseltamivir for prophylaxis of influenza in pediatric patients younger than 13 years of age have not been established. The recommended oral dose of Oseltamivir for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 7 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks. The duration of protection lasts for as long as dosing is continued.

Information derived from pharmacology and pharmacokinetic studies of Tamiflu suggests that clinically significant drug interactions are unlikely. Co-administration with amoxicillin does not alter plasma levels of either compound.

This product is contraindicated in patients with known hypersensitivity to any of the components of the product.

The most frequently reported adverse events are nausea and vomiting. These events generally of mild to moderate degree and usually are occurred on the first 2 days of administration. Additional adverse events occurring in <1% of patients receiving Tamiflu for treatment include unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.

Pregnancy Category C: There are insufficient human data upon which to base an evaluation of risk of Oseltamivir Phosphate to the pregnant woman or developing fetus.

Nursing Mothers: It is not known whether oseltamivir or oseltamivir carboxylate is excreted in human milk. Oseltamivir Phosphate should, therefore, be used only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.

General: There is no evidence for efficacy of Tamiflu Phosphate in any illness caused by agents other than influenza viruses Types A and B. Efficacy of Tamiflu Phosphate in patients who begin treatment after 40 hours of symptoms has not been established.

Hepatic Impairment: The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated.

Renal Impairment: Dose adjustment is recommended for patients with a serum creatinine clearance <30 mL/min.

Geriatric Use: The safety of Tamiflu Phosphate has been established in clinical studies.

Pediatric Use: The safety and efficacy of Tamiflu Phosphate in pediatric patients younger than 1 year of age have not been studied. Tamiflu Phosphate is not indicated for either treatment or prophylaxis of influenza in pediatric patients younger than 1 year of age.

At present there has been no experience of over dose. Single dose of up to 1000 mg of Tamiflu have been associated with nausea and/or vomiting.

Respiratory viral infections (Influenza)

Store at 25°C. Reconstituted susp: Store between 2-8°C for up to 17 days or at 25°C for up to 10 days. Do not freeze.