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based on Tamiflu usage data. What happens if I overdose? It is not known whether this medicine was the exact cause of these symptoms. Median simulated exposures of oseltamivir carboxylate for recommended treatment and prophylaxis regimens are provided in Table. It is not known if oseltamivir affects human milk production. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility In 2-year carcinogenicity studies in mice and rats given daily oral doses of the prodrug oseltamivir phosphate up to 400 mg/kg and 500 mg/kg, respectively, the prodrug and the active form oseltamivir carboxylate induced no statistically significant increases. The 75 mg capsule shell contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations. Last updated on Feb 7, 2019. A total of 859 pediatric subjects received treatment with Tamiflu for oral suspension either at a 2 mg per kg twice daily for 5 days or weight-band dosing.
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The median IC50 values of oseltamivir against influenza A/H1N1, influenza A/H3N2, and influenza B clinical isolates were.5 nM (range.93-4.16 nM, N74.96 nM (range.13-7.95 nM, N774 and 60 nM (20-285 nM, N256 respectively, in a neuraminidase assay with a fluorescently labeled munana. Follow your doctor's instructions. How do I mix the contents of Tamiflu capsules with sweetened liquids, if directed by my healthcare provider or pharmacist? Oseltamivir phosphate is a white crystalline solid with the chemical name acid, ethyl ester, phosphate (1:1). Data Human Data Published prospective and retrospective observational studies of more than 5,000 women exposed to Tamiflu during pregnancy, including more than 1,000 women exposed in the first trimester, suggest that the observed rate of congenital malformations was not increased above the rate in the. The H275Y (N1 numbering) or N294S (N2 numbering) oseltamivir resistance-associated substitutions observed in the N1 neuraminidase subtype, and the E119V or N294S oseltamivir resistance-associated substitutions observed in the N2 subtype (N2 numbering are associated with reduced susceptibility to oseltamivir but not zanamivir. Prophylaxis of Influenza The safety and efficacy of Tamiflu for the prophylaxis of influenza in pediatric patients 1 year to 17 years old has been established see Dosage and Administration (2.3), Clinical Pharmacology (12.3), and Clinical Studies (14.2) and is based on: 13. There were no effects on fertility, mating performance or early embryonic development at any dose level. The highest dose in this study was approximately 115 times the human systemic exposure (AUC0-24h) of oseltamivir carboxylate that occurs after administration of the maximum recommended human dose.
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