TAMIFLU- oseltamivir phosphate capsule
TAMIFLU- oseltamivir phosphate powder, for suspension
TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
TAMIFLU is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
- TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU [see Microbiology (12.4)].
- TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].
Administer TAMIFLU for the treatment of influenza in patients 2 weeks of age or older [see Dosage and Administration (2.2)] or for prophylaxis of influenza in patients 1 year and older [see Dosage and Administration (2.3)] using:
- TAMIFLU capsules or
- TAMIFLU for oral suspension (supplied as a powder). This is the preferred formulation (6 mg per mL) for patients who cannot swallow capsules. Prior to use, the supplied TAMIFLU powder must be constituted with water by the pharmacist to produce the oral suspension [see Dosage and Administration (2.5)].
The capsules and oral suspension may be taken with or without food; however, tolerability may be enhanced if TAMIFLU is taken with food.
Adjust the TAMIFLU dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)].
For patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. When TAMIFLU for oral suspension is not available from wholesaler or the manufacturer, TAMIFLU capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). During emergency situations and when neither the oral suspension or the age-appropriate strengths of TAMIFLU capsules to mix with sweetened liquids are available, then a pharmacist may prepare an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration (2.6)].
Initiate treatment with TAMIFLU within 48 hours of influenza symptom onset.
Adults and Adolescents (13 years of age and older)
The recommended oral dosage of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (one 75 mg capsule or 12.5 mL of oral suspension twice daily) for 5 days.
Pediatric Patients (2 weeks of age through 12 years of age)
Table 1 displays the recommended oral dosage of TAMIFLU for treatment of influenza in pediatric patients 2 weeks of age through 12 years of age and provides information about prescribing the capsule or the formulation for oral suspension.
Initiate post-exposure prophylaxis with TAMIFLU within 48 hours following close contact with an infected individual. Initiate seasonal prophylaxis with TAMIFLU during a community outbreak.
Adults and Adolescents (13 years of age and older)
The recommended dosage of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (one 75 mg capsule or 12.5 mL of oral suspension once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak. In immunocompromised patients, TAMIFLU may be continued for up to 12 weeks [see Use in Specific Populations (8.9)]. The duration of protection lasts for as long as TAMIFLU dosing is continued.
Pediatric Patients (1 year to 12 years of age)
Table 1 displays the recommended oral dosage of TAMIFLU for prophylaxis of influenza in pediatric patients 1 year to 12 years of age based on body weight and provides information about prescribing the capsule or the formulation for oral suspension. Prophylaxis in pediatric patients is recommended for 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak [see Use in Specific Populations (8.4) and Clinical Studies (14.2)].
|Weight||Treatment Dosage for 5 days||Prophylaxis Dosage for 10 days *||Volume of Oral Suspension (6 mg/mL) for each Dose†||Number of Bottles of Oral Suspension to Dispense||Number of Capsules to Dispense (Strength)‡|
|Patients from 2 Weeks to less than 1 Year of Age|
|Any weight||3 mg/kg twice daily||Not applicable||0.5 mL/kg §||1 bottle||Not applicable|
|Patients 1 to 12 Years of Age Based on Body Weight|
|15 kg or less||30 mg twice daily||30 mg once daily||5 mL||1 bottle||10 capsules(30 mg)|
|15.1 kg to 23 kg||45 mg twice daily||45 mg once daily||7.5 mL||2 bottles||10 capsules(45 mg)|
|23.1 kg to 40 kg||60 mg twice daily||60 mg once daily||10 mL||2 bottles||20 capsules(30 mg)|
|40.1 kg or more||75 mg twice daily||75 mg once daily||12.5 mL||3 bottles||10 capsules(75 mg)|
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