Dosing and Storage

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days.

Dosing for Treatment and Prophylaxis of Pediatric and Adult Patients

Tamiflu may be taken with or without food. However, when it is taken with food, tolerability may be enhanced in some patients. Use the dosing charts below to find the right dosage of Tamiflu for your pediatric and adult patients within 2 days of symptom onset.

Dosing chart for pediatric patients

Tamiflu Dosing Information for Influenza in Pediatric Patients chart

Tamiflu is not approved for prophylaxis of patients less than 1 year of age.

An oral dosing dispensing device that measures the appropriate volume in mL should be utilized with the oral suspension.

For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.

Oral Suspension is the preferred formulation for patients who cannot swallow capsules.

Dosing for adult patients

Flu treatment for adults and teens aged 13 years and older

  • Take 75 mg, twice daily, for 5 days.

Flu prevention for adults and teens aged 13 years and older

  • Take 1 dose, once daily, for 10 days or as long as prescribed.

One dose is 75 mg/12.5 mL for adults and teens

Capsules or suspension can be used for 30-mg dosing.

Assuming 3 hemodialysis sessions are performed in the 5-day period. Treatment can be initiated immediately if influenza symptoms develop during the 48 hours between hemodialysis sessions; however, the post-hemodialysis dose should still be administered independently of time of administration of the initial dose.

An initial dose can be administered prior to the start of dialysis.

Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

Please see the Tamiflu full Prescribing Information for complete safety information.

Commonly asked questions by healthcare professionals about the label and packaging

Has the drug product/formulation changed?

  • The drug product/formulation has not changed.

What has changed with Tamiflu (oseltamivir phosphate) for Oral Suspension (OS)?

  • The 10 mL dispenser (syringe and bottle adapter) has been removed from the carton.
  • Pharmacists should ensure patients have an appropriate dosing device.

What if the local pharmacy does not have any Tamiflu for Oral Suspension in stock?

Tamiflu provides the flexibility for healthcare professionals to treat and prevent influenza with alternatives to oral suspension:

  • Tamiflu 30-mg or 45-mg capsules, depending on the weight of the child.
  • For patients with difficulty swallowing capsules, contents can be mixed into sweetened liquids, such as chocolate syrup, by a caregiver.

In emergency situations, if commercially manufactured Tamiflu for Oral Suspension is not readily available from wholesalers or Genentech, a liquid suspension can be compounded by a pharmacist using Tamiflu 75-mg capsules. Instructions for dosing and compounding may be found in the Tamiflu Prescribing Information.

Taking Tamiflu with other medications1

Information derived from pharmacology and pharmacokinetic studies of oseltamivir suggests that clinically significant drug interactions are unlikely.

Oseltamivir is extensively converted to oseltamivir carboxylate by esterases, located predominantly in the liver.

Drug interactions involving competition for esterases have not been extensively reported in literature. Low protein binding of oseltamivir and oseltamivir carboxylate suggests that the probability of drug displacement interactions is low.

The concurrent use of Tamiflu and live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the possibility for interference between these products, LAIV should not be given within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of Tamiflu.1

In vitro studies showed no interference with the cytochrome P450 pathway.1

No pharmacokinetic interactions have been observed when co-administering oseltamivir with amoxicillin, acetaminophen, aspirin, cimetidine, antacids (magnesium and aluminum hydroxides and calcium carbonates), or warfarin.1

Storing Tamiflu for Oral Suspension1

Store dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Storing Constituted Tamiflu for Oral Suspension1

Store constituted suspension under refrigeration for up to 17 days at 2° to 8°C (36° to 46°F). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Did You Know?

In a clinical study, Tamiflu prophylaxis reduced postexposure flu transmission in children aged 1-12 years by 82%.2

Learn more >

References

  1. Tamiflu® (oseltamivir phosphate) Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; November 2014.
  2. Hayden FG, Belshe R, Villanueva C, et al. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004;189:440-449.

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Indications and Important Safety Information

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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