Generic Name
Oseltamivir
Brand Names
Oseltamavir, Tamiflu
FDA approval date: October 27, 1999
Classification: Neuraminidase Inhibitor
Form: Powder, Suspension, For, Capsule
What is Oseltamavir (Oseltamivir)?
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. , Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use :, Not a substitute for annual influenza vaccination. , Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. , Not recommended for patients with end-stage renal disease not undergoing dialysis.
Approved To Treat
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Brand Information
oseltamavir phosphate (oseltamavir phosphate)
1DOSAGE FORMS & STRENGTHS
Oseltamivir Phosphate Capsules, USP:
2CONTRAINDICATIONS
Oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme
3ADVERSE REACTIONS
The following serious adverse reactions are discussed below and elsewhere in the labeling:
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
* Adverse reactions that occurred in ≥1% of oseltamivir phosphate-treated adults and adolescents and ≥1% greater in oseltamivir phosphate-treated subjects compared to placebo-treated subjects in either the treatment or prophylaxis trials.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of oseltamivir phosphate. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to oseltamivir phosphate exposure.
General disorders and administration site conditions: Swelling of the face or tongue, allergy, anaphylactic/anaphylactoid reactions, hypothermia
Skin and subcutaneous tissue disorders: Rash, dermatitis, urticaria, eczema, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme [see Warnings and Precautions (
Gastrointestinal Disorders: Gastrointestinal bleeding, hemorrhagic colitis
Cardiac Disorders: Arrhythmia
Hepatobiliary Disorders: Hepatitis, abnormal liver function tests
Nervous System Disorders: Seizure
Metabolism and Nutrition Disorders: Aggravation of diabetes
Psychiatric Disorders: Abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions [see Warnings and Precautions (
4OVERDOSAGE
Reports of overdoses with oseltamivir phosphate have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Adverse reactions reported following overdose were similar in nature to those observed with therapeutic doses of oseltamivir phosphate
5DESCRIPTION
Oseltamivir phosphate capsules, USP an influenza neuraminidase inhibitor (NAI), is available as:
Oseltamivir phosphate, USP is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C
6HOW SUPPLIED/STORAGE AND HANDLING
Oseltamivir Phosphate Capsules, USP : 75 mg
75-mg capsules (75 mg free base equivalent of the phosphate salt): Light yellow cap and grey body size ‘2’ hard gelatin capsules containing white to off white granules with “75mg” on cap and “M55” on body imprinted with blue ink. Available in blister packages of 10 (NDC 71205-107-10), bottles of 30 (NDC 71205-107-30), bottles of 60 (NDC 71205-107-60), and bottles of 90 (NDC 71205-107-90).
Storage
Store capsules at 20° to 25°C (68° to 77°F); excursions permitted within 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Skin/Hypersensitivity Reactions
Advise patients and/or caregivers of the risk of severe allergic reactions (including anaphylaxis) or serious skin reactions. Instruct patients and/or caregiver to stop oseltamivir phosphate capsules and seek immediate medical attention if an allergic-like reaction occurs or is suspected [
Neuropsychiatric Events
Advise patients and/or caregivers of the risk of neuropsychiatric events in oseltamivir phosphate capsules-treated patients with influenza and instruct patients to contact their physician if they experience signs of abnormal behavior while receiving oseltamivir phosphate capsules
Important Dosing Information
Instruct patients to begin treatment with oseltamivir phosphate capsules as soon as possible from the first appearance of flu symptoms, within 48 hours of onset of symptoms. Similarly, instruct patients to start taking oseltamivir phosphate capsules for prevention as soon as possible after exposure [
Influenza Vaccines
Instruct patients that oseltamivir phosphate capsules are not a substitute for receiving an annual flu vaccination. Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices. Because of the potential for oseltamivir phosphate capsules to inhibit replication of live attenuated influenza vaccine (LAIV) and possibly reduce efficacy of LAIV, avoid administration of LAIV within 2 weeks or 48 hours after oseltamivir phosphate capsules administration, unless medically necessary
Manufactured by:
Revised October 2017
Relabeled By:
7.1
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8SPL PATIENT PACKAGE INSERT SECTION
Oseltamivir Phosphate (OH-sel-TAM-i-vir FOS-fate) Capsules
What are oseltamivir phosphate capsules?
Oseltamivir phosphate capsules are a prescription medicine used to:
• treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than two days.
• prevent the flu in people who are 1 year of age and older.
It is not known if oseltamivir phosphate capsules are:
• effective in people who start treatment after 2 days of developing flu symptoms.
• effective for the treatment of the flu in people with long-time (chronic) heart problems or breathing problems.
• effective for the treatment or prevention of flu in people who have weakened immune systems (immunocompromised)
• safe and effective for the treatment of the flu in children less than 2 weeks of age.
• safe and effective in the prevention of the flu in children less than 1 year of age.
Oseltamivir phosphate capsules do not treat or prevent illness that is caused by infections other than the influenza virus.
Oseltamivir phosphate capsules do not prevent bacterial infections that may happen with the flu.
Oseltamivir phosphate capsules are not recommended for people with end-stage renal disease (ESRD) who are not receiving dialysis.
Oseltamivir phosphate capsules do not take the place of receiving a flu vaccination. Talk to your healthcare provider about when you should receive an annual flu vaccination.
Who should not take oseltamivir phosphate capsules?
Do not take oseltamivir phosphate capsules if you are allergic to oseltamivir phosphate or any of the ingredients in oseltamivir phosphate capsules.
See the end of this leaflet for a complete list of ingredients in oseltamivir phosphate capsules.
What should I tell my healthcare provider before taking oseltamivir phosphate capsules?
Before you take oseltamivir phosphate capsules, tell your healthcare provider if you:
• have problems swallowing oseltamivir phosphate capsules
• have kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Available information indicate that oseltamivir phosphate capsules does not increase the risk of birth defects.
• are breastfeeding or plan to breastfeed. Oseltamivir phosphate can pass into breast milk in small amounts.
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take oseltamivir phosphate capsules?
• Take oseltamivir phosphate capsules exactly as your healthcare provider tells you to.
• Take oseltamivir phosphate capsules with food or without food. There is less chance of stomach upset if you take oseltamivir phosphate capsules with food.
• If you miss a dose of oseltamivir phosphate capsules, take it as soon as you remember. If it is 2 hours or less before your next dose, do not take the missed dose. Take your next dose of oseltamivir phosphate capsules at your scheduled time. Do not take 2 doses at the same time.
• If oseltamivir phosphate for oral suspension is not available or you cannot swallow oseltamivir phosphate capsules, your healthcare provider or pharmacist may instruct you to open oseltamivir phosphate capsules and mix the capsules contents with sweetened liquids such as chocolate syrup (regular or sugar-free), corn syrup, caramel topping, or light brown sugar (dissolved in water).
• If your healthcare provider or pharmacist has instructed you to open your oseltamivir phosphate capsules, read the detailed Instructions for Use at the end of this leaflet. Ask your pharmacist if you have any questions.
What are the possible side effects of oseltamivir phosphate capsules?
Oseltamivir phosphate capsules may cause serious side effects, including:
• Serious skin and allergic reactions. Oseltamivir phosphate capsules can cause serious skin and allergic reactions. Stop taking oseltamivir phosphate capsules and get medical help right away if you get any of the following symptoms:
What are oseltamivir phosphate capsules?
Oseltamivir phosphate capsules are a prescription medicine used to:
• treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than two days.
• prevent the flu in people who are 1 year of age and older.
It is not known if oseltamivir phosphate capsules are:
• effective in people who start treatment after 2 days of developing flu symptoms.
• effective for the treatment of the flu in people with long-time (chronic) heart problems or breathing problems.
• effective for the treatment or prevention of flu in people who have weakened immune systems (immunocompromised)
• safe and effective for the treatment of the flu in children less than 2 weeks of age.
• safe and effective in the prevention of the flu in children less than 1 year of age.
Oseltamivir phosphate capsules do not treat or prevent illness that is caused by infections other than the influenza virus.
Oseltamivir phosphate capsules do not prevent bacterial infections that may happen with the flu.
Oseltamivir phosphate capsules are not recommended for people with end-stage renal disease (ESRD) who are not receiving dialysis.
Oseltamivir phosphate capsules do not take the place of receiving a flu vaccination. Talk to your healthcare provider about when you should receive an annual flu vaccination.
Who should not take oseltamivir phosphate capsules?
Do not take oseltamivir phosphate capsules if you are allergic to oseltamivir phosphate or any of the ingredients in oseltamivir phosphate capsules.
See the end of this leaflet for a complete list of ingredients in oseltamivir phosphate capsules.
What should I tell my healthcare provider before taking oseltamivir phosphate capsules?
Before you take oseltamivir phosphate capsules, tell your healthcare provider if you:
• have problems swallowing oseltamivir phosphate capsules
• have kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Available information indicate that oseltamivir phosphate capsules does not increase the risk of birth defects.
• are breastfeeding or plan to breastfeed. Oseltamivir phosphate can pass into breast milk in small amounts.
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take oseltamivir phosphate capsules?
• Take oseltamivir phosphate capsules exactly as your healthcare provider tells you to.
• Take oseltamivir phosphate capsules with food or without food. There is less chance of stomach upset if you take oseltamivir phosphate capsules with food.
• If you miss a dose of oseltamivir phosphate capsules, take it as soon as you remember. If it is 2 hours or less before your next dose, do not take the missed dose. Take your next dose of oseltamivir phosphate capsules at your scheduled time. Do not take 2 doses at the same time.
• If oseltamivir phosphate for oral suspension is not available or you cannot swallow oseltamivir phosphate capsules, your healthcare provider or pharmacist may instruct you to open oseltamivir phosphate capsules and mix the capsules contents with sweetened liquids such as chocolate syrup (regular or sugar-free), corn syrup, caramel topping, or light brown sugar (dissolved in water).
• If your healthcare provider or pharmacist has instructed you to open your oseltamivir phosphate capsules, read the detailed Instructions for Use at the end of this leaflet. Ask your pharmacist if you have any questions.
What are the possible side effects of oseltamivir phosphate capsules?
Oseltamivir phosphate capsules may cause serious side effects, including:
• Serious skin and allergic reactions. Oseltamivir phosphate capsules can cause serious skin and allergic reactions. Stop taking oseltamivir phosphate capsules and get medical help right away if you get any of the following symptoms:
•
Manufactured for:
Manufactured by:
Revised August 2016
Relabeled By:
This Patient Information has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
Oseltamivir Phosphate (OH-sel-TAM-i-vir FOS-fate) Capsules, for Oral Use
How do I mix the contents of oseltamivir phosphate capsules with sweetened liquids, if directed by my healthcare provider or pharmacist?
You will need:
• the prescribed dose of oseltamivir phosphate capsules
• a small bowl
• sweetened liquid, such as chocolate syrup (regular or sugar-free), corn syrup, caramel topping, or light brown sugar (dissolved in water)
Step 1. Open the contents of the prescribed dose of oseltamivir phosphate capsules into a small bowl.
Step 2. Add a small amount of the sweetened liquid to the capsule contents.
Step 3. Stir the mixture and give the entire dose of oseltamivir phosphate capsules.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised 10/2016
PM02470902
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
