Label: OSELTAMIVIR PHOSPHATE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 21, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Influenza - Oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage and Administration Overview - Administer oseltamivir phosphate capsules for the treatment of influenza in patients 2 weeks of age or older [see Dosage and Administration (2.2)] or for ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Capsules: 30 mg, 45 mg, 75 mg - • 30-mg capsules (30 mg free base equivalent of the phosphate salt): size '4' hard gelatin capsules with light yellow cap imprinted with '30 mg' in blue ...
  • 4 CONTRAINDICATIONS
    Oseltamivir phosphate is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Skin/Hypersensitivity Reactions - Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed below and elsewhere in the labeling: • Serious skin and hypersensitivity reactions [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    7.1 Influenza Vaccines - Live Attenuated Influenza Vaccine - The concurrent use of oseltamivir phosphate with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women to inform a drug‐associated risk of adverse developmental outcomes ...
  • 10 OVERDOSAGE
    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 ...
  • 11 DESCRIPTION
    Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: • Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Oseltamivir is an antiviral drug with activity against influenza virus [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    14.1 Treatment of Influenza - Adults - Two randomized, placebo-controlled, double-blind clinical trials of oseltamivir phosphate were conducted in adults between 18 and 65 years old, one in the ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Oseltamivir Phosphate Capsules USP - 30-mg capsules (30 mg free base equivalent of the phosphate salt):  size '4' hard gelatin capsules with light yellow cap imprinted with '30 mg' in blue ink ...
  • 17 PATIENT 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 ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Oseltamivir Phosphate Capsules USP, for oral use - (OH-sel-TAM-i-vir FOS-fate) What is oseltamivir phosphate capsule? Oseltamivir phosphate capsule is a prescription ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 68788-8831-1 - Oseltamivir Phosphate Capsules USP - 75 mg - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information