Tamiflu 75 capsule

Tamiflu (Genentech), manufactured drug form of Oseltamivir phosphate, 75mg/capsule oseltamivir phosphate capsule, NDC 0004-0800

Available in:

NDC Product ID:

  • 0004-0800

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Mar 21, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1 Indications And Usage
  • No
  • TAMIFLU is an influenza neuraminidase inhibitor indicated for: Treatment of influenza in patients 1 year and older who have been symptomatic for no more than 2 days. (1.1) Prophylaxis of influenza in patients 1 year and older. (1.2) Important Limitations of Use : Efficacy not established in patients who begin therapy after 48 hours of symptoms. (1.3) Not a substitute for annual influenza vaccination. (1.3) No evidence of efficacy for illness from agents other than influenza viruses types A and B. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • Treatment of influenza (2.2) Adults and adolescents (13 years and older): 75 mg twice daily for 5 days Pediatric patients (1 year and older): Based on weight twice daily for 5 days Renally impaired patients (creatinine clearance 10-30 mL/min): Reduce to 75 mg once daily for 5 days (2.4) Prophylaxis of influenza (2.3) Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days Community outbreak: 75 mg once daily for up to 6 weeks Pediatric patients (1 year and older): Based on weight once daily for 10 days Community outbreak: Based on weight once daily for up to 6 weeks Renally impaired patients (creatinine clearance 10-30 mL/min): Reduce to 75 mg once every other day or 30 mg once daily (2.4)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Capsules: 30 mg, 45 mg, 75 mg (3) Powder for oral suspension: 360 mg oseltamivir base (constituted to a final concentration of 6 mg/mL) (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Patients with known serious hypersensitivity to oseltamivir or any of the components of TAMIFLU (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Serious skin/hypersensitivity reactions: Discontinue TAMIFLU and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1) Neuropsychiatric events: Patients with influenza, including those receiving TAMIFLU, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • Most common adverse reactions (>1% and more common than with placebo): Treatment studies – Nausea, vomiting (6.1) Prophylaxis studies – Nausea, vomiting, diarrhea, abdominal pain (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 34084-4
  • 7 Drug Interactions
  • No
  • Live attenuated influenza vaccine, intranasal (7): Do not administer until 48 hours following cessation of TAMIFLU. Do not administer TAMIFLU until 2 weeks following administration of the live attenuated influenza vaccine, unless medically indicated.
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Pregnancy: No data in pregnant women. Use only if clearly needed. (8.1) Nursing mothers: Caution should be exercised when administered to a nursing woman. (8.3). Pediatric use: Safety and efficacy not established in patients less than 1 year old. (8.4)
  • 43684-0
  • 10 Overdosage
  • No
  • 34088-5
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Discontinued:

  • No

Marketing start date:

  • Oct 27, 1999

Patents:

Patent expiry date:

  • Dec 27, 2016

FDA application number:

  • NDA021087

Color:

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Shape:

Size:

  • 18 mm (0.71 in )

Scoring:

  • 1

Imprint:

  • ROCHE;75;mg

Therapeutic equivalents:

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