Adult and Adolescent Subjects (13 years of age and older)
The efficacy of oseltamivir phosphate in preventing naturally occurring influenza illness has been demonstrated in three seasonal prophylaxis (community outbreak) clinical trials and one post-exposure prophylaxis trial in household contacts. The efficacy endpoint for all of these trials was the incidence of laboratory-confirmed clinical influenza defined as meeting all the following criteria (all signs and symptoms must have been recorded within
- oral temperature greater than or equal to 99ºF (37.2ºC),
- at least one respiratory symptom (cough, sore throat, nasal congestion),
- at least one constitutional symptom (aches and pain, fatigue, headache, chills/sweats), and
- either a positive virus isolation or a four-fold increase in virus antibody titers from baseline.
In a pooled analysis of two seasonal prophylaxis trials in healthy unvaccinated adults (aged 18 to 65 years), oseltamivir phosphate 75 mg once daily taken for 42 days during a community outbreak reduced the incidence of laboratory-confirmed clinical influenza from 5% (25/519) for the placebo group to 1% (6/520) for the oseltamivir phosphate group.
In the seasonal (community outbreak) prophylaxis trial in elderly residents of skilled nursing homes, about 80%, 43%, and 14% of the subjects were vaccinated, had cardiac disorders, and had chronic airway obstructive disorders, respectively. In this trial, subjects were randomized to oseltamivir phosphate 75 mg once daily or placebo taken orally for 42 days. The incidence of laboratory-confirmed clinical influenza was 4% (12/272) in the placebo-treated subjects compared to less than 1% (1/276) in the oseltamivir phosphate-treated subjects.
In the post-exposure prophylaxis trial in household contacts (aged 13 years or older) of an index influenza case, oseltamivir phosphate 75 mg once daily or placebo taken orally was administered within 48 hours of onset of symptoms in the index case and continued for 7 days (index cases did not receive oseltamivir phosphate treatment). The incidence of laboratory-confirmed clinical influenza was 12% (24/200) in the placebo-treated subjects compared to 1% (2/205) in the oseltamivir phosphate-treated subjects.
Pediatric Subjects (1 year to 12 years of age)
The efficacy of oseltamivir phosphate in preventing naturally occurring influenza illness was demonstrated in a randomized, open-label post-exposure prophylaxis trial in household contacts that included pediatric subjects aged 1 year to 12 years, both as index cases and as family contacts. All index cases in this trial received oseltamivir phosphate for oral suspension 30 to 60 mg taken orally once daily for 10 days. The efficacy parameter was the incidence of laboratory-confirmed clinical influenza in the household. Laboratory-confirmed clinical influenza was defined as meeting all of the following criteria:
- oral temperature at least 100°F (37.8°C),
- cough and/or coryza recorded within 48 hours, and
- either a positive virus isolation or a four-fold or greater increase in virus antibody titers from baseline or at illness visits.
Among household contacts 1 year to 12 years of age not already shedding virus at baseline, the incidence of laboratory-confirmed clinical influenza was lower in the group who received oseltamivir phosphate prophylaxis [3% (3/95)] compared to the group who did not receive oseltamivir phosphate prophylaxis [17% (18/106)].
A double-blind, placebo-controlled trial was conducted for seasonal prophylaxis of influenza in 475 immunocompromised subjects (including 18 pediatric subjects 1 year to 12 years of age) who had received solid organ (n=388; liver, kidney, liver and kidney) or hematopoietic stem cell transplants (n=87). Median time since transplant for solid organ transplant recipients was 1,105 days for the placebo group and 1,379 days for the oseltamivir phosphate group. Median time since transplant for hematopoietic stem cell transplant recipients was 424 days for the placebo group and 367 days for the oseltamivir phosphate group. Approximately 40% of subjects received influenza vaccine prior to entering the study. The primary efficacy endpoint was the incidence of confirmed clinical influenza, defined as oral temperature higher than 99°F (37.2°C) plus cough and/or coryza, all recorded within 24 hours, plus either a positive virus culture or a four-fold increase in virus antibody titers from baseline. Subjects received treatment with oseltamivir phosphate 75 mg or placebo once daily by mouth for 12 weeks. The incidence of confirmed clinical influenza was 3% (7/238) in the placebo group compared with 2% (5/237) in the oseltamivir phosphate group; this difference was not statistically significant. A secondary analysis was performed using the same clinical symptoms and RT-PCR for laboratory confirmation of influenza infection. Among subjects who were not already shedding virus at baseline, the incidence of RT-PCR-confirmed clinical influenza infection was 3% (7/231) in the placebo group and <1% (1/232) in the oseltamivir phosphate group.
Oseltamivir Phosphate Capsules USP, 30 mg are supplied as hard gelatin capsules with yellow ivory opaque cap and yellow ivory opaque body printed “AMNEAL” on cap and “264” on body with blue ink. They are available as follows:
Blister pack of 10: NDC 42291-666-10
Oseltamivir Phosphate Capsules USP, 75 mg are supplied as hard gelatin capsules with yellow ivory opaque cap and light gray opaque body printed “AMNEAL” on cap and “266” on body with blue ink. They are available as follows:
Blister pack of 10: NDC 42291-664-10
Store the capsules at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
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 and seek immediate medical attention if an allergic-like reaction occurs or is suspected [see Warnings and Precautions (5.1)].
Advise patients and/or caregivers of the risk of neuropsychiatric events in oseltamivir phosphate-treated patients with influenza and instruct patients to contact their physician if they experience signs of abnormal behavior while receiving oseltamivir phosphate [see Warnings and Precautions (5.2)].
Important Dosing Information
Instruct patients to begin treatment with oseltamivir phosphate 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 for prevention as soon as possible after exposure [see Dosage and Administration (2)]. Instruct patients to take any missed doses as soon as they remember, except if it is near the next scheduled dose (within 2 hours), and then continue to take oseltamivir phosphate at the usual times.
Instruct patients that oseltamivir phosphate is 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 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 administration, unless medically necessary [see Drug Interactions (7.1)].
Pulaski, TN 38478
Amneal Pharmaceuticals LLC
Brookhaven, NY 11719
Mfg. Rev. 01-2019-02 AV 02/19
Oseltamivir Phosphate (oh” sel tam’ i vir fos’ fate)
Capsules, USP, for oral use
What are oseltamivir phosphate capsules?
Oseltamivir phosphate capsules are a prescription medicine used to:
It is not known if oseltamivir phosphate capsules are:
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:
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?
What are the possible side effects of oseltamivir phosphate capsules?
Oseltamivir phosphate capsules may cause serious side effects, including:
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The most common side effects of oseltamivir phosphate capsules when used for treatment of the flu include nausea, vomiting, and headache.
The most common side effect of oseltamivir phosphate capsules when used for prevention of the flu include nausea, vomiting, headache, and pain.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of oseltamivir phosphate capsules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store oseltamivir phosphate capsules?
Keep oseltamivir phosphate capsules and all medicines out of the reach of children.
General information about the safe and effective use of oseltamivir phosphate capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use oseltamivir phosphate capsules for a condition for which it was not prescribed. Do not give oseltamivir phosphate capsules to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about oseltamivir phosphate capsules that is written for health professionals. For more information, go to www.avkare.com.
What are the ingredients in oseltamivir phosphate capsules?
Active ingredient: oseltamivir phosphate, USP
Oseltamivir phosphate capsules: croscarmellose sodium, povidone K-30, pregelatinized starch (maize), stearic acid, and talc
30mg capsule shell: gelatin, titanium dioxide, and yellow iron oxide
45mg capsules shell: black iron oxide, gelatin, and titanium dioxide
75mg capsules shell: black iron oxide, gelatin, titanium dioxide, and yellow iron oxide
Each capsule is printed with blue ink, which includes FD&C Blue No. 2 indigo carmine aluminum lake as the colorant, methanol, N-butyl alcohol, ethanol, shellac glaze, and titanium dioxide.
*All trademarks are the property of their respective owners.
Pulaski, TN 38478
Amneal Pharmaceuticals LLC
Brookhaven, NY 11719
Mfg. Rev. 04-2018-01
This Patient Information has been approved by the U.S. Food and Drug Administration.
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