Oseltamavir Phosphate (Oseltamavir Phosphate)

Trade Name : oseltamavir phosphate

Proficient Rx LP

CAPSULE

Strength 75 mg/1

OSELTAMIVIR PHOSPHATE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oseltamavir Phosphate (Oseltamavir Phosphate) which is also known as oseltamavir phosphate and Manufactured by Proficient Rx LP. It is available in strength of 75 mg/1 per ml. Read more

Oseltamavir Phosphate (Oseltamavir Phosphate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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u00a0 Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a004/2018

Oseltamivir phosphate capsules USP, is an influenza neuraminidase inhibitor (NAI) indicated for: u2022u00a0Treatment 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. () u2022u00a0Prophylaxis of influenza A and B in patients 1 year and older. () n n n u2022u00a0Not a substitute for annual influenza vaccination. () u2022u00a0Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. () u2022u00a0Not recommended for patients with end-stage renal disease not undergoing dialysis. ()

Treatment of influenza
Prophylaxis of influenza
2.2
2.4
2.4
2.4
2.4
2.3
2.4
2.4
2.4
2.4

Oseltamivir Phosphate Capsules, USP: u2022u00a030-mg capsules (30 mg free base equivalent of the phosphate salt): Light yellow cap and light yellow body size u20184u2019 hard gelatin capsules containing white to off white granules with u201c30mgu201d on cap and u201cM53u201d on body imprinted with blue ink. u2022u00a045-mg capsules (45 mg free base equivalent of the phosphate salt): Grey cap and grey body size u20184u2019 hard gelatin capsules containing white to off white granules with u201c45mgu201d on cap and u201cM54u201d on body imprinted with blue ink. u2022u00a075-mg capsules (75 mg free base equivalent of the phosphate salt): Light yellow cap and grey body size u20182u2019 hard gelatin capsules containing white to off white granules with u201c75mgu201d on cap and u201cM55u201d on body imprinted with blue ink.
u2022u00a0Capsules: 30 mg, 45 mg, 75 mg ()

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 .
Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate capsules ()

u2022u00a0Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate capsules and initiate appropriate treatment if allergic-like reactions occur or are suspected. () u2022u00a0Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate capsules, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. ()

The following serious adverse reactions are discussed below and elsewhere in the labeling: u2022u00a0Serious skin and hypersensitivity reactions [] u2022u00a0Neuropsychiatric events []
Most common adverse reactions (>1% and more common than with placebo): u2022u00a0Treatment studies u2013 Nausea, vomiting, headache. (
) u2022u00a0Prophylaxis studies u2013 Nausea, vomiting, headache, pain. (
) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or n
6.1
6.1

Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate capsules use, unless medically indicated. ()

No data

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 .

Oseltamivir phosphate capsules, USP an influenza neuraminidase inhibitor (NAI), is available as: u2022u00a0Capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, isopropyl alcohol, povidone, pregelatinised starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide. The 45 mg capsule shell contains gelatin, iron oxide black, titanium dioxide. The 75 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, iron oxide black. Each capsule is printed with blue ink, which includes shellac, propylene glycol and FD&C Blue No. 2 as the colorant.
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 CHNO (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows:n n n

No data

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 mg/kg, respectively, the prodrug and the active form oseltamivir carboxylate induced no statistically significant increases in tumors over controls. The mean maximum daily exposures to the prodrug in mice and rats were approximately 130- and 320-fold, respectively, greater than those in humans at the recommended clinical dose based on AUC comparisons. The respective safety margins of the exposures to the active oseltamivir carboxylate were 15- and 50-fold.
Oseltamivir was found to be non-mutagenic in the Ames test and the human lymphocyte chromosome assay with and without enzymatic activation and negative in the mouse micronucleus test. It was found to be positive in a Syrian Hamster Embryo (SHE) cell transformation test. Oseltamivir carboxylate was non-mutagenic in the Ames test and the L5178Y mouse lymphoma assay with and without enzymatic activation and negative in the SHE cell transformation test.
In a fertility and early embryonic development study in rats, doses of oseltamivir at 50, 250, and 1500 mg/kg/day were administered to females for 2 weeks before mating, during mating and until day 6 of pregnancy. Males were dosed for 4 weeks before mating, during mating, and for 2 weeks after mating. There were no effects on fertility, mating performance or early embryonic development at any dose level. The highest dose in this study was approximately 100 times the human systemic exposure (AUC) of oseltamivir carboxylate that occurs after administration of the maximum recommended human dose.

No data

Oseltamivir Phosphate Capsules, USPu00a0
75-mg capsules (75 mg free base equivalent of the phosphate salt): Light yellow cap and grey body size u20182u2019 hard gelatin capsules containing white to off white granules with u201c75mgu201d on cap and u201cM55u201d on body imprinted with blue ink. Available in blister packages of 10 (NDC 71205-107-10). 30 (NDC 71205-107-30) 60 (NDC 71205-107-60). 90 (NDC 71205-107-90)..
Storage
Store capsules at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted within 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].

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 [. 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 capsules at the usual times.
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 n Manufactured for :n n Plainsboro, NJ 08536
Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Revisedu00a0October 2017
Relabeled By;Proficient Rx LP.Thousand Oaks CA 91320
.

Oseltamivir Phosphate (OH-sel-TAM-i-vir FOS-fate) Capsulesn- What are oseltamivir phosphate capsules? n- 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. n- Who should not take oseltamivir phosphate capsules? n- See the end of this leaflet for a complete list of ingredients in oseltamivir phosphate capsules. n- What should I tell my healthcare provider before taking oseltamivir phosphate capsules? n- Before you take oseltamivir phosphate capsules, tell your healthcare provider if you:n- Tell your healthcare provider about all the medicines you take,n- . n- Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.n- How should I take oseltamivir phosphate capsules? n- 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.n- What are the possible side effects of oseltamivir phosphate capsules? n- Serious skin and allergic reactions.
u2022 People, especially children, who have the flu, can develop nervous system problems and abnormal behavior that can lead to death. During treatment with oseltamivir phosphate capsules, tell your healthcare provider right away if you or your child have confusion, speech problems, shaky movements, seizures, or start hearing voices or seeing things that are not really there (hallucinations). 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.n n n u2022u00a0Store oseltamivir phosphate capsules at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C). u2022u00a0Safely throw away any unused oseltamivir phosphate capsules that are out of date or no longer needed. n n n n 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, call Macleods Pharma USA, Inc. at 1-888-943-3210.n n n n oseltamivir phosphate n Oseltamivir phosphate capsules: croscarmellose sodium, isopropyl alcohol, povidone, pregelatinised starch, sodium stearyl fumarate and talc. u00a0n gelatin, iron oxide red, iron oxide yellow, titanium dioxide. n gelatin, iron oxide black, titanium dioxide.n gelatin, iron oxide red, iron oxide yellow, titanium dioxide, iron oxide black Each capsule is printed with blue ink, which includes shellac, propylene glycol and FD&C Blue No. 2 as the colorant.
Manufactured for :n n Plainsboro, NJ 08536
Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Revised August 2016
Relabeled By;Proficient Rx LP.Thousand Oaks CA 91320
This Patient Information has been approved by the U.S. Food and Drug Administration.n- u00a0INSTRUCTIONS FOR USEn- Oseltamivir Phosphate (OH-sel-TAM-i-vir FOS-fate) Capsules, for Oral Usen- How do I mix the contents of oseltamivir phosphate capsules with sweetened liquids, if directed by my healthcare provider or pharmacist? n- You will need:

No data

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Oseltamavir Phosphate (Oseltamavir Phosphate)

Trade Name : oseltamavir phosphate

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Oseltamavir Phosphate (Oseltamavir Phosphate)

Trade Name : oseltamavir phosphate

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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