Oseltamivir Phosphate (Oseltamivir Phosphate)

Trade Name : Oseltamivir Phosphate

NorthStar RxLLC

CAPSULE

Strength 30 mg/1

OSELTAMIVIR PHOSPHATE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oseltamivir Phosphate (Oseltamivir Phosphate) which is also known as Oseltamivir Phosphate and Manufactured by NorthStar RxLLC. It is available in strength of 30 mg/1 per ml. Read more

Oseltamivir Phosphate (Oseltamivir 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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u00a0Warnings and Precautions (5.2)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2018u00a0

Oseltamivir phosphateu00a0 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. n u2022u00a0Prophylaxis of influenza A and B in patients 1 year and older. n u00a0 u2022u00a0Not a substitute for annual influenza vaccination. n u2022u00a0Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.n u2022u00a0Not recommended for patients with end-stage renal disease not undergoing dialysis. n

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

u2022u00a0Oseltamivir Phosphate Capsules USP, 30 mg (30 mg free base equivalent of the phosphate salt) are light yellow opaque cap/light yellow opaque body size '4' hard gelatin capsules imprinted with 'H' on cap and '33' on body with blue ink, filled with white to off white granular powder. u2022u00a0Oseltamivir Phosphate Capsules USP, 45 mg (45 mg free base equivalent of the phosphate salt) are grey opaque cap/grey opaque body size '4' hard gelatin capsules imprinted with 'H' on cap and '32' on body with blue ink, filled with white to off white granular powder. u2022u00a0Oseltamivir Phosphate Capsules USP, 75 mg (75 mg free base equivalent of the phosphate salt) are light yellow opaque cap/grey opaque body size '2' hard gelatin capsules imprinted with 'H' on cap and '5' on body with blue ink, filled with white to off white granular powder.u00a0
u2022u00a0Capsules: 30 mg, 45 mg, 75 mg n

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 multiformen
Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate capsules n

u2022u00a0Serious skin/hypersensitivity reactions such as Stevens-Johnsonu00a0Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate and initiate appropriate treatment if allergic-like reactions occur or are suspected. n u2022u00a0Neuropsychiatric events: Patients with influenza, including thoseu00a0 receiving oseltamivir phosphate, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (n

The following serious adverse reactions are discussed below and elsewhere in the labeling: u2022u00a0Serious skin and hypersensitivity reactions n u2022u00a0Neuropsychiatric events [n
Most common adverse reactions (>1% and more common than with placebo): u2022u00a0Treatment studies u2013 Nausea, vomiting, headache.n u2022u00a0Prophylaxis studies u2013 Nausea, vomiting, headache, pain. (n n u00a0

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.n

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 [n n

Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: u2022u00a0Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch.u00a0 Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3u03b1,4u03b2,5u03b1)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is CHNO.HPO. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:

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 USP, 30 mg (30 mg free base equivalent of the phosphate salt) are light yellow opaque cap/light yellow opaque body size '4' hard gelatin capsules imprinted with 'H' on cap and '33' on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10u00a0 (1 x 10) unit-dose capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 16714-817-01 Oseltamivir Phosphate Capsules USP, 45 mg (45 mg free base equivalent of the phosphate salt) are grey opaque cap/grey opaque body size '4' hard gelatin capsules imprinted with 'H' on cap and '32' on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10 (1 x 10) unit-dose capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDCu00a0 16714-818-01 Oseltamivir Phosphate Capsules USP, 75 mg (75 mg free base equivalent of the phosphate salt) are light yellow opaque cap/grey opaque body size '2' hard gelatin capsules imprinted with 'H' on cap and '5' on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10 (1 x 10) unit-dose capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDCu00a016714-819-01n n u00a0u00a0u00a0u00a0u00a0 Store the capsules at 20o to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). n n 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 suspectedn n n 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 capsules n n n 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 n 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.u00a0u00a0 n n 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 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 n u00a0 Manufactured for: Northstar Rx LLC Memphis, TN 38141.n Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India.
Issued:u00a0July 2018

Oseltamivir Phosphaten n- Array
What is oseltamivir phosphate capsule?
Oseltamivir phosphate capsules are not recommended for people with end-stage renal disease (ESRD) who are not receiving dialysis.n n Do not take oseltamivir phosphate capsules if you are allergic to oseltamivir phosphate or any of the ingredients in oseltamivir phosphate capsules. u00a0u00a0 n : u2022u00a0have problems swallowing oseltamivir phosphate capsules. u2022u00a0have kidney problems u2022u00a0have any other medical conditions u2022u00a0are pregnant or plan to become pregnant. Available information indicate that oseltamivir phosphate capsules do not increase the risk of birth defects. u2022u00a0are breastfeeding or plan to breastfeed. Oseltamivir phosphate can pass into breast milk in small amounts.n , including prescription or over-the-counter medicines, vitamins, and herbal supplements. n n n n u2022u00a0Take oseltamivir phosphate capsules exactly as your healthcare provider tells you to. u2022u00a0Take oseltamivir phosphate capsules with food or without food. There is less chance of stomach upset if you take oseltamivir phosphate capsules with food.u00a0u00a0u00a0 u2022u00a0If 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.u00a0 u2022u00a0If 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).u00a0u00a0 u2022.u00a0 n u00a0 Oseltamivir phosphate capsules may cause serious side effects, including: u2022. 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: ou00a0skin rash or hivesu00a0u00a0 ou00a0swelling of your face, eyes, lips, tongue, or throat ou00a0your skin blisters and peels u00a0ou00a0trouble breathing ou00a0blisters or sores in your mouthu00a0ou00a0chest pain or tightness ou00a0itching u00a0 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.u00a0 The most common side effect of oseltamivir phosphate capsules when used for prevention of the flu include nausea, vomiting, headache, and pain.u00a0 Tell your healthcare provider if you have any side effect that bothers you or that does not go away.u00a0 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 atu00a0u00a0u00a0u00a0u00a0 1-800-FDA-1088. n u00a0 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 u00a0 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.u00a0 n u00a0u00a0 n oseltamivir phosphate USPn n Oseltamivir phosphate capsules: croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc.u00a0 n gelatin, titanium dioxide, yellow iron oxide and red iron oxide n : gelatin, titanium dioxide and black iron oxide n gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide
Manufactured for: Northstar Rx LLC Memphis, TN 38141.n Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India
u00a0u00a0
This Patient Information has been approved by the U.S. Food and Drug Administrationn Issued:u00a0July 2018
INSTRUCTIONS FOR USEn- Oseltamivir Phosphaten n- Array
How do I mix the contents of oseltamivir phosphate capsules with sweetened liquids, if directed by my healthcare provider or pharmacist? You will need:n

Oseltamivir Phosphate Capsules, USPu00a030 mg* Carton Label
Oseltamivir Phosphate Capsules, USPu00a045 mg* Carton Label
Oseltamivir Phosphate Capsules, USP 75 mg* Carton Label

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Oseltamivir Phosphate (Oseltamivir Phosphate)

Trade Name : Oseltamivir Phosphate

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Delivery Process

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

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Oseltamivir Phosphate (Oseltamivir Phosphate)

Trade Name : Oseltamivir 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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

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Swiss Drugs

NZ Drugs

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