Oseltamivir
Generic Name: oseltamivir
Brand Names:
Oseltamivir Phosphate
11 DESCRIPTION Oseltamivir phosphate, USP, 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 phosphate, USP In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K-30, pregelatinized starch (maize), stearic acid, and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide.
Overview
11 DESCRIPTION Oseltamivir phosphate, USP, 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 phosphate, USP In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K-30, pregelatinized starch (maize), stearic acid, and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide.
Uses
1 INDICATIONS AND USAGE Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment 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. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis.
Dosage
2 DOSAGE AND ADMINISTRATION Treatment of influenza (2.2) Adults and adolescents (13 years and older): 75 mg twice daily for 5 days Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days Pediatric patients 2 weeks to less than 1 year of age: 3 mg/kg twice daily for 5 days Renally impaired adult patients (creatinine clearance > 30 to 60 mL/min): Reduce to 30 mg twice daily for 5 days (2.4) Renally impaired adult patients (creatinine clearance > 10 to 30 mL/min): Reduce to 30 mg once daily for 5 days (2.4) ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle.
Side Effects
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 (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] Most common adverse reactions (> 1% and more common than with placebo): Treatment studies – Nausea, vomiting, headache. (6.1) Prophylaxis studies – Nausea, vomiting, headache, pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc.
Interactions
7 DRUG INTERACTIONS Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate use, unless medically indicated. (7) 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, because of the potential for oseltamivir phosphate to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate administration, unless medically indicated. Inactivated Influenza Vaccine Inactivated influenza vaccine can be administered at any time relative to use of oseltamivir phosphate.
Warnings
5 WARNINGS AND PRECAUTIONS Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1) Neuropsychiatric events: Patients with influenza, including those 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. (5.2) 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 reported in postmarketing experience with oseltamivir phosphate. 4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.1) ].
Pregnancy
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. Available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. However, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see Data and Clinical Pharmacology (12.3)].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
Frequently Asked Questions
What is Oseltamivir used for?▼
1 INDICATIONS AND USAGE Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment 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. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis.
What are the side effects of Oseltamivir?▼
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 (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] Most common adverse reactions (> 1% and more common than with placebo): Treatment studies – Nausea, vomiting, headache. (6.1) Prophylaxis studies – Nausea, vomiting, headache, pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc.
Can I take Oseltamivir during pregnancy?▼
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. Available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. However, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see Data and Clinical Pharmacology (12.3)].
What are the important warnings for Oseltamivir?▼
5 WARNINGS AND PRECAUTIONS Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1) Neuropsychiatric events: Patients with influenza, including those 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. (5.2) 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 reported in postmarketing experience with oseltamivir phosphate. 4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.1) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.