oseltamavir phosphate 45 mg/1
oseltamavir phosphate · CAPSULE · NuCare Pharmaceuticals, Inc.
oseltamavir phosphate is a capsule containing oseltamavir phosphate at 45 mg/1, taken oral. Manufactured by NuCare Pharmaceuticals, Inc..
Key Facts
- Brand Name
- oseltamavir phosphate
- Generic Name
- oseltamavir phosphate
- NDC Code (Product)
68071-3741- Manufacturer
- NuCare Pharmaceuticals, Inc.
- Strength
- 45 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207211
- Marketing Start
- 09/21/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Oseltamivir phosphate capsules USP, is 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. ( 1.3 ) 1.1 Treatment of Influenza Oseltamivir phosphate capsule is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. 1.2 Prophylaxis of Influenza Oseltamivir phosphate capsule is indicated for the prophylaxis of influenza A and B in patients 1 year and older. 1.3 Limitations of Use • Oseltamivir phosphate capsule is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for…
Dosage & Administration
2 DOSAGE & 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: 3mg/kg twice daily for 5 days • Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg twice daily for 5 days ( 2.4 ) • Renally impaired adult patients (creatinine clearance >10-30 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. Treatment duration not to exceed 5 days ( 2.4 ) • ESRD patients on CAPD: Reduce to a single 30 mg dose immediately ( 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 to 12 years of age: Based on weight once daily for 10 days -Community outbreak: Based on weight once daily for up to 6 weeks • Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg once daily ( 2.4 ) •…
Contraindications
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 )] . Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate capsules ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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. ( 7 ) 7.1 Influenza Vaccines Live Attenuated Influenza Vaccine The concurrent use of oseltamivir phosphate capsules with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for oseltamivir phosphate capsules 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 capsules administration, unless medically indicated. Inactivated Influenza Vaccine Inactivated influenza vaccine can be administered at any time relative to use of oseltamivir phosphate capsules. 7.2 Drugs Without Clinically Significant Drug Interaction with Oseltamivir Phosphate Capsules No dose adjustments are needed for either oseltamivir or the concomitant drug when coadministering oseltamivir with amoxicillin, acetaminophen, aspirin, cimetidine, antacids (magnesium and aluminum hydroxides and calcium carbonates), rimantadine, amantadine, …
Adverse Reactions
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 Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Treatment and Prophylaxis Trials in Adult and Adolescent Subjects (13 years of age and older) The overall safety profile of oseltamivir phosphate is based on data from 2,646 adult and adolescent subjects that received the recommended dosage of 75 mg orally twice daily for 5 days fo…
Frequently Asked Questions
What is oseltamavir phosphate used for?
oseltamavir phosphate contains oseltamavir phosphate. It is a capsule taken oral. Consult your doctor for specific uses.
Is oseltamavir phosphate a controlled substance?
oseltamavir phosphate is not classified as a controlled substance by the DEA.
What is the generic name for oseltamavir phosphate?
The generic name for oseltamavir phosphate is oseltamavir phosphate. There are no other listed brand versions of oseltamavir phosphate.
What is the NDC code for oseltamavir phosphate 45 mg/1?
The NDC (National Drug Code) for oseltamavir phosphate 45 mg/1 is 68071-3741, listed by NuCare Pharmaceuticals, Inc..
Other oseltamavir phosphate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)