EPIVIR 150 mg/1

lamivudine · TABLET, FILM COATED · ViiV Healthcare Company

No Recall History

Plain English

EPIVIR is a tablet, film coated containing lamivudine at 150 mg/1, taken oral. Manufactured by ViiV Healthcare Company.

Key Facts

Brand Name: EPIVIR
Generic Name: lamivudine
NDC Code (Product): 49702-203
Manufacturer: ViiV Healthcare Company
Strength: 150 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020564
Drug Class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Marketing Start: 10/04/2010

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: • The dosage of this product is for HIV‑1 and not for HBV. EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection. Limitations of Use: The dosage of this product is for HIV‑1 and not for HBV. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. ( 2.1 ) • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. ( 2.2 ) • Patients with Renal Impairment: Doses of EPIVIR must be adjusted in accordance with renal function. ( 2.3 ) 2.1 Recommended Dosage for Adult Patients The recommended dosage of EPIVIR in HIV-1–infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If lamivudine is administered to a patient infected with HIV‑1 and HBV, the dosage indicated for HIV‑1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage for Pediatric Patients EPIVIR scored tablet is the preferred formulation for HIV-1–infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to s…

Contraindications

4 CONTRAINDICATIONS EPIVIR is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. EPIVIR is contraindicated in patients with previous hypersensitivity reaction to lamivudine. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ( 7.2 ) 7.1 Drugs Inhibiting Organic Cation Transporters Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim) [see Clinical Pharmacology ( 12.3 )] . No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine. 7.2 Sorbitol Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )] .

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions ( 5.1 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.2 )] . • Pancreatitis [see Warnings and Precautions ( 5.3 )]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.4 )] . • The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. ( 6.1 ) • The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates …

Frequently Asked Questions

What is EPIVIR used for?

EPIVIR contains lamivudine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is EPIVIR a controlled substance?

EPIVIR is not classified as a controlled substance by the DEA.

What is the generic name for EPIVIR?

The generic name for EPIVIR is lamivudine. There are 12 other brand versions of lamivudine.

What is the NDC code for EPIVIR 150 mg/1?

The NDC (National Drug Code) for EPIVIR 150 mg/1 is 49702-203, listed by ViiV Healthcare Company.

Product NDC

49702-203

Package NDC

49702-203-18

Other Lamivudine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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