Lamivudine 300 mg/1
Lamivudine · TABLET · Ingenus Pharmaceuticals, LLC
Lamivudine is a tablet containing lamivudine at 300 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Lamivudine
- Generic Name
- Lamivudine
- NDC Code (Product)
50742-624- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206974
- Drug Class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Marketing Start
- 02/01/2017
Recall History
GlaxoSmithKline Inc
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
American Health Packaging
Failed dissolution specifications
American Health Packaging
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Silarx Pharmaceutical, Inc.
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Dosage & Administration
2 DOSAGE & ADMINISTRATION • Adults and Adolescents weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.1) • Pediatrics weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.2) • Because lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, lamivudine and zidovudine tablet is not recommended in patients requiring dosage adjustment or with hepatic impairment or experiencing dose-limiting adverse reactions. (2.3, 4) 2.1 Recommended Dosage for Adults and Adolescents The recommended dosage of lamivudine and zidovudine tablet in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) taken orally twice daily. 2.2 Recommended Dosage for Pediatric Patients The recommended dosage of scored lamivudine and zidovudine tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily. Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably…
Contraindications
4 CONTRAINDICATIONS Lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. Lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. (4)
Drug Interactions
7 DRUG INTERACTIONS • Agents antagonistic with zidovudine: Concomitant use should be avoided. (7.1) • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. (7.1) • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. (7.2) • Agents antagonistic with zidovudine: Concomitant use should be avoided. (7.1) • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. (7.1) • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. (7.2) 7.1 Zidovudine Agents Antagonistic with Zidovudine Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro : • Stavudine • Doxorubicine • Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration with the following drugs may increase the hematologic toxicity of zidovudine: • Ganciclovir • Interferon alfa • Ribavirin • Other bone marrow suppressive or cytoto…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions (5.1)]. • Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2)]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3)]. • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.4)]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.5)]. • Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.5)]. • Pancreatitis [see Warnings and Precautions (5.6)]. • Immune reconstitution syndrome [see Warnings and Precautions (5.7)]. • Lipoatrophy [see Warnings and Precautions (5.8)]. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in clinical trials of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hetero La…
Frequently Asked Questions
What is Lamivudine used for?
Lamivudine contains Lamivudine. It is a tablet taken oral. Consult your doctor for specific uses.
Is Lamivudine a controlled substance?
Lamivudine is not classified as a controlled substance by the DEA.
What is the generic name for Lamivudine?
The generic name for Lamivudine is Lamivudine. There are 7 other brand versions of Lamivudine.
What is the NDC code for Lamivudine 300 mg/1?
The NDC (National Drug Code) for Lamivudine 300 mg/1 is 50742-624, listed by Ingenus Pharmaceuticals, LLC.