Lamivudine is a hepatitis b virus nucleoside analog reverse transcriptase inhibitor sold in the U.S. under 2 brand and generic names, for acquired immunodeficiency syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Lamivudine (application ANDA202941). Other lamivudine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adults: 100 mg, once daily. ( 2.2 ) Pediatric Patients aged 2 to 17 years: 3 mg per kg once daily up to 100 mg once daily. Prescribe oral solution for pediatric patients requiring less than 100 mg daily. ( 2.3 ) Patients with Renal Impairment: Doses of lamivudine tablets (HBV) must be adjusted in accordance with renal function. ( 2.4 ) Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or emtricitabine. ( 2.5 ) 2.1 HIV Counseling and Testing HIV counseling and testing should be offered to all patients before beginning treatment with Lamivudine tablets (HBV) and periodically during treatment because of the risk of emergence of resistant human immunodeficiency virus type 1 (HIV-1) and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [ see Warnings and Precautions ( 5.2 ) ]. 2.2 Recommended Dosage for Adult Patients The recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily. 2.3 Recommended Dosage for Pediatric Patients The recommended oral dosage of lamivudine tablets (HBV) for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less…
The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis B after discontinuation of treatment [ see Warnings and Precautions ( 5.1 ) ]. Risk of emergence of resistant HIV-1 infection [ see Warnings and Precautions ( 5.2 ) ]. Risk of emergence of resistant HBV infection [ see Warnings and Precautions ( 5.3) ]. Lactic acidosis and severe hepatomegaly with steatosis [ see Warnings and Precautions ( 5.4 ) ]. The most common reported adverse reactions in those receiving lamivudine tablets (HBV) (incidence greater than or equal to 10% and reported at a rate greater than placebo) were ear, nose, and throat infections; sore throat; and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience in Adult Subjects with Chronic HBV Infection Clinical adverse reactions (regardless of investigator’s causality assessment) reported in greater than or equal to 10% of subjects who received lamivudine tablets (HBV) and reported at a…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 62/100 | Prescription | Solution | Generic | $0 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| TMT | 150 mg | white | round | — |
| L300 | 300 mg | white | round | — |
| APO;LMV;150 | 150 mg | white | diamond | — |
| I;115 | 150 mg / 300 mg | white | capsule | — |
| GXFC3 | 150 mg / 300 mg | white | oval | — |
| C;60 | 150 mg / 300 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Lamivudine tablets (HBV) are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine tablets (HBV) is contraindicated in patients with previous hypersensitivity reaction to lamivudine. ( 4 )
Sorbitol: Coadministration of lamivudine and sorbitol may result in decreased lamivudine concentrations; when possible, avoid chronic coadministration. Consider more frequent monitoring of HBV viral load when chronic coadministration cannot be avoided. ( 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 Clinical Pharmacology ( 12.3 )] . Consider more frequent monitoring of HBV viral load when chronic coadministration cannot be avoided.
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| Prescription |
| Solution |
| Generic |
| $0 |
| View → |
| white |
| capsule |
| — |
| ML6 | 150 mg / 300 mg | white | capsule | — |
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| H;2 | 150 mg / 300 mg | white | capsule | — |
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| GS;FC2 | 600 mg / 300 mg | orange | oval | — |
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| GS;FC2 | 600 mg / 300 mg | orange | oval | — |
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| GX;LL1 | 300 mg / 150 mg / 300 mg | blue | oval | — |
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| M112 | 300 mg / 300 mg | white | oval | — |
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