lamivudine
Pharmaranks rates Lamivudine 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lamivudine is a hepatitis b virus nucleoside analog reverse transcriptase inhibitor used to treat Acquired Immunodeficiency Syndrome.
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor · by Apotex
Generic of Epivir
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Lamivudine
- Form
- Tablet
- Strength
- Lamivudine 100MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- acquired immunodeficiency syndrome
- Manufacturer
- Apotex
- What the pharmacy pays
- ~$0.44 per ml — not your price
- FDA application
- ANDA202941
- FDA boxed warning
- Yes — see the boxed warning
What is Lamivudine?
From the FDA label:Lamivudine tablets (HBV) is a synthetic nucleoside analogue with activity against HBV. The drug substance used in lamivudine tablets (HBV) is lamivudine in the form of lamivudine methanol solvate. The chemical name of lamivudine methanol solvate is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl) )2(1H)-pyrimidinone methanol solvate. It has a molecular formula of C 8 H 11 N 3 O 3 S• O.2 CH 4 O C 8 H 11 N 3 O 3 S and a molecular weight of 235.66 g/mol. It has the following structural formula: Lamivudine is a white to off-white powder. It is highly soluble in water. Lamivudine tablets (HBV) are for oral administration. Each tablet contains lamivudine methanol solvate equivalent to 100 mg of lamivudine and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol and titanium dioxide. Meets with USP dissolution test # 2 chemical-structure.jpg
How to use
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 resistanthuman 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…
Side effects
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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy [including lamivudine tablets (HBV)]. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [ see Warnings and Precautions ( 5.1 )] Lamivudine tablets (HBV) is not approved for the treatment of human immunodeficiency virus type 1 (HIV-1) infection because the lamivudine dosage in lamivudine tablets (HBV) is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment [see Warnings and Precaution ( 5.1 ) ] W A RN I N G: EXACERBATIONS OF HEPATITIS B, and RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS (HBV) I S USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION See full prescribing information for complete boxed warning S e v er e acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy [including lamivudine tablets (HBV)]. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1 ) Lamivudine tablets (HBV) contain a lower dose of the same active ingredient (lamivudine) as Epivir tablets and oral solution used to treat human immunodeficiency virus type 1 (HIV-1) infection. HIV-1 resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV-1 infection because the lamivudine dosage in lamivudine tablets (HBV) is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment. ( 5.2 )
Warnings
Important safety information
Emergence of Resistance-Associated HBV Substitutions: Consider a switch to an alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment. ( 2.6 , 5.3 ) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.4 ) 5.1 Exacerbations of Hepatitis after Discontinuation of Treatment Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA commonly observed after stopping treatment; see Table 4 for more information regarding frequency of posttreatment ALT elevations [ see Adverse Reactions ( 6.1 ) ]. Although most events appear to have been self-limited, fatalities have been reported in some cases. The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with lamivudine tablets (HBV). There is insufficient evidence to determine whether re-initiation of lamivudine tablets (HBV) alters the course of posttreatment exacerbations of hepatitis. 5.2 Risk of HIV-1 Resistance if Lamivudine Tablets (HBV) is Used in Patients with Unrecognized or Untreated HIV-1 Infection Lamivudine tablets (HBV) contain a lower lamivudine dose than the lamivudine dose used to treat HIV-1 infection with Epivir tablets and oral solution or with lamivudine containing antiretroviral fixed-dose combination products. Lamivudine tablets (HBV) is not appropriate for patients co-infected with HBV and HIV-1. If a patient with unrecognized or untreated HIV-1 infection is prescribed lamivudine tablets (HBV) for the treatment of HBV, rapid emergence of HIV-1 resistance is likely to result because of the subtherapeutic dose and the inappropriate use of monotherapy for HIV-1 treatment. 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 rapid emergence of resistant HIV-1 and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B in a patient who has unrecognized or untreated HIV-1 infection or who acquires HIV-1 infection during treatment. 5.3 Emergence of Resistance-Associated HBV Substitutions In controlled clinical trials, YMDD-mutant HBV was detected in subjects with on–lamivudine tablets (HBV) re-appearance of HBV DNA after an initial decline below the assay limit [see Microbiology ( 12.4 )]. Subjects treated with lamivudine tablets (HBV) (adults and children) with YMDD-mutant HBV at 52 weeks showed diminished treatment responses in comparison with subjects treated with lamivudine tablets (HBV) without evidence of YMDD substitutions, including the following: lower rates of HBeAg seroconversion and HBeAg loss (no greater than placebo recipients), more frequent return of positive HBV DNA, and more frequent ALT elevations. In the controlled trials, when subjects developed YMDD-mutant HBV, they had a rise in HBV DNA and ALT from their previous on-treatment levels. Progression of hepatitis B, including death, has been reported in some subjects with YMDD-mutant HBV, including subjects from the liver transplant setting and from other clinical trials. In order to reduce the risk of resistance in patients receiving monotherapy with lamivudine tablets (HBV), a switch to an alternative regimen should be considered if serum HBV DNA remains detectable after 24 weeks of treatment. Optimal therapy should be guided by resistance testing. 5.4 Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine tablets (HBV). A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues. Most of these reports have described patients receiving nucleoside analogues for treatment of HIV infection, but there have been reports of lactic acidosis in patients receiving lamivudine for hepatitis B. Treatment with lamivudine tablets (HBV) should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.
Who should not take Lamivudine
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 )
Overdose — what happens if you take too much
There is no known specific treatment for overdose with lamivudine tablets (HBV). If overdose occurs, the patient should be monitored and standard supportive treatment applied, as required. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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.
Storing Lamivudine, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store lamivudine tablets at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].”
- “Store lamivudine tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].”
- “Store lamivudine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].”
Drug class
May treat (source: NIH RxClass)
See how Lamivudine ranks — best-rated hepatitis b virus nucleoside analog reverse transcriptase inhibitor for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Lamivudine treat?
- Lamivudine (Lamivudine) may be used to treat acquired immunodeficiency syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Lamivudine rated?
- pharmaranks gives Lamivudine a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Lamivudine cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.44 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Lamivudine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lamivudine. To pay less, Lamivudine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lamivudine?
- Lamivudine is marketed by Apotex. You can see Apotex's full profile, rating, and other products on pharmaranks.
- Is Lamivudine a brand-name or generic drug?
- Lamivudine is a generic medication; its active ingredient is Lamivudine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Lamivudine available over the counter?
- No. Lamivudine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lamivudine come in?
- Lamivudine is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Lamivudine?
- Lamivudine is classified as hepatitis b virus nucleoside analog reverse transcriptase inhibitor, human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Lamivudine FDA-registered?
- Lamivudine is on record with the U.S. FDA under application number ANDA202941. You can verify this on its official FDA label.
- Has Lamivudine been recalled by the FDA?
- Lamivudine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lamivudine safe?
- There's no single safe-or-not verdict. pharmaranks gives Lamivudine a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lamivudine?
- Lamivudine's side effects are taken directly from its FDA label. From the label: 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 ) ].… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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66/100