Mediclarum
Medicine guide

Lamivudine

150 mg · Tablet, Film Coated

  • Prescription only
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Active substance
Lamivudine
Made by
Camber Pharmaceuticals, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-01-09

What it is

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor

Used for
  • The dosage of this product is for HIV-1 and not for HBV. ( 1 )
The label’s usual adult dose

Adults:: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. ( 2.1 )

Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. ( 2.2 )

Full directions ↓
Serious warning

Exacerbations of hepatitis b, and different formulations of lamivudine warning:

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
25other products contain Lamivudine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Lamivudine tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-l) infection. Limitations of Use:

  • The dosage of this product is for HIV-1 and not for HBV. Lamivudine tablets are 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 )

From the official label · 2025-01-09 · DailyMed

How it works

From this product’s own US prescribing label.

Lamivudine is an antiretroviral agent [see Microbiology ( 12.4 )].

Peak level after0.3 h
Half-life5–7 h
Mostly cleared after≈ 30 hfive half-lives — our arithmetic
PeakHalf gone30 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Lamivudine is not significantly metabolized by cytochrome P450 enzymes.

How it leaves the body

The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion.

With food

Effects of Food on Oral Absorption: Lamivudine tablets and oral solution may be administered with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-01-09

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • EXACERBATIONS OF HEPATITIS B, AND DIFFERENT FORMULATIONS OF LAMIVUDINE WARNING:
  • EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-l) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-l and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )]. Important Differences among Lamivudine-Containing Products Lamivudine tablets (used to treat HIV-l infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-l infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions ( 5.1 )]. WARNING:
  • EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE See full prescribing information for complete boxed warning.
  • Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-l) and have discontinued lamivudine. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1 )
  • Patients with HIV-1 infection should receive only dosage forms of lamivudine appropriate for treatment of HIV-l. ( 5.1 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine tablets are contraindicated in patients with previous hypersensitivity reaction to lamivudine. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 lamivudine must be adjusted in accordance with renal function. ( 2.3 ) 2.1 Recommended Dosage for Adult Patients The recommended dosage of lamivudine tablets 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 Lamivudine 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 lamivudine scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow lamivudine tablets, the oral solution formulation may be prescribed [see Warnings and Precautions ( 5.5 )]. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1. Table 1. Dosing Recommendations for Lamivudine Scored (150-mg) Tablets in Pediatric Patients Weight (kg) Once-Daily Dosing Regimen a Twice-Daily Dosing Regimen Using Scored 150-mg Tablet AM Dose PM Dose Total Daily Dose 14 to <20 1 tablet (150 mg) ½ tablet (75 mg) ½ tablet (75 mg) 150 mg ≥20 to <25 1½ tablets (225 mg) ½ tablet (75 mg) 1 tablet (150 mg) 225 mg ≥25 2 tablets (300 mg) b 1 tablet (150 mg) 1 tablet (150 mg) 300 mg a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studie ( 14.2 )]. b Patients may alternatively take one 300-mg tablet, which is not scored. 2.3 Patients With Renal Impairment Dosing of lamivudine tablets is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology ( 12.3 )]. Table 2. Adjustment of Dosage of Lamivudine in
  • Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥50 30 to 49 15 to 29 5 to 14 <5 150 mg twice daily or 300mg once daily 150 mg once daily 150 mg first dose, then 100 mg once daily 150 mg first dose, then 50 mg once daily 50 mg first dose, then 25 mg once daily No additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis. Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Co-infected HIV-1/HBV Patients:
  • Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. ( 5.1 )
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.2 )
  • Pancreatitis:
  • Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate. ( 5.3 )
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ( 5.4 )
  • Lower virologic suppression rates and increased risk of viral resistance were observed in pediatric subjects who received lamivudine oral solution concomitantly with other antiretroviral oral solutions compared with those who received tablets. An all-tablet regimen should be used when possible. ( 5.5 ) 5.1 Patients with Hepatitis B Virus Co-infection Posttreatment Exacerbations of Hepatitis 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. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from postmarketing experience after changes from lamivudine-containing HIV-1 treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV-1 and HBV. 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. Important Differences among Lamivudine-Containing Products Lamivudine tablets contain a higher dose of the same active ingredient (lamivudine) than EPIVIR-HBV tablets and EPIVIR-HBV oral solution. EPIVIR-HBV was developed for patients with chronic hepatitis B. The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients co-infected with HIV-1 and HBV. Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients co-infected with HIV-1 and HBV. If treatment with EPIVIR-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy HIV-1 treatment. If a decision is made to administer lamivudine to patients co-infected with HIV-1 and HBV, lamivudine tablets, lamivudine oral solution, or another product containing the higher dose of lamivudine should be used as part of an appropriate combination regimen. Emergence of Lamivudine-Resistant HBV Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV (see full prescribing information for EPIVIR-HBV). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-1-infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. 5.2 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. 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. Treatment with lamivudine 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. 5.3 Pancreatitis In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, lamivudine should be used with caution. Treatment with lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur [see Adverse Reactions ( 6.1 )]. 5.4 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including lamivudine. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guilla in-Barrѐ syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.. 5.5 Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution Pediatric subjects who received lamivudine oral solution (at weight band-based doses approximating 8 mg per kg per day) concomitantly with other antiretroviral oral solutions at any time in the ARROW trial had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets [see Clinical Pharmacology ( 12.3 ), Microbiology ( 12.4 ), Clinical Studies ( 14.2 )]. Lamivudine 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. An all-tablet regimen should be used when possible to
  • avoid a potential interaction with sorbitol [see Clinical Pharmacology ( 12.3 )]. Consider more frequent monitoring of HIV-1 viral load when treating with lamivudine oral solution.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy.
  • Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
  • Risk Summary Available data from the APR show no difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population ( see Data ).
  • The APR uses the MACDP as the U.S. reference population for birth defects in the general population.
  • The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation.
  • The rate of miscarriage is not reported in the APR.
  • The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%.
  • The background risk for major birth defects and miscarriage for the indicated population is unknown.
  • In animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (AUC) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (C max ) 35 times the recommended clinical dose ( see Data ).
  • Data Human Data :
  • Based on prospective reports to the APR of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester), there was no difference between the overall risk of birth defects for lamivudine compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP.
  • The prevalence of defects in live births was 3.1% (95% CI:
  • 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% CI:
  • 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens.
  • Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in South Africa.
  • The trials assessed pharmacokinetics in 16 women at 36 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks' gestation using lamivudine 300 mg twice daily without other antiretrovirals.
  • These trials were not designed or powered to provide efficacy information.
  • Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples.
  • In a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans.
  • Based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9 (1.2 to 12.8)–fold greater compared with paired maternal serum concentration (n = 8).
  • Animal Data :
  • Lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gestation Days 7 through 16 [rat] and 8 through 20 [rabbit]).
  • No evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (C max ) approximately 35 times higher than human exposure at the recommended daily dose.
  • Evidence of early embryolethality was seen in the rabbit at system exposures (AUC) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (C max ) 35 times higher than human exposure at the recommended daily dose.
  • Studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta.
  • In the fertility/pre-and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal Day 20).
  • In the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine.
  • IN SPECIFIC POPULATIONS
  • Lactation:
  • Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population ( see Data ). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown. In animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (AUC) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (C max ) 35 times the recommended clinical dose ( see Data ). Data Human Data :
  • Based on prospective reports to the APR of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester), there was no difference between the overall risk of birth defects for lamivudine compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of defects in live births was 3.1% (95% CI:
  • 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% CI:
  • 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in South Africa. The trials assessed pharmacokinetics in 16 women at 36 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks' gestation using lamivudine 300 mg twice daily without other antiretrovirals. These trials were not designed or powered to provide efficacy information. Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. In a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans. Based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9 (1.2 to 12.8)–fold greater compared with paired maternal serum concentration (n = 8). Animal Data :
  • Lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gestation Days 7 through 16 [rat] and 8 through 20 [rabbit]). No evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (C max ) approximately 35 times higher than human exposure at the recommended daily dose. Evidence of early embryolethality was seen in the rabbit at system exposures (AUC) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (C max ) 35 times higher than human exposure at the recommended daily dose. Studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. In the fertility/pre-and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal Day 20). In the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine. 8.2 Lactation Risk Summary The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to
  • avoid risking postnatal transmission of HIV-1 infection. Lamivudine is present in human milk. There is no information on the effects of lamivudine on the breastfed infant or the effects of the drugs on milk production. Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving lamivudine. 8.4 Pediatric Use The safety and effectiveness of lamivudine in combination with other antiretroviral agents have been established in pediatric patients aged 3 months and older. Lamivudine 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 because pediatric subjects who received lamivudine oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets in the ARROW trial [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )]. 8.5 Geriatric Use Clinical trials of lamivudine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of lamivudine tablets in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 )]. 8.6 Patients With Impaired Renal Function Reduction of the dosage of lamivudine is recommended for patients with impaired renal function [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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 )].

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • There is no known specific treatment for overdose with lamivudine.
  • 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.

Quoted from the official label, section “Overdosage”.

Use in children

  • The safety and effectiveness of lamivudine in combination with other antiretroviral agents have been established in pediatric patients aged 3 months and older.
  • Lamivudine 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 because pediatric subjects who received lamivudine oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets in the ARROW trial [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical trials of lamivudine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • In general, caution should be exercised in the administration of lamivudine tablets in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following adverse reactions are discussed in other sections of the labeling:
  • Exacerbations of hepatitis B [see 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 Hetero Labs Limited at 1-866-495-1995 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 observed in clinical practice. The safety profile of lamivudine in
  • adults is primarily based on 3,568 HIV-l-infected subjects in 7 clinical trials. The most common adverse reactions are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough. Selected clinical adverse reactions in greater than or equal to 5% of subjects during therapy with lamivudine 150 mg twice daily plus RETROVIR 200 mg 3 times daily for up to 24 weeks are listed in Table 3. Table 3. Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in Four Controlled Clinical Trials (NUCA3001, NUCA3002, NUCB3001, NUCB3002) Adverse Reaction Lamivudine 150 mg Twice Daily plus RETROVIR (n = 251) RETROVIR a (n = 230) Body as a Whole Headache 35% 27% Malaise & fatigue 27% 23% Fever or chills 10% 12% Digestive Nausea 33% 29% Diarrhea 18% 22% Nausea & vomiting 13% 12% Anorexia and/or decreased appetite 10% 7% Abdominal pain 9% 11% Abdominal cramps 6% 3% Dyspepsia 5% 5% Nervous System Neuropathy 12% 10% Insomnia & other sleep disorders 11% 7% Dizziness 10% 4% Depressive disorders 9% 4% Respiratory Nasal signs & symptoms 20% 11% Cough 18% 13% Skin Skin rashes 9% 6% Musculoskeletal Musculoskeletal pain 12% 10% Myalgia 8% 6% Arthralgia 5% 5% a Either zidovudine monotherapy or zidovudine in combination with zalcitabine. Pancreatitis :
  • Pancreatitis was observed in 9 out of 2,613 adult subjects (0.3%) who received lamivudine in controlled clinical trials EPV20001, NUCA3001, NUCB3001, NUCA3002, NUCB3002, and NUCB3007 [see Warnings and Precautions ( 5.3 )]. Lamivudine 300 mg Once Daily:
  • The types and frequencies of clinical adverse reactions reported in subjects receiving lamivudine 300 mg once daily or lamivudine 150 mg twice daily (in 3-drug combination regimens in EPV20001 and EPV40001) for 48 weeks were similar. Selected laboratory abnormalities observed during therapy are summarized in Table 4. Table 4. Frequencies of Selected Grade 3 to 4 Laboratory Abnormalities in
  • Adults in Four 24-Week Surrogate Endpoint Trials (NUCA3001, NUCA3002, NUCB3001, NUCB3002) and a Clinical Endpoint Trial (NUCB3007) Test (Threshold Level) 24-Week Surrogate Endpoint Trials a Clinical Endpoint Trial a Lamivudine plus RETROVIR RETROVIR b Zidovudin eZ Lamivudine plus Current Therapy c Placebo plus Current Therapy c Absolute neutrophil count (<750/mm 3 ) Hemoglobin (<8 g/dL) Platelets (<50,000/mm 3 ) ALT (>5 x ULN) AST (>5 x ULN) Bilirubin (>2.5 x ULN) Amylase (>2 x ULN) 7.2% 2.9% 0.4% 3.7% 1.7% 0.8% 4.2% 5.4% 1.8% 1.3% 3.6% 1.8% 0.4% 1.5% 15% 2.2% 2.8% 3.8% 4.0 % ND 2.2% 13% 3.4% 3.8% 1.9% 2.1% ND 1.1% a The median duration on study was 12 months. b Either zidovudine monotherapy or zidovudine in combination with zalcitabine. c Current therapy was either zidovudine, zidovudine plus didanosine, or zidovudine plus zalcitabine. ULN = Upper limit of normal. ND = Not done. The frequencies of selected laboratory abnormalities reported in subjects receiving lamivudine 300 mg once daily or lamivudine 150 mg twice daily (in 3-drug combination regimens in EPV20001 and EPV40001) were similar. Clinical Trials Experience in Pediatric Subjects Lamivudine oral solution has been studied in 638 pediatric subjects aged 3 months to 18 years in 3 clinical trials. Selected clinical adverse reactions and physical findings with a greater than or equal to 5% frequency during therapy with lamivudine 4 mg per kg twice daily plus RETROVIR 160 mg per m 2 3 times daily in therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 5. Table 5. Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG300 Adverse Reaction Lamivudine plus RETROVIR (n = 236) Didanosine (n = 235) Body as a Whole Fever 25% 32% Digestive Hepatomegaly 11% 11% Nausea & vomiting 8% 7% Diarrhea 8% 6% Stomatitis 6% 12% Splenomegaly 5% 8% Respiratory Cough 15% 18% Abnormal breath sounds/wheezing 7% 9% Ear, Nose, and Throat Signs or symptoms of ears a 7% 6% Nasal discharge or congestion 8% 11% Other Skin rashes 12% 14% Lymphadenopathy 9% 11% a Includes pain, discharge, erythema, or swelling of an ear. Pancreatitis :
  • Pancreatitis, which has been fatal in some cases, has been observed in antiretroviral nucleoside-experienced pediatric subjects receiving lamivudine alone or in combination with other antiretroviral agents. In an open-label dose-escalation trial (NUCA2002), 14 subjects (14%) developed pancreatitis while receiving monotherapy with lamivudine. Three of these subjects died of complications of pancreatitis. In a second open-label trial (NUCA2005), 12 subjects (18%) developed pancreatitis. In Trial ACTG300, pancreatitis was not observed in 236 subjects randomized to lamivudine plus RETROVIR. Pancreatitis was observed in 1 subject in this trial who received open-label lamivudine in combination with RETROVIR and ritonavir following discontinuation of didanosine monotherapy [see Warnings and Precautions ( 5.3 )]. Paresthesias and Peripheral Neuropathies :
  • Paresthesias and peripheral neuropathies were reported in 15 subjects (15%) in Trial NUCA2002, 6 subjects (9%) in Trial NUCA2005, and 2 subjects (less than 1%) in Trial ACTG300. Selected laboratory abnormalities experienced by therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 6. Table 6. Frequencies of Selected Grade 3 to 4 Laboratory Abnormalities in Pediatric Subjects in Trial ACTG300 Test (Threshold Level) Lamivudine plus RETROVIR Didanosine Absoluteneutrophilcount (<400/mm3) Hemoglobin (<7 g/dL) Platelets (<50,000/mm3) ALT (>10 x ULN) AST (>10 x ULN) Lipase (>2.5 x ULN) Total Amylase (>2.5 x ULN) 8% 4% 1% 1% 2% 3% 3% 3% 2% 3% 3% 4% 3% 3% ULN = Upper limit of normal. Pediatric Subjects Once-Daily versus Twice-Daily Dosing (COL105677):
  • The safety of once-daily compared with twice-daily dosing of lamivudine was assessed in the ARROW trial. Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator. Neonates :Limited short-term safety information is available from 2 small, uncontrolled trials in South Africa in neonates receiving lamivudine with or without zidovudine for the first week of life following maternal treatment starting at Week 38 or 36 of gestation [see Clinical Pharmacology ( 12.3 )]. Selected adverse reactions reported in these neonates included increased liver function tests, anemia, diarrhea, electrolyte disturbances, hypoglycemia, jaundice and hepatomegaly, rash, respiratory infections, and sepsis; 3 neonates died (1 from gastroenteritis with acidosis and convulsions,1 from traumatic injury, and 1 from unknown causes). Two other nonfatal gastroenteritis or diarrhea cases were reported, including 1 with convulsions; 1 infant had transient renal insufficiency associated with dehydration. The absence of control groups limits assessments of causality, but it should be assumed that perinatally exposed infants may be at risk for adverse reactions comparable to those reported in pediatric and adult HIV-1-infected patients treated with lamivudine-containing combination regimens. Long-term effects of in utero and infant lamivudine exposure are not known. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of lamivudine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine. Body as a Whole Redistribution/accumulation of body fat. Endocrine and Metabolic Hyperglycemia. General Weakness. Hemic and Lymphatic Anemia (including pure red cell aplasia and severe anemias progressing on therapy). Hepatic and Pancreatic Lactic acidosis and hepatic steatosis [see Warnings and Precautions ( 5.2 )], posttreatment exacerbations of hepatitis B [see Warnings and Precautions ( 5.1 )]. Hypersensitivity Anaphylaxis, urticaria. Musculoskeletal Muscle weakness, CPK elevation, rhabdomyolysis. Skin Alopecia, pruritus.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Patients with Hepatitis B or C Co-infection Inform patients co-infected with HIV-1 and HBV that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued.
  • Advise patients to discuss any changes in regimen with their healthcare provider [see Warnings and Precautions ( 5.1 )].
  • Differences in Formulations of Lamivudine Advise patients that lamivudine tablets and oral solution contain a higher dose of the same active ingredient (lamivudine) as EPIVIR-HBV tablets and oral solution.
  • If a decision is made to include lamivudine in the HIV-1 treatment regimen of a patient co-infected with HIV-1 and HBV, the formulation and dosage of lamivudine in lamivudine tablets (not EPIVIR-HBV) should be used [see Warnings and Precautions ( 5.1 )].
  • Lactic Acidosis/Hepatomegaly with Steatosis Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals.
  • Advise patients to stop taking lamivudine if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions ( 5.2 )].
  • Risk of Pancreatitis Advise parents or guardians to monitor pediatric patients for signs and symptoms of pancreatitis [see Warnings and Precautions ( 5.3 )].
  • Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when lamivudine is started [see Warnings and Precautions ( 5.4 )].
  • Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution Advise patients that an all-tablet regimen should be used when possible due to an increased rate of treatment failure among pediatric subjects who received lamivudine oral solution concomitantly with other antiretroviral oral solutions [see Warnings and Precautions ( 5.5 )].
  • Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy [see Use in Specific Populations ( 8.1 )].
  • Lactation Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations ( 8.2 )].
  • Missed Dosage Instruct patients that if they miss a dose of lamivudine tablets, to take it as soon as they remember.
  • Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration ( 2 )].
  • The brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited.
  • Manufactured for:
  • Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 By:
  • HETERO TM Hetero Labs Limited,Unit V, Polepally, Jadcherla, Mahabubnagar-509 301, India.
  • Revised: 07/2019 camber1

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS & STRENGTHS
  • Lamivudine Scored Tablets 150 mg, are white capsule shaped, biconvex, scored film coated tablets debossed with 'J' on one side and '16' on the other side, 1 and 6 seperated by a score line.
  • Lamivudine Tablets 300 mg, are white capsule shaped, biconvex, film coated tablets debossed with '17' on one side and 'J' on the other side.
  • Tablets:150 mg, scored ( 3 )
  • Tablets: 300 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Lamivudine Scored Tablets, 150 mg White capsule shaped, biconvex, scored film coated tablets debossed with "J" on one side and "16" on the other side, 1 and 6 seperated by a score line.
  • Bottle of 60 tablets NDC 31722-753-60 Bottle of 600 tablets NDC 31722-753-06 Blister Card of 10 Unit-dose tablets NDC 31722-753-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-753-32 Lamivudine Tablets, 300 mg White capsule shaped, biconvex, film coated tablets debossed with "17" on one side and "J" on the other side.
  • Bottle of 30 tablets NDC 31722-754-30 Bottle of 600 tablets NDC 31722-754-06 Blister Card of 10 Unit-dose tablets NDC 31722-754-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-754-32 Recommended Storage:
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Preserve in well-closed, light-resistant containers.

Quoted from the official label, section “How Supplied”.

What is in it

  • Lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and HBV.
  • The chemical name of lamivudine USP is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1, 3-oxathio-lan-5-yl], (2R-cis)-.
  • It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26.
  • It has the following structural formula:
  • Lamivudine USP is a white to an off white solid and soluble in water.
  • Lamivudine tablets are for oral administration.
  • Each film-coated tablet contains 150 mg or 300 mg of lamivudine USP and the following inactive ingredients:
  • crospovidone, isomalt, isopropyl alcohol, magnesium stearate and methylene chloride.
  • The tablets are coated with opadry white containing hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. lamivudinestruc

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Sugar alcoholsisomaltSorbitol and similar can upset the stomach and matter with fructose intolerance.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (12)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 12 of 12

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (4)

France5 matching products

Every strength and form (14)

Canada3 matching products

Every strength and form (10)

Details

Made byCamber Pharmaceuticals, Inc.
Active substanceLamivudine
Used inAntibiotics, antivirals and antifungals taken into the body
Strength150 mg
FormTablet, Film Coated
RouteOral
Packs600 TABLET, FILM COATED in 1 BOTTLE · 10 TABLET, FILM COATED in 1 BLISTER PACK
NDC31722-753

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

25 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Epivir150 mgPrescription onlyTablet, Film Coated ViiV Healthcare Company · LamivudineEpivir300 mgPrescription onlyTablet, Film Coated ViiV Healthcare Company · LamivudineEpivir10 mg/mLPrescription onlySolution ViiV Healthcare Company · LamivudineLamivudine150 mgPrescription onlyTablet, Film Coated Major Pharmaceuticals · LamivudineLamivudine100 mgPrescription onlyTablet, Film Coated Camber Pharmaceuticals, Inc. · LamivudineLamivudine300 mgPrescription onlyTablet, Film Coated Camber Pharmaceuticals, Inc. · Lamivudine

See every product with Lamivudine