Lamivudine Teva: Uses, Dosage & Side Effects
Antiviral medication for chronic hepatitis B virus infection
Quick Facts About Lamivudine Teva
Key Takeaways About Lamivudine Teva
- For chronic hepatitis B only: The 100 mg formulation is specifically for HBV; different doses are used for HIV treatment
- Never stop abruptly: Sudden discontinuation can cause severe, potentially life-threatening hepatitis flare-ups requiring immediate medical attention
- Resistance risk: Up to 70% of patients may develop HBV resistance after 5 years; regular viral load monitoring is essential
- Taken once daily: One 100 mg tablet taken by mouth once daily, with or without food, at approximately the same time each day
- Regular monitoring required: Liver function tests, HBV DNA levels, and HBeAg/anti-HBe status should be checked regularly throughout treatment
What Is Lamivudine Teva and What Is It Used For?
Lamivudine Teva is an antiviral medication containing 100 mg of lamivudine, used to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication. It belongs to the nucleoside reverse transcriptase inhibitor (NRTI) class of antivirals.
Lamivudine is a synthetic nucleoside analogue that was first developed in the late 1980s and has been used clinically since the mid-1990s. It was originally developed for the treatment of HIV/AIDS, and subsequently a lower-dose formulation (100 mg) was approved specifically for the treatment of chronic hepatitis B. The medication is marketed under several brand names worldwide, with Lamivudine Teva being a generic formulation manufactured by Teva Pharmaceuticals.
Chronic hepatitis B is a significant global health burden, affecting approximately 296 million people worldwide according to the World Health Organization (WHO). The virus attacks the liver, causing inflammation that can progress over years or decades to cirrhosis (scarring of the liver), liver failure, and hepatocellular carcinoma (liver cancer). Effective antiviral therapy is crucial to suppress viral replication, reduce liver inflammation, and prevent these serious long-term complications.
Lamivudine works by inhibiting the HBV DNA polymerase enzyme, which the virus requires to replicate its genetic material. As a nucleoside analogue, lamivudine mimics the natural building blocks (nucleosides) used in DNA synthesis. When the virus incorporates lamivudine into its growing DNA chain instead of the natural nucleoside (deoxycytidine), the chain is terminated prematurely, effectively halting viral replication. This mechanism of action is highly specific to viral polymerases, which accounts for the drug's generally favourable safety profile in human cells.
It is important to understand that lamivudine does not cure hepatitis B. The hepatitis B virus integrates its genetic material (covalently closed circular DNA, or cccDNA) into the host liver cells, creating a persistent reservoir that current antiviral medications cannot eliminate. Treatment with lamivudine aims to suppress active viral replication to undetectable levels, thereby reducing liver inflammation and slowing or preventing progression of liver disease. Some patients may achieve HBeAg seroconversion (a marker of reduced viral activity), which can sometimes allow treatment to be discontinued under close medical supervision.
Lamivudine Teva 100 mg is specifically indicated for hepatitis B treatment. The higher-dose formulations (150 mg and 300 mg) are used as part of combination antiretroviral therapy for HIV. These are not interchangeable, and patients co-infected with both HIV and HBV require specialised management to avoid the development of HIV resistance.
What Should You Know Before Taking Lamivudine Teva?
Before starting Lamivudine Teva, your doctor must confirm your hepatitis B diagnosis, check for HIV co-infection, assess your liver function, and review all other medications you are taking. Certain medical conditions and drug interactions require dose adjustments or alternative treatments.
Contraindications
Lamivudine Teva must not be used if you have a known hypersensitivity (allergy) to lamivudine or any of the excipients (inactive ingredients) in the tablet. While true allergic reactions to lamivudine are rare, they can include skin rash, urticaria (hives), angioedema (swelling of the face, lips, tongue, or throat), and in extremely rare cases, anaphylaxis. If you have experienced any allergic reaction to lamivudine in the past, this medication should not be used.
A critical contraindication that must be considered is undiagnosed or untreated HIV co-infection. Approximately 5-20% of people living with HIV are also co-infected with hepatitis B. Using lamivudine 100 mg as monotherapy in an HIV-positive patient who is unaware of their HIV status can lead to the rapid development of HIV drug resistance, specifically the M184V mutation, which would compromise future HIV treatment options. For this reason, all patients should be tested for HIV before initiating lamivudine therapy for hepatitis B.
Warnings and Precautions
Several important warnings and precautions must be considered before and during treatment with lamivudine:
Discontinuation of lamivudine can result in severe exacerbations (flare-ups) of hepatitis B. These flares can occur weeks to months after stopping treatment and may be life-threatening, potentially leading to hepatic decompensation and liver failure. After discontinuation, hepatic function should be monitored at regular intervals (at least every 4 weeks) with both clinical and laboratory follow-up for a minimum of 6 months. Resumption of anti-hepatitis B therapy may be warranted.
Lactic acidosis: Nucleoside analogues, including lamivudine, have been associated with lactic acidosis, a rare but potentially fatal metabolic complication. This risk is greater in women, obese patients, and those with pre-existing liver disease. Symptoms include persistent nausea, vomiting, abdominal pain, rapid breathing, and general malaise. Treatment should be discontinued if clinical or laboratory findings suggestive of lactic acidosis develop.
Hepatic steatosis: Severe hepatomegaly (enlarged liver) with steatosis (fatty liver), including fatal cases, has been reported with the use of nucleoside analogues. Patients with pre-existing liver disease, obesity, or prolonged nucleoside exposure are at higher risk.
Renal impairment: Lamivudine is primarily excreted by the kidneys. Patients with impaired renal function (creatinine clearance less than 50 mL/min) require dose reduction. Your doctor will calculate the appropriate dose based on your kidney function tests. Lamivudine is removed by haemodialysis and peritoneal dialysis, and additional dosing considerations apply for dialysis patients.
HBV resistance: One of the most significant limitations of lamivudine therapy is the development of antiviral resistance. The HBV polymerase can develop mutations (most commonly YMDD mutations at position M204V/I) that reduce the virus's sensitivity to lamivudine. Resistance rates increase progressively with duration of treatment: approximately 15-30% after 1 year, rising to approximately 70% after 5 years of continuous therapy. Regular monitoring of HBV DNA levels is essential to detect treatment failure early, allowing timely switching to or addition of alternative antiviral agents.
Pregnancy and Breastfeeding
Lamivudine crosses the placenta and is present in breast milk. The use of lamivudine during pregnancy should be carefully considered, weighing the potential benefits against the risks to the foetus.
A large body of data from pregnant women (more than 1,000 outcomes from the first trimester and more than 1,000 from the second and third trimesters) collected primarily from HIV treatment registries indicates no increase in the rate of birth defects above the background rate of 2.7%. These data are reassuring, and lamivudine is considered one of the safer antiviral options during pregnancy when treatment is necessary.
In clinical practice, lamivudine may be used in the third trimester of pregnancy to reduce the risk of mother-to-child transmission (MTCT) of hepatitis B, particularly in women with very high viral loads (HBV DNA greater than 200,000 IU/mL). Current WHO and EASL guidelines support this approach as part of a comprehensive prevention strategy that includes hepatitis B vaccination and hepatitis B immunoglobulin (HBIG) for the newborn.
Breastfeeding while taking lamivudine should be discussed with your healthcare provider. Lamivudine is excreted into breast milk at concentrations similar to those found in serum. In settings where hepatitis B is a concern, the benefits of breastfeeding generally outweigh the risks, particularly when the infant has received appropriate vaccination and immunoglobulin.
How Does Lamivudine Teva Interact with Other Drugs?
Lamivudine has a relatively low potential for drug interactions because it is minimally metabolised by liver enzymes (cytochrome P450 system). However, several clinically significant interactions exist, particularly with medications that affect renal excretion or have overlapping mechanisms of action.
Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (via the organic cation transporter OCT2), drugs that compete for these renal pathways can affect lamivudine levels. Additionally, some drugs have pharmacodynamic interactions that can increase the risk of adverse effects or reduce therapeutic efficacy.
Major Interactions
| Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Emtricitabine | Pharmacodynamic (overlapping mechanism) | Both are cytidine analogues; no additional benefit and increased toxicity risk | Do not use together |
| Cladribine | Pharmacodynamic (intracellular competition) | Lamivudine may inhibit intracellular phosphorylation of cladribine, reducing its efficacy | Avoid concomitant use |
| High-dose trimethoprim/sulfamethoxazole (co-trimoxazole) | Pharmacokinetic (renal competition via OCT2) | Increases lamivudine exposure by approximately 40% | Use with caution; monitor for side effects. No dose adjustment needed at standard TMP/SMX doses |
| Sorbitol-containing medicines | Pharmacokinetic (reduced absorption) | Sorbitol can decrease lamivudine exposure by up to 40% | Avoid co-administration of sorbitol-containing medicines where possible |
Minor Interactions
Lamivudine is not significantly metabolised by cytochrome P450 enzymes and does not inhibit or induce these enzymes. Therefore, the risk of interactions with drugs metabolised through the CYP system is low. However, the following minor interactions have been noted:
- Zalcitabine: Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two are used concurrently. This interaction is largely of historical interest, as zalcitabine is no longer available in most markets.
- Ganciclovir and foscarnet: These drugs are also eliminated renally and could theoretically compete with lamivudine for renal excretion, although no clinically significant pharmacokinetic interactions have been demonstrated in studies.
- Food: Lamivudine can be taken with or without food. While food slightly delays the rate of absorption and reduces peak plasma concentration (Cmax), it does not affect the overall extent of absorption (AUC), so the clinical effect is not altered.
Tell your doctor or pharmacist about all medicines you are taking, including over-the-counter drugs, herbal supplements, and vitamins. Even though lamivudine has a low interaction potential, comprehensive medication review is an essential part of safe prescribing, particularly in patients with co-morbidities or those taking multiple medications.
What Is the Correct Dosage of Lamivudine Teva?
The standard adult dose of Lamivudine Teva for chronic hepatitis B is 100 mg (one tablet) taken orally once daily. The tablet can be taken with or without food. Dose adjustments are required for patients with renal impairment.
Lamivudine Teva should be prescribed by a physician experienced in the management of chronic hepatitis B. Treatment duration is variable and depends on the patient's clinical response, including HBV DNA suppression, ALT normalisation, HBeAg seroconversion status, and the development of resistance. In many cases, treatment is long-term or indefinite.
Adults
Standard Adult Dosage
Dose: 100 mg (one tablet) once daily
Route: Oral, with or without food
Duration: Long-term; minimum treatment duration is typically 1 year, but many patients require indefinite therapy
Optimal treatment duration is not established. Discontinuation may be considered in HBeAg-positive patients who achieve HBeAg seroconversion with HBV DNA suppression, maintained for at least 12 months of consolidation therapy. In HBeAg-negative patients, treatment is usually continued indefinitely unless contraindicated.
| Creatinine Clearance (mL/min) | Initial Dose | Maintenance Dose |
|---|---|---|
| ≥ 50 mL/min | 100 mg | 100 mg once daily |
| 30–49 mL/min | 100 mg | 50 mg once daily |
| 15–29 mL/min | 100 mg | 25 mg once daily |
| 5–14 mL/min | 35 mg | 15 mg once daily |
| < 5 mL/min | 35 mg | 10 mg once daily |
Note: For doses below 100 mg, the tablet formulation cannot be used, and an oral solution should be prescribed instead. The 100 mg tablets are not scored and should not be split.
Children
Paediatric Dosage (2 years and older)
Dose: 3 mg/kg once daily (maximum 100 mg/day)
Route: Oral (oral solution is preferred for accurate dosing in children)
Note: Lamivudine Teva 100 mg film-coated tablets are generally not suitable for children who require doses below 100 mg. An oral solution formulation should be used instead. Children under 2 years of age: limited data available; not recommended.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, elderly patients are more likely to have reduced renal function, so creatinine clearance should be assessed and the dose adjusted accordingly using the renal impairment guidelines above. Regular monitoring of renal function is recommended in elderly patients throughout the course of treatment.
Missed Dose
If you forget to take a dose of Lamivudine Teva, take it as soon as you remember. However, if it is almost time for your next scheduled dose (within a few hours), skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed one. Consistent daily dosing is important for maintaining adequate drug levels and minimising the risk of viral resistance development.
Overdose
There is limited clinical experience with overdose of lamivudine. In acute overdose situations, no specific signs or symptoms have been identified beyond those listed as adverse effects. If an overdose is suspected, supportive care should be provided, including monitoring of vital signs and observation of the patient's clinical status. Since lamivudine is dialysable, continuous haemodialysis could be employed if clinically indicated, although this has not been formally studied in the context of overdose management.
In clinical studies, single doses up to 20 times the therapeutic dose have been administered without serious adverse effects. Contact your local poison control centre or emergency medical services immediately if you suspect an overdose.
What Are the Side Effects of Lamivudine Teva?
Lamivudine Teva is generally well tolerated. The most commonly reported side effects include malaise, fatigue, headache, abdominal discomfort, nausea, and elevated liver enzymes (ALT). Serious but rare side effects include lactic acidosis, severe hepatitis flares after discontinuation, and pancreatitis.
Like all medicines, Lamivudine Teva can cause side effects, although not everybody gets them. The side effects listed below are based on data from clinical trials and post-marketing surveillance. The frequency categories are defined as: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).
Very Common (more than 1 in 10)
- Malaise and fatigue
- Elevated ALT (liver enzyme) levels
- Elevated creatine phosphokinase (CPK) levels
Common (1 in 10 to 1 in 100)
- Headache
- Nausea and vomiting
- Abdominal discomfort and pain
- Diarrhoea
- Fever
- Skin rash
- Alopecia (hair loss)
- Musculoskeletal pain (muscle and joint pain)
- Cough and nasal symptoms
Uncommon (1 in 100 to 1 in 1,000)
- Thrombocytopenia (low platelet count)
- Peripheral neuropathy (tingling, numbness in hands and feet)
- Elevated bilirubin levels
- Elevated amylase levels
Rare (less than 1 in 1,000)
- Pancreatitis (inflammation of the pancreas)
- Lactic acidosis (build-up of lactic acid in the blood)
- Rhabdomyolysis (muscle breakdown)
- Angioedema (swelling of face, lips, tongue or throat)
- Hepatitis flare on discontinuation
Severe abdominal pain (possible pancreatitis), persistent nausea with rapid breathing (possible lactic acidosis), yellowing of the skin or eyes (jaundice), severe skin reactions, swelling of the face, lips, tongue or throat (angioedema), or signs of hepatic decompensation (fluid retention, confusion, bleeding). These are rare but potentially serious conditions that require urgent evaluation.
It is important to note that elevations in liver enzymes (particularly ALT) are expected during treatment and may reflect the immune-mediated clearance of infected hepatocytes rather than drug toxicity. Your doctor will distinguish between drug-related liver injury and beneficial immune responses through regular monitoring. Significant ALT flares that occur during treatment should be evaluated to determine whether they represent immune reconstitution, drug resistance, or drug-induced liver injury.
Post-treatment ALT elevations are a distinct and more concerning phenomenon. These flares occur after discontinuation of lamivudine and are caused by the rebound of viral replication in the absence of antiviral suppression. They can be severe and, in rare cases, life-threatening. This is why discontinuation of lamivudine should only be done under close medical supervision with regular monitoring for at least 6 months afterward.
How Should You Store Lamivudine Teva?
Store Lamivudine Teva at room temperature below 30°C (86°F) in the original packaging to protect from moisture and light. Keep out of the reach and sight of children.
Proper storage of medications is essential to maintain their effectiveness and safety throughout the treatment period. Lamivudine Teva film-coated tablets should be stored according to the following guidelines:
- Temperature: Store below 30°C (86°F). Do not freeze. Brief exposure to temperatures up to 40°C during transport is generally acceptable, but prolonged exposure to extreme heat should be avoided.
- Packaging: Keep the tablets in their original blister packaging until the time of use to protect them from moisture and light. Do not transfer tablets to other containers unless specifically designed for medication storage.
- Moisture: Avoid storing in humid environments such as bathrooms. Excessive moisture can degrade the film coating and potentially affect the drug's stability.
- Light: Protect from direct sunlight and strong artificial light. Store in a drawer or cabinet rather than on a windowsill or open shelf.
- Children: Keep out of reach and sight of children. Consider using a locked cabinet or high shelf.
- Expiry date: Do not use Lamivudine Teva after the expiry date stated on the carton and blister packaging (Exp). The expiry date refers to the last day of that month.
Do not dispose of medications in household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment and prevent accidental ingestion by others.
What Does Lamivudine Teva Contain?
Each Lamivudine Teva film-coated tablet contains 100 mg of lamivudine as the active substance, along with several inactive ingredients (excipients) that contribute to the tablet's structure, stability, and coating.
Active substance: Lamivudine 100 mg per tablet. Lamivudine (also known by its chemical abbreviation 3TC) is a synthetic nucleoside analogue with the chemical name (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Its molecular formula is C8H11N3O3S, and it has a molecular weight of 229.26 g/mol.
Excipients (inactive ingredients): The inactive components of Lamivudine Teva film-coated tablets typically include:
- Tablet core: Microcrystalline cellulose (a bulking agent that helps form the tablet structure), sodium starch glycolate (a disintegrant that helps the tablet break apart in the gastrointestinal tract), and magnesium stearate (a lubricant used during the manufacturing process to prevent the tablet from sticking to machinery).
- Film coating: Hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171, provides the white colour), macrogol/polyethylene glycol (helps create a smooth coating), and polysorbate 80 (an emulsifier). Iron oxide (E172) may also be present depending on the specific formulation, contributing to the tablet's colour. The film coating protects the tablet from moisture and makes it easier to swallow.
Appearance: Lamivudine Teva 100 mg is a butterscotch-coloured (brownish-yellow), film-coated, round biconvex tablet. The exact appearance may vary slightly depending on the specific manufacturing batch and country of distribution.
If you have known allergies or intolerances to any of the listed excipients, inform your doctor or pharmacist before starting treatment. In particular, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should be aware if lactose is included in the formulation (check the specific product information for your tablet).
Frequently Asked Questions About Lamivudine Teva
References
All information on this page is based on the following peer-reviewed sources and official guidelines:
- European Medicines Agency (EMA). Lamivudine Teva – Summary of Product Characteristics (SmPC). European public assessment report. Available at: www.ema.europa.eu
- World Health Organization (WHO). Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection. WHO, 2024. Available at: www.who.int
- European Association for the Study of the Liver (EASL). EASL 2024 Clinical Practice Guidelines on the management of hepatitis B virus infection. Journal of Hepatology, 2024. DOI: 10.1016/j.jhep.2024.02.011
- Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560–1599. DOI: 10.1002/hep.29800
- Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report. Available at: www.apregistry.com
- Lai CL, Dienstag J, Schiff E, et al. Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clinical Infectious Diseases. 2003;36(6):687–696. DOI: 10.1086/368083
- British National Formulary (BNF). Lamivudine – Indications, dose, interactions, side-effects. NICE. Available at: bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). Epivir-HBV (lamivudine) – Prescribing Information. Available at: www.fda.gov
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