Lamivudine Teva Pharma BV
Nucleoside reverse transcriptase inhibitor (NRTI) for HIV and hepatitis B treatment
Quick Facts About Lamivudine Teva Pharma BV
Key Takeaways About Lamivudine
- Always used in combination: Lamivudine must be taken with other antiretroviral medicines for HIV treatment – never as monotherapy
- Never stop abruptly with hepatitis B: Stopping lamivudine suddenly can cause severe hepatitis B flares that may be life-threatening
- Well-tolerated antiviral: Lamivudine has one of the most favourable side effect profiles among NRTIs and is generally well tolerated
- Dose adjustment for kidney impairment: Patients with creatinine clearance below 50 mL/min require dose reduction
- WHO Essential Medicine: Listed on the WHO Model List of Essential Medicines as a key component of first-line HIV treatment
What Is Lamivudine Teva Pharma BV and What Is It Used For?
Lamivudine Teva Pharma BV is a generic antiviral medicine containing lamivudine 150 mg. It belongs to the nucleoside reverse transcriptase inhibitor (NRTI) class and is used as part of combination antiretroviral therapy (cART) for HIV-1 infection in adults and children, and for the treatment of chronic hepatitis B virus (HBV) infection.
Lamivudine, also known by its abbreviation 3TC, is a synthetic nucleoside analogue of cytidine. It was first approved for medical use in 1995 and has since become one of the cornerstones of antiretroviral therapy worldwide. The medicine works by mimicking the natural building blocks of viral DNA. When the virus attempts to replicate, lamivudine is incorporated into the growing DNA chain, causing premature termination of viral DNA synthesis.
Specifically, lamivudine inhibits two key viral enzymes: HIV-1 reverse transcriptase and hepatitis B virus DNA polymerase. After being taken up by cells, lamivudine undergoes sequential phosphorylation to its active triphosphate form (lamivudine-TP), which competes with the natural substrate deoxycytidine triphosphate (dCTP) for incorporation into viral DNA. Once incorporated, it acts as a chain terminator because it lacks the 3'-hydroxyl group necessary for further DNA chain elongation.
For HIV treatment, lamivudine is always prescribed as part of a combination regimen, typically alongside at least two other antiretroviral agents. This approach is essential to achieve adequate viral suppression and to minimise the risk of drug resistance. Common combinations include lamivudine with abacavir (as a dual NRTI backbone) or lamivudine with tenofovir, usually combined with a third agent from another drug class such as an integrase inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI).
For chronic hepatitis B, lamivudine can be used either as monotherapy or in combination with other antiviral agents. However, the development of HBV resistance during long-term lamivudine monotherapy is a significant clinical concern, and newer agents such as entecavir or tenofovir are often preferred as first-line options for hepatitis B treatment. Lamivudine remains an important option in settings where access to newer agents is limited.
If you are co-infected with both HIV and hepatitis B, lamivudine at the HIV dose (150 mg twice daily or 300 mg once daily) will provide activity against both viruses. However, if lamivudine is discontinued, there is a risk of severe hepatic flare due to HBV reactivation. Your doctor should monitor your liver function closely if treatment changes are being considered.
What Should You Know Before Taking Lamivudine Teva Pharma BV?
Before starting lamivudine, your doctor should test you for hepatitis B co-infection, assess your kidney function, and review your complete medication list. Lamivudine should not be used with emtricitabine or high-dose co-trimoxazole, and dose adjustments are needed for renal impairment.
Contraindications
Lamivudine Teva Pharma BV should not be taken if you have a known hypersensitivity to lamivudine or to any of the excipients in the tablet formulation. While true lamivudine hypersensitivity is rare, symptoms may include rash, gastrointestinal symptoms, and constitutional symptoms. If you experience a hypersensitivity reaction, treatment should be stopped immediately and not restarted.
Warnings and Precautions
Several important precautions should be observed before and during lamivudine treatment:
- Hepatitis B testing: All patients should be tested for HBV before starting lamivudine. If you are co-infected with hepatitis B, stopping lamivudine may cause severe hepatic flares (exacerbations) due to HBV reactivation. Clinical and laboratory monitoring should continue for at least four months after discontinuation.
- Renal impairment: Lamivudine is primarily eliminated by the kidneys. Patients with a creatinine clearance below 50 mL/min require dose reduction. The 150 mg tablet formulation is not suitable for patients requiring doses below 150 mg; an oral solution may be required instead.
- Lactic acidosis and hepatomegaly: As with all nucleoside analogues, there is a rare but potentially fatal risk of lactic acidosis with hepatic steatosis (fatty liver). This complication has been reported more frequently in women, particularly those who are obese or have prolonged nucleoside exposure. Symptoms include generalised fatigue, nausea, vomiting, abdominal pain, and unexplained weight loss. Treatment should be discontinued if clinical or laboratory findings suggestive of lactic acidosis develop.
- Immune reconstitution syndrome: In HIV patients with severe immune deficiency, an inflammatory reaction to previously dormant opportunistic infections may occur when antiretroviral therapy is started. This is known as immune reconstitution inflammatory syndrome (IRIS) and may require additional medical management.
- Lipodystrophy and metabolic effects: Combination antiretroviral therapy has been associated with body fat redistribution (lipodystrophy), including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, and breast enlargement. The risk increases with prolonged treatment duration and metabolic disturbances.
- Osteonecrosis: Although the cause is considered multifactorial, cases of osteonecrosis (bone death) have been reported in patients with advanced HIV disease and/or prolonged combined antiretroviral therapy. Patients should be advised to seek medical attention if they experience joint pain, stiffness, or difficulty moving.
Pregnancy and Breastfeeding
Lamivudine may be used during pregnancy when the expected benefit justifies the potential risk to the foetus. A large body of data from the Antiretroviral Pregnancy Registry, encompassing more than 1,000 first-trimester exposures, indicates that lamivudine is not associated with an increased risk of major birth defects compared to the background rate. International guidelines, including those from the WHO, the British HIV Association (BHIVA), and the US Department of Health and Human Services (DHHS), include lamivudine as one of the preferred NRTIs in pregnancy.
Lamivudine is excreted into human breast milk at concentrations similar to those found in serum. In HIV-infected mothers, breastfeeding is generally not recommended in resource-rich settings to avoid postnatal HIV transmission. In resource-limited settings where formula feeding is not safe or feasible, breastfeeding while on effective antiretroviral therapy may be recommended in line with WHO guidelines. The decision should be made in consultation with your healthcare provider.
Animal reproductive studies have not demonstrated teratogenicity. However, there was evidence of early embryo lethality in rabbits at relatively low systemic exposures comparable to human therapeutic levels. No such effect was seen in rats even at very high exposures.
How Does Lamivudine Teva Pharma BV Interact with Other Drugs?
Lamivudine has relatively few clinically significant drug interactions. The most important interactions involve trimethoprim/sulfamethoxazole (which increases lamivudine levels), sorbitol-containing medicines (which reduce lamivudine absorption), and emtricitabine (which should not be co-administered). Lamivudine does not significantly interact with cytochrome P450 enzymes.
Unlike many antiretroviral agents, lamivudine is not significantly metabolised by cytochrome P450 enzymes and does not inhibit or induce these enzymes. This contributes to its relatively clean drug interaction profile. Lamivudine is primarily eliminated unchanged via the kidneys through a combination of glomerular filtration and active tubular secretion via the organic cation transporter (OCT2).
Drugs that affect renal tubular secretion may alter lamivudine elimination. Your doctor should be aware of all medications you are taking, including over-the-counter medicines, vitamins, and herbal supplements.
| Interacting Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Trimethoprim/Sulfamethoxazole | Increases lamivudine AUC by 40% and Cmax by 44% | Major | No dose adjustment needed at prophylactic doses. Avoid high-dose co-trimoxazole for PCP treatment if possible. |
| Emtricitabine | Intracellular competition – same mechanism of action | Major | Do not co-administer. Emtricitabine and lamivudine are pharmacological analogues. |
| Sorbitol-containing medicines | Reduces lamivudine AUC by up to 20% and Cmax by up to 28% | Moderate | Avoid co-administration with sorbitol-containing solutions when possible. If unavoidable, consider more frequent viral load monitoring. |
| Zalcitabine (ddC) | Intracellular phosphorylation inhibition | Major | Do not co-administer. Zalcitabine is no longer available in most markets. |
| Cladribine | Possible reduction in cladribine efficacy due to intracellular competition | Moderate | Avoid concurrent use. Consider alternative antiretroviral if cladribine treatment is needed. |
Interactions with Common Medications
Lamivudine does not interact significantly with most commonly prescribed medications. It can be safely co-administered with other antiretroviral agents (except emtricitabine and zalcitabine), antibiotics (with the exception of high-dose co-trimoxazole), antifungals, and most cardiovascular medications. There is no interaction with oral contraceptives, which makes it particularly convenient for women of childbearing age.
Lamivudine has no clinically significant interaction with alcohol. However, as with all medications, excessive alcohol consumption should be avoided, particularly given the potential for hepatotoxicity when lamivudine is used in combination with other antiretroviral agents.
What Is the Correct Dosage of Lamivudine Teva Pharma BV?
The standard adult dosage of lamivudine for HIV is 150 mg twice daily or 300 mg once daily. Children weighing at least 25 kg may take the adult dose. Dose reduction is required for patients with impaired kidney function (creatinine clearance below 50 mL/min).
Lamivudine Teva Pharma BV 150 mg film-coated tablets should be swallowed whole with water. They can be taken with or without food, as food does not significantly affect the extent of absorption (only the rate). Consistent timing of doses is recommended to maintain steady drug levels.
Adults
Standard Adult Dose for HIV
150 mg twice daily (one tablet every 12 hours) OR 300 mg once daily (two tablets taken together once daily). Both regimens provide equivalent antiviral efficacy. The once-daily regimen may improve adherence but should be prescribed at the treating physician's discretion.
Children
Paediatric Dosing
Children aged 3 months and older are dosed by body weight. The recommended dose is 4 mg/kg twice daily, up to a maximum of 150 mg twice daily. Children weighing 25 kg or more may receive the standard adult dose of 150 mg twice daily or 300 mg once daily. An oral solution is available for children who cannot swallow tablets or who require doses not achievable with the 150 mg tablet.
| Patient Group | Dose | Frequency | Notes |
|---|---|---|---|
| Adults (HIV) | 150 mg or 300 mg | Twice daily or once daily | In combination with other ARVs |
| Children ≥25 kg | 150 mg | Twice daily | Or 300 mg once daily |
| Children <25 kg | 4 mg/kg | Twice daily | Max 150 mg per dose; oral solution may be needed |
| Renal impairment (CrCl 30–49) | 150 mg | Once daily | First dose: 150 mg, then 150 mg daily |
| Renal impairment (CrCl 15–29) | 150 mg first dose, then 100 mg daily | Once daily | Oral solution required for 100 mg dose |
| Renal impairment (CrCl 5–14) | 150 mg first dose, then 50 mg daily | Once daily | Oral solution required |
| Renal impairment (CrCl <5) | 50 mg first dose, then 25 mg daily | Once daily | Oral solution required |
Elderly
No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have reduced renal function, so creatinine clearance should be measured and dose adjustment made accordingly. Age-related decline in renal function should be considered when determining the appropriate dose.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Consistent adherence to your dosing schedule is crucial for maintaining viral suppression and preventing the development of drug resistance. If you frequently miss doses, discuss adherence strategies with your healthcare provider.
Overdose
There is limited experience of overdose with lamivudine. No specific signs or symptoms have been identified following acute overdose, aside from those already listed as adverse effects. In clinical trials, doses up to 20 times the standard therapeutic dose have been administered without serious toxic effects. Lamivudine is dialysable by continuous haemodialysis, although this is not expected to be necessary in most overdose situations. If overdose occurs, standard supportive treatment should be applied, with monitoring of the patient's clinical status and vital signs.
Changing your lamivudine dose without medical supervision can lead to subtherapeutic drug levels, viral resistance, or treatment failure. Always follow your prescriber's instructions precisely and discuss any concerns about your dosage.
What Are the Side Effects of Lamivudine Teva Pharma BV?
The most common side effects of lamivudine include headache, nausea, diarrhoea, fatigue, nasal symptoms and musculoskeletal disorders. Lamivudine is generally one of the best-tolerated antiretroviral agents. Rare but serious side effects include lactic acidosis and pancreatitis.
Like all medicines, lamivudine can cause side effects, although not everyone will experience them. Side effect data comes from clinical trials involving thousands of patients, as well as post-marketing surveillance. It is important to note that many reported side effects may also be attributable to the underlying HIV infection or to other antiretroviral agents used in combination with lamivudine.
The following side effects have been reported with lamivudine and are classified by their frequency of occurrence:
Very Common
- Headache
- Nausea
- Fatigue and malaise
- Nasal symptoms (cough, nasal congestion)
- Diarrhoea
- Musculoskeletal disorders (arthralgia, myalgia)
Common
- Insomnia
- Abdominal pain and cramps
- Vomiting
- Skin rashes
- Alopecia (hair thinning)
- Fever
- Elevated liver enzymes (transaminases)
- Elevated amylase levels
- Neutropenia and anaemia
- Thrombocytopenia
Uncommon
- Peripheral neuropathy (numbness, tingling in hands or feet)
- Pancreatitis (inflammation of the pancreas)
- Elevated creatine phosphokinase
Rare
- Lactic acidosis (build-up of lactic acid in the blood)
- Hepatic steatosis (fatty liver)
- Severe hepatomegaly with steatosis
- Pure red cell aplasia
- Rhabdomyolysis (muscle breakdown)
- Angioedema
When to Seek Immediate Medical Attention
Contact your doctor or seek emergency medical attention immediately if you experience any of the following symptoms, which may indicate serious complications:
- Lactic acidosis symptoms: Unexplained rapid breathing, drowsiness, nausea, vomiting, abdominal pain, and significant fatigue
- Pancreatitis symptoms: Severe upper abdominal pain that may radiate to the back, nausea, and vomiting
- Severe liver problems: Yellowing of the skin or eyes (jaundice), dark urine, pale stools, severe abdominal pain
- Allergic reactions: Skin rash, swelling of the face, lips, tongue or throat, difficulty breathing
- Signs of infection: Unexplained fever, sore throat, or mouth ulcers (which may indicate neutropenia)
It is particularly important to be aware of symptoms of lactic acidosis, as this is a medical emergency. The risk is higher in women (especially those who are overweight), patients with hepatomegaly, hepatitis, or other liver disease risk factors, and those on prolonged nucleoside analogue therapy. Early recognition and prompt discontinuation of nucleoside analogue therapy is essential to prevent progression to organ failure.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed here. You can also report side effects directly to your national pharmacovigilance system (e.g., the Yellow Card Scheme in the UK, MedWatch in the US, or EudraVigilance in the EU). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Lamivudine Teva Pharma BV?
Store Lamivudine Teva Pharma BV below 30°C in the original packaging to protect from moisture. Keep out of sight and reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of medication is essential to maintain its effectiveness and safety. Lamivudine Teva Pharma BV 150 mg film-coated tablets should be stored according to the following guidelines:
- Temperature: Store below 30°C (86°F). Do not freeze. Avoid exposure to excessive heat or direct sunlight.
- Moisture protection: Keep the tablets in their original blister packaging or container until you are ready to take them. This protects them from moisture, which can degrade the active ingredient.
- Keep out of reach of children: Store in a secure location that is not accessible to children or pets.
- Expiry date: Do not use the medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
- Disposal: Do not throw medicines away via household waste or wastewater. Ask your pharmacist how to properly dispose of medicines you no longer use. These measures help to protect the environment.
If your tablets have changed colour, have visible damage, or appear different from when you first received them, do not use them and consult your pharmacist. Damaged or degraded medication may not be as effective and could potentially be harmful.
What Does Lamivudine Teva Pharma BV Contain?
Each film-coated tablet contains 150 mg of lamivudine as the active substance, along with inactive ingredients (excipients) that contribute to the tablet's structure, stability, and coating.
Understanding what is in your medicine can help you identify potential allergens or substances you may need to avoid. The complete composition of Lamivudine Teva Pharma BV 150 mg film-coated tablets is as follows:
Active Substance
Each film-coated tablet contains 150 mg of lamivudine. Lamivudine is a white to off-white crystalline powder with a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g/mol.
Inactive Ingredients (Excipients)
The excipients used in the tablet core and film coating are pharmaceutical-grade substances commonly used in tablet manufacturing. These may include:
- Tablet core: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate
- Film coating: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
The tablets are typically white to off-white, diamond-shaped (or modified capsule-shaped) film-coated tablets with a score line that allows them to be divided into equal halves. The exact appearance may vary depending on the specific formulation approved in your country. Always check the patient information leaflet supplied with your medicine for the full list of excipients specific to your product.
Frequently Asked Questions About Lamivudine Teva Pharma BV
Lamivudine is available in different strengths for different indications. The 150 mg tablet is the standard strength for HIV treatment, typically taken as one tablet twice daily or two tablets once daily (300 mg total daily dose). A 300 mg tablet is also available from some manufacturers for once-daily dosing convenience. For chronic hepatitis B treatment alone (without HIV), a lower dose of 100 mg once daily is typically used, available as a separate formulation. It is essential that you take only the dose prescribed by your doctor.
Yes, lamivudine can be taken with or without food. While food slightly slows the rate of absorption (reduces Cmax and delays Tmax), it does not significantly affect the total amount of drug absorbed (AUC). This means that the overall therapeutic effect is the same regardless of whether you take it on an empty stomach or with a meal. For convenience, you can take it at mealtimes to help establish a consistent dosing routine.
Lamivudine Teva Pharma BV is a generic version of lamivudine. Generic medicines contain the same active substance in the same dose and dosage form as the originator product and must demonstrate bioequivalence through rigorous clinical testing. This means that the generic product is absorbed into the body at the same rate and to the same extent as the branded version. Generic medicines are approved by regulatory authorities (such as the EMA in Europe) only after meeting strict quality, safety, and efficacy standards.
For HIV treatment, lamivudine is usually taken as a lifelong treatment. Current medical evidence shows that continuous antiretroviral therapy is necessary to maintain viral suppression and prevent disease progression. Stopping treatment, even after achieving an undetectable viral load, will typically result in viral rebound within weeks. For chronic hepatitis B, the duration of treatment depends on various factors including your HBeAg status, degree of fibrosis, and treatment response. Your doctor will advise you on the appropriate duration based on your individual circumstances.
The most common resistance mutation associated with lamivudine is the M184V mutation in HIV reverse transcriptase. If resistance develops, your doctor will modify your treatment regimen based on resistance testing results. Importantly, the M184V mutation, while conferring high-level resistance to lamivudine, also reduces viral fitness and may increase susceptibility to other antiretroviral agents such as tenofovir and zidovudine. In some cases, your doctor may recommend continuing lamivudine even in the presence of the M184V mutation because of these beneficial effects on viral fitness and the maintained sensitivity to other drugs in the regimen.
No, lamivudine does not cure HIV or hepatitis B. For HIV, antiretroviral therapy including lamivudine suppresses viral replication to undetectable levels, which preserves immune function and prevents disease progression. However, the virus persists in latent reservoirs and will rebound if treatment is stopped. For hepatitis B, lamivudine can suppress viral replication and improve liver health, but a functional cure (HBsAg loss) occurs in only a minority of patients. Treatment is aimed at long-term viral suppression to prevent liver damage, cirrhosis, and hepatocellular carcinoma.
References
All medical information in this article is based on peer-reviewed research, international clinical guidelines, and regulatory documents. The following sources were consulted:
- European Medicines Agency (EMA). Lamivudine – Summary of Product Characteristics. Available at: www.ema.europa.eu
- World Health Organization (WHO). Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis. Geneva: WHO; 2021.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- British HIV Association (BHIVA). BHIVA guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy. HIV Medicine. 2022;23(Suppl 5):1–154.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. US Department of Health and Human Services (DHHS). Updated 2024.
- Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report. Available at: www.apregistry.com
- European Association for the Study of the Liver (EASL). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. Journal of Hepatology. 2017;67(2):370–398.
- 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.
- British National Formulary (BNF). Lamivudine. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- Wainberg MA. The impact of the M184V substitution on drug resistance and viral fitness. Expert Review of Anti-infective Therapy. 2004;2(1):147–155.
About the Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a multidisciplinary group of healthcare professionals with expertise in infectious disease, clinical pharmacology, and evidence-based medicine.
Medical Writers
Licensed physicians with specialist training in infectious disease and clinical pharmacology. All content is based on current international guidelines and peer-reviewed evidence.
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Independent review board of specialist physicians who verify all medical claims against current evidence and guidelines (WHO, EMA, FDA, BHIVA, EASL).
All content follows the GRADE evidence framework. We use only Level 1A evidence (systematic reviews and meta-analyses of RCTs) where available. No commercial funding or pharmaceutical sponsorship influences our content. Read more about our editorial standards.