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lamivudine (Rx)Brand and Other Names:Epivir, Epivir HBV, more...3TC

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg (Epivir HBV)
  • 150mg (Epivir)
  • 300mg (Epivir)

oral solution

  • 5mg/mL (Epivir HBV)
  • 10mg/mL (Epivir)
more...

HIV Infection

Epivir: 300 mg PO qDay or 150 mg PO q12hr

Chronic Hepatitis B

Epivir HBV: 100 mg PO qDay

Renal Impairment

CrCl ≥ 50 mL/min: 150 mg PO q12hr or 300 mg PO qDay

CrCl 30-49 mL/min: 150 mg PO qDay

CrCl 15-29 mL/min: 150 mg first dose, then 100 mg qDay

CrCl 5-14 mL/min: 150 mg first dose, then 50 mg qDay

CrCl <5 mL/min: 50 mg first dose, then 25 mg qDay

See Also Combos

with zidovudine (Combivir)

with abacavir (Epzicom)

with abacavir/zidovudine

Dosing Considerations

Monitor amylase q4-8week

Dosage Forms & Strengths

tablet

  • 100mg (Epivir HBV)
  • 150mg (Epivir)
  • 300mg (Epivir)

oral solution

  • 5mg/mL (Epivir HBV)
  • 10mg/mL (Epivir)
more...

HIV Infection

Epivir

  • Neonates (aged <4 weeks): 2 mg/kg PO q12hr (for prevention of transmission or treatment)
  • Infants 1-3 months: 4 mg/kg PO q12hr 
  • 3 months -16 years: 4 mg/kg PO q12hr or 8 mg/kg PO qDay; not to exceed 300 mg/day

Chronic Hepatitis B

Use Epivir HBV

<2 years: Safety and efficacy not established

≥2 years: 3 mg/kg PO qDay; not to exceed 100 mg/day 

Dosing Considerations

Monitor amylase q4-8week

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Interactions

Interaction Checker

lamivudine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Cough

            Diarrhea

            Fatigue & malaise

            Fever (peds)

            Headache

            Musculoskeletal pain

            Nausea

            Nervous system neuropathy

            Pancreatitis

            Peripheral neuropathy

            Nasal S/S

            Vomiting

            1-10%

            Abdominal cramps, abdominal pain

            Anorexia &/or decr appetite

            Arthralgia

            Chills

            Depression

            Dizziness

            Dyspepsia

            Insomnia

            Myalgia

            Rash

            Thrombocytopenia

            Creatine phosphokinase increased

            Frequency Not Defined

            Body fat redistribution

            Elevated amylase

            Neutropenia

            Hepatitis B exacerbation

            Postmarketing reports

            Immune reconstitution

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            Warnings

            Black Box Warnings

            Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination with other antiretrovirals

            Not FDA approved for treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIV

            Tablets and oral solution formulations used to treat HIV infection contain a higher dose of lamivudine than formulations indicated for chronic hepatitis B infection; patients with HIV should receive only formulation specific for HIV

            Contraindications

            Hypersensitivity

            Cautions

            (All NRTIs): risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals

            Exacerbation of hepatitis B in HBV/HIV coinfected patients may occur on discontinuation

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

            Discontinue immediately if signs or symptoms of pancreatitis occur in patients with history of pancreatitis

            Patients with HIV-1 infection should receive only dosage forms of lamivudine appropriate for treatment of HIV-1

            Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported

            Concomitant administration of emtricitabine with lamivudine-containing products not recommended

            Hepatic decompensation (some fatal) reported in HIV-1/HCV co-infected patients receiving interferon and ribavirin-based regimens; monitor for treatment-associated toxicities; discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both

            Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis; discontinue treatment as clinically appropriate

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            Pregnancy & Lactation

            Pregnancy Category: C; A pregnancy registry has been established to monitor maternal-fetal outcomes of women exposed to lamivudine: 1-800-258-4263

            Lactation: HIV+ women are advised not to breastfeed

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Nucleoside Reverse Transcriptase Inhibitor (NRTI); following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Useful in combination with ZDV

            ZDV-induced codon mutations result in viral sensitivity to drug

            Pharmacokinetics

            Absorption: Rapid

            Vd: 1.3 L/kg

            Protein Bound: <36%

            Metabolism: 5.6% to trans-sulfoxide metabolite

            Bioavailability: Absolute; Cp max decreased with food although AUC not significantly affected, 66% (children); 87% (adults)

            Half-life elimination: 2 hr (children); 5-7 hr (adults)

            Excretion: Primarily urine

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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