lamivudine/zidovudine (Rx)

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Brand and Other Names:Combivir, 3tc/zdv

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/zidovudine

tablet

  • 150mg/300mg
more...

HIV Infection

150 mg/300 mg (1 tablet) PO q12hr

Monitor amylase q4-8wk

Because of fixed dose, avoid administering to patients < 30 kg, patients with CrCl < 50 mL/min, or in hepatic impairment

Dosage Forms & Strengths

lamivudine/zidovudine

tablet

  • 150mg/300mg
more...

HIV Infection

<12 years: Not recommended; fixed-dose combination cannot be adjusted for children

> 12 years and < 30 kg: Not recommended

>12 years and >30 kg: As adults; 150 mg/300 mg (1 tablet) PO q12hr

Monitor amylase q4-8wk

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Interactions

Interaction Checker

and lamivudine/zidovudine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Headache (35%)

            Nausea (33%)

            Malaise & fatigue (27%)

            Cough (18%)

            Diarrhea (18%)

            Vomiting (13%)

            Musculoskeletal pain (12%)

            Neuropathy (12%)

            Insomnia & other sleep disorders (11%)

            1-10%

            Anorexia &/or decreased appetite (10%)

            Dizziness (10%)

            Fever or chills (10%)

            Abdominal pain (9%)

            Depressive disorders (9%)

            Skin rashes (9%)

            Myalgia (8%)

            Neutropenia (7.2% )

            Abdominal cramps (6%)

            Arthralgia (5%)

            Dyspepsia (5%)

            Anemia (2.9% )

            Frequency Not Defined (serious)

            Erythema multiforme

            Stevens-Johnson syndrome

            Lactic acidosis

            Pancreatitis

            Hepatomegaly (Severe)

            Steatosis of liver (Severe)

            Anaphylaxis

            Immune hypersensitivity reaction

            Rhabdomyolysis

            Postmarketing reports

            Immune reconstitution syndrome and fat redistribution

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            Warnings

            Black Box Warnings

            lamivudine

            • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals
            • Not FDA approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients coinfected 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; HIV patients should receive only formulation specific for HIV
            • Exacerbations of hepatitis reported after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment; if appropriate, initiate anti-hepatitis B therapy

            zidovudine

            • Neutropenia and severe anemia reported, particularly in patients with advanced HIV disease
            • Myopathy associated with prolonged use
            • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with nucleoside analogues alone or in combination

            Contraindications

            Hypersensitivity

            Patients requiring separate lamivudine or zidovudine dose reduction

            Cautions

            Risk of immune reconstitution syndrome

            Zidovudine use has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease; use with caution in patients who have bone marrow compromise evidenced by granulocyte count < 1,000 cells per mm³ or hemoglobin < 9.5 g/dL; frequent blood counts strongly recommended in patients with advanced HIV-1 disease; periodic blood counts recommended for other HIV-1-infected patients; if anemia or neutropenia develops, dosage interruption may be needed

            Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease associated with prolonged use of zidovudine

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues and other antiretrovirals; suspend treatment in patients who develop 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)

            Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment

            Emergence of hepatitis B virus variants associated with resistance to lamivudine reported in HIV-1-infected subjects who received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus

            Concomitant administration with other products containing lamivudine or zidovudine not recommended

            Closely monitor patients receiving interferon alfa with or without ribavirin for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia; consider discontinuation of therapy as medically appropriate; dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh greater than 6)

            Use with caution in patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis; treatment should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur Immune reconstitution syndrome reported

            During initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop 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 Guillain-Barré syndrome) have been reported to occur in setting of immune reconstitution; however, time to onset is more variable, and can occur many months after initiation of treatment

            Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy; mechanism and long-term consequences of these events are currently unknown; causal relationship not established

            Not recommended for use in patients with hepatic or renal (CrCl< 50 mL/min) impairment

            See also individual monographs

            • lamivudine
            • zidovudine
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not recommended

            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.

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            Pharmacology

            Mechanism of Action

            Lamivudine: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Zidovudine: NRTI; interferes with HIV viral RNA-dependent DNA polymerase (inhibits viral replication); thymidine analog

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            Formulary

            FormularyPatient Discounts

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            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.
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            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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