Lamivudine and Zidovudine
(la MI vyoo deen & zye DOE vyoo deen)
- AZT + 3TC (error-prone abbreviation)
- Zidovudine and Lamivudine
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Combivir: Lamivudine 150 mg and zidovudine 300 mg [scored]
Generic: Lamivudine 150 mg and zidovudine 300 mg
Brand Names: U.S.
- Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
The combination of zidovudine and lamivudine is believed to act synergistically to inhibit reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue as well as to delay the emergence of mutations conferring resistance
Use: Labeled Indications
HIV-1 infection: Treatment of HIV-1 infection in combination with other antiretrovirals.
Hypersensitivity to lamivudine or zidovudine, or any component of the formulation
Note: Because this is a fixed-dose combination product, avoid use in patients requiring dosage reduction.
HIV-1 infection, treatment: Oral: One tablet twice daily.
HIV-1 infection, treatment: Children and Adolescents weighing ≥30 kg: Refer to adult dosing.
Dosing: Renal Impairment
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Use is not recommended (use dose-adjusted individual components).
Dosing: Hepatic Impairment
Use is not recommended (use dose-adjusted individual components).
Oral: Administer without regard to food.
Store between 2°C and 30°C (36°F and 86°F).
Acyclovir-Valacyclovir: May enhance the CNS depressant effect of Zidovudine. Monitor therapy
Amodiaquine: Zidovudine may enhance the neutropenic effect of Amodiaquine. Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy
Clarithromycin: May enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Consider therapy modification
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination
Dexketoprofen: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
DOXOrubicin (Conventional): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Conventional) may diminish the therapeutic effect of Zidovudine. Consider therapy modification
DOXOrubicin (Liposomal): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Liposomal) may diminish the therapeutic effect of Zidovudine. Consider therapy modification
Emtricitabine: LamiVUDine may enhance the adverse/toxic effect of Emtricitabine. Avoid combination
Fluconazole: May decrease the metabolism of Zidovudine. Monitor therapy
Ganciclovir-Valganciclovir: May enhance the adverse/toxic effect of Zidovudine. Specifically, hematologic toxicity may be enhanced. Monitor therapy
Interferons: May enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Monitor therapy
Methadone: May increase the serum concentration of Zidovudine. Monitor therapy
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy
Probenecid: May decrease the metabolism of Zidovudine. Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Zidovudine. Monitor therapy
Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Zidovudine. Monitor therapy
Ribavirin (Oral Inhalation): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Oral Inhalation). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification
Ribavirin (Systemic): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Systemic). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended for ribavirin. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification
Rifamycin Derivatives: May decrease the serum concentration of Zidovudine. Exceptions: Rifabutin. Monitor therapy
Stavudine: Zidovudine may diminish the therapeutic effect of Stavudine. Avoid combination
Tenoxicam: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy
Teriflunomide: May increase the serum concentration of OAT3 Substrates. Monitor therapy
Trimethoprim: May increase the serum concentration of LamiVUDine. Monitor therapy
Valproate Products: May increase the serum concentration of Zidovudine. Monitor therapy
See individual agents.
Concerns related to adverse effects:
• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).
• Hematologic toxicity: [US Boxed Warning]: Zidovudine is associated with hematologic toxicity, including neutropenia and severe anemia. Use with caution in patients with bone marrow compromise (granulocytes <1,000 cells/mm3 or hemoglobin <9.5 g/dL).
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: [U.S Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Use with caution in patients with risk factors for liver disease (risk may be increased with female gender, obesity, pregnancy, or prolonged exposure) and discontinue in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Myopathy: [US Boxed Warning]: Prolonged use of zidovudine has been associated with symptomatic myopathy.
• Chronic hepatitis B: [US Boxed Warning]: Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 when therapy is discontinued; monitor patients with clinical and laboratory follow-up for at least several months after treatment discontinuation. Emergence of hepatitis B virus lamivudine-resistant variants has been reported in patients with concurrent HBV infection who received a lamivudine-containing regimen for HIV-1 treatment.
• Hepatic impairment: Lamivudine/zidovudine is not recommended for use in patients with hepatic impairment.
• Pancreatitis: Use with caution in patients with a history of pancreatitis or other significant risk factors for pancreatitis development. Discontinue immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur.
• Renal impairment: Lamivudine/zidovudine is not recommended for use in patients with renal impairment (CrCl <50 mL/minute).
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Amylase, bilirubin, signs and symptoms of pancreatitis. Monitor CBC with differential and platelet count at least every 2 weeks, liver function tests (including signs/symptoms of hepatomegaly), MCV, serum creatinine kinase, viral load, and CD4 count; observe for appearance of opportunistic infections; signs of muscle weakness or pain; blood lactate levels and signs of acidosis
Pregnancy Risk Factor
Adverse events were observed in animal reproduction studies. See individual agents.
In general, women who become pregnant on a stable combination antiretroviral therapy (cART) regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. The Health and Human Services (HHS) Perinatal HIV Guidelines consider lamivudine in combination with zidovudine as an alternative NRTI backbone for initial therapy in antiretroviral-naive pregnant women. Although use of this combination has the most experience for in pregnant women, it has an increased potential for hematologic toxicity and requires twice-daily dosing (HHS [perinatal] 2016).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, nausea, vomiting, diarrhea, rhinitis, rhinorrhea, lack of appetite, dizziness, or insomnia. Have patient report immediately to prescriber signs of infection, signs of too much lactic acid in the blood (lactic acidosis; fast breathing, fast heartbeat, abnormal heartbeat, vomiting, drowsiness, shortness of breath, feeling very tired or weak, severe dizziness, feeling cold, or muscle pain or cramps), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of a pancreas problem (pancreatitis; severe abdominal pain, severe back pain, severe nausea, vomiting), mood changes, burning or numbness feeling, bruising, bleeding, loss of strength and energy muscle weakness, or change in body fat (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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- Drug class: antiviral combinations
Other brands: Combivir