Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues; suspend treatment if lactic acidosis or pronounced hepatotoxicity occurs. Lamivudine: Severe acute exacerbations of hepatitis B reported in patients coinfected with hepatitis B virus (HBV) upon discontinuation of therapy; closely monitor hepatic function for at least several months. If appropriate, initiation of antihepatitis B therapy may be warranted. Zidovudine: Associated with hematologic toxicity (eg, neutropenia, anemia), particularly with advanced HIV-1 disease. Symptomatic myopathy associated with prolonged use.
View FDA-Approved Full Prescribing Information for Combivir
Nucleoside reverse transcriptase inhibitor (NRTI)
Treatment of HIV-1 infection in combination with other antiretrovirals.
Combination with Other Antiretrovirals:
1 tab bid
Combination with Other Antiretrovirals:
1 tab bid
CrCl <50mL/min: Not recommended for use
Not recommended for use
If child is unable to swallow tab, the liquid oral formulations should be prescribed: Epivir (lamivudine) oral sol and RETROVIR (zidovudine) syr
Tab: (Lamivudine-Zidovudine) 150mg-300mg* *scored
Do not use in pediatrics weighing <30 kg, or patients requiring dosage adjustment (eg, renal impairment [CrCl <50mL/min], hepatic impairment, or those experiencing dose-limiting adverse reactions). Caution with history or known risk factors for pancreatitis; d/c if pancreatitis occurs. Immune reconstitution syndrome reported. Autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) reported to occur in the setting of immune reconstitution and can occur many months after initiation of treatment. May cause redistribution/accumulation of body fat. Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and hepatomegaly with steatosis. Caution with any known risk factors for liver disease and in elderly. Lamivudine: Emergence of lamivudine-resistant HBV reported. Zidovudine: Caution with granulocyte count <1000 cells/mm3 or Hgb <9.5g/dL; monitor blood counts frequently with advanced HIV-1 and periodically with other HIV-1 infected patients. Interrupt therapy if anemia or neutropenia develops.
Lactic acidosis, severe hepatomegaly with steatosis, myopathy, hematologic toxicities, headache, malaise, fatigue, fever, chills, N/V, diarrhea, anorexia, insomnia, nasal signs and symptoms, cough.
Avoid with other lamivudine-, zidovudine-, and/or emtricitabine-containing products. Lamivudine: Avoid with zalcitabine. Hepatic decompensation may occur in HIV/hepatitis C virus (HCV) coinfected patients receiving interferon-alfa with or without ribavirin. Nelfinavir and trimethoprim/sulfamethoxazole may increase levels. Zidovudine: Avoid with stavudine, doxorubicin, and nucleoside analogues affecting DNA replication (eg, ribavirin). May increase risk of hematologic toxicities with ganciclovir, interferon alfa, ribavirin, bone marrow suppressors, or cytotoxic agents. Atovaquone, fluconazole, methadone, probenecid, and valproic acid may increase levels. Clarithromycin, nelfinavir, rifampin, and ritonavir may decrease levels.
PREGNANCY AND LACTATION
Category C, not for use in nursing.
MECHANISM OF ACTION
Nucleoside analogue combination; inhibits reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue.
Absorption: Lamivudine: Rapid; bioavailability (86%). Zidovudine: Rapid; bioavailability (64%). Distribution: Lamivudine: Vd=1.3L/kg; plasma protein binding (<36%); found in breast milk. Zidovudine: Vd=1.6L/kg; plasma protein binding (<38%); crosses the placenta; found in breast milk. Metabolism: Lamivudine: Trans-sulfoxide (metabolite). Zidovudine: Hepatic; 3'-azido-3'-deoxy-5'-O-β-D-glucopyranuronosylthymidine (GZDV) (major metabolite). Elimination: Lamivudine: (IV) Urine (70% unchanged); T1/2=5-7 hrs. Zidovudine: Urine (14% unchanged, 74% GZDV); T1/2=0.5-3 hrs.
Assess for advanced HIV disease, bone marrow compromise, liver function and risk factors for liver disease, hepatitis B infection, history of pancreatitis and risk factors for its development, renal function, hypersensitivity to drug, pregnancy/nursing status, and possible drug interaction. Obtain baseline weight and CBCs.
Monitor signs/symptoms that suggest pancreatitis, lactic acidosis, hepatotoxicity, myopathy and myositis, immune reconstitution syndrome (eg, opportunistic infections), autoimmune disorders, and hypersensitivity reactions. Monitor CBCs and renal/hepatic function.
Inform about risk for hematologic toxicities and advise on importance of close blood count monitoring while on therapy. Counsel about the possible occurrence of myopathy and myositis with pathological changes during prolonged use and that therapy may cause a rare but serious condition called lactic acidosis with hepatomegaly. Inform that deterioration of liver disease has occurred in patients coinfected with HBV with treatment d/c. Instruct to discuss with physician any changes in regimen. Caution patients about the use of other medication and instruct to avoid use with other lamivudine-, zidovudine-, and/or emtricitabine-containing products. Inform that hepatic decompensation has been reported in patients coinfected with HCV receiving interferon alfa with or without ribavirin. Inform that fat redistribution/accumulation may occur. Inform that therapy is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1. Advise to avoid doing things that can spread HIV-1 infection to others (eg, sharing of needles/inj equipment/personal items that can have blood or body fluids on them, having sex without protection, breastfeeding). Advise to take exactly as prescribed.
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