Trade Names:Combivir- Tablets lamivudine 150 mg/zidovudine 300 mg
Inhibits replication of HIV by incorporating into HIV DNA and producing an incomplete, nonfunctional DNA.
Treatment of HIV-1 infection in combination with other antiretroviral agents.
Hypersensitivity to any component of the product.
PO 1 tablet 2 times daily.Renal function impairment
Do not administer to patients with CrCl less than 50 mL/min.Hepatic function impairment
Not recommended for patients with impaired hepatic function.
Store at 36° to 86°F.
Zidovudine blood concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.Doxorubicin, ribavirin, stavudine
Avoid because antagonism of zidovudine has been demonstrated in vitro.Ganciclovir, interferon-alpha, ribavirin, other bone marrow–suppressive or cytotoxic agents
Hematologic toxicity of zidovudine may be increased.Nelfinavir, ritonavir
Zidovudine blood concentrations may be reduced.Trimethoprim/Sulfamethoxazole
Lamivudine blood concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.Zalcitabine
Concurrent use is not recommended.
None well documented.
Headache (35%); malaise/fatigue (27%); neuropathy (12%); insomnia/other sleep disorders (11%); dizziness (10%); depressive disorders (9%); paresthesia, peripheral neuropathy, seizures (postmarketing).
Skin rash (9%); alopecia, erythema multiforme, Stevens-Johnson syndrome, urticaria (postmarketing).
Nasal signs and symptoms (20%).
Nausea (33%); diarrhea (18%); nausea/vomiting (13%); anorexia/decreased appetite (10%); abdominal pain (9%); abdominal cramps (6%); dyspepsia (5%); oral mucosal pigmentation, pancreatitis, stomatitis (postmarketing).
Anemia, lymphadenopathy, splenomegaly (postmarketing).
Hepatic steatosis, posttreatment exacerbation of hepatitis B (postmarketing).
Neutropenia (7%); increased ALT, increased amylase (4%); anemia (3%); increased AST (2%); increased bilirubin (1%).
Hyperglycemia, lactic acidosis (postmarketing).
Musculoskeletal pain (12%); myalgia (8%); arthralgia (5%); CPK elevation, muscle weakness, rhabdomyolysis (postmarketing).
Cough (18%); abnormal breathing sounds/wheezing (postmarketing).
Fever/chills (10%); redistribution/accumulation of body fat, sensitization reactions including anaphylaxis, vasculitis, weakness (postmarketing).
Zidovudine has been associated with neutropenia and anemia, particularly in patients with advanced HIV disease. Myopathy has been associated with prolonged use. Lactic acidosis and hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus and HIV and who have discontinued lamivudine.
Frequent blood cell counts are recommended when using this drug combination in patients with advanced HIV disease; periodic blood cell counts are recommended when using in patients with asymptomatic or early HIV disease; monitor hepatic function for several months after discontinuation. Closely monitor patients receiving interferon alfa with or without ribavirin and lamivudine/zidovudine for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia.
Category C .
Excreted in breast milk. HIV-infected mothers should not breast-feed infants.
Not indicated for children weighing less than 30 kg because this fixed-dose combination cannot be adjusted for this patient population.
Select the dose with caution because of the greater frequency of decreased cardiac, hepatic, or renal function, and concomitant diseases or other drug therapy.
Dosage reduction is recommended in patients with impaired renal function. Do not administer to patients whose CrCl is less than 50 mL/min.
Dose reduction may be necessary in patients with mild to moderate hepatic function impairment or cirrhosis. Not recommended for patients with hepatic function impairment.
Use with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm 3 or Hgb less than 9.5 g/dL.
Redistribution and accumulation of body fat, including breast enlargement, central obesity, cushingoid appearance, dorsocervical fat enlargement (buffalo hump), facial wasting, and peripheral wasting, have occurred in patients receiving antiretroviral therapy.
Does not allow for dose reduction; do not use in patients requiring lamivudine or zidovudine dose reduction (eg, children weighing less than 30 kg, renal function impairment with CrCl less than 50 mL/min, hepatic function impairment, low body weight, patients experiencing dose-limiting adverse reactions).
During the initial phase of treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections.
Fatal cases have been reported.
Use with caution in patients with a history of pancreatitis or other risk factors for development of pancreatitis.
Confusion, dizziness, drowsiness, generalized tonic-clonic seizure, headache, hematologic changes (zidovudine), lethargy, nausea, vomiting.
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