Lamivudine / Zidovudine
Pronouncation: (la-MI-vyoo-deen/zye-DOE-vyoo-deen)Class: Nucleoside analog reverse transcriptase inhibitor combination
Trade Names:
Combivir
- Tablets lamivudine 150 mg/zidovudine 300 mg
Pharmacology
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Inhibits replication of HIV by incorporating into HIV DNA and producing an incomplete, nonfunctional DNA.
Indications and Usage
Treatment of HIV-1 infection in combination with other antiretroviral agents.
Contraindications
Hypersensitivity to any component of the product.
Dosage and Administration
Adults and children at least 12 yr of agePO 1 tablet 2 times daily.
Renal function impairmentDo not administer to patients with CrCl less than 50 mL/min.
Hepatic function impairmentNot recommended for patients with impaired hepatic function.
General Advice
- Administer without regard to food. Administer with food if GI upset occurs.
Storage/Stability
Store at 36° to 86°F.
Drug Interactions
Atovaquone, fluconazole, methadone, probenecid, valproic acidZidovudine blood concentrations may be elevated, increasing the pharmacologic and adverse reactions.
Doxorubicin, ribavirin, stavudineAvoid because antagonism of zidovudine has been demonstrated in vitro.
Ganciclovir, interferon-alpha, other bone marrow–suppressive or cytotoxic agentsHematologic toxicity of zidovudine may be increased.
Nelfinavir, ritonavirZidovudine blood concentrations may be reduced.
Nelfinavir, trimethoprim/sulfamethoxazoleLamivudine blood concentrations may be elevated, increasing the pharmacologic and adverse reactions.
ZalcitabineConcurrent use is not recommended.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Cardiomyopathy (postmarketing).
CNS
Headache (35%); malaise/fatigue (27%); neuropathy (12%); insomnia/other sleep disorders (11%); dizziness (10%); depressive disorders (9%); paresthesia, peripheral neuropathy, seizures (postmarketing).
Dermatologic
Skin rash (9%); alopecia, erythema multiforme, Stevens-Johnson syndrome, urticaria (postmarketing).
EENT
Nasal signs and symptoms (20%).
GI
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).
Genitourinary
Gynecomastia, hyperglycemia (postmarketing).
Hematologic-Lymphatic
Anemia, lymphadenopathy, splenomegaly (postmarketing).
Hepatic
Hepatic steatosis, posttreatment exacerbation of hepatitis B (postmarketing).
Lab Tests
Neutropenia (7%); increased ALT, increased amylase (4%); anemia (3%); increased AST (2%); increased bilirubin (1%).
Metabolic-Nutritional
Lactic acidosis (postmarketing).
Musculoskeletal
Musculoskeletal pain (12%); myalgia (8%); arthralgia (5%); CPK elevation, muscle weakness, rhabdomyolysis (postmarketing).
Respiratory
Cough (18%); abnormal breathing sounds/wheezing (postmarketing).
Miscellaneous
Fever/chills (10%); redistribution/accumulation of body fat, sensitization reactions including anaphylaxis, vasculitis, weakness (postmarketing).
Precautions
WarningsZidovudine has been associated with neutropenia and severe 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. |
MonitorFrequent 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. |
Pregnancy
Category C .
Lactation
Excreted in breast milk. HIV-infected mothers should not breast-feed infants.
Children
Not indicated in children younger than 12 yr of age.
Elderly
Select the dose with caution because of the greater frequency of decreased cardiac, hepatic, or renal function, and concomitant diseases or other drug therapy.
Renal Function
Do not administer to patients with CrCl less than 50 mL/min.
Hepatic Function
Not recommended. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity.
Bone marrow suppression
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.
Fat redistribution
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.
Fixed-dose combination
Does not allow for dose reduction; do not use in patients requiring lamivudine or zidovudine dose reduction (eg, children younger than 12 yr of age, renal function impairment with CrCl less than 50ߙmL/min, hepatic function impairment, low body weight, patients experiencing dose-limiting adverse reactions).
Immune reconstitution syndrome
During the initial phase of treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections.
Overdosage
Symptoms
Confusion, dizziness, drowsiness, generalized tonic-clonic seizure, headache, hematologic changes (zidovudine), lethargy, nausea, vomiting.
Patient Information
- Provide patient information leaflet.
- Inform patient that this medication is for oral use only and to take only as prescribed.
- Stress the importance of regular exams and laboratory work.
- Inform patient that this medication is not a cure for the HIV infection and that the patient may continue to develop opportunistic infections and other complications of HIV infection. Patients will need to remain under the close observation of health care providers experienced in the treatment of patients with HIV-associated diseases.
- Caution patient not to discontinue use of drug even when feeling better.
- Caution patient that long-term effects of this medicine are not known.
- Advise patient to notify health care provider of signs of infection, including sore throat, fever, cough, and respiratory congestion.
- Advise family to notify health care provider of changes in neurological status such as memory loss or confusion.
- Advise patient that it may take at least 4ߙwk for max effect.
- Warn patient that the risk of transmission of HIV to others through sexual contact or exposure to the patient's blood is still present. Instruct patient on methods to prevent transmission of the HIV virus.
- Caution HIV-infected mothers that breast-feeding could pass HIV infection or this drug to the baby.
- Advise women to inform health care provider immediately if suspecting pregnancy.
- Inform patient that the major toxicities are neutropenia and anemia and to have blood cell counts monitored closely.
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HIV Infection, Nonoccupational Exposure, Occupational Exposure
