Usual Adult Dose for HIV Infection

1 tablet orally twice a day

Use: In combination with other antiretrovirals, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 1 tablet orally every twice a day
Duration of therapy: 28 days

Comments:

• Recommended as part of a preferred NNRTI-based or protease inhibitor-based regimen for nonoccupational postexposure prophylaxis of HIV infection; also recommended as part of alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI)
• Prophylaxis should be started as soon as possible, within 72 hours of exposure.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:

• Recommended as part of alternative regimens for HIV postexposure prophylaxis
• Prophylaxis should be started as soon as possible, preferably within hours after exposure.
• The optimal duration of prophylaxis is unknown and may differ based on the institution protocol.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

At least 30 kg: 1 tablet orally twice a day

Comments:

• Use of the individual components is recommended for patients less than 30 kg; the manufacturer product information for lamivudine and zidovudine should be consulted.

Renal Dose Adjustments

CrCl less than 50 mL/min: Not recommended; individual components should be used.

Comments:

• The individual components should be used if dose reduction of either component required for patients with renal dysfunction.

Liver Dose Adjustments

Not recommended; individual components should be used.

Comments:

• Zidovudine levels increased in patients with liver dysfunction, which may increase risk of hematologic toxicity; hematologic toxicities should be monitored frequently.

Precautions

US BOXED WARNINGS:

• HEMATOLOGIC TOXICITY: Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), especially in patients with advanced HIV-1 disease.
• MYOPATHY: Prolonged zidovudine use has been associated with symptomatic myopathy.
• LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs and other antiretrovirals. This drug should be discontinued if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity.
• EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping lamivudine. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Dialysis

Data not available

Other Comments

Administration advice:

• Use in combination with other antiretroviral agents.
• May administer without regard to food
• If a patient is unable to reliably swallow a tablet, use the oral liquid formulations of each component.
• Do not use this drug in patients experiencing dose-limiting side effects; use the individual components.
• Consult the manufacturer product information regarding missed doses.

• Store between 2C and 30C (36F and 86F).

• Hematologic: Blood counts (frequently in patients with advanced HIV-1 disease; periodically in other HIV-1-infected patients)
• Hepatic: Hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)