18 yrs: 120mg/m bid. Do not exceed adult dosing recommendations. 2 Weeks-8 Months:
Increased frequency of liver function abnormalities in patients with preexisting liver dysfunction; consider interrupting or d/c therapy with evidence of worsening liver disease. Non-cirrhotic portal HTN and peripheral neuropathy reported; d/c if they develop. Retinal changes and optic neuritis reported; perform periodic retinal exam. Immune reconstitution syndrome reported. Autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) reported in the setting of immune reconstitution and can occur many months after initiation of treatment. May cause body fat redistribution/accumulation. Caution in elderly.
See Boxed Warning and Contraindications. Avoid with hydroxyurea with or without stavudine. Caution with drugs that may cause pancreatic toxicity or neurotoxicity (eg, stavudine). May increase levels of nelfinavir. May decrease levels of ganciclovir, ranitidine, sulfamethoxazole,
zidovudine. May increase the area under the curve and decrease the C of trimethoprim. max
Ganciclovir, metoclopramide, ranitidine, rifabutin, trimethoprim, and tenofovir may increase levels.
Category B, not for use in nursing.
Synthetic purine nucleoside analogue; inhibits activity of HIV-1 reverse transcriptase both by competing with natural substrate deoxyadenosine 5'-triphosphate and by its incorporation into viral DNA, causing termination of viral DNA chain elongation.
Absorption: Rapid. T=0.25-1.5 hrs. Distribution: Plasma protein binding (<5%). (Sol): V
=43.70L/m (adults), 28L/m (pediatrics 8 months-19 yrs). (Cap): Different parameters based on body weight, refer to PI. Elimination: (Sol): T=1.5 hrs (adults), 0.8 hrs (pediatrics 8 months-19 1/2
yrs), 1.2 hrs (pediatrics 2 weeks-4 months). (Cap): Different parameters based on body weight; refer to PI.
Inform about possible serious toxicity of pancreatitis and advise on the signs and symptoms of lactic acidosis, hepatotoxicity including fatal hepatic events, and peripheral neuropathy. Inform about reports on retinal changes, optic neuritis, fat redistribution/accumulation, and non-cirrhotic portal HTN, including cases leading to liver transplant or death. Caution about the use of medications or other substances, including alcohol, which may exacerbate drug toxicity. Inform that treatment is not a cure for HIV and patients may continue to experience illnesses associated with HIV. Avoid doing things that can spread HIV to others (eg, sharing needles, other inj equipment, or personal items that can have blood fluids on them; sex without protection; breastfeeding). Warn not to skip a dose.
Administration: Oral route. Cap: Take on empty stomach; swallow intact. Pediatric Powder for
Oral Sol: Refer to PI for reconstitution. Take on empty stomach, at least 30 min ac or 2 hrs pc.
Shake admixture well before use. Storage: Cap: 25 C (77 F); excursions permitted 15-30°C (5986°F). Store in tightly closed container. Powder: 15-30°C (59-86°F). Admixture: 2-8°C (36-46°F) for up to 30 days.
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