Usual Adult Dose for HIV Infection

200 mg orally twice a day after a meal

Comments:

• The same dosage is recommended for adult and pregnant patients.

Usual Pediatric Dose for HIV Infection

2 to less than 18 years:

• Weight 10 to less than 20 kg: 100 mg orally twice a day after a meal
• Weight 20 to less than 25 kg: 125 mg orally twice a day after a meal
• Weight 25 to less than 30 kg: 150 mg orally twice a day after a meal
• Weight at least 30 kg: 200 mg orally twice a day after a meal

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is highly protein-bound; significant removal by dialysis is unlikely.

Other Comments

Administration advice:

• Always use in combination with other antiretroviral agents.
• Administer after a meal; the type of food does not affect drug exposure.
• Swallow tablet(s) whole with a liquid (such as water).
• For patients unable to swallow tablet(s) whole: May disperse tablet(s) in water; drink the mixture immediately; rinse the glass several times (with water, orange juice, or milk) and completely swallow each rinse to ensure the entire dose is consumed.

• Store at 25C (77F) in original bottle; excursions permitted to 15C to 30C (59F to 86F).
• Keep bottle tightly closed to protect from moisture; do not remove desiccant pouches.

• To prepare dispersion:
• Place the tablet(s) in 5 mL of water, or at least enough liquid to cover the medication.
• Stir well until the water looks milky.
• Add about 15 mL of liquid; may use water but other liquids (such as orange juice or milk) may improve taste; do not place the tablet(s) in orange juice or milk without first adding water. Avoid using warm beverages (temperature above 40C [104F]) and carbonated beverages.

• Read the US FDA-approved patient labeling (Patient Information).
• Do not miss doses (can result in development of resistance); take after a meal twice a day on a regular dosing schedule; do not take more or less than the prescribed dose or discontinue therapy without consulting physician.
• Swallow tablets whole with liquid (e.g., water); do not chew the tablets.
• Contact healthcare provider at once if rash develops; stop this drug and seek medical attention immediately if rash associated with fever, general malaise, fatigue, muscle/joint aches, blisters, oral lesions, conjunctivitis, facial swelling, swelling of the eyes/lips/mouth, breathing difficulty, and/or signs/symptoms of liver problems (e.g., yellowing of skin/whites of eyes, dark/tea-colored urine, pale-colored stools/bowel movements, nausea, vomiting, loss of appetite, pain/aching/sensitivity on right side below ribs) develops.
• Notify healthcare provider at once of any symptoms of infection.