DOSAGE AND ADMINISTRATION
Adults
The recommended dosage of SUSTIVA (efavirenz) is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse reactions [see Clinical Pharmacology ]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions , Adverse Reactions , and Patient Counseling Information ].
Concomitant Antiretroviral Therapy
SUSTIVA must be given in combination with other antiretroviral medications [see Indications and Usage (1), Warnings and Precautions , Drug Interactions , and Clinical Pharmacology ].
Dosage Adjustment
If SUSTIVA is coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the SUSTIVA dose should be decreased to 300 mg once daily using the capsule formulation (one 200-mg and two 50-mg capsules or six 50-mg capsules). SUSTIVA tablets should not be broken. See Drug Interactions (7.1, Table 7) and Clinical Pharmacology (12.3, Tables 8 and 9) .
Pediatric Patients
It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. Table 1 describes the recommended dose of SUSTIVA for pediatric patients 3 years of age or older and weighing between 10 and 40 kg [see Use in Specific Populations ]. The recommended dosage of SUSTIVA for pediatric patients weighing greater than 40 kg is 600 mg once daily.
Table 1: Pediatric Dose to be Administered Once Daily | Body Weight | SUSTIVA Dose (mg) |
|---|
| kg | lbs |
| 10 to less than 15 | 22 to less than 33 | 200 |
| 15 to less than 20 | 33 to less than 44 | 250 |
| 20 to less than 25 | 44 to less than 55 | 300 |
| 25 to less than 32.5 | 55 to less than 71.5 | 350 |
| 32.5 to less than 40 | 71.5 to less than 88 | 400 |
| at least 40 | at least 88 | 600 |
DOSAGE FORMS AND STRENGTHS
• Capsules
200-mg capsules are gold color, reverse printed with "SUSTIVA" on the body and imprinted "200 mg" on the cap.
50-mg capsules are gold color and white, printed with "SUSTIVA" on the gold color cap and reverse printed "50 mg" on the white body.
• Tablets
600-mg tablets are yellow, capsular-shaped, film-coated tablets, with "SUSTIVA" printed on both sides.
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