Sustiva Dosage

Generic name: efavirenz
Dosage form: capsule, gelatin coated; tablet, film coated

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

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 (12.3)]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions (5.5), Adverse Reactions (6.1), and Patient Counseling Information (17)]. SUSTIVA capsules or tablets should be swallowed intact with liquid. For patients who cannot swallow capsules or tablets, the capsule sprinkle method of administration is recommended [see Dosage and Administration (2.3)].

Concomitant Antiretroviral Therapy

SUSTIVA must be given in combination with other antiretroviral medications [see Indications and Usage (1), Warnings and Precautions (5.2), Drug Interactions (7.1), and Clinical Pharmacology (12.3)].

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 5) and Clinical Pharmacology (12.3, Tables 7 and 8).]

If SUSTIVA is coadministered with rifampin to patients weighing 50 kg or more, an increase in the dose of SUSTIVA to 800 mg once daily is recommended [see Drug Interactions (7.1, Table 5) and Clinical Pharmacology (12.3, Table 8)].

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 months of age or older and weighing between 3.5 kg and 40 kg [see Clinical Pharmacology (12.3)]. The recommended dosage of SUSTIVA for pediatric patients weighing 40 kg or greater is 600 mg once daily. For pediatric patients who cannot swallow capsules, the capsule contents can be administered with a small amount of food or infant formula using the capsule sprinkle method of administration [see Dosage and Administration (2.3)].

Table 1: SUSTIVA Dosing in Pediatric Patients
Patient Body Weight SUSTIVA Daily Dose Number of Capsulesa or Tabletsb
and Strength to Administer
a  Capsules can be administered intact or as sprinkles [see Dosage and Administration (2.3)].
b  Tablets must not be crushed.

3.5 kg to less than 5 kg

100 mg

two 50 mg capsules

5 kg to less than 7.5 kg

150 mg

three 50 mg capsules

7.5 kg to less than 15 kg

200 mg

one 200 mg capsule

15 kg to less than 20 kg

250 mg

one 200 mg + one 50 mg capsule

20 kg to less than 25 kg

300 mg

one 200 mg + two 50 mg capsules

25 kg to less than 32.5 kg

350 mg

one 200 mg + three 50 mg capsules

32.5 kg to less than 40 kg

400 mg

two 200 mg capsules

at least 40 kg

600 mg

one 600 mg tablet OR
three 200 mg capsules

Capsule Sprinkle Method of Administration

For pediatric patients at least 3 months old and weighing at least 3.5 kg and adults who cannot swallow capsules or tablets, the capsule contents may be administered with a small amount (1 to 2 teaspoons) of food. Use of infant formula for mixing should only be considered for those young infants who cannot reliably consume solid foods. Patients and caregivers must be instructed to open the capsule carefully to avoid spillage or dispersion of the capsule contents into the air. The capsule should be held horizontally over a small container and carefully twisted to open. For patients able to tolerate solid foods, the entire capsule contents should be gently mixed with an age-appropriate soft food, such as applesauce, grape jelly, or yogurt, in the small container. For young infants receiving the capsule sprinkle-infant formula mixture, the entire capsule contents should be gently mixed into 2 teaspoons (10 mL) of reconstituted room temperature infant formula in a medicine cup by carefully stirring with a small spoon, and then drawing up the mixture into a 10 mL oral dosing syringe for administration. After administration of the SUSTIVA-food or -formula mixture, an additional small amount (approximately 2 teaspoons) of food or formula must be added to the empty mixing container, stirred to disperse any remaining SUSTIVA residue, and administered to the patient. The SUSTIVA-food or -formula mixture should be administered within 30 minutes of mixing. No additional food should be consumed for 2 hours after administration of SUSTIVA.

Further patient instructions on the capsule sprinkle method of administration are provided in the FDA-approved patient labeling (see Patient Information and Instructions for Use).

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