"May 20, 2011 -- The FDA has approved Edurant (rilpivirine) for use in anti-HIV drug cocktails.
In a head-to-head clinical trial, Edurant was as effective as the popular drug Sustiva (efavirenz). Edurant and Sustiva are in the class of"...
DOSAGE AND ADMINISTRATION
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 INFORMATION]. 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.
Concomitant Antiretroviral Therapy
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 , Table 5 and CLINICAL PHARMACOLOGY, 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, Table 5 and CLINICAL PHARMACOLOGY, Table 8].
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]. 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.
Table 1: SUSTIVA Dosing in Pediatric Patients
|Patient Body Weight||SUSTIVA Daily Dose||Number of Capsulesa or Tabletsb and Strength to Administer|
|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|
|aCapsules can be administered intact or as sprinkles.
bTablets must not be crushed.
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).
Dosage Forms And Strengths
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.
600 mg tablets are yellow, capsular-shaped, film-coated tablets, with “SUSTIVA” printed on both sides.
Storage And Handling
SUSTIVA® (efavirenz) capsules are available as follows:
Capsules 200 mg are gold color, reverse printed with “SUSTIVA” on the body and imprinted “200 mg” on the cap.
Bottles of 90 NDC 0056-0474-92
Capsules 50 mg are gold color and white, printed with “SUSTIVA” on the gold color cap and reverse printed “50 mg” on the white body.
Bottles of 30 NDC 0056-0470-30
SUSTIVA® (efavirenz) tablets are available as follows:
Tablets 600 mg are yellow, capsular-shaped, film-coated tablets, with “SUSTIVA” printed on both sides.
Bottles of 30 NDC 0056-0510-30
SUSTIVA capsules and SUSTIVA tablets should be stored at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].
Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Issued: May 2014
Last reviewed on RxList: 6/5/2014
This monograph has been modified to include the generic and brand name in many instances.
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