EFAVIRENZ- efavirenz tablet, film coated
Efavirenz tablets in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
Monitor hepatic function prior to and during treatment with efavirenz tablets
Warnings and Precautions (5.9)]
Efavirenz tablets are not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C) [see Warnings and Precautions (5.9) and Use in Specific Populations (8.6)] .
The recommended dosage of efavirenz tablets is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that efavirenz tablets be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of efavirenz tablets 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 (5.6), Adverse Reactions (6.1), and Patient Counseling Information (17)] . Efavirenz tablets should be swallowed intact with liquid . For patients who cannot swallow tablets, the capsule sprinkle method of administration is recommended [see Dosage and Administration (2.4)].
Concomitant Antiretroviral Therapy
Efavirenz tablets must be given in combination with other antiretroviral medications [see Indications and Usage (1), Warnings and Precautions (5.3), Drug Interactions (7.1), and Clinical Pharmacology (12.3)] .
If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the efavirenz 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). Efavirenz tablets must not be broken. [See Drug Interactions (7.1, Table 5) and Clinical Pharmacology (12.3, Tables 7 and 8).]
If efavirenz is coadministered with rifampin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg once daily is recommended [see Drug Interactions (7.1, Table 5) and Clinical Pharmacology (12.3, Table 8)].
It is recommended that efavirenz tablets be taken on an empty stomach, preferably at bedtime. Table 1 describes the recommended dose of efavirenz tablets 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 efavirenz tablets 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 (2.4)] .
|Patient Body Weight||Efavirenz Daily Dose||Number of Capsules a or Tablets b and Strength to Administer|
|a Capsules can be administered intact or as sprinkles [see Dosage and Administration (2.4)] . 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|
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 should 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 of reconstituted room temperature infant formula in a small container 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 efavirenz-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 efavirenz residue, and administered to the patient. The efavirenz-food or -formula mixture should be administered within 30 minutes of mixing. No additional food should be consumed for 2 hours after administration of efavirenz.
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