INDICATIONS & USAGE
ATRIPLA® is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. 
DOSAGE & ADMINISTRATION
Recommended dose in adults and pediatric patients (12 years of age and older and weighing at least 40 kg): One tablet once daily taken orally on an empty stomach, preferably at bedtime. (2)
Dose in renal impairment: Should not be administered in patients with creatinine clearance below 50 mL/min. (2)
With rifampin coadministration, an additional 200 mg/day of efavirenz is recommended for patients weighing 50 kg or more. (2)
Adults and pediatric patients 12 years of age and older with body weight at least 40 kg (at least 88 lbs): The dose of ATRIPLA is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.
Renal Impairment: Because ATRIPLA is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL/min).
Rifampin Coadministration: When ATRIPLA is administered with rifampin to patients weighing 50 kg or more, an additional 200 mg/day of efavirenz is recommended [See Drug Interactions (7.3), Table 4, and Clinical Pharmacology (12.3), Table 5].
DOSAGE FORMS & STRENGTHS
ATRIPLA is available as tablets. Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil). The tablets are pink, capsule-shaped, film-coated, debossed with "123" on one side and plain-faced on the other side
CONTRAINDICATIONS
Previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA. (4.1)
For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (e.g., cardiac arrhythmias, prolonged sedation, or respiratory depression). (4.2)
ATRIPLA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a com
For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (e.g., cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with ATRIPLA are listed in Table 1.
Table 1 Drugs That Are Contraindicated or Not Recommended for Use With ATRIPLA  Drug Class: Drug Name Clinical Comment
Antifungal: voriconazole Efavirenz significantly decreases voriconazole plasma concentrations, and coadministration may decrease the therapeutic effectiveness of voriconazole. Also, voriconazole significantly increases efavirenz plasma concentrations, which may increase the risk of efavirenz-associated side effects. Because ATRIPLA is a fixed-dose combination product, the dose of efavirenz cannot be altered. [See Clinical Pharmacology (12.3) Tables 5 and 6]
Ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergon