Efavirenz / Emtricitabine / Tenofovir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Approved indication: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Approved indication: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Renal Dose Adjustments

Estimated CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments

Mild liver dysfunction: Caution recommended.
Moderate or severe liver dysfunction: Not recommended.

Dose Adjustments

Concomitant rifampin:
Patients weighing 50 kg or more: An additional 200 mg/day of efavirenz is recommended.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

CrCl less than 50 mL/min: Not recommended.

Comments:
-Hemodialysis removes about 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of dosing.
-Tenofovir is removed by hemodialysis with an extraction coefficient of about 54% and about 10% of the tenofovir dose is removed over a 4-hour hemodialysis session.
-Hemodialysis is unlikely to significantly remove efavirenz from the blood.

Peritoneal dialysis: Data not available

Other Comments

Administration advice:
-Take on an empty stomach.
-Dosing at bedtime may improve tolerability of nervous system symptoms.

Monitoring:
-General: Pregnancy testing (before starting therapy)
-Hepatic: Liver enzymes (before and during therapy); for chronic hepatitis B (HBV) in all patients (before therapy); hepatic function of HIV-/HBV coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Metabolic: Serum phosphorus in patients at risk of renal dysfunction (before starting and periodically during therapy)
-Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: Estimated CrCl in all patients (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in patients at risk of renal dysfunction (before starting and periodically during therapy)

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