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Emtricitabine Capsules
  • Professionals
  • FDA PI

Emtricitabine Capsules

Dosage form: capsule
Drug class:Nucleoside reverse transcriptase inhibitors (NRTIs)

Medically reviewed by Drugs.com. Last updated on Apr 1, 2022.

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine.Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].

Indications and Usage for Emtricitabine Capsules

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Emtricitabine Capsules Dosage and Administration

2.1 Testing Prior to Initiation of Treatment with Emtricitabine

Prior to or when initiating emtricitabine, test patients for hepatitis B virus infection [seeWarnings and Precautions (5.1)].

Recommended Dosage

Emtricitabine is taken by mouth once daily and may be taken without regard to food [see Clinical Pharmacology (12.3)].

Recommended Dosage in Adult Patients (18 years of age and older)

Emtricitabine Capsules: One 200 mg capsule administered once daily orally.

Recommended Dosage in Pediatric Patients (3 months...