HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MEPRON suspension safely and effectively. See full prescribing information for MEPRON suspension.
MEPRON (atovaquone) oral suspension
Initial U.S. Approval: 1992
INDICATIONS AND USAGE
MEPRON suspension is a quinone antimicrobial drug indicated for:
• Prevention of Pneumocystis jiroveci pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). ( 1.1)
• Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ( 1.2)
Limitations of Use (1.3):
• Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with MEPRON has not been studied.
• The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.
DOSAGE AND ADMINISTRATION
• Prevention of PCP: 1,500 mg (10 mL) once daily with food ( 2.1)
• Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ( 2.2)
• Supplied in Foil Pouches and Bottles:
• Foil Pouch: For a 5-mL dose, take entire contents by mouth either by dispensing into a spoon or cup or directly into the mouth. For a 10-mL dose, take two pouches. ( 2.3)
• Bottle: Shake bottle gently before use. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 750 mg per 5 mL. ( 3)
CONTRAINDICATIONS
Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of MEPRON. ( 4)
WARNINGS AND PRECAUTIONS
• Failure to administer MEPRON suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Patients with gastrointestinal disorders may have limited absorption resulting in suboptimal atovaquone concentrations. ( 5.1)
• Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. ( 5.2)
ADVERSE REACTIONS
• PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ( 6.1)
• PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with MEPRON suspension is not recommended. ( 7.1)
• Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of MEPRON if coadministration of tetracycline is necessary. ( 7.2)
• Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. ( 7.3)
• Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary. ( 7.4)
See 17 for PATIENT COUNSELING INFORMATION.
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