Atovaquone

What it is and how it works

Mechanism of Action Atovaquone is a quinone antimicrobial drug .

Indications

1 INDICATIONS AND USAGE ------------------- INDICATIONS AND USAGE -------------------- Atovaquone oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX . Limitations of Use : Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] > 45 mm Hg) with atovaquone has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied. Prevention of Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).

Dosage and administration (summary)

2 DOSAGE AND ADMINISTRATION Dosage for the Prevention of P. jirovecii Pneumonia The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food. Dosage for the Treatment of Mild-to-Moderate P. jirovecii Pneumonia The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days. Important Administration Instructions Administer atovaquone oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy . Shake gently before administering the recommended dosage.

Contraindications

4 CONTRAINDICATIONS Atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension.

Warnings and precautions

5 WARNINGS AND PRECAUTIONS Risk of Limited Oral Absorption Absorption of orally administered atovaquone oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer atovaquone oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Consider therapy with other agents in patients who have difficulty taking atovaquone oral suspension with food or in patients who have gastrointestinal disorders that may limit absorption of oral medications .

Pregnancy

Pregnancy Risk Summary Available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

16 HOW SUPPLIED/STORAGE AND HANDLING Atovaquone oral suspension, USP 750 mg/5 mL is an opaque yellow, artificial mixed berry-flavored, oral suspension. It is supplied in the following: NDC 81033-104-05: 5 mL unit-dose cup NDC 81033-104-42: Carton containing 42 unit-dose cups of 5 mL each NDC 81033-104-22: Carton containing 20 unit-dose cups of 5 mL…

Source: Atovaquone (Atovaquone) — US FDA prescribing information, 2025-09-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.