Atovaquone
Atovaquone Prescribing Information
Atovaquone oral suspension is a quinone antimicrobial drug indicated for:
- Prevention ofPneumocystis jiroveciipneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (
1.1 Prevention ofPneumocystis jiroveciiPneumoniaAtovaquone oral suspension is indicated for the prevention of
Pneumocystis jiroveciipneumonia (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
1.2 Treatment of Mild-to-ModeratePneumocystis jiroveciiPneumoniaAtovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
Clinical experience with atovaquone for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO2] ≤ 45 mm Hg). Treatment of more severe episodes of PCP with atovaquone has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.
- 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 PCP: 1,500 mg (10 mL) once daily with food
2.1 Dosage for the Prevention ofP. jiroveciiPneumoniaThe recommended oral dosage is 1,500 mg (10 mL) once daily administered with food.
- Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days
2.2 Dosage for the Treatment of Mild-to-ModerateP. jiroveciiPneumoniaThe recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days.
- Supplied in bottles: Shake bottle gently before use.
2.3 Important Administration InstructionsAdminister atovaquone oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy
[see Warnings and Precautions (5.1),Clinical Pharmacology ( 12.3)].Shake bottle gently before administering the recommended dosage.
Atovaquone oral suspension, USP is an opaque yellow, artificial mixed berry-flavored, containing 750 mg of atovaquone, USP per 5 mL. Atovaquone oral suspension, USP is supplied in 210 mL bottles.
Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. (
The Centers for Disease Control and Prevention recommend that HIV-1
In a rat study with doses of 10 mg and 250 mg/kg given orally by gavage on postpartum Day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. The concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk.
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.
- Failure to administer atovaquone oral 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 Risk of Limited Oral AbsorptionAbsorption 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
[see Clinical Pharmacology(12.3)]. - Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported.
5.2 HepatotoxicityCases of cholestatic hepatitis, elevated liver enzymes, and fatal liver failure have been reported in patients treated with atovaquone
[see Adverse Reactions(6.2)].If treating patients with severe hepatic impairment, closely monitor patients following administration of atovaquone oral suspension.