Atovaquone and proguanil

Preview FDA label, BluePoint Laboratories, oral, effective 2026-09-03. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Renal Impairment Do not use atovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [See Contraindications] . Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure.

No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology.

Dosing in liver impairment

Hepatic Impairment No dosage adjustments are needed in patients with mild or moderate hepatic impairment [see Clinical Pharmacology] . No trials have been conducted in patients with severe hepatic impairment