Atovaquone and proguanil

Malarone

Approved uses

• treatment of acute, uncomplicated P. falciparum malaria. Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. Treatment of Malaria MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria.

Forms and strengths

• Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil hydrochloride.
• Pediatric tablets: 62.5 mg atovaquone and 25 mg proguanil hydrochloride.

How it is taken

• MALARONE should be taken with food or a milky drink. Prophylaxis:
• Pediatric Patients: Dosage based on body weight (see Table 1). Treatment:
• Pediatric Patients: Dosage based on body weight (see Table 2). Renal Impairment:

Must not be used when

• Known serious hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation.
• Prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min).

Interactions

• Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with MALARONE is not recommended.
• Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. Caution advised when initiating or withdrawing MALARONE in patients on anticoagulants; coagulation tests should be closely monitored.
• Tetracycline may reduce atovaquone concentrations; parasitemia should be closely monitored. Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin is known to reduce atovaquone concentrations. The concomitant administration of MALARONE and rifampin or rifabutin is not recommended.

Warnings and precautions

• Atovaquone absorption may be reduced in patients with diarrhea or vomiting. If used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required.
• In mixed P. falciparum and Plasmodium vivax (P. vivax) infection, P. vivax relapse occurred commonly when patients were treated with MALARONE alone.
• In the event of recrudescent P. falciparum infections after treatment or prophylaxis failure, patients should be treated with a different blood schizonticide.
• Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophylactic use.
• Severe Cutaneous Adverse Reactions (SCARs): Cases of SCARs such as Stevens‑Johnson syndrome (SJS) have been reported. SCARs can be life‑threatening or fatal. If symptoms or signs of SCARs develop, discontinue MALARONE immediately and institute appropriate therapy.
• MALARONE has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria. Patients with severe malaria are not candidates for oral therapy. Vomiting and Diarrhea Absorption of atovaquone may be reduced in patients with diarrhea or vomiting.

Common side effects

• The following clinically significant adverse reactions are discussed in another section of the labeling: • Vomiting and Diarrhea. • Hepatotoxicity. • Severe Cutaneous Adverse Reactions. • Prophylaxis: Common adverse reactions (≥4%) in adults were diarrhea, dreams, oral ulcers, and headache;

Pregnancy

Available data from published literature and postmarketing experience with use of MALARONE in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. The proguanil component of MALARONE acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue folate supplementation to prevent neural tube defects.

How it acts

MALARONE, a fixed-dose combination of atovaquone and proguanil hydrochloride, is an antimalarial agent.

Label holder:

GlaxoSmithKline LLC

Label version:

10 June 2026

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.