Fixed-dose combination
Atovaquone and Proguanil is a fixed-dose combination of an antimalarial and an antiprotozoal indicated for prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported, among other approved uses. MedsAcross supplies Atovaquone and Proguanil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Atovaquone and Proguanil Hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. • treatment of acute, uncomplicated P. falciparum malaria.
Source: US FDA prescribing information
Atovaquone and Proguanil Hydrochloride tablets, a fixed-dose combination of atovaquone and proguanil hydrochloride, is an antimalarial agent.
Source: US FDA prescribing information
The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken. Atovaquone and Proguanil Hydrochloride tablets may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets. • Atovaquone and Proguanil Hydrochloride tablets should be taken with food or a milky drink. Prophylaxis: • Start prophylaxis 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return. • Adults: One adult strength tablet per day. Treatment: • Adults: Four adult strength tablets as a single daily dose for 3 days. Renal Impairment: • Do not use for prophylaxis of malaria in patients with severe renal impairment.
Source: US FDA prescribing information
• Atovaquone and Proguanil Hydrochloride tablets are contraindicated in individuals with known hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation. • Atovaquone and Proguanil Hydrochloride tablets are contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia in patients with severe renal impairment treated with proguanil. • Known serious hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation.
Source: US FDA prescribing information
• 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 atovaquone and proguanil hydrochloride 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.
Source: US FDA prescribing information
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, these events occurred in a similar or lower proportion of subjects receiving atovaquone and proguanil hydrochloride than an active comparator. Common adverse reactions (≥5%) in pediatric patients included abdominal pain, headache, cough, and vomiting. • Treatment: Common adverse reactions (≥5%) in adolescents and adults were abdominal pain, nausea, vomiting, headache, diarrhea, asthenia, anorexia, and dizziness. Common adverse reactions (≥6%) in pediatric patients included vomiting, pruritus, and diarrhea.
Source: US FDA prescribing information
• Administration with rifampin or rifabutin is known to reduce atovaquone concentrations, concomitant use with Atovaquone and Proguanil Hydrochloride tablets is not recommended. • Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. Caution advised when initiating or withdrawing Atovaquone and Proguanil Hydrochloride tablets in patients on anticoagulants, coagulation tests should be closely monitored. • Tetracycline may reduce atovaquone concentrations, parasitemia should be closely monitored.
Source: US FDA prescribing information
Storage Conditions Store at 25°C (77°F). Temperature excursions are permitted to 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Atovaquone and Proguanil, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Atovaquone and Proguanil 250 mg/100 mg tabletOralGeneric name | Atovaquone and Proguanil | — | US FDA | Available on request |
| Atovaquone and Proguanil 62.5 mg/25 mg tabletOralGeneric name | Atovaquone and Proguanil | — | US FDA | Available on request |
| Malarone 250 mg/100 mg tabletOral | Atovaquone and Proguanil | GlaxoSmithKline | US FDA | Available on request |
| Malarone 62.5 mg/25 mg tabletOral | Atovaquone and Proguanil | GlaxoSmithKline | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 July 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 4 presentations of Atovaquone and Proguanil and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Atovaquone and Proguanil, including Malarone.
Yes. The US FDA first approved Atovaquone and Proguanil on 14 July 2000, according to Drugs@FDA.
No listed presentation of Atovaquone and Proguanil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.