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National Drug Formulary

MALARONE TABLET [SIN09761P]

Active ingredients: MALARONE TABLET

View product's general information
Last updated 24 April 2026

Product Info

MALARONE TABLET

[SIN09761P]

Product information

Active Ingredient and Strength

ATOVAQUONE - 250 MG
PROGUANIL HCL - 100 MG

Dosage Form

TABLET, FILM COATED

Manufacturer and Country

BORA PHARMACEUTICAL SERVICES INC. - CANADA
GLAXO WELLCOME S.A. (PRIMARY AND SECONDARY PACKING) - SPAIN

Registration Number

SIN09761P

Licence Holder

GLAXOSMITHKLINE PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

P01BB51

Prescription-only Medicines with Exemptions for Supply without Prescription

As an oral solid preparation containing Atovaquone and Proguanil HCl 250mg/100mg

  • Indication: Malaria prophylaxis

  • Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration in the selection of chemoprophylaxis of malaria.

  • Maximum daily dose: One 250mg atovaquone/100mg proguanil tablet daily

  • Maximum supply: Max supply is determined by the duration of travel. Prophylaxis should start 1 to 2 days before entering a malaria-endemic area, and be continued daily until 7 days after leaving the area

  • Minimum age: Adults 18 years and above, with body weight of at least 40kg.

Indication

Indications

Malarone is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide. It is indicated for:

  • Prophylaxis of Plasmodium falciparum malaria.

  • Treatment of Plasmodium falciparum malaria.

Because Malarone is effective against drug sensitive and drug resistant P. falciparum, it is especially recommended for prophylaxis and treatment of P. falciparum malaria in areas where the pathogen may be resistant to other antimalarials.

Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities guidelines.

Dosing

Dosage and Administration

Pharmaceutical form: Film-coated tablets.

The daily dose should be taken with food or a milky drink at the same time each day.

In the event of vomiting within 1 hour of dosing, a repeat dose should be taken.

PROPHYLAXIS:
Prophylaxis should start 1 to 2 days before entering a malaria-endemic area, and be continued daily until 7 days after leaving the area.

Dosage in Adults:
One Malarone tablet (250 mg atovaquone/100 mg proguanil) daily.

Dosage in Children:
Greater than 40 kg bodyweight – One Malarone tablet daily.

TREATMENT:
Dosage in Adults:
Four Malarone tablets (total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose for three consecutive days.

Table caption

11–20 kg bodyweight

– One Malarone tablet daily for three consecutive days.

21–30 kg bodyweight

– Two Malarone tablets as a single dose for three consecutive days.

31–40 kg bodyweight

– Three Malarone tablets as a single dose for three consecutive days.

>40 kg bodyweight

– Four Malarone tablets as a single dose for three consecutive days.

Dosage in the Elderly (Prophylaxis and Treatment):
Pharmacokinetic studies indicate that no dosage adjustments are needed in the elderly (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in Hepatic Impairment (Prophylaxis and Treatment):
There are no studies in children with hepatic impairment. However, a pharmacokinetic study in adults indicates that no dosage adjustments are needed in patients with mild to moderate hepatic impairment.
No studies have been conducted in patients with severe hepatic impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in Renal Impairment (Prophylaxis and Treatment):
There are no studies in children with renal impairment. However, pharmacokinetic studies in adults indicate that no dosage adjustments are needed in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance <30 mL/min) alternatives to Malarone should be recommended for treatment of acute P. falciparum malaria whenever possible (see Warnings and Precautions and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For prophylaxis of P. falciparum malaria in patients with severe renal impairment (see Contraindications).

Contraindications

Contraindications

Malarone is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or any component of the formulation.

Malarone is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min).