Generic Name
Atovaquone
Brand Names
Malarone, Mepron
FDA approval date: February 28, 1995
Classification: Antimalarial
Form: Tablet, Suspension
What is Malarone (Atovaquone)?
Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
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Brand Information
MALARONE (atovaquone and proguanil hydrochloride)
1DOSAGE AND ADMINISTRATION
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.
MALARONE may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.
1.1Prevention of Malaria
Start prophylactic treatment with MALARONE 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return.
Adults
One MALARONE tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Pediatric Patients
The dosage for prevention of malaria in pediatric patients is based upon body weight (
1.2Treatment of Acute Malaria
Adults
Four MALARONE tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.
Pediatric Patients
The dosage for treatment of acute malaria in pediatric patients is based upon body weight (
1.3Renal Impairment
Do not use MALARONE for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min)
2DOSAGE FORMS AND STRENGTHS
Each MALARONE tablet (adult strength) contains 250 mg atovaquone and 100 mg proguanil hydrochloride. MALARONE tablets are pink, film‑coated, round, biconvex tablets engraved with “GX CM3” on one side.
Each MALARONE pediatric tablet contains 62.5 mg atovaquone and 25 mg proguanil hydrochloride. MALARONE pediatric tablets are pink, film‑coated, round, biconvex tablets engraved with “GX CG7” on one side.
3CONTRAINDICATIONS
- MALARONE is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation.
- MALARONE is contraindicated for prophylaxis of
4OVERDOSAGE
There is no information on overdoses of MALARONE substantially higher than the doses recommended for treatment.
There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable. Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose.
Overdoses of proguanil hydrochloride as large as 1,500 mg have been followed by complete recovery, and doses as high as 700 mg twice daily have been taken for over 2 weeks without serious toxicity. Adverse experiences occasionally associated with proguanil hydrochloride doses of 100 to 200 mg/day, such as epigastric discomfort and vomiting, would be likely to occur with overdose. There are also reports of reversible hair loss and scaling of the skin on the palms and/or soles, reversible aphthous ulceration, and hematologic side effects.
5DESCRIPTION
MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride.
The chemical name of atovaquone is
The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C
Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride and each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride. The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
MALARONE tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride.
- Bottle of 100 tablets with child-resistant closure (NDC 0173-0675-01).
- Unit Dose Pack of 24 tablets with child-resistant lid foil (NDC 0173-0675-02).
MALARONE pediatric tablets, containing 62.5 mg atovaquone and 25 mg proguanil hydrochloride.
- Bottle of 100 tablets with child-resistant closure (NDC 0173-0676-01).
Storage Conditions
Store at 25°C (77°F). Temperature excursions are permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
7PATIENT COUNSELING INFORMATION
Patients should be instructed:
- to take MALARONE at the same time each day with food or a milky drink.
- to take a repeat dose of MALARONE if vomiting occurs within 1 hour after dosing.
- to take a dose as soon as possible if a dose is missed, then return to their normal dosing schedule. However, if a dose is skipped, the patient should not double the next dose.
- that rare serious adverse events such as hepatitis, severe skin reactions, neurological events, and hematological events have been reported when MALARONE was used for the prophylaxis or treatment of malaria.
- to consult a healthcare professional regarding alternative forms of prophylaxis if prophylaxis with MALARONE is prematurely discontinued for any reason.
- that protective clothing, insect repellents, and bed nets are important components of malaria prophylaxis.
- that no chemoprophylactic regimen is 100% effective; therefore, patients should seek medical attention for any febrile illness that occurs during or after return from a malaria‑endemic area and inform their healthcare professional that they may have been exposed to malaria.
- that falciparum malaria carries a higher risk of death and serious complications in pregnant women than in the general population. Pregnant women anticipating travel to malarious areas should discuss the risks and benefits of such travel with their physicians.
Trademark is owned by or licensed to the GSK group of companies.
Distributed by:
GlaxoSmithKline
Durham, NC 27701
©2023 GSK group of companies or its licensor.
MLR:11PI
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