GNH USA

Europe — EMA

Malarone

GNH USA supplies Malarone (Atovaquone/Proguanil), an antimalarial for prevention and treatment of malaria caused by Plasmodium falciparum and vivax.

Proguanil Hydrochloride, Atovaquone

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What is Proguanil Hydrochloride, Atovaquone?

Atovaquone/Proguanil, the active ingredient in Malarone, is an antimalarial presented as a 250 mg atovaquone / 100 mg proguanil tablet for oral use. It treats and prevents malaria caused by Plasmodium falciparum and Plasmodium vivax in travelers, expatriates, and residents of endemic regions.

GNH USA supplies Malarone as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and regulatory compliance to ensure product integrity. Malarone is manufactured under EU GMP guidelines and distributed to a global network of healthcare providers.

What is Proguanil Hydrochloride, Atovaquone used for?

Malarone (atovaquone/proguanil) is used in the prevention and treatment of malaria, an infectious disease caused by Plasmodium parasites.

- Prevention of malaria (travel prophylaxis): provides protective antimalarial activity for individuals traveling to or residing in endemic areas. - Treatment of acute uncomplicated malaria (Plasmodium falciparum): clears infection and resolves symptoms in patients with confirmed falciparum malaria. - Treatment of acute uncomplicated malaria (Plasmodium vivax): effective against blood‑stage infection of vivax malaria.

What are the side effects of Proguanil Hydrochloride, Atovaquone?

Malarone may cause a range of adverse reactions, from mild to serious.

Common Side Effects: - Gastrointestinal upset: nausea, abdominal pain, or diarrhea. - Headache: mild to moderate intensity. - Dizziness: occasional sensation of light‑headedness. - Metallic taste: transient alteration of taste perception.

Serious or Rare Side Effects: - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Hepatotoxicity: elevated liver enzymes or hepatitis. - Blood dyscrasias: neutropenia, thrombocytopenia, or anemia. - Hypersensitivity: anaphylaxis or severe allergic reactions.

What precautions apply to Proguanil Hydrochloride, Atovaquone?

Before prescribing Malarone, consider the following safety measures.

- Pregnancy: safety not established; use only if benefit outweighs risk. - Renal impairment: dose adjustment may be required; monitor renal function. - Hepatic impairment: use with caution; monitor liver enzymes. - Concomitant antiretrovirals: may reduce efficacy; assess drug interactions. - Travel to high‑risk areas: ensure adequate prophylactic regimen and adherence. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.

What does Proguanil Hydrochloride, Atovaquone interact with?

Malarone can interact with several medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid): - Rifampin: induces metabolism and reduces plasma concentrations of both components, compromising efficacy. - CYP2C8 inhibitors (e.g., gemfibrozil): increase atovaquone levels, raising risk of toxicity. - Protease inhibitors (e.g., ritonavir): may increase proguanil concentrations, leading to adverse effects.

Moderate Interactions (Monitor Closely): - Antacids containing aluminum or magnesium: may decrease atovaquone absorption; separate dosing by at least 2 hours. - Warfarin: proguanil may potentiate anticoagulant effect; monitor INR. - Macrolide antibiotics (e.g., erythromycin): may increase proguanil concentrations; observe for side effects.

Frequently asked questions

What is Malarone used for?+
Malarone is indicated for the prevention of malaria in travelers and residents of endemic regions, as well as for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax.
How does Atovaquone/Proguanil work?+
The combination pairs atovaquone, which blocks mitochondrial electron transport in the parasite, with proguanil, which inhibits folate metabolism via dihydrofolate reductase inhibition. Together they produce a synergistic effect that stops parasite replication in the blood stage.
What is the usual dose of Malarone?+
The dosage of Malarone is determined by a qualified prescriber based on the indication, patient weight, age, and renal or hepatic function. Patients should follow the exact regimen prescribed by their healthcare professional.
Is Malarone safe in pregnancy or breastfeeding?+
Safety of Malarone in pregnancy and lactation has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and under medical supervision.
How do I order Malarone from GNH USA?+
To order Malarone, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Malarone compare with other antimalarial options?+
Malarone offers a convenient once‑daily oral regimen with a dual mechanism of action, providing high efficacy against chloroquine‑resistant strains. Alternatives such as doxycycline or mefloquine have different dosing schedules and side‑effect profiles, making Malarone a preferred choice for many travelers when tolerated.
What are the storage and handling requirements for Malarone?+
Malarone tablets should be stored at ambient temperature, below 25 °C, in their original blister pack. Protect them from moisture and direct light to maintain stability throughout their shelf life.
How is Malarone administered?+
Malarone is taken orally with food or a milky drink to enhance absorption. For prophylaxis, it is usually started 1–2 days before entering a malaria‑risk area, continued daily during exposure, and continued for 7 days after leaving the area. Treatment regimens follow the prescriber’s instructions.
What are the most serious risks to watch for while taking Malarone?+
Serious adverse events include severe skin reactions such as Stevens‑Johnson syndrome, liver injury, blood‑cell abnormalities, and hypersensitivity reactions including anaphylaxis. Patients should seek immediate medical attention if they develop rash, jaundice, unexplained bruising, or signs of an allergic reaction.
Who should not use Malarone?+
Malarone is contraindicated in individuals with known hypersensitivity to atovaquone, proguanil, or any component of the formulation. Caution is advised for patients with severe renal or hepatic impairment, and it should be avoided in pregnant women unless the benefit outweighs the risk.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Proguanil Hydrochloride, Atovaquone
Route
Oral Use
Manufacturer
Glaxosmithkline - Produtos Farmaceuticos, Lda
Origin
EU

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