Product image of Malarone Pediátrico (Proguanil Hydrochloride, Atovaquone) supplied by GNH India

Malarone Pediátrico

Active Ingredient:
Proguanil Hydrochloride, Atovaquone
Origin:
EU

Malarone Pediátrico (Proguanil Hydrochloride, Atovaquone)

Atovaquone/proguanil, the active ingredient in Malarone Pediátrico, is an antimalarial presented as an oral tablet for pediatric use. It provides both prophylaxis and treatment of uncomplicated malaria caused by Plasmodium species in children and adolescents.

GNH India supplies Malarone Pediátrico as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with EU regulatory standards and is manufactured under GMP conditions, offering reliable antimalarial therapy for children.

Manufacturer / TM Owner

Glaxosmithkline, S.A.

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Indications & Clinical Uses

Malarone Pediátrico, a combination antimalarial, is indicated for malaria prophylaxis and treatment.

  • Prophylaxis of malaria: prevents Plasmodium infection in children traveling to endemic areas.
  • Treatment of acute uncomplicated malaria: clears parasitemia in pediatric patients with P. falciparum or other species.
  • Post‑exposure prophylaxis: reduces risk of malaria after a known mosquito bite in an endemic region.

How It Works

  • Atovaquone interferes with the mitochondrial electron transport chain of Plasmodium parasites, halting ATP synthesis, while proguanil is metabolised to cycloguanil, which inhibits the parasite's dihydrofolate reductase enzyme. The combined actions produce a synergistic blockade of parasite replication and energy production, leading to parasite death.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Rash: mild skin irritation or erythema.

Serious or Rare Side Effects

  • Stevens‑Johnson syndrome: severe skin reaction requiring immediate medical attention.
  • Hepatic dysfunction: elevated liver enzymes or hepatitis.
  • Severe neutropenia: marked reduction in white blood cells.
  • Anaphylaxis: rapid onset allergic reaction with breathing difficulty.
  • Hemolysis: breakdown of red blood cells, especially in susceptible individuals.

Precautions & Warnings

Before prescribing Malarone Pediátrico, consider the following precautions:

  • Assess G6PD deficiency: consider alternative therapy in severe deficiency.
  • Hypersensitivity: avoid in patients with known allergy to atovaquone or proguanil.
  • Hepatic impairment: use with caution and monitor liver function.
  • Renal impairment: dose adjustment may be required in severe renal dysfunction.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Malarone Pediátrico may interact with several medicines. Review patient medication lists carefully.

Major Interactions (Avoid)

  • Rifampin: reduces atovaquone plasma concentrations, decreasing efficacy.
  • Cimetidine: may increase atovaquone levels, raising risk of toxicity.
  • Protease inhibitors (e.g., ritonavir): can lower drug effectiveness.

Moderate Interactions (Monitor Closely)

  • Warfarin: may enhance anticoagulant effect, requiring INR monitoring.
  • Phenytoin: may decrease proguanil levels, reducing therapeutic benefit.
  • Oral contraceptives: may reduce hormonal efficacy, advise additional contraception.

Frequently Asked Questions

Malarone Pediátrico is a prescription oral tablet that combines atovaquone and proguanil to prevent malaria infection (prophylaxis) and to treat acute uncomplicated malaria in children and adolescents traveling to or living in endemic regions.

Atovaquone blocks the mitochondrial electron transport chain of the malaria parasite, halting energy production, while proguanil is converted to cycloguanil, which inhibits the parasite’s dihydrofolate reductase enzyme. Together they stop parasite replication and lead to parasite death.

The specific dose of Malarone Pediátrico is determined by the prescribing clinician based on the child’s age, weight, and the intended use (prophylaxis or treatment). Dosing instructions are provided on the prescription label and should be followed exactly.

Safety data for atovaquone/proguanil in pregnancy and lactation are limited. The medication should only be used if the potential benefit justifies the potential risk to the fetus or infant, and this decision must be made by a qualified healthcare professional.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India 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.

Malarone Pediátrico offers a fixed‑dose combination that provides both prophylactic and therapeutic activity, reducing the need for separate drugs. Compared with older agents such as chloroquine, it retains efficacy against many resistant Plasmodium strains, though cost and availability may differ from alternatives like doxycycline or mefloquine.

Store the tablets at ambient temperature below 25 °C, in the original blister pack, protected from moisture and direct sunlight. Do not refrigerate or freeze the product, and keep it out of reach of children.

Malarone Pediátrico is taken orally with water, usually with food to improve absorption. The tablet should be swallowed whole and not chewed or crushed unless specifically instructed by a healthcare professional.

Serious risks include severe skin reactions such as Stevens‑Johnson syndrome, hepatic dysfunction, significant neutropenia, and rare cases of anaphylaxis. Patients should seek immediate medical attention if they develop rash, jaundice, fever, or breathing difficulties.

Malarone Pediátrico should be avoided in children with known hypersensitivity to atovaquone, proguanil, or any component of the formulation, and in those with severe G6PD deficiency. Caution is also advised for patients with significant liver or kidney disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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