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

Malarone Paediatric

Active Ingredient:
Proguanil Hydrochloride, Atovaquone
Origin:
EU

Malarone Paediatric (Proguanil Hydrochloride, Atovaquone)

Proguanil hydrochloride and atovaquone, the active ingredients in Malarone Paediatric, are antimalarial agents presented as an oral paediatric formulation for oral use. They prevent malaria infection and treat acute uncomplicated malaria in children and adolescents.

GNH India supplies Malarone Paediatric as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Glaxosmithkline Trading Services Limited

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Indications & Clinical Uses

Malarone Paediatric, a combination antimalarial, is indicated for the following malaria‑related conditions.

  • Prevention of malaria infection: provides prophylactic protection for children traveling to or residing in malaria‑endemic areas.
  • Treatment of acute uncomplicated malaria caused by Plasmodium falciparum: clears infection in pediatric patients with confirmed P. falciparum malaria.
  • Treatment of acute uncomplicated malaria caused by chloroquine‑resistant Plasmodium species: effective against resistant strains in children.

How It Works

  • Atovaquone disrupts mitochondrial electron transport in Plasmodium parasites, halting energy production, while proguanil is metabolised to cycloguanil, which inhibits the parasite's dihydrofolate reductase enzyme. The dual action produces a synergistic parasiticidal effect, rapidly reducing parasite load and preventing replication.

Side Effects

Common side effects are generally mild and reversible.

Common Side Effects

  • Nausea
  • Abdominal pain
  • Headache
  • Vomiting
  • Loss of appetite
  • Diarrhoea
  • Rash

Serious or Rare Side Effects

  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Hepatic dysfunction or elevated transaminases
  • Hemolytic anaemia in patients with G6PD deficiency
  • Severe neutropenia or agranulocytosis
  • Anaphylactic or severe hypersensitivity reactions

Precautions & Warnings

Malarone Paediatric should be used with attention to specific safety considerations.

  • Pregnancy: safety not established; use only if potential benefit outweighs risk.
  • Breastfeeding: consider possible exposure to infant; discuss with healthcare provider.
  • Renal impairment: dose adjustment may be required; monitor renal function.
  • Hepatic impairment: use with caution; monitor liver enzymes.
  • Drug interactions: review concomitant medications for potential interactions.
  • Store at ambient temperature: keep in original container, protect from moisture and heat.

Avoid Interactions

Malarone Paediatric may interact with several medicines; classification guides monitoring.

Major Interactions (Avoid)

  • Rifampicin: markedly reduces plasma concentrations of both components, compromising efficacy.
  • Protease inhibitors (e.g., ritonavir): may increase atovaquone levels, raising risk of toxicity.
  • Strong CYP2C19 inhibitors (e.g., fluconazole): can elevate proguanil concentrations.

Moderate Interactions (Monitor Closely)

  • Phenytoin: may lower atovaquone exposure, reducing effectiveness.
  • Barbiturates: can decrease drug levels, necessitating efficacy monitoring.
  • Macrolide antibiotics (e.g., erythromycin): may increase atovaquone concentrations, requiring observation for adverse effects.

Frequently Asked Questions

Malarone Paediatric is an oral combination of proguanil and atovaquone indicated for the prevention of malaria infection and for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum or chloroquine‑resistant Plasmodium species in children and adolescents.

Atovaquone blocks mitochondrial electron transport in the malaria parasite, halting energy production, while proguanil is converted to cycloguanil, which inhibits the parasite's dihydrofolate reductase enzyme. The two mechanisms act together to kill the parasite and prevent its replication.

The appropriate dose is determined by the prescribing clinician based on the child’s weight, age, and the indication (prophylaxis or treatment). Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data in pregnancy are limited, so the drug should only be used when the potential benefit justifies any possible risk. During breastfeeding, exposure to the infant is possible; a healthcare professional should evaluate the risk‑benefit balance before use.

To place an 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 required import documentation.

Compared with older agents such as chloroquine, Malarone Paediatric offers a broader spectrum against chloroquine‑resistant strains and a synergistic dual‑mechanism that reduces the likelihood of resistance. It is generally well tolerated, but like all antimalarials, it requires adherence to dosing schedules for optimal efficacy.

The product should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and excessive heat. Keep the container tightly closed and out of reach of children.

Malarone Paediatric is taken orally, usually with food or a milky drink to improve absorption. The tablets (or chewable formulation) should be swallowed whole unless the prescriber advises otherwise.

Serious adverse events, although rare, include severe skin reactions such as Stevens‑Johnson syndrome, hepatic dysfunction, hemolytic anaemia in patients with G6PD deficiency, and severe hypersensitivity reactions. Prompt medical attention is required if any of these occur.

Patients with known hypersensitivity to proguanil, atovaquone, or any component of the formulation should avoid the drug. Caution is advised in individuals with severe renal or hepatic impairment, and it is generally contraindicated in children with G6PD deficiency due to the risk of hemolysis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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