MALARONE TABLET [SIN09761P]

Product Info

MALARONE TABLET

[SIN09761P]

4.1. Therapeutic 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 malaria, 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.

4.2. Posology and Method of Administration

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.

Dosage in Children:
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 5.2. Pharmacokinetic Properties – 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 5.2. Pharmacokinetic Properties – 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 4.4. Special Warnings and Special Precautions for Use and 5.2. Pharmacokinetic Properties – 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 4.3. Contra-indications.

4.3. Contra-indications

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

Malarone is contra-indicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 ml/min).