Medicinal Products

ATOVAQUONE / PROGUANIL BIOGARAN 250 mg / 100 mg

Generic drug of Malarone
Therapeutic class: Infectiology - Parasitology
Active ingredients: Atovaquone, Proguanil
laboratory: Glaxosmithkline

Coated tablet
Box of 12
All forms

Indication

Treatment of simple (uncomplicated) malaria access to Plasmodium falciparum.

Prophylaxis of Plasmodium falciparum malaria especially in travelers to endemic areas where strains resistant to amino-4-quinoline (chloroquine, amodiaquine ...).

Dosage ATOVAQUONE / PROGUANIL BIOGARAN 250 mg / 100 mg Film-coated tablet Box of 12

Oral way.

The tablets should be administered with a meal or a milk drink to promote the absorption of atovaquone.

Curative treatment of malaria access to Plasmodium falciparum

Adults and children over 40 kg body weight (approximately 12 years of age):

4 tablets in a single dose per day for 3 consecutive days at 24 hour intervals.

Subjects from 11 to 40 kg body weight:

· 31 to 40 kg: 3 tablets taken once a day for 3 consecutive days at 24 hours intervals.

· 21 to 30 kg: 2 tablets taken once a day for 3 consecutive days at 24 hours intervals.

· 11 to 20 kg: 1 tablet daily for 3 consecutive days at 24 hours intervals.

In children under 11 kg body weight, the lowest dose dosage of ATOVAQUONE / PROGUANIL BIOGARAN should be used.

Prophylaxis of Plasmodium falciparum malaria

Treatment will be started the day before or the day of departure in an endemic area. It will be continued for the duration of the risk of malnutrition and 7 days after leaving the endemic area.

The duration of administration of ATOVAQUONE / PROGUANIL BIOGARAN in this indication should be limited to 3 months.

Adult and child over 40 kg body weight (approximately 12 years of age):

1 tablet per day at a fixed time.

In subjects weighing less than 40 kg, the lower dose dosage of ATOVAQUONE / PROGUANIL BIOGARAN should be used.

Elderly:

There is no need for special precautions or dose adjustments in elderly patients.

Hepatic insufficiency :

There is no need for dose adjustment in subjects with hepatic impairment. The absence of studies in subjects with severe hepatic impairment, however, does not allow to determine the efficacy and tolerance in these cases.

Renal failure :

There is no need for dose adjustment in subjects with mild to moderate renal impairment.

In severe renal impairment (creatinine clearance <30 ml / min), prophylactic treatment with atovaquone / proguanil is contraindicated. To treat malaria in this situation, alternative healing should be used as far as possible.

Against indications

History of hypersensitivity to atovaquone or proguanil hydrochloride or to any other component of the specialty.

Severe renal insufficiency (creatinine clearance <30 ml / min) for prophylactic use of malaria.

Adverse effects Atovaquone / Proguanil Biogaran

Adverse effects are listed below by organ system and frequency. Frequencies are defined as: very common (≥1 / 10), frequent (≥1 / 100 and <1/10), infrequent (≥1 / 1000 and <1/100), rare (≥1 / 10, 000 and <1/1000), very rare (<1 / 10, 000). Very common, frequent, and infrequent side effects were determined from clinical trials. Adverse effects of "unknown" frequency are effects whose frequency can not be estimated from the available data.

The adverse effects of each component of atovaquone / proguanil taken individually may be expected with atovaquone / proguanil. At doses used for the treatment and prophylaxis of malaria, the adverse effects of atovaquone / proguanil are generally of mild intensity and limited duration. There is no evidence of additional toxicity following co-administration of atovaquone and proguanil

Adverse events reported are summarized as follows:

Hematological and lymphatic system disorders:

Frequent: anemia, neutropenia reported with atovaquone.

Not known: pancytopenia including megaloblastic anemia in patients with severe renal impairment treated with proguanil.

Immune system disorders:

Uncommon: urticaria.

Unknown: Quincke's edema, anaphylactic shock.

Metabolism and nutrition disorders:

Frequent: Hyponatremia more specifically attributed to atovaquone, anorexia.

Uncommon: hyperamylasemia observed with atovaquone.

Nervous system disorders:

Very common: headache.

Frequent: dizzying sensations.

Gastrointestinal disorders:

Very common: abdominal pain, nausea, vomiting, diarrhea.

Uncommon: stomatitis.

Not known: Oral ulcers more specifically attributed to proguanil.

Hepatobiliary disorders:

Frequent: elevation of liver enzymes.

Not known: Hepatitis often associated with manifestations of hypersensitivity (fever, rash, eosinophilia) more specifically attributed to the presence of proguanil.

Skin and subcutaneous tissue disorders:

Common: rash, pruritus.

Uncommon: depigmentation or hair loss reported with proguanil.

Not known: cutaneous vasculitis.

General disorders and administration site defects:

Frequent: fever more specifically attributed to atovaquone.

Respiratory, thoracic and mediastinal disorders:

Frequent: coughing

Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. She permits
continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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