ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC

Electrolyte / Mineral

Brand names: Atovaquone and Proguanil Hydrochloride Pediatric, Atovaquone and Proguanil Hydrochloride

Oral

Mechanism of Action

12.1 Mechanism of Action Atovaquone and proguanil hydrochloride tablets, fixed-dose combination of atovaquone and proguanil hydrochloride is an antimalarial agent [see Microbiology ( 12.4 )] .

Indications

1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria

including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute

uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria

including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute

uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine

halofantrine

Contraindications

• anaphylaxis
• erythema multiforme or Stevens-Johnson syndrome
• angioedema
• Clinical Pharmacology ( 12.3 )].

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Atovaquone absorption may be reduced in patients with diarrhea or vomiting

Known Side Effects

10 documented side effects by frequency

Fever

1-10%

Diarrhea

1-10%

Nausea

1-10%

Drug Not Working

1-10%

Vomiting

1-10%

Fatigue

1-10%

Rash

1-10%

Shortness of Breath

1-10%

Headache

0.1-1%

Condition Worsened

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral