Malarone Pediatric Generic Name & Formulations
Legal Class
Rx
General Description
Atovaquone 62.5mg, proguanil HCl 25mg; tabs.
Pharmacological Class
Naphthoquinone + dihydrofolate reductase inhibitor.
See Also
How Supplied
Tabs—24, 100; Ped tabs—100
Manufacturer
Malarone Pediatric Indications
Indications
Prophylaxis of P. falciparum malaria (including chloroquine-resistant strains). Treatment of acute uncomplicated P. falciparum malaria.
Malarone Pediatric Dosage and Administration
Adults and Children
Take at the same time each day with food or a milky drink. Children: may crush and mix with condensed milk if unable to swallow tabs. Repeat dose if vomiting occurs within 1 hour. Prophylaxis (once daily starting 1–2 days before entering endemic area, during stay, and for 7 days after return): <11kg: not recommended (see Treatment); 11–20kg: 62.5mg atovaquone/25mg proguanil; 21–30kg: 125mg/50mg; 31–40kg: 187.5mg/75mg. >40kg: 250mg/100mg. Treatment (give as single daily dose for 3 consecutive days): <5kg: not recommended; 5–8kg: 125mg/50mg; 9–10kg: 187.5mg/75mg; 11–20kg: 250mg/100mg; 21–30kg: 500mg/200mg; 31–40kg: 750mg/300mg. >40kg: 1g/400mg.
Malarone Pediatric Contraindications
Contraindications
Prophylaxis in severe renal impairment (CrCl <30mL/min).
Malarone Pediatric Boxed Warnings
Not Applicable
Malarone Pediatric Warnings/Precautions
Warnings/Precautions
Use other therapy in severe malaria, recrudescence, or prophylaxis failure. Monitor parasitemia closely and consider other therapy in severe or persistent diarrhea or vomiting (may use antiemetics). Hepatic or renal impairment (CrCl <30mL/min): consider alternate therapy for treatment. Elderly. Pregnancy (Cat.C; may continue folate supplements). Nursing mothers.
Malarone Pediatric Pharmacokinetics
See Literature
Malarone Pediatric Interactions
Interactions
Concomitant rifampin, rifabutin: not recommended. Atovaquone antagonized by tetracycline, metoclopramide. Proguanil may potentiate warfarin or other coumarin-based anticoagulants (monitor). Caution with indinavir, CYP2C19 substrates or inhibitors.
Malarone Pediatric Adverse Reactions
Adverse Reactions
GI upset/pain, headache, asthenia, anorexia, dizziness, elevated liver function tests; rare: anaphylaxis, vasculitis, hepatitis, cholestasis. Children: vomiting, pruritus.
Malarone Pediatric Clinical Trials
See Literature
Malarone Pediatric Note
Not Applicable
Malarone Pediatric Patient Counseling
See Literature