DOSAGE AND ADMINISTRATION
Treatment of Uncomplicated P. falciparum Malaria
For treatment of uncomplicated P. falciparum malaria in adults: Orally, 648 mg (two capsules) every 8 hours for 7 days [see Clinical Studies
].
QUALAQUIN should be taken with food to minimize gastric upset [see Clinical Pharmacology
].
Renal Impairment
In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg QUALAQUIN followed 12 hours later by maintenance doses of 324 mg every 12 hours.
The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known [see Use in Specific Populations, Clinical Pharmacology
].
Hepatic Impairment
Adjustment of the recommended dose is not required in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but patients should be monitored closely for adverse effects of quinine. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment [see Use in Specific Populations, Clinical Pharmacology
].
DOSAGE FORMS AND STRENGTHS
324 mg capsules - hard gelatin, clear cap/clear body, imprinted with 'AR 102'
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