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QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies].
QUALAQUIN oral capsules are not approved for:
- Treatment of severe or complicated P. falciparum malaria.
- Prevention of malaria.
- Treatment or prevention of nocturnal leg cramps [see WARNINGS AND PRECAUTIONS].
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].
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.
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'
Storage And Handling
QUALAQUIN capsules USP, 324 mg are available as clear/clear capsules imprinted AR 102:
Bottles of 30 NDC 49708-153-07
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature]
Dispense in a tight container as defined in the USP.
Manufactured by: Mutual Pharmaceutical Company, Inc. Philadelphia, PA 19124. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202. Rev, July 2014
Last reviewed on RxList: 7/18/2014
This monograph has been modified to include the generic and brand name in many instances.
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