Qualaquin
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Qualaquin
INDICATIONS
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].
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 pharmacokine tics of quinine sulfate are not known [see Use in Specific Populations, CLINICAL PHARMACOLOGY].
HOW SUPPLIED
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 13310-153-07
Bottles of 100 NDC 13310-153-01
Bottles of 500 NDC 13310-153-05
Bottles of 1000 NDC 13310-153-10
Storage
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 for: AR Scientific, Inc. Philadelphia, PA 19124 USA by: Mutual Pharmaceutical Company, INC. Philadelphia, PA 19124 USA. Revised: 2/2013
Last reviewed on RxList: 3/8/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Qualaquin Information
Qualaquin - User Reviews
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