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Qualaquin (Quinine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Malaria

Qualaquin is 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 patients with severe or complicated P. falciparum malaria.

Qualaquin oral capsules are not approved for prevention of malaria.

Qualaquin oral capsules are not approved for the treatment or prevention of nocturnal leg cramps.

DOSAGE AND ADMINISTRATION

(SEE INDICATIONS AND USAGE)

For treatment of uncomplicated P. falciparum malaria in adults, the Qualaquin dosage is 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).

For patients with hepatic impairment

In otherwise healthy subjects with Child-Pugh B hepatic impairment, the AUC of quinine increased by 55% compared to subjects with normal liver function. In patients with mild to moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively), dosage reduction is not warranted but patients should be monitored closely for adverse reactions associated with quinine (See CLINICAL PHARMACOLOGY/Special Populations ). The effects of severe hepatic impairment (Child-Pugh C) on the safety and pharmacokinetics of quinine sulfate are not known.

For patients with renal impairment

In otherwise healthy subjects with severe chronic renal failure not receiving any form of dialysis (mean serum creatinine = 9.6 mg/dL), the median plasma quinine exposure (AUC) increased by 195% compared to subjects with normal renal function. In patients with acute uncomplicated malaria and severe chronic renal failure, the following modified dosage regimen is recommended: one loading dose of 648 mg Qualaquin followed 12 hours later by maintenance doses of 324 mg every 12 hours (See CLINICAL PHARMACOLOGY/Special Populations). The effects of mild and moderate renal impairment on the pharmacokinetics and safety of quinine sulfate are not known.

HOW SUPPLIED

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

Store at 25 – 30°C (77 – 86°F).

Dispense in a tight container as defined in the USP.

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