For treatment of uncomplicated P. falciparum malaria in adults, the dosage is 648 mg (two capsules) every 8 hours for 7 days (See CLINICAL STUDIES).

Quinine sulfate 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 quinine sulfate 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 controlled room temperature, 25 - 30 ^oC (77 - 86 ^oF).
Dispense in a tight container as defined in the USP.