Drug Catalog - Product Detail
QUININE SULFATE CAP CP 324MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 53489-0700-07 | SUN PHARMACEUTICALS | 30 | 324MG | CAPSULE |
PACKAGE FILES
Generic Name
QUININE SULFATE
Substance Name
QUININE SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA021799
Description
11 DESCRIPTION Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C 20 H 24 N 2 O 2 ) 2 •H 2 SO 4 •2H 2 O and a molecular weight of 782.96. The structural formula of quinine sulfate is: Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc. Structure
How Supplied
16 HOW SUPPLIED / STORAGE AND HANDLING How Supplied Quinine sulfate capsules, USP, 324 mg are available as clear/clear capsules imprinted AR 102: Bottles of 30 NDC 53489-700-07 Bottles of 100 NDC 53489-700-01 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.
Indications & Usage
1 INDICATIONS AND USAGE Quinine sulfate capsules are 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 (14) ]. Limitations of Use: Quinine sulfate 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 (5.1) ]. Quinine sulfate is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. ( 1 ) Limitations of Use: Quinine sulfate is not approved for: • Treatment of severe or complicated P. falciparum malaria. • Prevention of malaria. • Treatment or prevention of nocturnal leg cramps
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Adults (≥ 16 years of age): 648 mg (two capsules) every 8 hours for 7 days. ( 2.1 ) • Patients with Severe Chronic Renal Impairment: One loading dose of 648 mg (two capsules) followed 12 hours later by 324 mg (one capsule) every 12 hours for 7 days. ( 2.2 ) 2.1 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 (14) ]. Quinine sulfate capsules should be taken with food to minimize gastric upset [ see Clinical Pharmacology (12.3) ]. 2.2 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 quinine sulfate capsules 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 (8.6) and Clinical Pharmacology (12.3) ]. 2.3 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 (8.7) and Clinical Pharmacology (12.3) ].