Quinine Sulfate
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Uses
Quinine sulfate capsules, USP 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)].
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)].History
There is currently no drug history available for this drug.
Other Information
Quinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2•H2SO4•2H2O 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.
Sources
Quinine Sulfate Manufacturers
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American Health Packaging
![Quinine Sulfate Capsule [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Quinine Sulfate | American Health Packaging
2.1 Treatment of Uncomplicated P. falciparum MalariaFor 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, USP should be taken with food to minimize gastric upset [see Clinical Pharmacology (12.3)].
2.2 Renal ImpairmentIn 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, USP 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), Clinical Pharmacology (12.3)].
2.3 Hepatic ImpairmentAdjustment 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), Clinical Pharmacology (12.3)].
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Mutual Pharmaceutical Company, Inc.
Quinine Sulfate | Mutual Pharmaceutical Company, Inc.
2.1 Treatment of Uncomplicated P. falciparum MalariaFor 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, USP should be taken with food to minimize gastric upset [see Clinical Pharmacology (12.3)].
2.2 Renal ImpairmentIn 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, USP 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), Clinical Pharmacology (12.3)].
2.3 Hepatic ImpairmentAdjustment 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), Clinical Pharmacology (12.3)].
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Teva Pharmaceuticals Usa Inc
Quinine Sulfate | Sterling-knight Pharmaceuticals,llc
Take two capsules daily with or without food or as directed by a physician.
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Mylan Pharmaceuticals Inc.
Quinine Sulfate | Mylan Pharmaceuticals Inc.
2.1 Treatment of Uncomplicated P. falciparum MalariaFor 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 ImpairmentIn 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 ImpairmentAdjustment 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)].
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Riconpharma Llc
Quinine Sulfate | Riconpharma Llc
2.1 Treatment of Uncomplicated P. falciparum MalariaFor 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 ImpairmentIn patients with acute uncomplicated malaria and severe chronic renal impairment, the following 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.
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), Clinical Pharmacology (12.3)].
2.3 Hepatic ImpairmentAdjustment 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), Clinical Pharmacology (12.3)].
2.1 Treatment of Uncomplicated P. falciparum MalariaFor 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 ImpairmentIn patients with acute uncomplicated malaria and severe chronic renal impairment, the following 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.
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), Clinical Pharmacology (12.3)].
2.3 Hepatic ImpairmentAdjustment 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), Clinical Pharmacology (12.3)].
![Quinine Sulfate Capsule [Mutual Pharmaceutical Company, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b5bbefd-5b56-46f9-84f5-1456371577fd&name=quinine-02.jpg)
![Quinine Sulfate Capsule [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f2789149-42bc-4587-bc11-83f90c90d70d&name=Macuvex60ct.jpg)
![Quinine Sulfate Capsule [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c807aee-de5e-4523-8660-1611712efe7d&name=image-02.jpg)
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