Quinine Sulfate label

Quinine Sulfate

Quinine Sulfate Recall

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Manufacturer Warnings

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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)].

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History

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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 structural formula

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.

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Quinine Sulfate Manufacturers

  • American Health Packaging
    Quinine Sulfate | American Health Packaging
    No Recall

    Quinine Sulfate | American Health Packaging

    Quinine Sulfate | American Health Packaging
    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, USP 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, 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 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), Clinical Pharmacology (12.3)].

  • Mutual Pharmaceutical Company, Inc.
    Quinine Sulfate | Mutual Pharmaceutical Company, Inc.
    No Recall

    Quinine Sulfate | Mutual Pharmaceutical Company, Inc.

    Quinine Sulfate | Mutual Pharmaceutical Company, Inc.
    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, USP 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, 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 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), Clinical Pharmacology (12.3)].

  • Teva Pharmaceuticals Usa Inc
    Quinine Sulfate | Sterling-knight Pharmaceuticals,llc
    No Recall

    Quinine Sulfate | Sterling-knight Pharmaceuticals,llc

    Quinine Sulfate | Sterling-knight Pharmaceuticals,llc

    Take two capsules daily with or without food or as directed by a physician.

  • Mylan Pharmaceuticals Inc.
    Quinine Sulfate | Mylan Pharmaceuticals Inc.
    No Recall

    Quinine Sulfate | Mylan Pharmaceuticals Inc.

    Quinine Sulfate | Mylan Pharmaceuticals Inc.
    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)].

  • Riconpharma Llc
    Quinine Sulfate | Riconpharma Llc
    No Recall

    Quinine Sulfate | Riconpharma Llc

    Quinine Sulfate | Riconpharma Llc
    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 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 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), Clinical Pharmacology (12.3)].

    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 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 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), Clinical Pharmacology (12.3)].

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