Quinine
Generic Name: quinine
Brand Names:
Quinine Sulfate
11 DESCRIPTION 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 (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, USP occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste.
Overview
11 DESCRIPTION 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 (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, USP occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste.
Uses
1 INDICATIONS AND USAGE Quinine sulfate is 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 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 capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria.
Dosage
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) ] .
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions are a cluster of symptoms called “cinchonism”, which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system.
Interactions
7 DRUG INTERACTIONS Table 1 below presents clinically significant drug interactions with quinine sulfate. Table 1: Clinically Significant Drug Interactions with Quinine Sulfate Drug(s) Clinical Impact Recommendation Effects of Drugs and Other Substances on Quinine Pharmacokinetics Antacids Antacids containing aluminum and/or magnesium may delay or decrease absorption of quinine. Concomitant administration of these antacids with quinine sulfate should be avoided. Antiepileptics (AEDs) (carbamazepine, phenobarbital, and phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently with quinine sulfate.
Warnings
WARNING: HEMATOLOGIC REACTIONS Quinine sulfate use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. 5 WARNINGS AND PRECAUTIONS Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. (5.2) Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug if hemolytic anemia occurs. (5.3) QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use with drugs known to prolong QT interval. (5.4) Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported. (5.5) Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression. (5.6) Serious and Life-Threatening Hypersensitivity Reactions: Discontinue drug. (4 , 5.7) Atrial Fibrillation and Flutter: Paradoxical increase in ventricular rate may occur. 4 CONTRAINDICATIONS Quinine sulfate capsules are contraindicated in patients with the following: Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see Warnings and Precautions (5.4) ] . Known hypersensitivity reactions to quinine.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Quinine Sulfate Capsules USP, 324 mg are clear transparent size ‘0’ hard gelatin capsules filled with white to off-white powder and imprinting ‘AMNEAL’ on the cap and ‘811’ on the body.
Frequently Asked Questions
What is Quinine used for?▼
1 INDICATIONS AND USAGE Quinine sulfate is 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 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 capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria.
What are the side effects of Quinine?▼
6 ADVERSE REACTIONS Most common adverse reactions are a cluster of symptoms called “cinchonism”, which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system.
What are the important warnings for Quinine?▼
WARNING: HEMATOLOGIC REACTIONS Quinine sulfate use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. 5 WARNINGS AND PRECAUTIONS Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. (5.2) Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug if hemolytic anemia occurs. (5.3) QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use with drugs known to prolong QT interval. (5.4) Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported. (5.5) Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression. (5.6) Serious and Life-Threatening Hypersensitivity Reactions: Discontinue drug. (4 , 5.7) Atrial Fibrillation and Flutter: Paradoxical increase in ventricular rate may occur. 4 CONTRAINDICATIONS Quinine sulfate capsules are contraindicated in patients with the following: Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see Warnings and Precautions (5.4) ] . Known hypersensitivity reactions to quinine.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.