Quinine is an antimalarial sold in the U.S. under 2 brand and generic names, for babesiosis, muscle cramp and falciparum malaria. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Quinine Sulfate (application ANDA202581). Other quinine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 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…
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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or www.lupinpharmaceuticals.com. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system. The most common adverse events associated with quinine use are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine. Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception. More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine. The following ADVERSE REACTIONS have been reported with quinine sulfate. Because these reactions have been reported voluntarily from a population of uncertain…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 64/100 | Prescription | Capsule | Generic | $23 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LU;Y51 | 324 mg | white | capsule | — |
| 93;3002;93;3002 | 324 mg | white | capsule | — |
| AMNEAL;811 | 324 mg | white | capsule | — |
| 201 | 324 mg | white | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency ( 4 ) Myasthenia gravis ( 4 ) Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 ) Optic neuritis ( 4 ) Quinine sulfate is 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 ( 5.3 )]. • Glucose-6-phosphate dehydrogenase (G6PD) deficiency. • Hemolysis can occur in patients with G6PD deficiency receiving quinine. • Known hypersensitivity reactions to quinine. • These include, but are not limited to, the following [see WARNINGS AND PRECAUTIONS ( 5.6 )] : • Thrombocytopenia • Idiopathic thrombocytopenia purpura (ITP) and Thrombotic thrombocytopenic purpura (TTP) • Hemolytic uremic syndrome (HUS) • Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) • Known hypersensitivity to mefloquine or quinidine: cross-sensitivity to quinine has been documented [see WARNINGS AND PRECAUTIONS ( 5.6 )]. • Myasthenia gravis. Quinine has neuromuscular blocking activity, and may exacerbate muscle weakness. • Optic neuritis. Quinine may exacerbate active optic neuritis…
Interacting Drug Interaction Drugs known to prolong QT interval (e.g., Class IA and Class III antiarrhythmic agents). Quinine sulfate prolongs QT interval, ECG abnormalities including QT prolongation and Torsades de Pointes. Avoid concomitant use ( 5.3 ). Other antimalarials (e.g., halofantrine, mefloquine). ECG abnormalities including QT prolongation Avoid concomitant use ( 5.3 , 7.2 ). CYP3A4 inducers or inhibitors Alteration in plasma quinine concentration. Monitor for lack of efficacy or increased adverse events of quinine ( 7.1 ). CYP3A4 and CYP2D6 substrates Quinine is an inhibitor of CYP3A4 and CYP2D6. Monitor for lack of efficacy or increased adverse events of the co-administered drug ( 7.2 ). Digoxin Increased digoxin plasma concentration ( 5.8 , 7.1 ). See full prescribing information for a complete list of reported and potential interactions. 7.1 Effects of Drugs and Other Substances on Quinine Pharmacokinetics Quinine is a P-gp substrate and is primarily metabolized by CYP3A4. Other enzymes, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 may contribute to the metabolism of quinine [see CLINICAL PHARMACOLOGY ( 12.3 )] . 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,…
| 56/100 |
| Prescription |
| Capsule |
| Generic |
| $23 |
| View → |