Drugplain

QUININE SULFATE 324 mg/1

QUININE SULFATE · CAPSULE · Ingenus Pharmaceuticals, LLC

1 Recall on Record
Plain English

QUININE SULFATE is a capsule containing quinine sulfate at 324 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.

Key Facts

Brand Name
QUININE SULFATE
Generic Name
QUININE SULFATE
NDC Code (Product)
50742-238
Manufacturer
Ingenus Pharmaceuticals, LLC
Strength
324 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA204372
Marketing Start
12/11/2017

Recall History

1 Recall on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug abuse725 reports
toxicity to various agents488 reports
dyspnoea483 reports
fall450 reports
nausea449 reports
pain427 reports
diarrhoea373 reports
vomiting367 reports
dizziness337 reports
muscle spasms305 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Quinine sulfate capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria ( 1 ). Quinine sulfate capsule USP 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 )] . Quinine sulfate capsules USP 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 )] .

Dosage & 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 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)…

Contraindications

4 CONTRAINDICATIONS 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 b…

Drug Interactions

7 DRUG INTERACTIONS 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 Antacid…

Adverse Reactions

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 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…

Frequently Asked Questions

What is QUININE SULFATE used for?

QUININE SULFATE contains QUININE SULFATE. It is a capsule taken oral. Consult your doctor for specific uses.

Is QUININE SULFATE a controlled substance?

QUININE SULFATE is not classified as a controlled substance by the DEA.

What is the generic name for QUININE SULFATE?

The generic name for QUININE SULFATE is QUININE SULFATE. There are 7 other brand versions of QUININE SULFATE.

What is the NDC code for QUININE SULFATE 324 mg/1?

The NDC (National Drug Code) for QUININE SULFATE 324 mg/1 is 50742-238, listed by Ingenus Pharmaceuticals, LLC.

Product NDC

50742-238

Package NDC

50742-238-30

Other QUININE SULFATE Dosages

Other Quinine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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