Quinine

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Quinine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
* Quinine sulphate 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. The risk associated with Quinine sulphate use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit

Overview

Quinine is a cinchona alkaloid, antimalarial and anti-Infective Agent, that is FDA approved for the treatment of of uncomplicated Plasmodium falciparum malaria. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Quinine sulphate oral capsules are not approved for:

Dosing Information

  • Quinine sulphate should be taken with food to minimize gastric upset.
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 sulphate followed 12 hours later by maintenance doses of 324 mg every 12 hours.
Hepatic Impairment

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding off-label use and dosage for adults.

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Quinine sulphate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Quinine sulphate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quinine sulphate in pediatric patients.

Contraindications

Quinine sulphate is contraindicated in patients with the following:

Prolonged QT interval:
Glucose-6-phosphate dehydrogenase deficiency(G6PD):
Known hypersensitivity reactions to quinine:
  • These include, but are not limited to, the following:

Hemolytic uremic syndrome (HUS)

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
* Quinine sulphate 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. The risk associated with Quinine sulphate use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit

Use of Quinine for Treatment or Prevention of Nocturnal Leg Cramps:

Thrombocytopenia
  • Quinine-induced thrombocytopenia is an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported, including cases of HUS/TTP. Chronic renal impairment associated with the development of TTP has also been reported. Thrombocytopenia usually resolves within a week upon discontinuation of quinine. If quinine is not stopped, a patient is at risk for fatal hemorrhage. Upon re-exposure to quinine from any source, a patient with quinine-dependent antibodies could develop thrombocytopenia that is more rapid in onset and more severe than the original episode.
QT Prolongation and Ventricular Arrhythmias:
Concomitant Use of Rifampin:
  • Treatment failures may result from the concurrent use of rifampin with Quinine sulphate, due to decreased plasma concentrations of quinine, and concomitant use of these medications should be avoided.
Concomitant Use of Neuromuscular Blocking Agents:
Hypersensitivity
  • Quinine sulphate should be discontinued in case of any signs or symptoms of hypersensitivity.
Atrial Fibrillation and Flutter:
  • Quinine sulphate should be used with caution in patients with atrial fibrillation or atrial flutter. A paradoxical increase in ventricular response rate may occur with quinine, similar to that observed with quinidine. If digoxin is used to prevent a rapid ventricular response, serum digoxin levels should be closely monitored, because digoxin levels may be increased with use of quinine.
Hypoglycemia

Adverse Reactions

Clinical Trials Experience

Overall

  • The following ADVERSE REACTIONS have been reported with quinine sulfate. Most of these reactions are thought to be uncommon, but the actual incidence is unknown:
General:
Hematologic:
Neuropsychiatric:
Dermatologic:
Respiratory:
Cardiovascular:
Gastrointestinal:
Hepatobiliary:
Metabolic:
Musculoskeletal:
Renal:
Special Senses:

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Quinine sulphate in the drug label.

Drug Interactions

There is limited information regarding Quinine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Quinine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Quinine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Quinine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Quinine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Quinine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Quinine in geriatric settings.

Gender

There is no FDA guidance on the use of Quinine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Quinine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Quinine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Quinine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Quinine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Quinine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Quinine Administration in the drug label.

Monitoring

There is limited information regarding Quinine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Quinine and IV administrations.

Overdosage

There is limited information regarding Quinine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Quinine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Quinine Mechanism of Action in the drug label.

Structure

There is limited information regarding Quinine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Quinine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Quinine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Quinine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Quinine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Quinine How Supplied in the drug label.

Storage

There is limited information regarding Quinine Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

There is limited information regarding Quinine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Quinine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Quinine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Quinine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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