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U.S. Department of Health and Human Services

Safety

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Qualaquin (quinine sulfate) capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

 

April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

QT Prolongation and Ventricular Arrhythmias
  • Qualaquin has been shown to cause concentration-dependent prolongation of the PR and QRS interval…
 

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • In patients with severe hepatic impairment (Child-Pugh C), quinine oral clearance (CL/F) is decreased, volume of distribution (Vd/F) is increased, and half-life is prolonged, relative to subjects with normal liver function…

 

February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

QT Prolongation and Ventricular Arrhythmias
  • Qualaquin has been shown to cause concentration-dependent prolongation of the PR and QRS interval. At particular risk are patients with underlying structural heart disease and preexisting conduction system abnormalities, elderly patients with sick sinus syndrome, patients with atrial fibrillation with slow ventricular response, patients with myocardial ischemia or patients receiving drugs known to prolong the PR interval (e.g. verapamil) or QRS interval (e.g. flecainide or quinidine).
 

USE IN SPECIFIC POPULATIONS

Pregnancy
  • In animal developmental studies conducted in multiple animal species, pregnant animals received quinine by the subcutaneous or intramuscular route at dose levels similar to the maximum recommended human dose (MRHD; 32 mg/kg/day) based on body surface area (BSA) comparisons. There were increases in fetal…
  • In a pre- postnatal study in rats, an estimated oral dose of quinine sulfate of 20 mg/kg/day corresponding to approximately 0.1 times the MRHD based on BSA comparison resulted in offspring with impaired growth, lower body weights at birth and during the lactation period, and delayed physical development of teeth eruption and eye opening during the lactation period.

 

December 2009

Summary View

 

DRUGS INTERACTIONS

Effects of Drugs and Other Substances on Quinine Pharmacokinetics
  • Theophylline or aminophylline: In 20 healthy subjects who received multiple doses of Qualaquin (648 mg every 8 hours x 7 days) with a single 300 mg oral dose of theophylline, the quinine mean Cmax and AUC were increased by 13% and 14 % respectively.  Although no change in Qualaquin dosage regimen is necessary with concomitant theophylline or aminophylline, patients should be monitored closely for adverse reactions associated with quinine.
Effects of Quinine on the Pharmacokinetics of Other Drugs
  • Midazolam (CYP3A4 substrate): In 23 healthy subjects who recieved multiple doses of Qualaquin (324 mg three times daily x 7 days) with a single oral 2-mg dose of midazolam, the mean...
  • Theophylline or aminophylline (CYP1A2 substrate): In 19 healthy subjects who received multiple doses of Qualaquin (648 mg every 8 hours x 7 days) with a single 300 mg oral dose of theophylline, the mean theophylline AUC was 10% lower than when theophylline was given alone.  There was no significant effect on mean...