Quinidine precautions

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

List of precautions

Heart block

Carcinogenesis, mutagenesis, impairment of fertility

Pregnancy

Labor and delivery

Nursing mothers

Pediatric use

Geriatric use

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Heart block

In patients without implanted pacemakers who are at high risk of complete atrioventricular block (eg, those with digitalis intoxication, second–degree atrioventricular block, or severe intraventricular conduction defects), Quinidine should be used only with caution. Return to top

Carcinogenesis, mutagenesis, impairment of fertility

Animal studies to evaluate Quinidine's carcinogenic or mutagenic potential have not been performed. Similarly, there are no animal data as to Quinidine's potential to impair fertility. Return to top

Pregnancy

Pregnancy Category C — Animal reproductive studies have not been conducted with Quinidine. There are no adequate and well–controlled studies in pregnant women. Quinidine should be given to a pregnant woman only if clearly needed.
In one neonate whose mother had received Quinidine throughout her pregnancy, the serum level of Quinidine was equal to that of the mother, with no apparent ill effect. The level of Quinidine in amniotic fluid was about three times higher than that found in serum. Return to top

Labor and delivery

Quinine is said to be oxytocic in humans, but there are no adequate data as to Quinidine's effect (if any) on human labor and delivery. Return to top

Nursing mothers

Quinidine is present in human milk at levels slightly lower than those in maternal serum; a human infant ingesting such milk should (scaling directly by weight) be expected to develop serum Quinidine levels at least an order of magnitude lower than those of the mother. On the other hand, the pharmacokinetics and pharmacodynamics of Quinidine in human infants have not been adequately studied, and neonates' reduced protein binding of Quinidine may increase their risk of toxicity at low total serum levels. Administration of Quinidine should (if possible) be avoided in lactating women who continue to nurse. Return to top

Pediatric use

In antimalarial trials, Quinidine was as safe and effective in pediatric patients as in adults. Notwithstanding the known pharmacokinetic differences between pediatric patients and adults, pediatric patients in these trials received the same doses (on a mg/kg basis) as adults.
Safety and effectiveness of antiarrhythmic use in pediatric patients have not been established. Return to top

Geriatric use

Safety and efficacy of Quinidine in elderly patients has not been systematically studied. Clinical studies of Quinidine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. The reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.