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| __NOTOC__
| | #REDIRECT [[Disopyramide#Use in Specific Populations]] |
| {{Disopyramide}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use in Specific Populations==
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| ===Pregnancy===
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| ===Teratogenic Effects===
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| ====Pregnancy Category C====
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| Norpace was associated with decreased numbers of implantation sites and decreased growth and survival of pups when administered to pregnant rats at 250 mg/kg/day (20 or more times the usual daily human dose of 12 mg/kg, assuming a patient weight of at least 50 kg), a level at which weight gain and food consumption of dams were also reduced. Increased resorption rates were reported in rabbits at 60 mg/kg/day (5 or more times the usual daily human dose). Effects on implantation, pup growth, and survival were not evaluated in rabbits. There are no adequate and well-controlled studies in pregnant women. Norpace or Norpace CR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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| ====Nonteratogenic Effects====
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| Norpace has been reported to stimulate contractions of the pregnant uterus. Disopyramide has been found in human fetal blood.
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| ===Labor and Delivery===
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| It is not known whether the use of Norpace or Norpace CR during labor or delivery has immediate or delayed adverse effects on the fetus, or whether it prolongs the duration of labor or increases the need for forceps delivery or other obstetric intervention.
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| ===Nursing Mothers===
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| Studies in rats have shown that the concentration of disopyramide and its metabolites is between one and three times greater in milk than it is in plasma. Following oral administration, disopyramide has been detected in human milk at a concentration not exceeding that in plasma. Because of the potential for serious adverse reactions in nursing infants from Norpace or Norpace CR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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| ===Pediatric Use===
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| Safety and effectiveness in pediatric patients have not been established (see Dosage and Administration).
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| ===Geriatric Use===
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| Clinical studies of Norpace/Norpace CR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other 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.
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| Because of its anticholinergic activity, disopyramide phosphate should not be used in patients with [[glaucoma]], [[urinary retention]], or [[benign prostatic hypertrophy]] (medical conditions commonly associated with the elderly) unless adequate overriding measures are taken (see Warnings: Anticholinergic Activity). In the event of increased anticholinergic side effects, plasma levels of disopyramide should be monitored and the dose of the drug adjusted accordingly. A reduction of the dose by one third, from the recommended 600 mg/day to 400 mg/day, would be reasonable, without changing the dosing interval.
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| This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see Precautions: Renal Impairment and Dosage and Administration).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e2aa1642-d262-4520-bc6a-9fd3ad795677 | publisher = | date = | accessdate = 3 March 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| [[Category:Pyridines]]
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| [[Category:Sodium channel blockers]]
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| [[Category:Amides]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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