DICYCLOMINE HYDROCHLORIDE - search results

United States - English - NLM (National Library of Medicine)

dicyclomine hydrochloride capsule

remedyrepack inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations ( 8.4)] , nursing mothers [see use in specific populations ( 8.3)] , and in patients with: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see warnings and precautions ( 5.4)] - glaucoma [see adverse reactions ( 6.3) and drug interactions ( 7.1)] - obstructive uropathy [see warnings and precautions ( 5.8)] - obstructive disease of the gastrointestinal tract [see warnings and precautions ( 5.5)] - severe ulcerative colitis [see warnings and precautions ( 5.7)] - reflux esophagitis pregnancy category b adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. dicyclomine hydrochloride is contraindicated in women who are breastfeeding. dicyclomine hydrochloride is excreted in human milk. because of the potential for serious adverse reactions in breast-fed infants from dicyclomine hydrochloride, 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 [see use in specific populations ( 8.4)] . safety and effectiveness in pediatric patients have not been established. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see contraindications ( 4)] . there are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established. clinical studies of dicyclomine hydrochloride 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 in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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. effects of renal impairment on pk, safety and efficacy of dicyclomine hydrochloride have not been studied. dicyclomine hydrochloride 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. dicyclomine hydrochloride should be administered with caution in patients with renal impairment. effects of renal impairment on pk, safety and efficacy of dicyclomine hydrochloride have not been studied. dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

United States - English - NLM (National Library of Medicine)

dicyclomine hydrochloride capsule

nucare pharmaceuticals,inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations ( 8.4)] , nursing mothers [see use in specific populations ( 8.3)] , and in patients with: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see warnings and precautions ( 5.4)] - glaucoma [see adverse reactions ( 6.3) and drug interactions ( 7.1)] - obstructive uropathy [see warnings and precautions ( 5.8)] - obstructive disease of the gastrointestinal tract [see warnings and precautions ( 5.5)] - severe ulcerative colitis [see warnings and precautions ( 5.7)] - reflux esophagitis pregnancy c

United States - English - NLM (National Library of Medicine)

dicyclomine hydrochloride capsule

aphena pharma solutions - tennessee, llc - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations (8.4)] , nursing mothers [see use in specific populations (8.3)] , and in patients with: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see warnings and precautions (5.4)] - glaucoma [see adverse reactions (6.3) and drug interactions (7.1)] - obstructive uropathy [see warnings and precautions (5.8)] - obstructive disease of the gastrointestinal tract [see warnings and precautions (5.5)] - severe ulcerative colitis [see warnings and precautions (5.7)] - reflux esophagitis pregnancy category b adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to w

United States - English - NLM (National Library of Medicine)