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

cardinal health - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - 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: adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day 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 sho

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

state of florida doh central pharmacy - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - for the treatment of functional bowel/irritable bowel syndrome. - obstructive uropathy - obstructive disease of the gastrointestinal tract - severe ulcerative colitis (see precautions.) - reflux esophagitis - unstable cardiovascular status in acute hemorrhage - glaucoma - myasthenia gravis - evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations - infants less than 6 months of age (see warnings and precautions: information for patients.) - nursing mothers (see warnings and precautions: information for patients.) abuse of and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.

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

lannett company, inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 20 mg - 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)

mylan institutional inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - 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)]

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

contract pharmacy services-pa - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - 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)]

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

actavis pharma, inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - 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 teratogenic effects: 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 breastmilk. because of the potential for serious adverse reactions in breastfed 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 syrup 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 has not been studied. dicyclomine hydrochloride 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. 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)

mylan pharmaceuticals inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - 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: adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day 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 shoul

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

aidarex pharmaceuticals llc - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 20 mg - 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)

state of florida doh central pharmacy - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - for the treatment of functional bowel/irritable bowel syndrome. - obstructive uropathy obstructive uropathy - obstructive disease of the gastrointestinal tract obstructive disease of the gastrointestinal tract - severe ulcerative colitis (see precautions) severe ulcerative colitis (see precautions) - reflux esophagitis reflux esophagitis - unstable cardiovascular status in acute hemorrhage unstable cardiovascular status in acute hemorrhage - glaucoma glaucoma - myasthenia gravis myasthenia gravis - evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations - infants less than 6 months of age (see warnings and precautions: information for patients.) infants less than 6 months of age (see warnings and precautions: information for patients.) - nursing mothers (see warnings and precautions: information for patients). nursing mothers (see war

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

lake erie medical dba quality care products llc - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 20 mg - for the treatment of functional bowel/irritable bowel syndrome. - obstructive uropathy obstructive uropathy - obstructive disease of the gastrointestinal tract obstructive disease of the gastrointestinal tract - severe ulcerative colitis (see precautions) severe ulcerative colitis (see precautions) - reflux esophagitis reflux esophagitis - unstable cardiovascular status in acute hemorrhage unstable cardiovascular status in acute hemorrhage - glaucoma glaucoma - myasthenia gravis myasthenia gravis - evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations - infants less than 6 months of age (see warnings and precautions: information for patients.) infants less than 6 months of age (see warnings and precautions: information for patients.) - nursing mothers (see warnings and precautions: information for patients). nursing mothers (see war