|Drug Name:||Dicyclomine Hydrochloride|
|Manufacturer:||Mylan Pharmaceuticals Inc.|
|Other Info:||Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED OCTOBER 1999CDICY:R2|
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.)
In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating).
If symptoms occur, the drug should be discontinued and supportive measures instituted.Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.
In this instance, treatment with this drug would be inappropriate and possibly harmful.Dicyclomine hydrochloride may produce drowsiness or blurred vision.
The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.Psychosis has been reported in sensitive individuals given anticholinergic drugs.
CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.There are reports that administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma.
Death has been reported.
No causal relationship between these effects observed in infants and dicyclomine administration has been established.
DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS.(See CONTRAINDICATIONS and PRECAUTIONS: Nursing Mothers and Pediatric Use.)Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.