CONTRAINDICATIONS
- Infants less than 6 months of age ( 4)
- Glaucoma ( 4)
- Nursing mothers ( 4)
- Obstructive uropathy ( 4)
- Unstable cardiovascular status in the acute hemorrhage ( 4)
- Obstructive disease of gastrointestinal tract ( 4)
- Myasthenia gravis ( 4)
- Severe ulcerative colitis ( 4)
- Reflux esophagitis ( 4)
WARNINGS AND PRECAUTIONS
- Cardiovascular conditions: worsening of conditions ( 5.2)
- Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted ( 5.3)
- Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride tablets ( 5.3)
- Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride tablets should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4)
- Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride tablets would be inappropriate and possibly fatal ( 5.5)
- Salmonella dysenteric patients: due to risk of toxic megacolon ( 5.6)
- Ulcerative colitis: Dicyclomine hydrochloride tablets should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon ( 5.7)
- Prostatic hypertrophy: Dicyclomine hydrochloride tablets should be used with caution in these patients; may lead to urinary retention ( 5.8)
- Hepatic and renal disease: should be used with caution ( 5.9)
- Geriatric: use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events ( 5.10)
ADVERSE REACTIONS
The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma LLC, at 210-944-6920 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Safety and Prescribing Information: DailyMed
