Dicyclomine Hydrochloride
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Check Drug InteractionsDicyclomine Hydrochloride Prescribing Information
Dicyclomine hydrochloride injection, USP is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dosage must be adjusted to individual patient needs.
- Dicyclomine hydrochloride injection USP, 20 mg/2 mL (10 mg/mL) is supplied as vial and ampule.
- Pregnancy: use only if clearly needed (8.1)
- Pediatric Use: safety and effectiveness not established (8.4)
- Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function (8.6)
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
- For Intramuscular injection only; should not be administered by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions (5.1)
- 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 (5.3)
- Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride 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 would be inappropriate and possibly fatal (5.5)
- Salmonella dysenteric patients: due to risk of toxic megacolon (5.6)
- Ulcerative colitis: Dicyclomine hydrochloride 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 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)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available