Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12) ] .
They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system.
These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2, 5.3) ].
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 Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients.
Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.
5 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 (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;
Like all medications, Dicyclomine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: