DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride solution
Carilion Materials Management
1 INDICATIONS AND USAGE
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
2 DOSAGE AND ADMINISTRATION
Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day.
After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
3 DOSAGE FORMS AND STRENGTHS
Dicyclomine hydrochloride oral solution 10 mg/5 mL
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
5 WARNINGS AND PRECAUTIONS
5.2 Cardiovascular Conditions
Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [ see Adverse Reactions (6.3)].
5.3 Peripheral and Central Nervous System
The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [ see Adverse Reactions (6)].
In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis has been reported in sensitive individuals given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.
Dicyclomine hydrochloride may produce drowsiness, dizziness 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 dicyclomine hydrochloride.
5.4 Myasthenia Gravis
With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [ see Contraindications (4)].
5.5 Intestinal Obstruction
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or olostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful [ see Contraindications (4)].
Rarely development of Ogilvie’s syndrome (colonic pseudo-obstruction) has been reported. Ogilvie’s syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.
5.6 Toxic Dilatation of Intestinemegacolon
Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.
5.7 Ulcerative Colitis
Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [ see Adverse Reactions (6.3)]. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [ see Contraindications (4)].
5.8 Prostatic Hypertrophy
Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [ see Adverse Reactions (6.3)].
5.9 Hepatic and Renal Disease
Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.
5.10 Geriatric Population
Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.
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)].
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