Dicyclomine Hydrochloride
Dicyclomine Hydrochloride Prescribing Information
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dosage must be adjusted to individual patient needs.
Dicyclomine hydrochloride oral solution 10 mg/5 mL
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age
Safety and effectiveness in pediatric patients have not been established.
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age
Safety and effectiveness in pediatric patients have not been established.
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age
- unstable cardiovascular status in acute hemorrhage
- myasthenia gravis[]
5.4 Myasthenia GravisWith 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)]. - glaucoma [and
6.3 Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic ActionGastrointestinal: anorexia,
Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia
Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
Ophthalmologic: diplopia, increased ocular tension
Dermatologic/Allergic: urticaria, itching, and other dermal manifestations
Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy
Cardiovascular: hypertension
Respiratory: apnea
Other: decreased sweating, sneezing, throat congestion, impotence
]7.1 Antiglaucoma AgentsAnticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended
[ see Contraindications (4)]. - obstructive uropathy []
5.8 Prostatic HypertrophyDicyclomine 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)]. - obstructive disease of the gastrointestinal tract []
5.5 Intestinal ObstructionDiarrhea 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
[ 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.
- severe ulcerative colitis []
5.7 Ulcerative ColitisCaution 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)]. - reflux esophagitis
The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism:
- a specific anticholinergic effect (antimuscarinic) at the acetylcholinereceptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and
- a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.
Atropine did not affect responses to these two agonists.
Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.
The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms
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 [
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form:
- Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). Dicyclomine hydrochloride oral solution also contains inactive ingredients glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucrose with D&C Red #33, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 as coloring and natural and artificial tropical fruit punch flavoring.
Dicyclomine hydrochloride is [bicyclohexyl]-1‑carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H 35NO2•HCl and the following structural formula:
Molecular weight: 345.95
Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.