Dicyclomine Hydrochloride

What it is and how it works

Mechanism of Action 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 acetylcholine-receptor 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.

Indications

Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules, USP are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome

Dosage and administration (summary)

Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride capsules must be adjusted to individual patient needs . If a dose is missed, patients should continue the normal dosing schedule . Oral in adults : Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day.

Contraindications

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age , nursing mothers and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis glaucoma obstructive uropathy obstructive disease of the gastrointestinal tract severe ulcerative colitis reflux esophagitis Infants less than 6 months of age Nursing mothers Unstable cardiovascular status in acute hemorrhage Myasthenia gravis Glaucoma Obstructive uropathy Obstructive disease of the gastroin…

Warnings and precautions

Cardiovascular conditions : worsening of conditions 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 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 Myasthenia Gravis : overdose may lead to muscular weakness and paralysis.

Pregnancy

Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day.

Storage and supply

Dicyclomine hydrochloride capsules, USP 10 mg are supplied as Blue/Blue Capsule Printed “West-ward 3126” in White Ink and are available in: Bottles of 100 capsules NDC 51407-783-01 Bottles of 1000 capsules NDC 51407-783-10 Store at 20° to 25°C (68° to 77°F). . Protect from light and moisture. To prevent fading, avoid exposure to direct sunlight.

Source: Dicyclomine Hydrochloride (Dicyclomine Hydrochloride) — US FDA prescribing information, 2023-07-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.