Dicyclomine hydrochloride

Warning

Contraindicated in infants less than 6 months of age, nursing mothers, and patients with certain conditions such as unstable cardiovascular status, myasthenia gravis, and glaucoma

Contraindications

• Infants less than 6 months of age
• Nursing mothers
• Unstable cardiovascular status in acute hemorrhage
• Myasthenia gravis
• Glaucoma
• Obstructive uropathy
• Obstructive disease of the gastrointestinal tract
• Severe ulcerative colitis
• Reflux esophagitis

Adverse Reactions

• Dizziness
• Dry mouth
• Vision blurred
• Nausea
• Somnolence
• Asthenia
• Nervousness

General Guidance

Dose reduction from 160 mg daily to an average daily dose of 90 mg may be required in patients with side effects

Pregnancy

• Adequate and well-controlled studies have not been conducted
• Epidemiologic studies did not show an increased risk of structural malformations
• Use during pregnancy only if clearly needed

Nursing Mothers

• Contraindicated
• Dicyclomine hydrochloride is excreted in breastmilk
• Decision should be made whether to discontinue nursing or to discontinue the drug

Pediatric Use

• Safety and effectiveness not established
• Contraindicated in infants less than 6 months of age
• Published cases reporting serious respiratory symptoms and other adverse reactions in infants

Geriatric Use

• Clinical studies did not include sufficient numbers of subjects aged 65 and over
• Dose selection should be cautious, usually starting at the low end of the dosing range
• Monitor renal function