Version May 2024
Biliary disorders, irritable bowel syndrome: Oral: Initial: 50 mg 3 times/day; dose may be increased up to 100 mg 3 times/day (maximum dose: 300 mg/day).
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to very low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to very low systemic absorption.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
<1%:
Dermatologic: Allergic skin reaction
Gastrointestinal: Abdominal distention, constipation, diarrhea, epigastric fullness, epigastric pain, heartburn, nausea, xerostomia
Nervous system: Drowsiness, headache, vertigo
Postmarketing:
Dermatologic: Erythema of skin, pruritus, skin rash, urticaria
Gastrointestinal: Abdominal pain, dysphagia, vomiting
Hypersensitivity: Anaphylactic shock, angioedema, hypersensitivity reaction
Hypersensitivity to pinaverium or any component of the formulation
Concerns related to adverse effects:
• Esophageal irritation: May cause esophageal irritation; minimize risk by administering with a full glass of water with a meal/snack (do not crush/chew or suck tablets). Patients must be advised not to take medication when lying down or at bedtime. Use caution in patients with possible gastroesophageal reflux or hiatal hernia.
Disease-related concerns:
• GI motility: Avoid using to treat motility dysfunction associated with underlying disease states.
Special populations:
• Hereditary galactose intolerance: Contains lactose; avoid use in patients with hereditary problems of galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption.
Not available in the US
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Dicetel: 50 mg, 100 mg [contains fd&c yellow #6(sunset yellow)alumin lake]
Generic: 50 mg, 100 mg
Oral: Do not crush, chew, or suck tablet. Should be taken with a glass of water with meals or snacks. The tablet should not be swallowed when in the lying position or just before bedtime.
Note: Not approved in the US
Biliary disorders: Treatment of symptoms related to functional disorders of the biliary tract
Irritable bowel syndrome: Treatment and relief of symptoms associated with irritable bowel syndrome (IBS)
None known.
There are no known significant interactions.
Animal reproduction studies are insufficient and information from human pregnancies is not available. The presence of bromine in the formulation poses a theoretical risk of causing neurologic effects (sedation, hypotony) to newborns if pinaverium is used late in pregnancy, though no such cases have been reported.
Manufacturer advises against administration in breast-feeding women.
Should be taken with a full glass of water with a meal/snack.
Blocks influx of calcium via voltage-sensitive channels within smooth muscle cells of the gastrointestinal tract resulting in a spasmolytic effect in the gut.
Absorption: Poor.
Protein binding: 97%.
Metabolism: Hepatic via demethylation, hydroxylation.
Bioavailability: <1%.
Half-life elimination: ~1.5 hours.
Time to peak: Within 1 hour.
Excretion: Feces.
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