Pinaverium

Pharmacologic Category

Calcium Channel Antagonist, Gastrointestinal

Dosing: Adult

IBS, biliary disorders: Oral: Initial: 50 mg 3 times/day; dose may be increased up to 100 mg 3 times/day (maximum dose: 300 mg/day)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to very low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to very low systemic absorption.

Use: Labeled Indications

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)

Administration: Oral

Do not crush or chew 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.

Dietary Considerations

Should be taken with a full glass of water with a meal/snack.

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F) in original blister packs.

Contraindications

Hypersensitivity to pinaverium or any component of the formulation

Warnings/Precautions

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 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, Lapp lactase deficiency, or glucose-galactose malabsorption.

Pregnancy Considerations

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.

Breast-Feeding Considerations

Manufacturer advises against administration in breast-feeding women.

Adverse Reactions

<1%, postmarketing, and/or case reports: Abdominal distension, abdominal pain, allergic skin reaction, anaphylactic shock, angioedema, constipation, diarrhea, drowsiness, dysphagia, epigastric pain, erythema, headache, heartburn, hypersensitivity reaction, nausea, pruritus, skin rash, urticaria, vertigo, vomiting, xerostomia

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Product Availability

Not available in the US

Dosage Forms: Canada

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 aluminum lake]

Generic: 50 mg, 100 mg

Anatomic Therapeutic Chemical (ATC) Classification

• A03AX04

Generic Available (US)

Yes

Mechanism of Action

Blocks influx of calcium via voltage-sensitive channels within smooth muscle cells of the gastrointestinal tract resulting in a spasmolytic effect in the gut.

Pharmacodynamics/Kinetics

Absorption: Poor

Protein binding: 97%

Metabolism: Hepatic via demethylation, hydroxylation

Bioavailability: <1%

Half-life elimination: ~1.5 hours

Time to peak: 1 hour

Excretion: Feces

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Pinaverium Bromide

References

Dicetel (pinaverium bromide) [product monograph]. Etobicoke, Ontario, Canada: BGP Pharma Inc; January 2016.

Jailwala J, Imperiale TF, and Kroenke K, “Pharmacologic Treatment of the Irritable Bowel Syndrome: A Systematic Review of Randomized, Controlled Trials,” Ann Intern Med, 2000, 133(2):136-47.[PubMed 10896640]

Brand Names: International

Dicetel (AE, AR, AT, BE, BG, BR, CH, CN, CO, CY, CZ, EC, EG, FR, GR, HN, HR, HU, IT, KW, LU, MY, NL, PE, PT, QA, SA, SK, TH, TR, TW, UA, UY, VE); Eldicet (CL, ES, IN, PH, PY); Pinar (PE, PY); Pinaver (EC); Pinavix (EC); Spascolon (EG); Spastec (TW); Tintel (KR); Verupinol (CR, DO, GT, HN, NI, PA, SV)

Last Updated 7/21/19