Canada-Approved Medicine

This monograph describes a medication approved for use in Canada by the Therapeutic Products Directorate, a division of Health Canada’s Health Products and Food Branch. The medication is not approved by the United States Food and Drug Administration; however, a similar formulation carrying a different generic or brand name might be available in the US.

• Management of symptoms of irritable bowel syndrome, (IBS) including abdominal pain, bowel disturbances and discomfort.
• Treatment of symptoms related to biliary tract disorders.

Contraindicated in:

• Known hypersensitivity
• Galactose intolerance/Lapp lactase deficiency/glucose-galactose malabsorption (tablets contain lactose)
• Lactation: Avoid use if breast feeding
• Pedi: Safety and effectiveness not established, use is not recommended.

Use Cautiously in:

• Pre-existing eosphageal lesions/hiatal hernia (glass of water and snack should be taken with each dose)
• OB: Should be used only if essential to welfare of patient.

All less than 1%

CNS: drowsiness, headache, vertigo.

GI: constipation, diarrhea, distention, dry mouth, epigastric pain/fullness, esophageal irritation, nausea.

Derm: rash.

Drug-Drug:

• Concurrent use of anticholinergics may ↑ spasmolytic effects.

• Tablets (contain lactose): 50 mg; 100 mg;

• PO (Adults): 50 mg 3 times daily; may be ↑ as needed/tolerated up to 100 mg 3 times daily.

• Acts as a calcium channel blocker with specific selectivity for intestinal smooth muscle.
• Relaxes gastrointestinal (mainly colon) and biliary tracts, inhibits colonic motor response to food/pharmacologic stimulation.

• Decreased symptoms of IBS.

Therapeutic Classification: anti irritable bowel syndrome agents

Pharmacologic Classification: calcium channel blockers

Absorption: Poorly absorbed (1–10%).

Distribution: Distributes selectively to digestive tract.

Protein Binding: 97%.

Metabolism/Excretion: Minimal enterohepatic cycling, eliminated almost entirely in feces. Some metabolism.

Half-life: 1.5 hr.

Dicetel

(blood levels)

• Instruct patient to take pinaverium as directed. Take missed doses as soon as remembered unless almost time for next dose; do not double doses.
• Caution patient to inform health care professional if the following side effects persist or worsen: stomach pain or fullness, nausea, constipation or diarrhea, heartburn, headache, dry mouth, dizziness, skin rash.
• Instruct patient to avoid alcohol intake while taking this medication.
• Advise female patient to inform health care professional if pregnancy is planned or suspected or if breast feeding.

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