DICETEL 50/MG FC TAB 20/FC TAB

Indications

Approved Uses

Symptomatic treatment of irritable bowel syndrome and other functional gastrointestinal (intestinal) disorders with abdominal pain/spasm and bowel habit disturbance.

Dosage & Administration

Dosing by Condition

IBS/functional intestinal spasm: 50 mg orally three times daily with meals; if needed, may increase to 100 mg three times daily (maximum 300 mg/day).

Initial Dose

50mg three times daily with meals

Maintenance Dose

50-100mg three times daily with meals

Maximum Dose

300mg per day.

How to Take

Swallow the film‑coated tablet whole with a full glass of water during a meal; do not chew, crush, or suck; take while sitting/standing and avoid taking while lying down or just before bedtime.

Side Effects

Common Side Effects

Nausea, abdominal pain/discomfort, constipation, diarrhea, dyspepsia/heartburn, abdominal distension/bloating, and dry mouth; headache may occur.

Safety & Warnings

Contraindications

Known hypersensitivity to pinaverium bromide or any excipient

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required (seek medical advice if symptoms persist/return)

Monitoring Requirements

No routine monitoring required.

Pharmacology

Mechanism of Action

Gastrointestinal-selective calcium channel blocker that inhibits calcium influx in intestinal smooth muscle, reducing spasms and abdominal pain without typical systemic anticholinergic effects.

Onset of Action

Not well defined; some symptom relief may occur after initial doses, but meaningful IBS improvement often requires several days of regular dosing.

Duration of Effect

Not well established/variable; clinical benefit is assessed by symptom control over days to weeks rather than a defined per-dose duration.

Bioavailability

<1% systemic bioavailability (minimal absorption).

Metabolism

Systemically absorbed fraction undergoes hepatic metabolism; overall systemic exposure is very low due to minimal absorption.

Excretion

Primarily fecal.

Protein Binding

High protein binding (approximately 95-97%) for the absorbed fraction, though clinical relevance is limited by minimal systemic absorption.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 50mg pinaverium bromide

OTC Alternatives

No OTC alternative

Gi Condition

IBS

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