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DUSPATALIN RETARD 200/MG 30/CAP
- Sku : I-001850
Key features
DUSPATALIN 200MG 30 CAP is a modified-release capsule formulation containing mebeverine hydrochloride 200 mg. It is a musculotropic antispasmodic that directly relaxes gastrointestinal smooth muscle to relieve spasm while largely preserving normal gut motility, with proposed effects on ion channels such as sodium and calcium channels. It is indicated for the symptomatic treatment of irritable bowel syndrome, including abdominal pain/cramps, bowel habit disturbance and intestinal spasm, and may be used for gastrointestinal spasm secondary to organic disease where clinically appropriate. Supplied as modified-release capsules in a pack of 30.- Brand: DUSPATALIN
- Active Ingredient: MEBEVERINE HYDROCHLORIDE 200mg
- Strength: 200mg
- Dosage Form: Modified-release capsule
- Pack Size: 30 Capsules
- Route: Oral use
- Prescription Status: Prescription
- Therapeutic Class: Gastrointestinal
- Pharmacological Group: Antispasmodics
- Drug Class: Antispasmodic (ATC A03AA04); musculotropic smooth-muscle relaxant.
- Manufacturer: AJA PHARMACEUTICAL INDUSTRIES
- Country of Origin: Saudi Arabia
- SFDA Registration No.: 0604233492
- Shelf Life: 36 months
- Storage: store below 30°c
- Gi Condition: IBS
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Indications
Approved Uses
Symptomatic treatment of irritable bowel syndrome (IBS) and associated symptoms such as abdominal pain/cramps, bowel habit disturbance and intestinal spasm; may also be used for gastrointestinal spasm secondary to organic disease where clinically appropriate.
Dosage & Administration
Dosing by Condition
IBS / gastrointestinal spasm (adults): 200 mg modified-release capsule twice daily (morning and evening), preferably ~20 minutes before meals.
Initial Dose
One 200mg prolonged-release capsule twice daily.
Maintenance Dose
One 200mg prolonged-release capsule twice daily.
Maximum Dose
400mg per day
How to Take
Swallow the modified-release capsule whole with water; do not crush, chew, or open. Take preferably about 20 minutes before meals (typically morning and evening).
Side Effects
Common Side Effects
Generally uncommon; most reported are hypersensitivity reactions (rash, urticaria, angioedema) and occasionally dizziness or headache; gastrointestinal effects such as nausea/constipation may occur but are not prominent.
Side Effect Frequency
Most reported adverse effects are hypersensitivity reactions (e.g., rash, urticaria, angioedema/face oedema) and are uncommon/rare; gastrointestinal or CNS effects (e.g., nausea, constipation, headache, dizziness) may occur but are not consistently listed as common with defined frequencies across labels.
Safety & Warnings
Contraindications
Hypersensitivity to mebeverine hydrochloride or to any excipients.
Driving Warning
Safe
Drug Interactions
Drug Interactions
No clinically significant drug interactions are known/expected; avoid duplicative use with other antispasmodics/IBS symptom-relief medicines unless advised by a clinician.
Interaction Severity
No clinically significant drug interactions are known/expected.
Special Populations
Elderly
Standard adult dosing.
Storage & Patient Advice
Patient Counseling
Take 1 modified‑release capsule (200 mg) twice daily, about 20 minutes before meals (typically before breakfast and before the evening meal). Swallow whole with water; do not crush or chew. If a dose is missed, skip it and take the next dose at the usual time (do not double). Seek urgent care for signs of hypersensitivity (rash, urticaria, facial/throat swelling, breathing difficulty). Store below 30°C.
Pharmacology
Mechanism of Action
Musculotropic antispasmodic that directly relaxes gastrointestinal smooth muscle, relieving spasm without significantly affecting normal motility; proposed mechanisms include effects on ion channels (e.g., sodium/calcium) but the exact mechanism is not fully established.
Onset of Action
About 1 hour (roughly 30-60 minutes) for symptom relief, recognizing individual variability.
Duration of Effect
Approximately 12 hours per dose for the 200 mg modified-/prolonged-release capsule (supports twice-daily dosing).
Half-Life
For the modified‑release capsule, the effective elimination half‑life reported for the main circulating metabolite (DMAC) is approximately 5-6 hours; the parent compound is rapidly metabolized and does not have a clinically meaningful half‑life.
Bioavailability
Oral bioavailability of the parent drug is low/limited because mebeverine undergoes extensive first‑pass metabolism; systemic exposure is mainly to metabolites (some sources describe high relative bioavailability of the MR formulation vs immediate‑release, but not high absolute parent bioavailability).
Protein Binding
Protein binding is not well-established/commonly specified in major labeling for mebeverine MR (treat as unknown/undocumented for clinical decision-making).
Product Information
Available Dosage Forms
For Duspatalin/mebeverine products: immediate-release tablets (commonly 135 mg) and modified-/prolonged-release capsules (200 mg).
Composition per Dose
Each prolonged-release capsule: 200mg mebeverine hydrochloride
Generic Availability
Yes
Gi Condition
IBS
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