In the pharmaceutical industry, Mebeverine 135 mg is a musculotropic antispasmodic primarily indicated for Irritable Bowel Syndrome (IBS) and other functional gastrointestinal disorders. As a pharmacist and manufacturer, I view this molecule as an “Intelligence Antispasmodic”—it targets the smooth muscles of the gut directly without interfering with normal intestinal motility or causing the typical dry-mouth side effects of anticholinergic drugs.
At your WHO-GMP facility in Mumbai, where you likely manufacture 135 mg film-coated tablets, this product is a staple for gastrointestinal portfolios due to its high tolerability and established efficacy in chronic care.
Primary Clinical Indications
Mebeverine 135 mg is used to alleviate the symptomatic “spasm-pain” complex:
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Irritable Bowel Syndrome (IBS): Relief of abdominal pain, cramps, bloating, and flatulence.
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Motility Disorders: Management of chronic irritable colon, spastic constipation, and mucous colitis.
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Functional Bowel Problems: Alleviating spasms secondary to organic diseases.
Mechanism: Direct Musculotropic Action
Mebeverine is a direct relaxant that acts on the smooth muscle of the gastrointestinal tract, particularly the colon.
Ion Channel Modulation: It blocks voltage-gated sodium channels and regulates calcium ($Ca^{2+}$) exchange, which prevents the over-contraction of the gut muscles.
Sympathetic Potentiation: It acts as a local anesthetic and blocks the reuptake of noradrenaline, aiding in the inhibitory control of gut spasms.
Selective Motility: Unlike many other antispasmodics, it relieves painful spasms without slowing down normal digestion (peristalsis) or causing systemic anticholinergic effects (like blurred vision or urinary retention).
Administration & Pharmacokinetics
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Optimal Timing: For maximum efficacy, the 135 mg tablet should be taken 20 minutes before meals, three times daily. This allows the drug to be absorbed and ready to prevent post-meal spasms.
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Absorption: It is rapidly and completely absorbed after oral administration, with peak plasma levels appearing in 1–3 hours.
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Metabolism: It is a prodrug that is completely metabolized by hydrolysis into veratric acid and mebeverine alcohol. It does not accumulate in the body.
The Pharmacist’s “Technical Warning”
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Lactose/Sucrose Content: Most 135 mg formulations (like Colofac) contain lactose and sucrose. As a manufacturer, you must ensure this is clearly labeled for patients with sugar intolerances.
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Hypersensitivity: While rare, some patients may experience mild skin reactions (rash/urticaria). Serious allergic reactions (anaphylaxis) are extremely uncommon but require immediate cessation.
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Age Restriction: Standard 135 mg tablets are generally not recommended for children under 18 due to insufficient safety data.
The Manufacturer’s Perspective: Technical & Export
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The “MR” Advantage: On your marketplace, highlight if you also offer the 200 mg Modified-Release (MR/SR) capsules. The twice-daily dosing of the MR version significantly improves patient compliance over the three-times-daily 135 mg schedule.
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Stability for Export: Mebeverine is sensitive to environmental conditions. Utilizing Alu-Alu blister packaging ensures a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for private B2B pharmacy networks.