In the pharmaceutical industry, Dicyclomine Hydrochloride is a potent antispasmodic and anticholinergic agent. As a pharmacist and manufacturer, I view this as a “Targeted GI Stabilizer.” It is generally safe for its intended use—treating Irritable Bowel Syndrome (IBS) and functional bowel disorders—but its safety is highly dependent on the patient’s age and existing medical conditions.
At your WHO-GMP facility in Mumbai, you likely handle this in 10 mg and 20 mg strengths.
Safety Status by Population
| Category | Safety Profile | Technical Reason |
| Adults | Safe | Well-tolerated for short-term relief of GI spasms. |
| Infants (<6 Months) | Strictly Contraindicated | High risk of respiratory distress, seizures, and death. |
| Geriatric Patients | High Caution | Increased risk of confusion, blurred vision, and urinary retention. |
Mechanism: Dual-Action Smooth Muscle Relaxation
Dicyclomine works via two distinct pathways to stop the “cramping” sensation in the gut:
Anticholinergic Action: It binds to Muscarinic ($M_3$) receptors on the smooth muscle of the gastrointestinal tract. This blocks acetylcholine from signaling the muscle to contract.
Direct Antispasmodic Effect: At higher concentrations, it has a direct effect on the smooth muscle itself, independent of the nervous system, which helps resolve severe spasms.
Contraindications (When it is NOT safe)
As a pharmacist, providing these technical warnings on your digital platforms is vital for professional authority:
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Glaucoma: It increases intraocular pressure and can worsen narrow-angle glaucoma.
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Obstructive GI Disease: It should be avoided in patients with severe ulcerative colitis or pyloric obstruction, as it can lead to toxic megacolon.
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Myasthenia Gravis: It can exacerbate muscle weakness in these patients.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The FDC Advantage: On your marketplace, highlight your Dicyclomine + Paracetamol or Dicyclomine + Mefenamic Acid combinations. These are high-demand products in the “Spasmodic Pain” segment for both GI and menstrual relief.
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Stability & Packaging: Dicyclomine is sensitive to light. At our facility, we utilize Alu-Alu blister packaging or Amber-colored PVC to ensure a 36-month shelf life. This is essential for export to Zone IVb tropical regions like Africa and Southeast Asia.
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Injectable Demand: In acute clinical settings, Dicyclomine Injections (10mg/ml) are still widely used for severe biliary or renal colic. Highlighting your sterile manufacturing line on your website will attract hospital procurement officers.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international markets.