Dicyclomine HCl Tablets Manufacturer

Description

Dicyclomine Tablets (10mg / 20mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Dicyclomine Hydrochloride Tablets in India. Dicyclomine is an anticholinergic/antispasmodic medicine used to reduce gastrointestinal smooth-muscle spasm in selected functional bowel conditions, including irritable bowel syndrome (IBS). Treatment is symptomatic and should be individualized because anticholinergic adverse effects and contraindications can limit its use.

2. Product Specifications

3. Manufacturing Technology

• Formulation & Taste Control: Excipients and, where registered, film coating may be selected to support tablet handling, swallowing and acceptable organoleptic characteristics.
• Blend Uniformity: Validated dispensing and blending processes support consistent Dicyclomine content across dosage units.
• Tablet Performance: Compression, hardness, friability, disintegration and dissolution are controlled according to the registered product specification.
• Combination Capability: Any Dicyclomine combination with another active ingredient requires its own approved formulation, safety assessment and destination-market registration.

4. Quality Assurance

• Dissolution: Drug release is tested against applicable pharmacopoeial or registered acceptance criteria rather than a universal fixed percentage/time claim.
• Assay & Uniformity: Potency and dosage-unit uniformity are verified according to approved specifications.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.
• Stability: Shelf life is supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Dicyclomine has antimuscarinic activity and also reduces gastrointestinal smooth-muscle spasm, helping relieve cramping in appropriately selected patients.

• Irritable Bowel Syndrome: May provide symptomatic relief of abdominal cramping/spasm in some patients with IBS.
• Functional Bowel Disorders: May be used for selected gastrointestinal spasm where an anticholinergic antispasmodic is appropriate.
• Not for Infant Colic: Dicyclomine is contraindicated in infants younger than 6 months in labeling such as the U.S. prescribing information because serious respiratory and neurologic adverse events have been reported. It should not be promoted as an infant-colic treatment.
• Other Pain Conditions: Use for menstrual or other non-gastrointestinal pain depends on the exact formulation, local approval and clinician judgment; it should not be presented as a universal indication.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Packaging: Finished blister/bottle presentations can be configured according to approved destination-market labeling.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Dicyclomine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Dicyclomine tablet formulations in India.

Q: Is Dicyclomine available under brand names?
A: Yes. Dicyclomine is marketed under various brands. Generic equivalence/interchangeability depends on the specific registered product and applicable regulatory requirements.

Q: Can Dicyclomine cause drowsiness or blurred vision?
A: Yes. Dizziness, drowsiness and blurred vision can occur. Patients should avoid driving or hazardous activities until they know how the medicine affects them.

Q: Can Dicyclomine be used in infants?
A: It should not be used in infants younger than 6 months where contraindicated by the registered label; serious adverse reactions have been reported in this age group.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Dose and frequency should follow the registered product information and prescriber's directions. Response and anticholinergic tolerability should be assessed rather than applying a universal fixed regimen.
• Administration: Follow the specific product label regarding timing with food or meals; administration instructions can vary by formulation and market.
• Older Adults: Greater susceptibility to confusion, blurred vision, constipation, urinary retention and other anticholinergic effects may require particular caution.

9. Side Effects and Precautions

• Anticholinergic Effects: Dry mouth, blurred vision, constipation, urinary retention, reduced sweating, dizziness and tachycardia may occur.
• Heat Exposure: Reduced sweating can increase the risk of heat exhaustion or heat stroke in hot environments.
• CNS: Drowsiness, dizziness, confusion or other central nervous system effects can occur, especially in susceptible or older patients.
• Contraindications / Cautions: Follow the registered label for conditions including obstructive gastrointestinal/urologic disease, severe ulcerative colitis, reflux esophagitis, glaucoma, myasthenia gravis and relevant cardiovascular conditions.
• Drug Interactions: Other medicines with anticholinergic effects can increase adverse effects; a medication review may be appropriate.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Keep in a dry place and protect from excessive heat, light and moisture.
• Keep in original packaging and out of reach of children.