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. is a specialized Manufacturer of Dicyclomine Hydrochloride Tablets in India. Dicyclomine is a widely used Anticholinergic / Antispasmodic agent designed to relieve muscle spasms in the gastrointestinal tract. It is the first-line symptomatic treatment for Irritable Bowel Syndrome (IBS) and functional bowel disorders characterized by abdominal pain, cramping, and bloating.

We offer Contract Manufacturing (Third Party) services for this high-volume digestive aid. Dicyclomine is an amine with a distinct bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to mask this bitterness effectively, ensuring patient compliance. We also offer combination formulations (e.g., with Paracetamol or Mefenamic Acid) for enhanced pain relief. Healthy Inc manages the export logistics, supplying pharmacy chains and gastroenterology clinics across the USA, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Relief from the “knot” in the stomach.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Dicyclomine HCl is intensely bitter and can cause numbness in the mouth if uncoated. We use a robust Hydroxypropyl Methylcellulose (HPMC) film coating to create a tasteless barrier that facilitates easy swallowing.

  • Dissolution Control: Antispasmodics need to work quickly. We optimize the disintegration time to ensure the drug releases within 15-20 minutes, providing rapid relief from acute abdominal cramps.

  • Combination Formulations: We have the capability to manufacture bi-layer or mixed granulation tablets combining Dicyclomine with analgesics (like Paracetamol) or anti-flatulents (like Simethicone) for comprehensive symptom management.

• The Exporter: Healthy Inc

  • Bulk Solutions: We supply bulk loose tablets for repackaging in varying markets, as well as finished blister packs compliant with local regulatory labeling requirements.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 93-107% of the label claim.

• Related Substances: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Dicyclomine?

It relaxes the gut muscles.

• Mechanism: Dicyclomine acts as an Anticholinergic drug. It blocks the Muscarinic Acetylcholine Receptors on the smooth muscle cells of the stomach and intestines. By blocking acetylcholine (the chemical that causes contraction), it directly relaxes the muscle, stopping the spasm and the pain associated with it.

• Key Indications:

  • Irritable Bowel Syndrome (IBS): Reduces the cramping and pain associated with IBS-D (Diarrhea) or IBS-C (Constipation).

  • Functional Bowel Disorders: Treats abdominal pain, bloating, and spasm without an organic cause.

  • Infant Colic: (Used cautiously in syrup form, less common in tablets).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Dicyclomine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Bentyl?

  A: Bentyl is the brand name (AbbVie). We manufacture the Generic Equivalent (Dicyclomine HCl), which works exactly the same way.

• Q: Does it cause drowsiness?

  A: Yes. It is a common side effect. Do not drive or operate heavy machinery until you know how the drug affects you.

• Q: Can I take it for period pain?

  A: Yes. It is often prescribed (sometimes with Mefenamic Acid) to relax uterine spasms during menstruation.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults (IBS): Start with 20mg four times daily. After one week, increase to 40mg four times daily if tolerated.

• Administration: Take 30 minutes to 1 hour before meals and at bedtime.

9. Side Effects and Precautions

• Anticholinergic Effects: Dry mouth, blurred vision, constipation, urinary retention, and decreased sweating (risk of heatstroke in hot weather).

• CNS: Dizziness, drowsiness, confusion (especially in elderly).

• Contraindications: Glaucoma, Myasthenia Gravis, Obstructive Uropathy (prostate enlargement), and severe Ulcerative Colitis.

• Pediatrics: Contraindicated in infants < 6 months due to risk of respiratory distress/seizures.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep away from direct heat.