Description

Loperamide Tablets (2mg)

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 Loperamide Hydrochloride Tablets in India. Loperamide is the world’s most widely used Anti-Diarrheal Agent. It is an opioid receptor agonist that acts locally in the gut to slow down peristalsis, allowing the body to absorb more fluids and nutrients, effectively firming up the stool and reducing the frequency of bowel movements.

We offer Contract Manufacturing (Third Party) services for this high-volume OTC and prescription drug. Since the active dose is very low (only 2mg), achieving perfect Content Uniformity is the primary manufacturing challenge. Our WHO-GMP certified facility in Mumbai utilizes advanced Geometric Blending and high-precision compression machines to ensure that every single tablet contains exactly 2mg of the drug, preventing efficacy failure or potential toxicity. Healthy Inc manages the export logistics, supplying pharmacy chains and travel clinics across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision dosing for patient safety.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Geometric Dilution: To mix a tiny amount of API (2mg) into a larger tablet mass (100mg+), we use a multi-stage blending process (Geometric Dilution). This ensures the drug is evenly distributed throughout the batch, preventing “hot spots” (tablets with too much drug) or “dead spots” (tablets with no drug).

  • Direct Compression: We use specialized excipients (like Spray Dried Lactose) that allow for direct compression. This method reduces the exposure of the drug to heat and moisture, preserving its stability.

  • Hardness Control: The tablets are compressed to a specific hardness that prevents crumbling in blister packs but ensures they break down in the stomach within 15 minutes.

• The Exporter: Healthy Inc

  • Travel-Ready Packaging: We specialize in small “Wallet Packs” or “Pocket Blisters” (4 or 6 tablets) which are preferred for Over-The-Counter (OTC) sales and travel medicine kits.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

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

5. Why Use Loperamide?

It acts as a “brake” for the intestine.

• Mechanism: Loperamide binds to the opiate receptors in the gut wall. This blocks the release of acetylcholine and prostaglandins, thereby reducing the propulsive peristalsis (wave-like movements) of the intestine. It also increases the tone of the anal sphincter, reducing incontinence and urgency.

• Key Indications:

  • Acute Diarrhea: Sudden onset diarrhea (e.g., Traveler’s Diarrhea, viral gastroenteritis).

  • Chronic Diarrhea: Management of diarrhea associated with IBS (Irritable Bowel Syndrome).

  • Ileostomy Control: Reduces the volume of discharge for patients with an ileostomy.

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 Loperamide Tablets?

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

• Q: Is it Imodium?

  A: Imodium is the brand name (Johnson & Johnson). We manufacture the Generic Equivalent (Loperamide HCl), which is bioequivalent and works exactly the same way.

• Q: Can I use it for dysentery (blood in stool)?

  A: NO. If you have fever or bloody stool, you likely have a bacterial infection. Stopping the diarrhea keeps the bacteria inside you, which is dangerous. Use antibiotics instead.

• Q: Is it addictive?

  A: No. While it is an opioid, it does not cross the blood-brain barrier efficiently at normal doses, so it does not cause a “high” or pain relief—it only affects the gut.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Acute Diarrhea (Adults): Initial dose of 4mg (2 tablets), followed by 2mg (1 tablet) after every loose stool.

• Max Dose: Do not exceed 16mg (8 tablets) per day.

• Administration: Swallow whole with water. Drink plenty of fluids to prevent dehydration.

9. Side Effects and Precautions

• Constipation: The most common side effect. Stop taking if constipation occurs.

• Cardiac Events: FDA Warning: Extremely high doses (abuse) can cause serious heart problems (Torsades de Pointes / Cardiac Arrest). Do not exceed the recommended dose.

• CNS: Drowsiness or dizziness may occur (common in children).

• Pediatrics: Contraindicated in children under 2 years (risk of respiratory depression).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep out of reach of children. (Serious risk if accidentally ingested).