Description

Cimetidine Tablets (200mg / 400mg / 800mg)

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 Cimetidine Tablets in India. Cimetidine is the pioneering Histamine H2-Receptor Antagonist that revolutionized the treatment of Peptic Ulcers. It works by blocking the specific histamine receptors in the stomach lining that trigger acid production. While newer generations exist, Cimetidine remains a vital drug for specific cases of Duodenal Ulcers, Benign Gastric Ulcers, and hypersecretory conditions like Zollinger-Ellison Syndrome.

We offer Contract Manufacturing (Third Party) services for this legacy gastroenterology product. Cimetidine has a notoriously bitter taste and high dosage volume. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating Technology to effectively mask the taste and improve patient compliance. We also employ high-compressibility granulation techniques to keep the large 800mg tablets easy to swallow. Healthy Inc manages the export logistics, supplying hospitals and pharmacy chains across Africa, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Masking the bitterness, delivering the relief.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Cimetidine is extremely bitter. Uncoated tablets often lead to patient non-compliance. We apply a specialized Opadry Polymer Film Coat that completely seals the core, ensuring the patient tastes nothing until the tablet reaches the stomach.

  • High-Load Formulation: The 800mg strength requires a tablet containing nearly 1 gram of material. We use high-density grades of Cimetidine and super-compacting binders to keep the tablet size “patient-friendly” and prevent capping (splitting) during compression.

  • Dissolution Control: Despite the coating, we engineer the core to disintegrate rapidly, ensuring the drug is available to block acid secretion within 30-45 minutes.

• The Exporter: Healthy Inc

  • Cost-Effective Bulk: We offer highly competitive bulk packaging options (1000s jars) for hospital tenders where cost-per-dose is a critical factor.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 15 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 stability over the 3-year shelf life.

5. Why Use Cimetidine?

The original acid blocker.

• Mechanism: The stomach lining contains Parietal Cells, which have “H2 Receptors.” When Histamine binds to these receptors, the cell pumps acid into the stomach. Cimetidine competes with Histamine for these receptors. By blocking the binding site, it shuts down the “acid pump,” significantly reducing both basal (fasting) and food-stimulated acid secretion.

• Key Indications:

  • Duodenal & Gastric Ulcers: Promotes rapid healing (4-8 weeks).

  • GERD: Relieves heartburn (though usually 2nd line now).

  • Zollinger-Ellison Syndrome: Controls massive acid overproduction.

  • Dermatology (Off-label): Used for warts (due to immune-modulating effects).

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 Cimetidine Tablets?

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

• Q: Is it Tagamet?

  A: Tagamet is the brand name (GSK). We manufacture the Generic Equivalent (Cimetidine), which is bioequivalent.

• Q: Does it interact with other drugs?

  A: YES (Important). Cimetidine inhibits liver enzymes (CYP450). It can increase the levels of Warfarin, Theophylline, and Phenytoin in the blood. Doctors must monitor doses of these drugs carefully.

• Q: Does it cause side effects in men?

  A: Rarely. Long-term high doses can cause Gynecomastia (breast swelling) or libido changes due to a weak anti-androgenic effect. This reverses when the drug is stopped.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Active Ulcer: 800mg once daily at bedtime OR 300mg/400mg twice daily.

• GERD: 400mg four times daily or 800mg twice daily.

• Maintenance: 400mg at bedtime.

• Renal Impairment: Dosage reduction is mandatory (e.g., 300mg every 12 hours) as drug accumulates in kidney failure.

• Administration: Take with meals or at bedtime.

9. Side Effects and Precautions

• CNS: Confusion or hallucinations (mostly in elderly or critically ill patients).

• Endocrine: Gynecomastia, impotence (reversible, rare).

• GI: Diarrhea, headache, dizziness.

• Interaction Warning: Increases blood levels of Warfarin (bleeding risk), Theophylline (toxicity), Phenytoin, and Lidocaine.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.