Description

Clarithromycin Tablets (250mg / 500mg)

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 Clarithromycin Tablets in India. Clarithromycin is an advanced Macrolide Antibiotic derived from Erythromycin but with superior stability and fewer gastrointestinal side effects. It is a cornerstone therapy for H. pylori eradication (Peptic Ulcers) and is widely prescribed for upper and lower Respiratory Tract Infections (Pharyngitis, Sinusitis, Pneumonia) and skin infections.

We offer Contract Manufacturing (Third Party) services for this high-demand antibiotic. Clarithromycin has an intensely bitter and lingering metallic taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Taste-Masking Film Coating technology to ensure the tablet is palatable and easy to swallow. We also manufacture Modified Release (XL) formulations for once-daily dosing. Healthy Inc manages the export logistics, supplying gastroenterology centers and pharmacy chains across the USA, Europe, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Superior stability, masked bitterness.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: The API is notoriously bitter. We apply a specialized Non-Functional Coating that dissolves only after passing the taste buds, ensuring patient compliance without delaying absorption in the stomach.

  • Bioavailability: Clarithromycin is a Class II drug (low solubility). We use Micronized API and specific surfactants to ensure rapid dissolution and high bioavailability, matching the innovator’s pharmacokinetic profile.

  • Acid Stability: Unlike Erythromycin, Clarithromycin is stable in stomach acid. Our formulation ensures it remains intact until absorption, reducing the nausea often associated with older macrolides.

• The Exporter: Healthy Inc

  • Combi-Kits: We specialize in manufacturing “H. pylori Kits” (Clarithromycin + Amoxicillin + Lansoprazole/Omeprazole) in a single convenient blister pack for the 7-14 day eradication regimen.

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.

• Crystallinity: We check the crystal form (Polymorph Form II) to ensuring stability and solubility are maintained.

5. Why Use Clarithromycin?

The “Triple Therapy” anchor.

• Mechanism: Clarithromycin binds reversibly to the 50S ribosomal subunit of susceptible bacteria. This blocks the translocation of peptides, effectively stopping bacterial protein synthesis (Bacteriostatic/Bactericidal depending on concentration).

• Key Indications:

  • H. pylori Infection: The most effective antibiotic component in the standard “Triple Therapy” for treating duodenal ulcers.

  • Respiratory Infections: Pneumonia, Bronchitis, Sinusitis (especially effective against “Atypical” bacteria like Mycoplasma and Chlamydia).

  • Skin Infections: Cellulitis and folliculitis.

  • MAC Complex: Prevention of Mycobacterium avium complex (MAC) in HIV patients.

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 Clarithromycin Tablets?

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

• Q: Is it Biaxin?

  A: Biaxin is the brand name (Abbott/AbbVie). We manufacture the Generic Equivalent (Clarithromycin).

• Q: Why do I have a bad taste in my mouth?

  A: “Metallic Taste” (Dysgeusia) is the most common side effect. It is harmless and disappears after the course is finished. Chewing gum or mints can help.

• Q: Can I take it with Statins?

  A: CAUTION. Clarithromycin inhibits the liver enzyme (CYP3A4) that breaks down cholesterol drugs (Statins). Taking them together can cause severe muscle damage (Rhabdomyolysis). Your doctor usually pauses the statin while you are on this antibiotic.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• General Infection: 250mg to 500mg twice daily for 7-14 days.

• H. pylori: 500mg twice daily (combined with Amoxicillin 1000mg + PPI) for 10-14 days.

• Administration: Can be taken with or without food. Swallow whole; do not chew.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, diarrhea, abdominal pain (less than Erythromycin).

• Sensory: Metallic/bitter taste, reversible hearing loss (rare, high doses).

• Cardiac: QT Prolongation (Heart rhythm issue). Avoid in patients with history of arrhythmias.

• Interaction: Potent CYP3A4 Inhibitor. Increases levels of Carbamazepine, Theophylline, Digoxin, and Warfarin.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.