Azithromycin Dispersible Tablets

Azithromycin Dispersible Tablet 100mg

Each Dispersible tablet contain:

  • Azithromycin Dihydrate
  • Eq.To Anhydrous Azithromycin(100mg)
  • Std:IP(ACT)
  • Excipients(QS)(EXC)

Azithromycin Tablets IP 250 mg

Each Filmcoated tablet contains:

  • Azithromycin Dihydrate IP
  • Eq. To Anhydrous Azithromycin 250 mg
  • Excipients q.s
  • Azithromycin Tablets IP 500 mg

Each Filmcoated Tablet contains:

  • Azithromycin Dihydrate IP
  • Eq. To Anhydrous Azithromycin 500 mg
  • Excipients q.s
  • Colour : Ponceau 4R
  • Azithromycin Tablets IP 500 mg

Each Filmcoated Tablet contains:

Azithromycin Dihydrate IP

Eq. To Anhydrous Azithromycin 500 mg
Excipients q.s
Colour : Ponceau 4R

Azithromycin Tablets IP 1 gm

Each Film coated tablet contains:
Azithromycin Anhydrous IP 1 gm
As Azithromycin Dihydrate IP

LAMITHROCIN / Azithromycin Tablets USP 500 Mg

Each film coated tablet contains:

– Azithromycin Dihydrate

eq. to Azithromycin USP (500 mg)
– Excipients (- QS)

Usage: – chest infections

Category: – Antibiotic drugs

Therapeutic category: – Antibiotic

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Description

Azithromycin Dispersible Tablets (100mg / 250mg)

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 Azithromycin Dispersible Tablets (DT) in India. Azithromycin is a broad-spectrum Macrolide Antibiotic widely used for respiratory, skin, and systemic infections. Our Dispersible Tablet (DT) formulation is specifically designed for pediatric and geriatric patients who have difficulty swallowing conventional tablets.

 

We offer Contract Manufacturing (Third Party) services for this high-demand pediatric formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced Taste-Masking Technology to neutralize the naturally bitter taste of Azithromycin, ensuring high patient compliance. Healthy Inc manages the export logistics, supplying hospitals, pharmacies, and NGO health programs across Africa, Southeast Asia, and Latin America.

 

2. Product Specifications

ParameterSpecification
Product NameAzithromycin Dispersible Tablets
Generic NameAzithromycin Dispersible Tablets USP / BP / IP
CAS Number83905-01-5 (Azithromycin Dihydrate)
Strength100mg / 250mg
Dosage FormDispersible Tablet (DT) / Soluble Tablet
StandardUSP / BP / IP Compliant
Therapeutic ClassMacrolide Antibiotic
Shelf Life24 to 36 Months
Packaging10×6 Blister / 10×10 Alu-Alu / Dry Syrup equivalent

3. Manufacturing Azithromycin Dispersible Tablets

Producing a palatable soluble antibiotic requires specialized formulation.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd.

    Azithromycin is inherently bitter. We employ Micro-Encapsulation or complexation with ion-exchange resins, along with premium sweeteners and flavors (like Peppermint, Orange, or Strawberry), to mask the bitterness effectively. We use super-disintegrants to ensure the tablet disperses completely in a teaspoon of water within 3 minutes, creating a fine, easy-to-drink suspension.

     

  • The Exporter: Healthy Inc

    Healthy Inc ensures that these sensitive tablets reach global markets in perfect condition. We prioritize Alu-Alu Cold Form Blisters to provide the highest barrier against moisture, as humidity can cause the tablet to harden or degrade. We handle all export documentation, including Certificate of Analysis (COA) and Country of Origin certificates.

4. Quality Assurance

We adhere to strict testing protocols for Dispersible Tablets:

  • Disintegration Time: We verify that every batch disperses rapidly (typically < 3 minutes) in water.

  • Dispersion Fineness: We ensure the dispersed particles are fine and do not feel gritty in the mouth.

  • Assay: We confirm the precise potency of Azithromycin (100mg/250mg) to ensure clinical efficacy.

5. Why Use Azithromycin DT?

It combines potent antibacterial action with ease of administration.

  • Mechanism: It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, stopping bacterial growth (bacteriostatic/bactericidal).

     

  • Key Indications:

    • Respiratory Infections: Tonsillitis, Pharyngitis, Sinusitis, and Pneumonia.

    • Typhoid Fever: Effective alternative for uncomplicated typhoid.

    • Otitis Media: Middle ear infections in children.

    • Skin Infections: Soft tissue infections.

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 Azithromycin DT?

    A: Healthy Life Pharma Pvt. Ltd. manufactures them in India with expertise in taste-masking.

  • Q: How do I administer this to a child?

    A: Drop the tablet into a teaspoon (5-10ml) of boiled and cooled water. Allow it to disperse (dissolve), then give it to the child immediately.

  • Q: Is it better than the suspension (liquid)?

    A: Dispersible tablets are often preferred for export because they are lighter to ship, have a longer shelf life, and don’t require refrigeration after opening (unlike reconstituted syrups).


CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Pediatric Dosage: Typically 10 mg/kg once daily for 3 days. Or as prescribed by a physician.

  • Adult Dosage: 500mg (2 x 250mg tablets) once daily for 3 days.

  • Administration: Azithromycin can be taken with or without food, though taking it with food reduces stomach upset.

     

9. Side Effects and Precautions

  • Common Side Effects: Diarrhea, nausea, abdominal pain, and vomiting.

     

  • Cardiac Warning: Can cause QT prolongation. Use with caution in patients with heart conditions.

     

  • Liver: Excreted via the liver; caution in severe hepatic impairment.

     

10. Storage Instructions

  • Store below 30°C in a dry place.

  • Keep strictly protected from moisture (keep in blister until use).