Ciprofloxacin Dispersible Tablets

Description

Ciprofloxacin 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 Ciprofloxacin Dispersible Tablets in India. Ciprofloxacin is a fluoroquinolone antibacterial medicine used for selected infections caused by susceptible bacteria. Dispersible formulations provide an alternative method of administration where an appropriate registered product is indicated. We offer contract manufacturing services for dispersible and conventional tablet presentations, while Healthy Inc manages international export logistics.

2. Product Specifications

3. Manufacturing Ciprofloxacin Dispersible Tablets

• Taste Masking: Suitable formulation techniques, sweeteners and approved flavors may be used to improve palatability while maintaining the registered release characteristics.
• Rapid Dispersion: Appropriate disintegrants and validated formulation parameters support rapid and uniform dispersion according to the finished-product specification.
• Moisture Protection: High-barrier packaging such as Alu-Alu may be selected where supported by stability data to protect dispersible tablets from environmental moisture.
• The Exporter: Healthy Inc. Healthy Inc manages export documentation and market-specific packaging requirements.

4. Quality Assurance

• Disintegration / Dispersion: Dispersible presentations are tested against the applicable registered or pharmacopoeial requirements.
• Dissolution & Assay: Drug release, potency and dosage-unit uniformity are verified against approved specifications.
• Related Substances: Specified impurities and degradation products are monitored during release and stability testing.
• Microbial Quality: Finished products are tested as applicable for non-sterile oral dosage forms.

5. Why Use Ciprofloxacin?

Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication and producing a bactericidal effect against susceptible organisms.

Key Uses:

• Urinary and Other Bacterial Infections: May be used for susceptible infections when supported by local guidelines, culture results and clinical assessment.
• Gastrointestinal Infections: Certain bacterial gastrointestinal infections may be treated with Ciprofloxacin where susceptibility and local resistance patterns support its use.
• Respiratory Infections: Use is limited to appropriate susceptible infections and should follow antimicrobial guidelines; Ciprofloxacin is not suitable for every type of pneumonia.
• Antimicrobial Stewardship: Fluoroquinolones should be reserved for appropriate bacterial infections to reduce resistance and avoid unnecessary serious adverse effects.

6. Export and Regulatory Support

• Dossier Support: CTD and ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to commercial and regulatory requirements.

7. Frequently Asked Questions

Q: Who manufactures Ciprofloxacin Dispersible Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Ciprofloxacin tablet formulations in India.

Q: How should a dispersible tablet be taken?
A: Follow the instructions for the specific registered product. Where the label directs dispersion in water, use the specified volume, mix as instructed and administer promptly to ensure the intended dose.

Q: Can a dispersible tablet be swallowed whole?
A: This depends on the specific formulation and approved label. Follow the product instructions rather than assuming all dispersible tablets can be used interchangeably with conventional tablets.

Q: Can Ciprofloxacin be taken with antacids or mineral supplements?
A: Products containing magnesium, aluminium, calcium, iron or zinc can reduce Ciprofloxacin absorption. Separation intervals should follow the approved prescribing information.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dose and treatment duration depend on infection type, organism susceptibility, patient age, kidney function and local antimicrobial guidance.
• Pediatric Use: Ciprofloxacin use in children is restricted to specific indications in many jurisdictions and requires clinician-directed, weight-based dosing.
• Minerals / Antacids: Ciprofloxacin should be appropriately separated from antacids and supplements containing polyvalent cations according to the registered prescribing information.
• Complete the Course: When prescribed for a bacterial infection, use exactly as directed and do not stop or extend therapy without medical advice.

9. Side Effects and Precautions

• Common Effects: Nausea, diarrhea, abdominal discomfort, headache or dizziness can occur.
• Tendons: Fluoroquinolones can cause tendinitis and tendon rupture. New tendon pain, swelling or inflammation requires prompt medical assessment and adherence to prescribing-information instructions.
• Nervous System: Peripheral neuropathy and central nervous system effects can occur and may be serious.
• Myasthenia Gravis: Fluoroquinolones can worsen muscle weakness in patients with myasthenia gravis.
• Cardiac / Other Risks: QT-related effects and other serious fluoroquinolone warnings may apply depending on patient risk factors and local labeling.
• Photosensitivity: Photosensitivity reactions can occur; patients should follow medical advice regarding excessive sunlight or UV exposure.

10. Storage Instructions

• Store below 30°C in a dry place.
• Protect from moisture and excessive heat.
• Keep tablets in the original blister or packaging until use.
• Keep out of reach of children.