Ciprofloxacin with Tinidazole Tablets

Description

Ciprofloxacin and Tinidazole Tablets (500mg + 600mg)

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 manufacturer of Ciprofloxacin and Tinidazole Tablets in India. This fixed-dose combination contains Ciprofloxacin, a fluoroquinolone antibacterial agent, and Tinidazole, a nitroimidazole antimicrobial active against susceptible anaerobic organisms and protozoa. Use of this combination should be limited to infections for which both components are clinically appropriate and supported by local prescribing guidance. Contract manufacturing and export support are available for registered markets.

2. Product Specifications

3. Manufacturing Ciprofloxacin + Tinidazole

• Combination Uniformity: Validated blending and granulation processes are used to maintain uniform distribution of both active ingredients.
• Film Coating: A suitable film coat can improve swallowability and help mask the unpleasant taste of the active ingredients.
• Moisture Protection: High-barrier packaging such as Alu-Alu may be used where supported by stability data and market requirements.
• The Exporter: Healthy Inc. Healthy Inc manages market-specific documentation, packaging and international logistics.

4. Quality Assurance

• Assay & Uniformity: Both active ingredients are quantitatively tested against approved finished-product specifications.
• Dissolution: Release of both components is verified using the applicable validated or compendial methods.
• Related Substances: Specified impurities and degradation products are monitored during batch release and stability studies.

5. Why Use Ciprofloxacin + Tinidazole?

Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Tinidazole is reduced within susceptible anaerobic organisms and protozoa to reactive intermediates that damage DNA. The combination therefore provides activity against different classes of susceptible pathogens, but should not be used empirically when a narrower or safer therapy is appropriate.

Potential Uses:

• Mixed Gastrointestinal Infections: May be prescribed in jurisdictions where the combination is approved and both antibacterial and antiprotozoal/antianaerobic coverage is indicated.
• Amoebic / Protozoal Disease: Tinidazole has activity against susceptible protozoa; treatment selection should follow diagnosis and local guidance.
• Other Mixed Infections: Dental, pelvic or other infections require condition-specific regimens; this FDC should be used only when both components are appropriate.
• Antimicrobial Stewardship: Not every case of diarrhea or gastrointestinal illness requires antibiotics. Unnecessary fluoroquinolone use can promote resistance and expose patients to 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 regulatory and commercial requirements.

7. Frequently Asked Questions

Q: Who manufactures Ciprofloxacin + Tinidazole Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures the formulation in India.

Q: Is the combination always better than Ciprofloxacin alone?
A: No. The appropriate treatment depends on the diagnosed or suspected organisms, local resistance patterns and patient factors. Combination therapy should be used only when coverage from both medicines is indicated.

Q: Can alcohol be consumed while taking Tinidazole?
A: Alcohol should be avoided during Tinidazole treatment and for the period specified in the approved product information after the last dose because an unpleasant alcohol-related reaction may occur.

Q: Can antacids or mineral supplements affect this medicine?
A: Magnesium, aluminium, calcium, iron and zinc can reduce Ciprofloxacin absorption. Follow the separation interval stated in the approved prescribing information.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose & Duration: Treatment should follow the approved local product information and clinician assessment. Fixed-duration statements should not replace diagnosis-specific prescribing.
• Administration: Swallow the film-coated tablet as directed. Food instructions should follow the registered product label.
• Minerals / Antacids: Separate Ciprofloxacin from polyvalent-cation-containing products according to approved prescribing information.
• Renal / Hepatic Considerations: Patient organ function and concomitant medicines should be reviewed before prescribing.

9. Side Effects and Precautions

• Gastrointestinal / Taste: Nausea, abdominal symptoms and a metallic or unpleasant taste may occur.
• Alcohol: Avoid alcohol during treatment and for the post-treatment interval specified by the approved Tinidazole label.
• Tendon Injury: Ciprofloxacin and other fluoroquinolones can cause tendinitis and tendon rupture. New tendon pain or swelling requires prompt medical assessment.
• Nervous System: Fluoroquinolones can cause peripheral neuropathy and CNS adverse effects; Tinidazole can also cause neurologic adverse reactions.
• Myasthenia Gravis: Fluoroquinolones may worsen muscle weakness in patients with myasthenia gravis.
• Drug Interactions: Review concomitant medicines for clinically important Ciprofloxacin and Tinidazole interactions before use.

10. Storage Instructions

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