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Norfloxacin Tablets

Norfloxacin Tablets

Composition: Norfloxacin IP 400 mg (film-coated tablet); Flonor Norfloxacin BP 400 mg (film-coated tablet).

Usage: Treatment of selected susceptible bacterial infections under medical supervision.

Category: Antibiotic Drugs

Therapeutic category: Fluoroquinolone antibiotic

SKU: Norfloxacin Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Norfloxacin Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification status subject to verification)
Exporter: Healthy Inc (exporter status subject to verification)

1. Product Introduction

Norfloxacin is a fluoroquinolone antibacterial medicine. This product listing includes Norfloxacin Tablets IP 400 mg and Flonor Tablets BP 400 mg, each described as a film-coated tablet. Norfloxacin may be prescribed for selected susceptible bacterial infections, particularly certain urinary tract infections, subject to local approval, susceptibility and clinical guidelines.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied product information. Facility certification, supply availability and export permissions should be independently confirmed before publication or procurement.

2. Product Specifications

Product nameNorfloxacin Tablets / Flonor Tablets
Active ingredientNorfloxacin
Strength400 mg per tablet
VariantsNorfloxacin IP 400 mg; Flonor Norfloxacin BP 400 mg
Dosage formFilm-coated tablet
CAS number70458-96-7
Therapeutic classFluoroquinolone antibiotic
CategoryAntibiotic Drugs
Packaging and shelf lifeConfirm from approved label and batch documentation

3. Manufacturing Technology

Formulation development for norfloxacin tablets should address drug dissolution, content uniformity, coating performance and stability. Light and moisture protection must be established through product-specific stability studies rather than assumed. Specific processes such as API micronization, controlled lighting and coating composition require confirmation against actual manufacturing records.

4. Quality Assurance

Release testing should follow the applicable approved IP or BP monograph and registered specifications, as relevant to each variant. Typical controls include identification, assay, dissolution, uniformity, related substances and stability testing. Exact acceptance limits and expiry dates should come from validated methods, approved specifications and supporting stability data; they are not asserted here.

5. Pharmacology and Clinical Use

Norfloxacin inhibits bacterial DNA gyrase and topoisomerase IV, interfering with bacterial DNA replication. Its clinical use is restricted by antimicrobial resistance and important fluoroquinolone safety concerns. Depending on the country, approvals may include selected urinary tract infections or prostatitis; it should only be used when clinically appropriate and supported by susceptibility information. It is not effective against viral infections.

Fluoroquinolones are generally reserved for situations where appropriate alternatives are unsuitable for certain uncomplicated infections. Historical uses for gonorrhea or diarrheal infections must not be presented as routine current recommendations.

6. Export and Regulatory Support

For B2B enquiries, confirm product registration status, manufacturing licences, GMP certificates, certificate of analysis, stability documentation and any applicable CTD/ACTD dossier availability with the supplier. Import authorizations and indications vary by destination country. WHO-GMP certification and exporter status are not independently verified on this page.

7. Frequently Asked Questions

Q: What strengths are listed?
A: Both the IP and Flonor BP variants supplied here contain norfloxacin 400 mg.

Q: Can it treat every bacterial infection?
A: No. Use depends on the infection, local approval, bacterial susceptibility and safety assessment.

Q: Can dairy or antacids affect absorption?
A: Yes. Dairy products, mineral supplements and antacids containing certain metal ions can reduce absorption. Follow the exact spacing instructions on the approved product label.

Q: Is it suitable for everyone?
A: No. Tendon, nerve, neurological, cardiac and other risks require clinician assessment.

8. Dosage and Administration

Dosage and duration must be prescribed based on indication, kidney function, local product labeling and susceptibility results. Do not self-medicate or reuse old antibiotic courses. Take as directed with water and observe label instructions for separation from dairy, antacids, iron, zinc and multivitamin products. Dose adjustment may be required in renal impairment.

9. Side Effects and Precautions

Potential adverse effects include nausea, dizziness, headache and photosensitivity. Serious fluoroquinolone warnings include tendon inflammation or rupture, peripheral neuropathy, central nervous system effects, worsening myasthenia gravis and potentially prolonged or disabling reactions. Additional concerns may include QT prolongation, blood glucose disturbances and rare aortic complications in susceptible patients. Seek urgent medical advice for tendon pain, numbness, severe allergic reactions, marked confusion or other serious symptoms. Check interactions, including antacids, mineral supplements and other prescribed medicines.

10. Storage Instructions

Store according to the approved pack label, protected from unsuitable light, moisture and heat. Keep in original packaging and out of reach of children. Exact storage temperature and expiry date must be verified against the registered product information.