Composition: Ofloxacin IP 200 mg (film-coated); YALLEY FLOX and Ofnis-200: Ofloxacin BP 200 mg (film-coated).
Usage: Treatment of selected susceptible bacterial infections as prescribed.
Category: Antibiotic Drugs
Therapeutic category: Fluoroquinolone antibiotic
SKU: Ofloxacin Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Ofloxacin 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.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification subject to verification)
Exporter: Healthy Inc (export credentials subject to verification)
Ofloxacin is a fluoroquinolone antibiotic used to treat certain bacterial infections when the organism is susceptible and treatment is appropriate under local prescribing guidance. This listing covers the supplied 200 mg film-coated variants: Ofloxacin Tablets IP, YALLEY FLOX BP and Ofnis-200 BP. The 400 mg strength described in promotional text has not been confirmed by the supplied composition.
Fluoroquinolones can cause serious and potentially lasting adverse reactions; they are not suitable for every infection and may be reserved for situations where appropriate alternatives are unavailable.
| Product name | Ofloxacin Tablets / YALLEY FLOX / Ofnis-200 |
|---|---|
| Composition | Ofloxacin IP 200 mg; branded variants Ofloxacin BP 200 mg |
| Confirmed strength | 200 mg |
| Dosage form | Film-coated tablet |
| CAS number | 82419-36-1 |
| Therapeutic class | Fluoroquinolone antibacterial |
| Pharmacopoeial standard | IP or BP according to the respective supplied composition; USP not confirmed |
| Shelf life / packaging | Verify using approved label, stability data and batch documents |
Manufacturing controls for film-coated ofloxacin tablets should address blend uniformity, dissolution, coating quality, degradation products and stability under proposed storage conditions. Specific techniques such as HPMC coating, micronization, UV-controlled production or Alu-Alu packaging must be confirmed against actual manufacturing and validation records.
Quality assessment includes identity, assay, dosage-unit uniformity, dissolution, related substances, microbiological quality where applicable, and packaging integrity under the relevant approved pharmacopoeial specification. Numeric dissolution limits and a fixed 36-month shelf life should not be asserted without product-specific data.
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication. Potential indications depend on local approval and organism susceptibility and may include selected urinary tract, respiratory, skin and other bacterial infections. It is not a universal first-choice treatment for typhoid, gonorrhea or respiratory infection; antimicrobial resistance and local guidelines are critical.
Antibiotics do not treat viral illnesses. Treatment should be based on clinical assessment and culture or susceptibility results where appropriate.
For procurement, request product-specific manufacturing authorization, GMP evidence, certificate of analysis, approved labeling, stability data, and applicable CTD/ACTD or other registration documents. Availability of COPP, FSC, dossier support, shipping terms and destination-country authorization must be confirmed with the supplier.
Q: Which strengths are confirmed?
A: Ofloxacin 200 mg for all three supplied variants; 400 mg is unverified.
Q: Can it be taken with antacids or supplements?
A: Magnesium/aluminum antacids, iron, zinc and some multivitamins can reduce absorption. Follow the product label for dose separation.
Q: Is ofloxacin appropriate for every UTI or typhoid infection?
A: No. Prescribing depends on susceptibility, resistance patterns, patient risk and applicable guidelines.
Q: Is it safe for children?
A: Pediatric use is restricted or carefully assessed in many settings because of safety concerns; follow specialist advice and local labeling.
For registered medical practitioners and patient reference; not a substitute for approved prescribing information.
Dose and duration depend on the infection, renal function, patient characteristics, bacterial susceptibility and approved labeling. Do not self-prescribe or use a fixed course from promotional materials. Take as directed by the prescriber; avoid taking at the same time as mineral-containing antacids or supplements when separation is required.
Important fluoroquinolone risks include tendon inflammation or rupture, peripheral neuropathy, central nervous system effects, blood glucose disturbances, QT prolongation, allergic reactions and potentially severe diarrhea. Patients with myasthenia gravis may experience worsening weakness. Seek prompt medical assessment for tendon pain, numbness, severe dizziness, palpitations or severe rash. Use in pregnancy, breastfeeding and children requires individualized medical assessment. Check drug interactions and adjust dosing when renal function is impaired.
Store in the original approved packaging, protected from excess heat, moisture and light as directed on the final product label. Confirm the exact storage temperature and expiry date from approved stability data.