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Linezolid tablets - original product photograph

Linezolid Tablets

Composition: Each film-coated tablet contains Linezolid 600 mg.

Usage: Selected serious bacterial infections caused by susceptible Gram-positive organisms.

Category: Antibiotic drugs

Therapeutic category: Oxazolidinone antibiotic

SKU: Linezolid Tablets

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

Product Information

Linezolid Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

1. Product Introduction

Linezolid is an oxazolidinone antibiotic used for selected serious infections caused by susceptible Gram-positive bacteria, including certain MRSA and vancomycin-resistant Enterococcus faecium infections. Its use should follow susceptibility testing, local treatment guidance and antimicrobial stewardship principles.

Manufacturer: Healthy Life Pharma Pvt. Ltd. (as supplied). Exporter: Healthy Inc (as supplied). Claims regarding certifications, export approvals and product availability require documentary confirmation.

2. Product Specifications

Product nameLinezolid Tablets
CompositionEach film-coated tablet contains Linezolid 600 mg (per supplied product details)
CAS number165800-03-3
Dosage formFilm-coated tablet
Therapeutic classOxazolidinone antibiotic
SKULinezolid Tablets
Pharmacopoeial standardConfirm against approved batch documentation; USP/BP/IP compliance not independently verified
Shelf life / packagingAs per approved stability data and marketed pack label; not confirmed

3. Manufacturing Technology

Manufacturing of a 600 mg film-coated tablet requires validated blending or granulation, compression, coating, and in-process controls. Solid-state characteristics, uniformity, disintegration and dissolution should be evaluated as part of the product-specific control strategy. The exact manufacturing process and coating materials must be confirmed from approved records.

4. Quality Assurance

Release and stability testing may include identification, assay, uniformity of dosage units, dissolution, related substances, microbial quality where applicable, and packaging integrity. Acceptance limits must follow the applicable approved specification; numerical assay or dissolution claims are not asserted without supporting documents.

5. Pharmacology and Clinical Use

Linezolid binds to bacterial 23S rRNA on the 50S ribosomal subunit and inhibits formation of the functional initiation complex for protein synthesis. It has high oral bioavailability, supporting clinically appropriate IV-to-oral transitions, but this does not itself prove that a particular marketed tablet is bioequivalent to another product.

Depending on approved labeling and susceptibility, indications may include hospital-acquired or community-acquired pneumonia, complicated skin and skin-structure infections, and infections due to vancomycin-resistant E. faecium. It does not treat Gram-negative infections without additional appropriate coverage.

6. Export and Regulatory Support

For B2B inquiries, request the applicable product registration status, manufacturing license, certificate of analysis, stability data, approved artwork, and any available CTD/ACTD documentation. WHO-GMP, COPP, FSC and other certifications should be confirmed for the specific manufacturing site and product before being advertised or supplied.

7. Frequently Asked Questions

What is the strength? The supplied formulation is Linezolid 600 mg per film-coated tablet.

Is it the same as Zyvox? Linezolid is the same active ingredient; therapeutic equivalence and interchangeability depend on product-specific regulatory approval.

Can I eat aged cheese? Large quantities of tyramine-rich foods and drinks may cause blood-pressure elevations during linezolid treatment. Follow the prescriber’s dietary advice.

Can I take it with antidepressants? Potentially serious serotonin syndrome can occur with serotonergic medicines. The prescriber must review all medicines before treatment.

8. Dosage and Administration

For certain approved adult indications, product labels commonly describe 600 mg orally every 12 hours, but the dose and duration depend on infection, age, clinical status and local approved labeling. Use only as prescribed. Tablets may generally be taken with or without food. Do not extend therapy without specialist assessment.

9. Side Effects and Precautions

  • Myelosuppression: Thrombocytopenia, anemia or leukopenia can occur; complete blood counts are generally monitored weekly, particularly with prolonged therapy or risk factors.
  • Serotonin syndrome: Risk with SSRIs, SNRIs and other serotonergic agents; urgent assessment is needed if symptoms develop.
  • Neuropathy: Peripheral and optic neuropathy, especially with prolonged courses; report visual changes promptly.
  • Other risks: Lactic acidosis, hypoglycemia, elevated blood pressure with tyramine or interacting medicines, and antibiotic-associated diarrhea.
  • Duration: Safety and efficacy beyond 28 days have not been established in some major product labels.

10. Storage Instructions

Store in the original, securely closed package under the temperature, light and moisture conditions stated on the approved product label. A universal below-25°C limit cannot be confirmed from the supplied composition alone. Keep out of reach of children.