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Linezolid (Linezolid)

Trade Name : Linezolid

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 600 mg/1

LINEZOLID Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Linezolid (Linezolid) which is also known as Linezolid and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 600 mg/1 per ml. Read more

Linezolid (Linezolid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [].
  • Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (); Community-acquired pneumonia (); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (); Uncomplicated skin and skin structure infections (); Vancomycin-resistant infections. (1.3)
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablet formulations and other antibacterial drugs, linezolid tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ()
  • The recommended dosage for linezolid tablets for the treatment of infections is described in Table 1.
  • No dose adjustment is necessary when switching from intravenous to oral administration.
  • 600 mg tablet u2013 white, film-coated, modified capsule-shaped unscored tablets, debossed with u201cTVu201d on one side and with u201c7490u201d on the other side of the tablet.
  • Tablet: 600 mg linezolid ()
  • No data
  • Known hypersensitivity to linezolid or any of the other product components. (4.1); Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)
  • No data
  • Myelosuppression: Monitor complete blood counts weekly. Consider discontinuation in patients who develop or have worsening myelosuppression. ()
  • Peripheral and optic neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. ()
  • Serotonin syndrome: Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. ()
  • A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. ()
  • Clostridium difficile
  • Potential interactions producing elevation of blood pressure: monitor blood pressure. ()
  • Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. ()
  • Most common adverse reactions (> 5% of adult and/or pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, , , , )
  • No data
  • In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was administered. Data are not available for removal of linezolid with peritoneal dialysis or hemoperfusion. Clinical signs of acute toxicity in animals were decreased activity and ataxia in rats and vomiting and tremors in dogs treated with 3000 mg/kg/day and 2000 mg/kg/day, respectively.
  • Linezolid tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is ()--[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide.
  • The chemical structure is represented below:
  • CHFNOM.W. 337.35
  • Linezolid tablets for oral administration contain 600 mg linezolid as film-coated, modified capsule-shaped tablets. Inactive ingredients are croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, maize starch, mannitol, polyethylene glycol, povidone, and titanium dioxide. The sodium (Na) content is 4.3 mg (0.2 mEq) per 600 mg tablet.
  • No data
  • No data
  • No data
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  • No data
  • Patients should be counseled that antibacterial drugs including linezolid tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When linezolid tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by linezolid tablets or other antibacterial drugs in the future.
  • Patients should be advised that:
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. I 2/2018
  • No data

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

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