LINEZOLID SANDOZ FILM COATED TABLET 600MG

Novartis Pharmaceuticals S.R.L. (ROMANIA)🇸🇬 Health Sciences Authority

Approval Date: Feb 10, 2016
Approval ID: cc49b73199be0533
Company: Novartis Pharmaceuticals S.R.L. (ROMANIA)
Type: Therapeutic

Approval Details

Approval Id: cc49b73199be0533
Drug Name: LINEZOLID SANDOZ FILM COATED TABLET 600MG
Product Name: LINEZOLID SANDOZ FILM COATED TABLET 600MG
Approval Number: SIN14946P
Approval Date: 2016-02-10
Registrant: SANDOZ SINGAPORE PTE. LTD.
Licence Holder: SANDOZ SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Patients whose therapy is started with linezolid injection may be switched to linezolid tablets with no dosage adjustment. <img src="/TGIF/LinezolidSandoz-Table1.png" alt="Linezolid Sandoz Dosage Table 1" /> Elderly patients No dose adjustment is required. Patients with renal insufficiency No dose adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with severe renal insufficiency (i.e. CLCR < 30 ml/min): No dose adjustment is required. Due to the unknown clinical significance of higher exposure (up to 10-fold) to the two primary metabolites of linezolid in patients with severe renal insufficiency, linezolid should be used with special caution in these patients and only when the anticipated benefit is considered to outweigh the theoretical risk. As approximately 30% of a linezolid dose is removed during 3 hours of hemodialysis, linezolid should be given after dialysis in patients receiving such treatment. The primary metabolites of linezolid are removed to some extent by hemodialysis, but the concentrations of these metabolites are still considerably higher following dialysis than those observed in patients with normal renal function or mild to moderate renal insufficiency. Therefore, linezolid should be used with special caution in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk. To date, there is no experience of linezolid administration to patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than hemodialysis). Patients with hepatic insufficiency No dose adjustment is required. However, there are limited clinical data and it is recommended that linezolid should be used in such patients only when the anticipated benefit is considered to outweigh the theoretical risk (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Method of administration The recommended linezolid dose should be administered orally every 12 hours. Route of administration: Oral use. The film-coated tablets may be taken with or without food. The film-coated tablets should be swallowed whole with some water.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Linezolid Sandoz is indicated for the treatment of adults and adolescents (12 years and older) with the following infections caused by susceptible strains of Gram-positive bacteria only. Linezolid is not indicated for the treatment of Gram-negative infections. Specific Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <ul> <li>Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-sensitive strains only), including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-sensitive strains only).</li> <li>Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-sensitive and methicillin-resistant strains) or Streptococcus pneumoniae (penicillin-sensitive strains only).</li> <li>Uncomplicated skin and soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive strains only) or Streptococcus pyogenes.</li> <li>Complicated skin and soft tissue infections, caused by Staphylococcus aureus (methicillin-sensitive and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.</li> <li>Vancomycin-resistant Enterococcus faecium infections including cases with concurrent bacteremia.</li> </ul> Linezolid should not be initiated as a first line therapy for community-acquired pneumonia or uncomplicated skin infection, but may be considered if resistant strains are suspected or proven or in presence of drug allergy.
Contraindications: 4.3 Contraindications Linezolid is contraindicated in patients who have previously demonstrated hypersensitivity to linezolid or any of the other product components. Monoamine Oxidase Inhibitors Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. Potential Interactions Producing Elevation of Blood Pressure Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine, phenylpropanolamine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Potential Serotonergic Interactions Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, linezolid should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: J01XX08
Atc Item Name: linezolid
Pharma Manufacturer Name: SANDOZ SINGAPORE PTE. LTD.

Active Ingredients

Linezolid

600mg

Linezolid

600mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 10, 2016

Approval ID

cc49b73199be0533

Type

Therapeutic

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