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Antibiotics

Linestad 600

 

Pack size: 

Box of 2 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains Linezolid 600 mg.

 

Shelf-life:

24 months from the date of manufacturing. 

Store in a well-closed container, in a dry place. Do not store above 30oC. 

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria.
  • Treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.
  • Administered orally with or without food. 
     
  • Adult and children ≥ 12 years: 600 mg every 12 hours usually for 10 - 14 days (max. duration of treatment 28 days).
  • Elderly patients, patients with renal insufficiency, hepatic insufficiency: No dose adjustment is required.
     

Or as prescribed by physicians.

 

  • Hypersensitivity to linezolid or to any ingredient of the drug.
  • Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) or within two weeks of taking any such medicinal product.
  • Unless there are facilities available for close observation and monitoring of blood pressure, linezolid should not be administered to patients with the following underlying clinical conditions or on the following types of concomitant medications: 
    Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute confusional states.
    Patients taking any of the following medications: Serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), directly and indirectly acting sympathomimetic agents (including the adrenergic bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine), pethidine or buspirone.

     

Common 

  • Candidiasis, oral candidiasis, vaginal candidiasis, fungal infections.
  • Headache, taste perversion (metallic taste), dizziness.
  • Diarrhoea, nausea, vomiting, localised or general abdominal pain, constipation, dyspepsia.
  • Abnormal liver function test; increased AST, ALT or alkaline phosphatase. 
  • Increased BUN. 
  • Insomnia.
  • Anaemia.
  • Hypertension.
  • Pruritus, rash.
  • Fever.

Uncommon

  • Vaginitis.
  • Leucopenia, neutropenia, thrombocytopenia, eosinophilia.
  • Convulsions, hypoaesthesia, paraesthesia.
  • Blurred vision.
  • Tinnitus. 
  • Arrhythmia (tachycardia).
  • Transient ischaemic attacks, phlebitis, thrombophlebitis.
  • Pancreatitis, gastritis, abdominal distention, dry mouth, glossitis, loose stools, stomatitis, tongue discolouration or disorder.
  • Increased total bilirubin.
  • Urticaria, dermatitis, diaphoresis.
  • Renal failure, increased creatinine, polyuria.
  • Vulvovaginal disorder.
  • Hyponatraemia.
  • Chills, fatigue, increased thirst.

Rare 

  • Pancytopenia.
  • Antibiotic-associated colitis, including pseudomembranous colitis.
  • Changes in visual field defect.
  • Superficial tooth discolouration.

Frequency not known

  • Myelosuppression, sideroblastic anaemia.
  • Anaphylaxis.
  • Lactic acidosis.
  • Serotonin syndrome, peripheral neuropathy.
  • Optic neuropathy, optic neuritis, loss of vision, changes in visual acuity, changes in colour vision. 
  • Bullous disorders such as those described as Stevens-Johnson syndrome and toxic epidermal necrolysis, angioedema, alopecia.

     

  • Hematologic effects: Myelosuppression (e.g., anemia, leukopenia, pancytopenia, thrombocytopenia) has been reported in patients receiving linezolid. Complete blood cell counts should be monitored weekly during linezolid therapy, especially in patients receiving the drug for more than 2 weeks and in those who have preexisting myelosuppression, are receiving concomitant drugs that produce bone marrow suppression, or have a chronic infection that was or is being treated with concomitant anti-infective therapy. Discontinuance of linezolid should be considered if myelosuppression develops or worsens. Hematologic parameters generally have increased toward pretreatment values following discontinuance of the drug.
  • Mortality: In a study in seriously ill patients with intravascular catheter-related infections, mortality was higher in linezolid-treated patients than in those treated with a comparator anti-infective (vancomycin, dicloxacillin, oxacillin).
  • Monoamine oxidase inhibition: Linezolid is a weak, nonselective, reversible inhibitor of monoamine oxidase (MAO). The drug potentially may interact with MAO inhibitors and adrenergic and serotonergic agents. A significant pressor response has been reported when tyramine doses greater 100 mg were used in adults receiving linezolid. Patients should be instructed to consume less than 100 mg of tyramine per meal while they are taking linezolid.
  • Serotonin syndrome (including some fatalities) has been reported in patients receiving linezolid concomitantly with serotonergic drugs (e.g., selective serotonin-reuptake inhibitors [SSRIs]). Signs and syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering, shaking, diarrhea, loss of coordination, and/or fever. Because of the risk of serotonin syndrome, linezolid generally should not be used in patients receiving serotonergic drugs.
  • Superinfection/Clostridium difficile-associated diarrhea and colitis (CDAD): Treatment with anti-infectives may permit overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis has been reported with nearly all anti-infectives, including linezolid, and may range in severity from mild diarrhea to fatal colitis. Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Carefully medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued. If CDAD is suspected or confirmed, discontinuance of antiinfectives not directed against C. difficile may be needed.
  • Anaphylaxis, angioedema, and bullous skin disorders, such as those described as Steven-Johnson syndrome, reported. 
  • Lactic acidosis, characterized by recurrent nausea and vomiting, has been reported in patients receiving linezolid. Patients who develop recurrent nausea and vomiting, unexplained acidosis, or a low bicarbonate concentration while receiving linezolid should undergo immediate medical evaluation.
  • Peripheral and optic neuropathy, sometimes progressing to loss of vision, has been reported in patients receiving linezolid; these events have occurred primarily in patients receiving the drug for longer than the maximum recommended duration of therapy (28 days). Blurred vision has been reported in some patients receiving the drug for less than 28 days. If a patient experiences symptoms of visual impairment (e.g., changes in visual acuity or color vision, blurred vision, or visual field defect), an ophthalmic evaluation should be promptly performed. All patients receiving linezolid for extended periods of time (i.e., 3 months or longer) should have their visual function monitored. In addition, all patients reporting a new visual symptom, regardless of the length of therapy, should have their visual function monitored. If peripheral or optic neuropathy occurs, weigh potential benefits versus risks of continued therapy with linezolid.
  • Seizures have been reported in patients receiving linezolid. A history of seizures or risk factors for seizures noted in some of these cases.
  • Impairment of fertility: Linezolid reversibly decreased fertility and induced abnormal sperm morphology in adult male rats at exposure levels approximately equal to those expected in humans; possible effects of linezolid on the human male reproductive system are not known.
  • Pregnancy: There are no adequate data from the use of linezolid in pregnant women. A potential risk for humans exists. Linezolid should not be used during pregnancy unless clearly necessary i.e. only if the potential benefit outweighs the theoretical risk.
  • Lactation: Linezolid and its metabolites may pass into breast milk and, accordingly, breastfeeding should be discontinued prior to and throughout administration.
  • Fertility: Linezolid may cause a reduction in fertility.
  • Patients should be warned about the potential for dizziness or symptoms of visual impairment whilst receiving linezolid and should be advised not to drive or operate machinery if any of these symptoms occurs.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

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Email : stada@stada.com.vn
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