Zyrolin Tablet
In-house product
Offer
Indications
Linezolid is indicated for the treatment of:
Nosocomial pneumonia
Community-acquired pneumonia
Complicated skin and skin structure infection including diabetic foot infections, without concomitant osteomyelitis
Uncomplicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections
Limitations of use: Linezolid is not indicated for the treatment of Gram-negative infections. The safety and efficacy of Linezolid given for longer than 28 days have not been evaluated in controlled clinical trials.
Interaction
Drug interaction with medication: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic agents. Some individuals receiving linezolid may experience a reversible enhancement of the pressor response to indirect acting sympathomimetic agents, vasopressor or dopaminergic agents. 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 serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone. Drug interaction with food and others: Advice patients to avoid large quantities of foods or beverages with high tyramine content while taking linezolid.
Contraindications
Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. 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. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.
Side Effects
Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.
Dosage
Linezolid tablets should be taken in oral route with or without food. Linezolid IV infusion should be administered by intravenous infusion over a period of 30 to 120 minutes. The recommended daily dosage for Linezolid tablets and IV infusion is described in the following table:
Infection
Dosage, route and frequency of administration
Pediatric patients* (birth through 11 years of age)
Adults and adolescent(12 years and older)
Recommended duration of treatment (consecutive days)
Nosocomial pneumonia
10 mg/kg orally or intravenously every 8 hours
600 mg orally or intravenously every12 hours
10 to 14
Community-acquired pneumonia, including concurrent bacteremia
Complicated skin and skin structure infections
Complicated skin and skin structure infections
10 mg/kg orally or intravenously every 8 hours
600 mg orally or intravenously every 12 hours
14 to 28
Uncomplicated skin and skin structure infections
less than 5 years: 10 mg/kg orally every 8 hours5-11 years: 10 mg/kg orally every 12 hours
Adults: 400 mg orally every 12 hours Adolescents: 600 mg orally every 12 hours
10 to 14
* Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.
No dose adjustment is necessary when switching from intravenous to oral administration.Intravenous administration: Linezolid IV infusion should be inspected visually against a light source for particulate matter prior to administration. Linezolid IV infusion may exhibit a yellow color that can intensify over time without adversely affecting potency. Do not use this intravenous infusion vial in series connections. Additives should not be introduced into this solution. Discard unused portion after single use.Hepatic impairment: No dose adjustment is recommended for patients with mild-to-moderate hepatic impairment. The pharmacokinetics of Linezolid in patients with severe hepatic impairment have not been evaluated.Use in children and adolescents: The dose of linezolid for children and adolescents have been described in dose and administration section. The use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended
Administration
n/a
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