Linez is indicated for the treatment of:
Linez is not indicated for the treatment of Gram-negative infections. The safety and efficacy of Linez given for longer than 28 days have not been evaluated in controlled clinical trials.
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Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram-positive aerobic bacteria, some Gram-positive anaerobic bacteria, and certain Gram-negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.
Route of Administration:
Recommended Dosage Table:
Infection | Pediatric Patients (Birth through 11 years) | Adults and Adolescents (12 years and older) | Duration (Days) |
---|---|---|---|
Nosocomial pneumonia | 10 mg/kg orally or IV every 8 hours | 600 mg orally or IV every 12 hours | 10 to 14 |
Community-acquired pneumonia | 10 mg/kg orally or IV every 8 hours | 600 mg orally or IV every 12 hours | 10 to 14 |
Complicated skin infections | 10 mg/kg orally or IV every 8 hours | 600 mg orally or IV every 12 hours | 14 to 28 |
Uncomplicated skin infections | - <5 years: 10 mg/kg orally every 8 hours | Adults: 400 mg orally every 12 hours | 10 to 14 |
- 5-11 years: 10 mg/kg orally every 12 hours | Adolescents: 600 mg orally every 12 hours |
Neonates (<7 Days Old):
Note: No dose adjustment is required when switching from IV to oral administration.
Drug Interaction with Medications:
Drug Interaction with Food and Other Substances:
Contraindicated in patients with a known hypersensitivity to Linezolid or its components.
Monoamine Oxidase Inhibitors (MAOIs): Should not be used in patients taking medicinal products that inhibit monoamine oxidases A or B (e.g., Phenelzine, Isocarboxazid) or within two weeks of discontinuing these agents.
Pre-existing Conditions:
Concurrent Medications: Avoid use with:
Pregnancy:
Available data on the use of Linezolid during pregnancy have not shown a clear risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, Linezolid should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.
Lactation:
Linezolid is present in breast milk. The decision to breastfeed should consider the benefits of breastfeeding for the child and the clinical need for Linezolid for the mother, along with any potential risks. Lactating women should monitor their infants for diarrhea and vomiting.
Complete Blood Counts (CBC):
Weekly monitoring of complete blood counts is recommended for patients receiving Linezolid, especially if:
Vision Changes:
If patients experience symptoms of visual impairment (e.g., changes in visual acuity, color vision, blurred vision, or visual field defects), an ophthalmic evaluation is recommended.
Infection Site Concerns:
Linezolid is not approved for treating catheter-related bloodstream infections or catheter-site infections.
Clostridium Difficile-Associated Diarrhea (CDAD):
CDAD can occur up to two months after antibiotic treatment. If suspected or confirmed, antibiotic therapy not directed against C. difficile should be stopped.
Hypertension & Related Conditions:
Linezolid should be used with caution in patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, or those taking sympathomimetic agents, vasopressors, or dopaminergic agents. Blood pressure should be monitored regularly.
Gastrointestinal & Metabolic Issues:
If patients develop recurrent nausea or vomiting, unexplained acidosis, or low bicarbonate levels, they should receive immediate medical evaluation.
Hypoglycemia Management:
If hypoglycemia occurs, a dose adjustment of insulin or oral hypoglycemic agents may be required, or the medication may need to be discontinued.
Store in a cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
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