Linexil 2 mg/ml (IV Infusion)
Medicine Details
Category | Details |
---|---|
Generic | Linezolid |
Company | Opsonin pharma ltd |
Also available as |
Indications
- Nosocomial pneumonia
- Community-acquired pneumonia
- Complicated skin and skin structure infection
- Diabetic foot infections
- Uncomplicated skin and skin structure infections
- Vancomycin-resistant Enterococcus faecium infections
Pharmacology
Synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones. In vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria, and certain Gram negative bacteria. Selectively inhibits bacterial protein synthesis via a mechanism of action different from other antibacterial agents. 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.
Dosage & Administration
- Dosage, route and frequency of administration:
- Pediatric patients (birth through 11 years of age): 10 mg/kg orally or intravenously every 8 hours
- Adults and adolescent (12 years and older): 600 mg orally or intravenously every 12 hours
- Recommended duration of treatment (consecutive days): 10 to 14 days (nosocomial pneumonia), 14 to 28 days (complicated skin and skin structure infections), 10 to 14 days (uncomplicated skin and skin structure infections)
- Intravenous administration: Inspected visually against a light source for particulate matter. IV infusion may exhibit a yellow color. No dose adjustment is necessary when switching from intravenous to oral administration. Additives should not be introduced into the IV solution.
- Hepatic impairment: No dose adjustment recommended for patients with mild-to-moderate hepatic impairment.
- Use in children and adolescents: Dose described in dosage and administration section. Not recommended for the empiric treatment of pediatric patients with central nervous system infections.
Interaction
- Drug interaction with medication: Reversible, nonselective inhibitor of monoamine oxidase. Potential for interaction with adrenergic and serotonergic agents.
- Drug interaction with food and others: Patients should avoid large quantities of foods or beverages with high tyramine content while taking this medicine.
Contraindications
- Known hypersensitivity to Linezolid or any of the other product components
- 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
- Uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome
- Patients taking directly and indirectly acting sympathomimetic agents, vasopressive agents, and dopaminergic agents
Side Effects
- Diarrhea
- Headache
- Nausea
- Oral moniliasis
- Vaginal moniliasis
- Hypertension
- Dyspepsia
- Localized abdominal pain
- Pruritus
- Tongue discoloration
Pregnancy & Lactation
- Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Lactation: Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for linezolid. Advise monitoring of breastfed infant for diarrhea and vomiting.
Precautions & Warnings
- Complete blood counts should be monitored weekly in patients who receive this medication for longer than two weeks
- Prompt ophthalmic evaluation is recommended if patients experience symptoms of visual impairment
- Not approved for the treatment of patients with catheter-related bloodstream infections
- Monitor patients for potential increases in blood pressure
- Careful medical history is necessary since Clostridium difficile-associated Diarrhea (CDAD) can occur over two months after antibiotic administration
Overdose Effects
No cases of overdose reported. Symptomatic and supportive care advised together with maintenance of glomerular filtration. Approximately 30% of a dose is removed during 3 hours of haemodialysis.
Therapeutic Class
Macrolides
Reconstitution
- Oral suspension: Reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.
- Intravenous Administration: IV infusion bottles should not be used in series connections. Additives should not be introduced into the IV solution. Store at room temperature and protected from freezing.
Storage Conditions
- Room temperature (15°C-30°C)
- Away from light and moisture
Related Brands
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