Indications
Arlin is prescribed for the treatment of:
- Nosocomial pneumonia
- Community-acquired pneumonia
- Complicated skin and skin structure infections, including diabetic foot infections (without accompanying osteomyelitis)
- Uncomplicated skin and skin structure infections
- Infections caused by Vancomycin-resistant Enterococcus faecium
Usage Limitations:
Arlin is not recommended for treating Gram-negative infections. Its safety and effectiveness for use beyond 28 days have not been studied in controlled clinical trials.
Pharmacology
Arlin contains Linezolid, a synthetic antibacterial from the oxazolidinone class. It targets Gram-positive aerobic bacteria, some Gram-positive anaerobes, and specific Gram-negative bacteria. Linezolid disrupts bacterial protein synthesis uniquely by binding to the 23S ribosomal RNA of the 50S ribosomal subunit, preventing the formation of the functional 70S initiation complex crucial for bacterial translation. Time-kill studies indicate that Linezolid is bacteriostatic against enterococci and staphylococci, while it is bactericidal against most streptococci strains.
Dosage & Administration
- Oral Administration: Linezolid tablets can be taken with or without food.
- Intravenous Administration: Administer Linezolid IV infusion over 30 to 120 minutes.
Dosage Recommendations:
| Infection | Pediatric Dosage | Adult Dosage | Treatment Duration |
|---|---|---|---|
| Nosocomial Pneumonia | 10 mg/kg every 8 hours | 600 mg every 12 hours | 10 to 14 days |
| Community-acquired Pneumonia | 10 mg/kg every 8 hours | 600 mg every 12 hours | 14 to 28 days |
| Complicated Skin Infections | 10 mg/kg every 8 hours | 600 mg every 12 hours | 14 to 28 days |
| Uncomplicated Skin Infections | <5 years: 10 mg/kg every 8 hours; 5-11 years: 10 mg/kg every 12 hours | Adults: 400 mg every 12 hours; Adolescents: 600 mg every 12 hours | 10 to 14 days |
Note for Neonates: For pre-term neonates under 7 days of age, initiate with 10 mg/kg every 12 hours. Consider 10 mg/kg every 8 hours for sub-optimal responses, transitioning to the 8-hour regimen by 7 days of life.
Intravenous Administration: Inspect Linezolid IV infusion visually for particulate matter before use. The infusion may become yellow over time but remains effective. Do not use additives or series connections with the infusion bottle. Discard any unused solution after single use.
Hepatic Impairment: No dosage adjustment is required for mild-to-moderate hepatic impairment. The effects of Linezolid in severe hepatic impairment are not well-studied.
Use in Children and Adolescents: Refer to the dosing information for pediatric use. Linezolid is not recommended for empiric treatment of central nervous system infections in pediatric patients.
Drug Interactions
Arlin may interact with adrenergic and serotonergic agents due to its reversible, nonselective MAO inhibition. Monitor for serotonin syndrome, especially if combined with other serotonergic drugs. Avoid large amounts of tyramine-rich foods.
Contraindications
Arlin should not be used in individuals with known hypersensitivity to Linezolid or its components, those on MAO inhibitors, or patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, or carcinoid syndrome. It should not be administered with sympathomimetic agents, vasopressors, dopaminergic agents, serotonin re-uptake inhibitors, tricyclic antidepressants, triptans, meperidine, or buspirone.
Side Effects
Common side effects include diarrhea, headache, and nausea. Other possible effects are oral and vaginal moniliasis, hypertension, dyspepsia, abdominal pain, pruritus, and tongue discoloration.
Pregnancy & Lactation
- Pregnancy: No significant risk of birth defects has been identified. Use Arlin during pregnancy only if the benefits outweigh potential risks.
- Lactation: Linezolid is excreted in breast milk. Weigh the benefits of breastfeeding against potential risks to the infant. Monitor breastfed infants for diarrhea and vomiting.
Precautions & Warnings
Monitor complete blood counts weekly for patients on Arlin, especially those on long-term therapy or with myelosuppression. Perform ophthalmic evaluations if visual disturbances occur. Arlin is not approved for catheter-related bloodstream infections. Monitor for Clostridium difficile-associated diarrhea (CDAD) and consider discontinuing antibiotic use if CDAD is suspected. Be cautious of blood pressure changes and potential hypoglycemia.
Overdose Effects
No overdose cases have been reported. In case of overdose, provide symptomatic and supportive care, and maintain glomerular filtration. About 30% of Arlin is removed by hemodialysis. There is no data on its removal by peritoneal dialysis or hemoperfusion.
Therapeutic Class
Macrolides
Reconstitution Instructions
- Oral Suspension: Shake the bottle to loosen powder. Add 75 ml of boiled and cooled water in two portions, shaking well after each addition. Store the reconstituted suspension in a cool, dry place and use within 21 days.
- Intravenous Administration: Use the ready-to-use infusion bottles. Do not mix with additives or use in series connections. Store at room temperature, protect from freezing, and note that the solution may become yellow over time without affecting potency.
Storage Conditions
Store Arlin at room temperature (15°C-30°C), protected from light and moisture. Keep out of reach of children.
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