Linezolid

Linezolid for Oral Suspension is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1. 2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1. 3); Uncomplicated skin and skin structure infections ( 1. 4); Vancomycin-resistant Enterococcus faecium infections. ( 1. 5) Limitations of Use ( 1.6 ): • Linezolid is not indicated for the treatment of Gram-negative infections. …

• Dosage, Route, and Frequency of Administration Infection
• Pediatric Patients (Birth through 11 Years of Age)
• Adults and Adolescents (12 Years and Older) Duration (Days) Nosocomial pneumonia Community-acquired pneumonia, including concurrent bacteremia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous or oral every 12 hours 10 to 14 Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous or oral every 12 hours 14 to 28 Uncomplicated skin and skin structure infections less than 5 yrs: 10 mg/kg oral every 8 hours 5 to 11 yrs: 10 mg/kg oral every 12 hours
• Adults: 400 mg oral every 12 hours Adolescents: 600 mg oral every 12 hours 10 to 14 General Dosage and Administration The recommended dosage for linezolid formulations
• For the treatment of infections is described in Table 1
• Table 1
• Dosage Guidelines for Linezolid Infection Due to the designated pathogens [see Indications and Usage ]
• Dosage, Route, and Frequency of Administration Recommended Duration of Treatment (Consecutive Days)
• Pediatric Patients
• 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. …

Linezolid for Oral Suspension: dry, white to tan, orange-flavored powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. • For oral suspension: 100 mg of linezolid per each 5 mL. ( 3 )

• The safety and effectiveness of linezolid
• For the treatment of pediatric patients with the following infections are supported by evidence from adequate and well-controlled studies
• In adults, pharmacokinetic data
• In pediatric patients, and additional data from a comparator-controlled study of Gram-positive infections
• In pediatric patients ranging in age from birth through 11 years [see Indications and Usage , Clinical Pharmacology and Clinical Studies ]: • nosocomial pneumonia • complicated skin and skin structure infections • community-acquired pneumonia (also supported by …

Of the 2,046 patients treated with linezolid in Phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals …

• Important Administration Instructions Advise patients that linezolid may be taken with or without food
• Peripheral and Optic Neuropathy Advise patients to inform their physician if they experience changes in vision while taking linezolid [see Warnings and Precautions ]
• Serotonin Syndrome Advise patients to inform their physician if taking serotonergic agents, including serotonin reuptake inhibitors or other antidepressants and opioids
• Advise patients of the increased risk of serotonin syndrome when Linezolid is used concomitantly with serotonergic agents [see Warnings and Precautions ]. …

• Known hypersensitivity to linezolid or any of the other product components. • Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI
• Hypersensitivity Linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components . …

Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. ( 4.2 , 5.3 , 5.6 , 7 , 12.3 ) 7.1 Monoamine Oxidase Inhibitors Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see Contraindications ( 4.2 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Adrenergic and Serotonergic Agents Linezolid has the potential for interaction with adrenergic and serotonergic agents [see Warnings and Precautions ( 5.3 , 5.6 ) and Clinical Pharmacology ( 12.3 )] .

• Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. ( 5.1 ) • Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. ( 5.2 ) • Serotonin Syndrome: Monitor patients taking Linezolid concomitantly with serotonergic agents for signs of serotonin syndrome. …

Most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid) include diarrhea, vomiting, headache, nausea, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ()] Peripheral and Optic Neuropathy [see Warnings and Precautions ()] Serotonin Syndrome [see Warnings and Precautions ()] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ()] Lactic Acidosis [see Warnings and Precautions ()] …

8.1 Pregnancy Risk Summary Available data from published and postmarketing case reports with linezolid use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. …

In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was administered. Data are not available for removal of linezolid with peritoneal dialysis or hemoperfusion. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.