Generic Zyvox

LINEZOLID
Tablets: 400 and 600 mg2 (Rx) Zyvox (Pharmacia)
Powder for reconstitution: 100 mg/5 ml (Rx)
Lotion: 2 mg/mL (Rx)

Indications
Vancomycin-resistant Enterococcus faecium infections: For the treatment of vancomycin-resistant E. faecium infections including cases with concurrent bacteremia.
Nosocomial pneumonia: For the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). Combination therapy may be indicated if the documented of presumptive pathogens include gram-negative organisms.
Complicated skin and skin structure infections: For the treatment of complicated skin and skin structure infections caused by S. aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. It has not been studied in the treatment of diabetic foot and decubitus ulcers. Combination therapy may be clinically indicated if the documented or presumptive pathogens include gram-negative organisms.
Uncomplicated skin and skin structure infections: For the treatment of uncomplicated skin and skin structure infections caused by S. aureus (methicillin-susceptible strains only) or S. pyogenes.
Community-acquired pneumonia: For the treatment of community-acquired pneumonia caused by S. pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia, or S. aureus (methicillin-susceptible strains only).
Because of concerns about inappropriate use of antibiotics leading to increase in resistant organisms, carefully consider alternatives before initiating treatment with linezolid in the outpatient setting.

Administration and Dosage
Administer without regard to meals.
Treat patients with methicillin-resistant S. aureus (MRSA) infection with linezolid 600 mg/12 hours.
No dose adjustment is necessary when switching from IV to oral administration. Patients who are started on IV therapy may be switched to tablets or oral suspension when clinically indicated.
IV administration: Administer over a period of 30 to 120 minutes. Do not use IV infusion bag in series connections. Do not introduce additives into this solution. Do not administer concomitantly with another drug; administer each drug separately.
Compatible IV solutions: 5% Dextrose Injection, 0.9% NaCl Injection; Lactated Ringer's Injection.
Admixture incompatibilities: Physical incompatibilities resulted when linezolid IV injection was combined with the following drugs during simulated Y-site administration: Amphotericin B, chlorpromazine HC1, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when linezolid IV injection was combined with ceftriaxone sodium.
If the same IV line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of IV injection with an infusion solution compatible with linezolid IV injection and with any other drug(s) administered via this common line.

Actions
Pharmacology: Linezolid binds to a site on the bacterial 23S ribosomal RNA of the 50S subunit 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.
Pharmacokinetics:
Absorption - Linezolid is rapidly and extensively absorbed after oral dosing with an absolute bioavailability of about 100%.
Distribution - The plasma protein binding of linezolid is about 31% and is concentration-independent. The volume of distribution of linezolid at steady-state averaged 40 to 50 L in healthy adult volunteers.
Metabolism - Linezolid is primarily metabolized by oxidation of the morpholine ring, which results in 2 inactive ring-opened carboxylic acid metabolites.
Excretion – Non-renal clearance accounts for approximately 65% of the total clearance of linezolid. Under steady-state conditions, about of the dose appears in the urine as linezolid, 40% as metabolite B, and 10% as metabolite A. The renal clearance of linezolid is low (average, 40 ml/min) and suggests net tubular re-absorption. Virtually, no linezolid appears in the feces, while about 6% of the dose appears in the feces as metabolite  and 3% as metabolite A.
Special populations -
Children: Currently, there are limited data on the pharmacokinetics of linezolid during multiple dosing in pediatric patients of all ages. No data have been collected in infants Pharmacokinetic information indicates that pediatric patients dosed with 10 mg/kg IV have a similar Cmax but a higher average clearance when corrected by body weight and shorter apparent elimination half-life than adults receiving 625 mg of linezolid.
Gender: Females have a slightly lower volume of distribution of linezolid than males. Plasma concentrations are higher in females than in males, which is partly due to body weight differences. After a 600 mg dose, mean oral clearance is "> 38% lower in females than in males. However, there are no significant gender differences in mean apparent elimination-rate constant or half-life. Thus, drug exposure in females is not expected to substantially increase beyond levels known to be well tolerated. Therefore, dose adjustment by gender does not appear to be necessary.
Renal function impairment: The pharmacokinetics of the patent drug, linezolid, are not altered in patients with any degree of renal insufficiency; however, the 2 primary metabolites of linezolid may accumulate in patients with renal insufficiency, with the amount of accumulation increasing with the severity of renal dysfunction. The clinical significance of accumulation of these 2 metabolites has not been determined in patients with severe renal insufficiency. Given the absence of information on the clinical significance of accumulation of the primary metabolites, weigh the use of linezolid in patients with renal insufficiency against the potential risks of accumulation of these metabolites. Linezolid and the 2 metabolites are eliminated by dialysis. No information is available on the effect of peritoneal dialysis on the pharmacokinetics of linezolid. Approximately 30% of a dose was eliminated in a 3-hour dialysis session beginning 3 hours after the dose of linezolid was administered; therefore, give linezolid after hemodialysis.

Contraindications
Hypersensitivity to linezolid or any of the other product components.

Warnings
Myelosuppression: Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters rose toward pretreatment levels. Monitor complete blood counts weekly in patients who receive linezolid, particularly in those who receive linezolid for > 2 weeks, those with preexisting myelosuppression, those receiving concomitant drugs that produce bone marrow suppression or those with a chronic infection who have received previous or concomitant antibiotic therapy. Consider discontinuation of therapy with linezolid in patients who develop or have worsening myelosuppression.
Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including linezolid, and may range in severity from mild to life-threatening.
Pregnancy: Category C.
Lactation: Linezolid and its metabolites are excreted in the milk of lactating rats. Concentrations in milk were similar to those in maternal plasma. It is not known whether linezolid is excreted in human breast milk.
Children: Drug clearance of linezolid is increased in pediatric patients compared with adults, resulting in a shorter half-life. Pediatric dosing regimens that provide a pharmacokinetic profile similar to adults have not been determined.

Precautions
Duration of therapy: The safety and efficacy of linezolid formulations given for > 28 days have not been evaluated in controlled clinical trials.
Phenylcetonurics: Each 5 mL of the 100 mg/5 mL oral suspension contains 20 mg phenylalanine. The other linezolid formulations do not contain phenylalanine. Advise patients to contact their physician or pharmacist.

Drug Interactions
Drugs that may interact with linezolid include monoamine oxidase inhibitors, SSRIs, and adrenergic agents.
Drug/Food interactions: Large quantities of foods or beverages with high tyramine content should be avoided while taking linezolid.

Adverse Reactions
Thrombocytopenia - Linezolid has been associated with thrombocytopenia when used in doses 2 weeks of treatment). The platelet counts for most patients returned to the not-mal range/baseline during the follow-up period.
During clinical trials, 2% to 3% of linezolid patients discontinued therapy because of adverse effects. Adverse reactions occurring in > 3% of patients include diarrhea, nausea, and lab test abnormalities (hemoglobin, ALT, alkaline phosphatase, and lipase).
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