Buy Zyvox Online

Zyvox (linezolid)

THERAPEUTIC CLASS

Oxazolidinone class antibacterial

DEA CLASS

RX

INDICATIONS

Treatment of nosocomial pneumonia; community-acquired pneumonia, including cases w/ concurrent bacteremia; complicated skin and skin structure infections (SSSIs), including diabetic foot infections, w/o concomitant osteomyelitis; uncomplicated SSSIs; and vancomycin-resistant Enterococcus faecium infections, including cases w/ concurrent bacteremia, caused by susceptible strains of designated microorganisms.

ADULT DOSAGE

Pneumonia

Nosocomial/Community-Acquired Pneumonia, Including Concurrent Bacteremia:
600mg q12h for 10-14 consecutive days

Vancomycin-Resistant Enterococcus faecium Infections

Including Concurrent Bacteremia:
600mg q12h for 14-28 consecutive days

Skin and Skin Structure Infections

Complicated:
IV/Oral:
600mg q12h for 10-14 consecutive days

Uncomplicated:
Oral:
400mg q12h for 10-14 consecutive days

PEDIATRIC DOSAGE

Skin and Skin Structure Infections

Preterm Neonates <7 Days of Age:
Initial: 10mg/kg q12h
Titrate: Increase to 10mg/kg q8h if clinical response is suboptimal. All neonates should receive 10mg/kg q8h by 7 days of life
Treatment Duration: 10-14 consecutive days

Complicated:
IV/Oral:
Birth-11 Years:
10mg/kg q8h for 10-14 consecutive days
≥12 Years:
600mg q12h for 10-14 consecutive days

Uncomplicated:
Oral:
<5 Years:
10mg/kg q8h for 10-14 consecutive days
5-11 Years:
10mg/kg q12h for 10-14 consecutive days
≥12 Years:
600mg q12h for 10-14 consecutive days

Pneumonia

Nosocomial/Community-Acquired Pneumonia, Including Concurrent Bacteremia:

Preterm Neonates <7 Days of Age:
Initial:
10mg/kg q12h
Titrate:
Increase to 10mg/kg q8h if clinical response is suboptimal. All neonates should receive 10mg/kg q8h by 7 days of life
Treatment Duration:
10-14 consecutive days

Birth-11 Years:
10mg/kg q8h for 10-14 consecutive days

≥12 Years:
600mg q12h for 10-14 consecutive days

Vancomycin-Resistant Enterococcus faecium Infections

Including Concurrent Bacteremia:

Neonates <7 Days of Age:
Initial: 10mg/kg q12h
Titrate: Increase to 10mg/kg q8h if clinical response is suboptimal. All neonates should receive 10mg/kg q8h by 7 days of life
Treatment Duration: 14-28 consecutive days

Birth-11 Years:
10mg/kg q8h for 14-28 consecutive days

≥12 Years:
600mg q12h for 14-28 consecutive days

ADMINISTRATION

Oral/IV route

May be administered w/o regard to the timing of meals.

IV
May exhibit a yellow color that can intensify over time w/o adversely affecting potency.
Infuse over 30-120 min.
Do not use infusion bag in series connections.
Do not introduce additives into linezolid inj sol; if given concomitantly w/ another drug, give each drug separately.

Compatible IV Sol:
0.9% NaCl
D5 inj
Lactated Ringer's inj

Refer to PI for incompatibilites.

Sus
Reconstitute w/ 123mL distilled water in 2 portions; shake vigorously after each portion.
After constitution, before using, gently mix by inverting the bottle 3-5X.
Do not shake.
Store reconstituted sus at room temperature; use w/in 21 days.

HOW SUPPLIED

Inj: 2mg/mL [100mL, 200mL, 300mL]; Sus: 100mg/5mL [150mL]; Tab: 600mg

CONTRAINDICATIONS

Use of MAOIs A or B (eg, phenelzine, isocarboxazid) either concomitantly or w/in 2 weeks of taking such drugs.

WARNINGS/PRECAUTIONS

Myelosuppression (eg, anemia, leukopenia, pancytopenia, thrombocytopenia) reported; monitor CBC weekly, particularly in those who receive treatment for >2 weeks, w/ preexisting myelosuppression, receiving concomitant drugs that produce bone marrow suppression, or w/ a chronic infection who have received previous or concomitant antibiotic therapy. Consider discontinuation if myelosuppression develops or worsens. Peripheral and optic neuropathies and visual blurring reported; prompt ophthalmic evaluation is recommended if patient experiences visual impairment symptoms. Monitor visual function if used for extended periods (≥3 months) or if new visual symptoms develop. Weigh continued use against potential risk if peripheral/optic neuropathy occurs. Do not administer w/ carcinoid syndrome. Not approved and should not be used for the treatment of catheter-related bloodstream infections or catheter-site infections. Not indicated for the treatment of gram-negative infections; initiate specific gram-negative therapy immediately if a concomitant gram-negative pathogen is documented or suspected. Clostridium difficile-associated diarrhea (CDAD) reported; may need to d/c if CDAD is suspected or confirmed. Do not administer w/ uncontrolled HTN, pheochromocytoma, or thyrotoxicosis, unless patients are monitored for potential increases in BP. Lactic acidosis reported; evaluate immediately if recurrent N/V, unexplained acidosis, or a low bicarbonate level develops. Convulsions reported. May result in bacterial resistance if used in the absence of a proven or suspected bacterial infection or a prophylactic indication.

ADVERSE REACTIONS

Diarrhea, headache, N/V, anemia, thrombocytopenia, abnormal Hgb/WBCs/neutrophils, serum AST/ALT/alkaline phosphatase/lipase/total bilirubin elevations.

DRUG INTERACTIONS

See Contraindications. Serotonin syndrome reported w/ serotonergic agents, including antidepressants such as SSRIs; do not administer in patients taking serotonin reuptake inhibitors, TCAs, 5-HT1 receptor agonists (triptans), meperidine, bupropion, or buspirone, unless clinically appropriate and patients are carefully observed for signs/symptoms of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions. If alternatives to linezolid are not available and the potential benefits of linezolid outweigh the risks of serotonin syndrome or NMS-like reactions, promptly d/c the serotonergic antidepressant and administer linezolid; monitor for 2 weeks (5 weeks if fluoxetine was taken) or until 24 hrs after the last dose of linezolid, whichever comes 1st. Do not administer w/ directly and indirectly acting sympathomimetic agents (eg, pseudoephedrine), vasopressive agents (eg, epinephrine, norepinephrine), or dopaminergic agents (eg, dopamine, dobutamine), unless patients are monitored for potential increases in BP. Symptomatic hypoglycemia reported in patients w/ diabetes mellitus (DM) receiving insulin or oral hypoglycemic agents when treated w/ linezolid; may need to decrease dose of insulin or oral hypoglycemic agent, or d/c the oral hypoglycemic agent, insulin, or linezolid, if hypoglycemia occurs.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Oxazolidinone antibacterial; inhibits bacterial protein synthesis. 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.

PHARMACOKINETICS

Absorption: (PO) Extensive. Absolute bioavailability (100%). Distribution: Vd=40-50L; plasma protein binding (31%). Metabolism: Oxidation of the morpholine ring. Elimination: Urine (30% unchanged), feces.

Administration of variable doses resulted in different pharmacokinetic parameters.

ASSESSMENT

Assess for hypersensitivity to drug, myelosuppression, catheter-related bloodstream/catheter-site infections, uncontrolled HTN, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for peripheral/optic neuropathy, CDAD, lactic acidosis, convulsions, potential increases in BP, and other adverse reactions. Monitor CBC weekly. Monitor visual function if used for extended periods (≥3 months) or if new visual symptoms develop.

PATIENT COUNSELING

Explain that therapy should only be used to treat bacterial, not viral, infections. Instruct to take exactly ud even if the patient feels better early in the course of therapy. Inform that skipping doses or not completing the full course of therapy may decrease effectiveness of treatment and increase bacterial resistance. Instruct to notify physician if patient has a history of HTN or seizures, is taking medications containing pseudoephedrine or phenylpropanolamine (eg, cold remedies, decongestants) or antidepressants, or is experiencing visual changes. Instruct to avoid large quantities of foods or beverages w/ high tyramine-containing. Inform phenylketonurics that oral sus contains phenylalanine. Advise that diarrhea is a common problem caused by therapy that usually ends when therapy is discontinued. Instruct to immediately contact physician if watery and bloody stools (w/ or w/o stomach cramps and fever) occur, even as late as ≥2 months after having taken the last dose. Inform patients, particularly those w/ DM, that hypoglycemia may occur; instruct to contact physician if this occurs.

STORAGE

25°C (77°F). Protect from light. (IV) Keep infusion bags in the overwrap until ready to use. Protect from freezing. (Tab/Sus) Protect from moisture.

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