Contraindications

Hypersensitivity

Within 14 days of taking MAO inhibitor

Cautions

Use caution in patients with pheochromocytoma, concurrent apraclonidine, brimonidine, uncontrolled hypertension, thyrotoxicosis, carcinoid syndrome, diabetes mellitus, or seizure disorders

Phenylalanine can be harmful to patients with phenylketonuria (PKU); oral suspension contains phenylalanine, a component of aspartame; each 5 mL of the 100 mg/5 mL oral suspension contains 20 mg of phenylalanine; before prescribing oral suspension to patient with PKU, consider combined daily amount of phenylalanine from all sources, including oral suspension; the other formulations do not contain phenylalanine

Not approved for gram-negative bacteria or for catheter-related infections; clinical study showed higher mortality rate with linezolid than with other antibiotics for these conditions

Evaluate for clostridium difficile if diarrhea occurs

Peripheral and optic neuropathy reported, especially in patients given extended courses of therapy >28 days

May cause hypoglycemia; monitor blood glucose levels

Lactic acidosis reported with use; immediately evaluate patients who develop recurrent unexplained acidosis with nausea and vomiting

Superinfection may develop

Myelosuppression

• Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) reported in patients receiving this medication; in cases where outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels
• Thrombocytopenia reported more often in patients with severe renal impairment, whether or not on dialysis, and in patients with moderate to severe hepatic impairment
• Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those with severe renal impairment or moderate to severe hepatic impairment, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibacterial drug therapy
• Consider discontinuation of therapy in patients who develop or have worsening myelosuppression

Hyponatremia

• Postmarketing cases of hyponatremia and/or syndrome of inappropriate antidiuretic hormone secretion (SIADH) reported; in reported cases, the signs and symptoms included confusion, somnolence, generalized weakness, and in severe cases led to respiratory failure and even death
• Monitor serum sodium levels regularly in the elderly, in patients taking diuretics, and in other patients at risk of hyponatremia and/or SIADH while taking drug
• If signs and symptoms of hyponatremia and/or SIADH occur, discontinue therapy and institute appropriate supportive measures

Serotonin syndrome

• Avoid coadministration with serotonergic psychiatric drugs (eg, SSRIs, SNRIs, TCAs, MAOIs, bupropion, buspirone, serotonin 5-HT1 receptor agonists (triptans), and opioids, including meperidine) unless indicated for life-threatening or urgent infections (eg, vancomycin-resistant enterococcal infections, nosocomial pneumonia, complicated skin and skin structure infections such as methicillin-resistant S aureus), due to increased risk of serotonin syndrome; linezolid may increase serotonin CNS levels by MAO-A inhibition
• If linezolid must be administered to a patient currently taking a serotonergic drug, stop serotonergic drug immediately and monitor for CNS toxicity; serotonergic therapy may be resumed 24 hours after last linezolid dose or after 2 weeks of monitoring (5 weeks if fluoxetine was taken), whichever comes first; serotonergic psychiatric medications should be stopped at least 2 weeks in advance of linezolid therapy; fluoxetine should be stopped at least 5 weeks in advance due to longer half-life

Pregnancy & Lactation