11 DESCRIPTION Linezolid for Oral Suspension contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is N-[[(S)-3-(3-Fluoro-4-morpholinophenyl)-2-oxo-5-ox- azolidinyl]methyl] acetamide. The molecular formula is C 16 H 20 FN 3 O 4 . Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid for Oral Suspension is supplied as an orange-flavored powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid. Inactive ingredients are aspartame, carboxymethylcellulose sodium, citric acid (anhydrous), colloidal silicon dioxide, hypromellose, mannitol, microcrystalline cellulose, natural orange flavor, sodium benzoate, sodium chloride, sodium citrate, sucrose, and xanthan gum [see Patient Counseling Information ( 17 )]. The sodium (Na + ) content is 8.52 mg per 5 mL (0.4 mEq per 5 mL). chem-structure.jpg
⚠️ Warnings
• Linezolid has some ability to inhibit the enzyme MAO or monoamine oxidase. This enzyme plays a role in breaking down chemicals like adrenaline, dopamine and serotonin. Therefore, inhibition of the enzyme results in increased levels of these chemicals in the body. High adrenaline levels can cause increase in blood pressure, while high serotonin levels can result in a condition called serotonin syndrome. Symptoms of serotonin syndrome include confusion, seizures, high blood pressure, tremors, stomach cramps and muscle spasms. Therefore, linezolid should be avoided with other drugs that could have an additive effect. For the same reason, tyramine rich foods like cheese, bananas, yogurt, raisins, avocados and papaya products should be avoided when the patient is on linezolid.
• Caution should be exercised in patients with history of high blood pressure, overactive thyroid, kidney disease, eye problems, low blood cell counts, carcinoid tumors (tumors which secrete serotonin), prior allergies, children, during pregnancy and breastfeeding. It may cause dizziness, do not drive a car or operate machinery while taking this medication. Avoid alcohol consumption. Avoid long-term use of this medication; otherwise it may cause secondary infection. It may decrease platelet counts; avoid bruising or injury. Monitor complete blood counts regularly while taking this medication.