ZYVOX Solution for Infusion IV, ZYVOX Film Coated Tablets, ZYVOX Powder for Oral Suspension) contain Linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide.
The empirical formula is C16H20FN3O4. Its molecular weight is 337.35.
Linezolid (ZYVOX) Film Coated Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet.
Linezolid (ZYVOX) for Powder for Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of linezolid.
Linezolid (ZYVOX) Solution for Infusion (IV) is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid.
Excipients/Inactive Ingredients: Tablet: Inactive ingredients are carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide. The sodium (Na+) content is 2.92 mg per 600-mg tablet (0.1 mEq/tablet).
Powder for Oral Suspension: Inactive ingredients are aspartame, citric acid, colloidal silicon dioxide, flavors, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose and xanthan gum (see Patient Counselling Information). The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL).
Infusion: Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300-mL bag and 1.7 mEq/100-mL bag).
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