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56/100Limited · 1 source
Based on 1 source · Manufacturer recall-safety score (FDA recall history) — not an efficacy or quality rating. methodology →
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$1.48 /mL
Overview
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
How to use
Dosage, Route, and Frequency of Administration Infection Pediatric Patients (Birth through 11 years of age) Adults and Adolescents (12 years and older) Duration (Days) Nosocomial pneumonia Community-acquired pneumonia, including concurrent bacteremia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous or oral every 12 hours 10 to 14 Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous or oral every 12 hours 14 to 28 Uncomplicated skin and skin structure infections less than 5 yrs: 10 mg/kg oral every 8 hours 5 to 11 yrs: 10 mg/kg oral every 12 hours Adults: 400 mg oral every 12 hours Adolescents: 600 mg oral every 12 hours 10 to 14 2.1 General Dosage and Administration The recommended dosage for linezolid formulations for the treatment of infections is described in Table 1. Table 1. Dosage Guidelines for Linezolid Infection Due to the designated pathogens [see Indications and Usage ( 1 )]. Dosage, Route, and Frequency of Administration Recommended Duration of Treatment (Consecutive Days) Pediatric Patients Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older…
Side effects
Most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ()] Peripheral and Optic Neuropathy [see Warnings and Precautions ()] Serotonin Syndrome [see Warnings and Precautions ()] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ()] Lactic Acidosis [see Warnings and Precautions ()] Convulsions [see Warnings and Precautions ()] Rhabdomyolysis [see Warnings and Precautions ()] Hypoglycemia [see Warnings and Precautions ()] Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) [see Warnings and Precautions ()] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults : The safety of linezolid formulations was evaluated in 2,046 adult patients enrolled in seven Phase 3 comparator-controlled clinical…
Warnings
Important safety information
5 WARNINGS AND PRECAUTIONS • Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. ( 5.1 ) • Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. ( 5.2 ) • Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. ( 5.3 ) • A mortality imbalance was seen in an investigational study in linezolid‑treated patients with catheter-related bloodstream infections. ( 5.4 ) • Clostridioides difficile- Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.5 ) • Potential interactions producing elevation of blood pressure: monitor blood pressure. ( 5.6 ) • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue linezolid and initiate appropriate therapy. ( 5.9 ) •…
Interactions
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. ( 4.2 , 5.3 , 5.6 , 7 , 12.3 ) 7.1 Monoamine Oxidase Inhibitors Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see Contraindications ( 4.2 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Adrenergic and Serotonergic Agents Linezolid has the potential for interaction with adrenergic and serotonergic agents [see Warnings and Precautions ( 5.3 , 5.6 ) and Clinical Pharmacology ( 12.3 )] .
Drug class
May treat
Dosage forms
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Frequently asked questions
- What is Zyvox?
- 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
- What does Zyvox treat?
- Zyvox (Linezolid) is indicated for staphylococcal infections, streptococcal infections, skin diseases, bacterial, pneumonia, bacterial, soft tissue infections, per its drug-label indications. This is general reference, not medical advice.
- How is Zyvox rated?
- pharmaranks gives Zyvox a composite score of 2.8 out of 5, combining 1 weighted source (regulatory data weighted highest) and 126 user reviews. See our methodology at /how-we-rate.
- How much does Zyvox cost?
- Zyvox has a typical acquisition cost of about $1.48 per ml, based on CMS NADAC data.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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56/100