Zyvoxid - General Information:Zyvoxid is a synthetic antibiotic, the first of the oxazolidinone class, used for the treatment of infections caused by multi-resistant bacteria including streptococcus and methicillin-resistant Staphylococcus aureus (MRSA). The drug works by inhibiting the initiation of bacterial protein synthesis.
Pharmacology:Zyvoxid is a synthetic antibacterial agent of a new class of antibiotics, the oxazolidinones, which has clinical utility in the treatment of infections caused by aerobic Gram-positive bacteria. The in vitro spectrum of activity of linezolid also includes certain Gram-negative bacteria and anaerobic bacteria. Susceptible organisms include methicillin- and vancomycin-resistant staphylococci, vancomycin-resistant enterococci, penicillin-resistant pneumococci and anaerobes. Oxazolidinones inhibit protein synthesis by binding at the P site at the ribosomal 50S subunit. Resistance to other protein synthesis inhibitors does not affect oxazolidinone activity, however rare development of oxazolidinone resistance cases, associated with 23S rRNA alterations during treatment have been reported. Zyvoxid inhibits bacterial protein synthesis through a mechanism of action different from that of other antibacterial agents; therefore, cross-resistance between linezolid and other classes of antibiotics is unlikely.
Zyvoxid for patients
Patients should be advised that:
· ZYVOX may be taken with or without food.
· They should inform their physician if they have a history of hypertension.
· Large quantities of foods or beverages with high tyramine content should be avoided while taking ZYVOX. Quantities of tyramine consumed should be less than 100 mg per meal. Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavor, such as aged cheeses (0 to 15 mg tyramine per ounce); fermented or air-dried meats (0.1 to 8 mg tyramine per ounce); sauerkraut (8 mg tyramine per 8 ounces); soy sauce (5 mg tyramine per 1 teaspoon); tap beers (4 mg tyramine per 12 ounces); red wines (0 to 6 mg tyramine per 8 ounces). The tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.9,10
· They should inform their physician if taking medications containing pseudoephedrine HCl or phenylpropanolamine HCl, such as cold remedies and decongestants.
· They should inform their physician if taking serotonin re-uptake inhibitors or other antidepressants.
· Phenylketonurics: Each 5 mL of the 100 mg/5 mL ZYVOX for Oral Suspension contains 20 mg phenylalanine. The other ZYVOX formulations do not contain phenylalanine. Contact your physician or pharmacist.
· They should inform their physician if they experience changes in vision.
Patients should be counseled that antibacterial drugs including ZYVOX should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZYVOX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZYVOX or other antibacterial drugs in the future.
9. Walker SE et al. Tyramine content of previously restricted foods in monoamine oxidase inhibitor diets. Journal of Clinical Psychopharmacology 1996;16(5):383-388.
10. DaPrada M et al. On tyramine, food, beverages and the reversible MAO inhibitor moclobemide. Journal of Neural Transmission 1988; [Supplement] 26:31-56. 11. Fine MJ, Auble TE, Yealy DM, et al. A Prediction Rule to Identify Low-Risk Patients with Community-Acquired Pneumonia. The New England Journal of Medicine. 1997;336 (4):243-250.
Monoamine Oxidase Inhibition: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic agents.
Adrenergic Agents:Some individuals receiving ZYVOX may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Commonly used drugs such as phenylpropanolamine and pseudoephedrine have been specifically studied. Initial doses of adrenergic agents, such as dopamine or epinephrine, should be reduced and titrated to achieve the desired response.
Serotonergic Agents: Co-administration of linezolid and serotonergic agents was not associated with serotonin syndrome in Phase 1, 2 or 3 studies. Spontaneous reports of serotonin syndrome associated with co-administration of ZYVOX and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported. Patients who are treated with ZYVOX and concomitant serotonergic agents should be closely observed for signs and symptoms of serotonin syndrome (e.g., cognitive dysfunction, hyperpyrexia, hyperreflexia, incoordination). If any signs or symptoms occur physicians should consider discontinuation of either one or both agents (ZYVOX or concomitant serotonergic agents).
Drug-Laboratory Test Interactions
There are no reported drug-laboratory test interactions.
ZYVOX formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
Additional information about ZyvoxidZyvoxid Indication: For the treatment of bacterial infections caused by susceptible strains of vancomycin resistant Enterococcus faecium, Staphylococcal aureus (methicillin resistant and susceptible strains), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae.
Mechanism Of Action: Zyvoxid is a synthetic antibacterial agent of the oxazolidinone class of antibiotics. It has in vitro activity against aerobic Gram positive bacteria, certain Gram negative bacteria and anaerobic microorganisms. It selectively inhibits bacterial protein synthesis through binding to sites on the bacterial ribosome and prevents the formation of a functional 70S-initiation complex. Specifically, linezolid 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. The results of time-kill studies have shown linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, linezolid was found to be bactericidal for the majority of strains. Zyvoxid is also a reversible, nonselective inhibitor of monoamine oxidase. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic agents.
Drug Interactions: Citalopram Combination associated with possible serotoninergic syndrome
Escitalopram Combination associated with possible serotoninergic syndrome
Fluvoxamine Combination associated with possible serotoninergic syndrome
Nefazodone Combination associated with possible serotoninergic syndrome
Paroxetine Combination associated with possible serotoninergic syndrome
Sertraline Combination associated with possible serotoninergic syndrome
Venlafaxine Combination associated with possible serotoninergic syndrome
Terbutaline Possible increase of arterial pressure
Salbutamol Possible increase of arterial pressure
Pseudoephedrine Possible increase of arterial pressure
Procaterol Possible increase of arterial pressure
Pirbuterol Possible increase of arterial pressure
Phenylpropanolamine Possible increase of arterial pressure
Dobutamine Possible increase of arterial pressure
Dopamine Possible increase of arterial pressure
Ephedra Possible increase of arterial pressure
Ephedrine Possible increase of arterial pressure
Epinephrine Possible increase of arterial pressure
Fluoxetine Possible increase of arterial pressure
Fenoterol Possible increase of arterial pressure
Isoproterenol Possible increase of arterial pressure
Mephentermine Possible increase of arterial pressure
Metaraminol Possible increase of arterial pressure
Methoxamine Possible increase of arterial pressure
Norepinephrine Possible increase of arterial pressure
Orciprenaline Possible increase of arterial pressure
Phenylephrine Possible increase of arterial pressure
Food Interactions: Take without regard to meals.
Generic Name: Linezolid
Synonyms: Not Available
Drug Category: Anti-Infective Agents; Antibacterial Agents; Protein Synthesis Inhibitors
Drug Type: Small Molecule; Approved
Other Brand Names containing Linezolid: Linezlid; Zyvox; Zyvoxid;
Absorption: Linezolid is rapidly and extensively absorbed after oral dosing. Maximum plasma concentrations are reached approximately 1 to 2 hours after dosing, and the absolute bioavailability is approximately 100%.
Toxicity (Overdose): Clinical signs of acute toxicity lead to decreased activity, ataxia, vomiting and tremors.
Protein Binding: 31%
Biotransformation: Linezolid is primarily metabolized by oxidation of the morpholine ring, which results in two inactive ring-opened carboxylic acid metabolites: the aminoethoxyacetic acid metabolite (A), and the hydroxyethyl glycine metabolite
Half Life: 4.5-5.5 hours
Dosage Forms of Zyvoxid: Solution Intravenous
Chemical IUPAC Name: N-[[(5S)-3-(3-fluoro-4-morpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl]acetamide
Chemical Formula: C16H20FN3O4
Linezolid on Wikipedia: http://en.wikipedia.org/wiki/Linezolid
Organisms Affected: Gram negative and gram positive bacteria
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