What is zyvox medication

The cure rates by pathogen for microbiologically evaluable patients are presented in Table Adult patients with clinically documented complicated skin and skin structure infections were enrolled in a randomized, multi-center, double-blind, double-dummy trial comparing study medications administered intravenously followed by medications given orally for a total of 10 to 21 days of treatment.

Injection mg every 12 hours followed by ZYVOX Tablets mg every 12 hours; the other group received oxacillin 2 g every 6 hours intravenously followed by dicloxacillin mg every 6 hours orally. Patients could receive concomitant aztreonam if clinically indicated. There were linezolid-treated and oxacillin-treated patients enrolled in the study. A modified intent-to-treat MITT analysis of linezolid-treated patients and oxacillin-treated patients included subjects who met all criteria for study entry.

This was a randomized, open-label trial in hospitalized adult patients with documented or suspected MRSA infection. The other group of patients received vancomycin 1 g every 12 hours intravenously. Both groups were treated for 7 to 28 days, and could receive concomitant aztreonam or gentamicin if clinically indicated. Adult diabetic patients with clinically documented complicated skin and skin structure infections "diabetic foot infections" were enrolled in a randomized ratio , multi-center, open-label trial comparing study medications administered intravenously or orally for a total of 14 to 28 days of treatment.

Patients in the comparator group could also be treated with vancomycin 1 g every 12 hours intravenously if MRSA was isolated from the foot infection. Patients in either treatment group who had Gram-negative bacilli isolated from the infection site could also receive aztreonam 1 to 2 g every 8—12 hours intravenously. All patients were eligible to receive appropriate adjunctive treatment methods, such as debridement and off-loading, as typically required in the treatment of diabetic foot infections, and most patients received these treatments.

There were linezolid-treated and comparator-treated patients in the intent-to-treat ITT study population. In the ITT population, the cure rates were A critical post-hoc analysis focused on linezolid-treated and 60 comparator-treated patients who had a Gram-positive pathogen isolated from the site of infection or from blood, who had less evidence of underlying osteomyelitis than the overall study population, and who did not receive prohibited antimicrobials.

None of the above analyses were adjusted for the use of adjunctive therapies. Adult patients with documented or suspected vancomycin-resistant enterococcal infection were enrolled in a randomized, multi-center, double-blind trial comparing a high dose of ZYVOX mg with a low dose of ZYVOX mg given every 12 hours either intravenously IV or orally for 7 to 28 days. Patients could receive concomitant aztreonam or aminoglycosides.

There were 79 patients randomized to high-dose linezolid and 66 to low-dose linezolid. The intent-to-treat ITT population with documented vancomycin-resistant enterococcal infection at baseline consisted of 65 patients in the high-dose arm and 52 in the low-dose arm. The cure rates for the ITT population with documented vancomycin-resistant enterococcal infection at baseline are presented in Table 15 by source of infection.

These cure rates do not include patients with missing or indeterminate outcomes. The cure rate was higher in the high-dose arm than in the low-dose arm, although the difference was not statistically significant at the 0. A safety and efficacy study provided experience on the use of ZYVOX in pediatric patients for the treatment of nosocomial pneumonia, complicated skin and skin structure infections, and other infections due to Gram-positive bacterial pathogens, including methicillin-resistant and -susceptible Staphylococcus aureus and vancomycin-resistant Enterococcus faecium.

Pediatric patients ranging in age from birth through 11 years with infections caused by the documented or suspected Gram-positive bacteria were enrolled in a randomized, open-label, comparator-controlled trial.

All patients were treated for a total of 10 to 28 days and could receive concomitant Gram-negative antibacterial drugs if clinically indicated. In the intent-to-treat ITT population, there were patients randomized to linezolid and patients randomized to vancomycin.

After the study was completed, 13 additional patients ranging from 4 days through 16 years of age were enrolled in an open-label extension of the VRE arm of the study. Table 17 provides clinical cure rates by pathogen for microbiologically evaluable patients including microbiologically evaluable patients with vancomycin-resistant Enterococcus faecium from the extension of this study. Injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap.

The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes:. Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.

Advise patients to inform their physician if taking serotonergic agents, including serotonin re-uptake inhibitors or other antidepressants and opioids [ see Warnings and Precautions 5.

Advise patients to inform their physician if they experience repeated episodes of nausea or vomiting while receiving ZYVOX [ see Warnings and Precautions 5. Advise patients to inform their physician if they have a history of seizures or convulsions [ see Warnings and Precautions 5.

Advise patients to inform their physician if they have diabetes mellitus. Hypoglycemic reactions, such as diaphoresis and tremulousness, along with low blood glucose measurements may occur when treated with linezolid. If such reactions occur, patients should contact a physician or other health professional for proper treatment [ see Warnings and Precautions 5. Phenylalanine can be harmful to patients with phenylketonuria. Patients should be counseled that antibacterial drugs including ZYVOX should only be used to treat bacterial infections.

They do not treat viral infections e. 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 [ see Warnings and Precautions 5. Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued.

Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools with or without stomach cramps and fever even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [ see Warnings and Precautions 5. This product's labeling may have been updated.

For the most recent prescribing information, please visit www. Do not freeze. Each mL contains: linezolid 2 mg dextrose, USP Sterile and nonpyrogenic. Single dose container. Do not add supplementary medication. Do not use in series connections. For intravenous administration Check for leaks by squeezing container. If leaks are found, discard, as sterility may be impaired. Check linezolid solution for clarity; it may exhibit a yellow color that intensifies over time, with no adverse effect on potency.

Linezolid is sensitive to light. Retain overwrap prior to use. Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

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Approval: The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials. Consider discontinuation in patients who develop or have worsening myelosuppression.

If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. Patients taking serotonergic antidepressants should receive ZYVOX only if no other therapies are available.

Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions 5.

The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials [ see Clinical Studies 14 ]. Table 1. Adults The safety of ZYVOX formulations was evaluated in 2, adult patients enrolled in seven Phase 3 comparator-controlled clinical trials, who were treated for up to 28 days.

Table 2. Headache 8. Pediatric Patients The safety of ZYVOX formulations was evaluated in pediatric patients ranging in age from birth through 11 years, and in pediatric patients aged 5 through 17 years of these were age 5 through 11 and were age 12 to Table 3.

Patients 12 years or older received ZYVOX mg by mouth every 12 hours or cefadroxil mg by mouth every 12 hours. Diarrhea 7. Laboratory Abnormalities ZYVOX has been associated with thrombocytopenia when used in doses up to and including mg every 12 hours for up to 28 days. Table 4. Table 5. Table 6. Table 7. Patients 12 years or older received ZYVOX mg mouth every 12 hours or cefadroxil mg by mouth every 12 hours.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure; Myelosuppression including anemia, leukopenia, pancytopenia, and thrombocytopenia [ see Warnings and Precautions 5. Peripheral neuropathy, and optic neuropathy sometimes progressing to loss of vision [ see Warnings and Precautions 5.

Lactic acidosis [ see Warnings and Precautions 5. Although these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days, these events have also been reported in patients receiving shorter courses of therapy.

Serotonin syndrome has been reported in patients receiving concomitant serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors SSRIs and opioids, and ZYVOX [ see Warnings and Precautions 5.

Convulsions [ see Warnings and Precautions 5. Anaphylaxis, angioedema, bullous skin disorders including severe cutaneous adverse reactions SCAR such as toxic epidermal necrolysis and Stevens-Johnson syndrome, and hypersensitivity vasculitis.

Superficial tooth discoloration and tongue discoloration have been reported with the use of linezolid. The tooth discoloration was removable with professional dental cleaning manual descaling in cases with known outcome.

Hypoglycemia, including symptomatic episodes [ see Warnings and Precautions 5. Data Animal Data In mice, embryo-fetal toxicities were observed only at doses that caused maternal toxicity clinical signs and reduced body weight gain. Clinical Considerations Advise lactating women to monitor a breastfed infant for diarrhea and vomiting. Table 8. Absorption Linezolid is extensively absorbed after oral dosing. Distribution Animal and human pharmacokinetic studies have demonstrated that linezolid readily distributes to well-perfused tissues.

Metabolism 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 B.

Specific Populations Geriatric Patients The pharmacokinetics of linezolid are not significantly altered in elderly patients 65 years or older. Pediatric Patients The pharmacokinetics of linezolid following a single intravenous dose were investigated in pediatric patients ranging in age from birth through 17 years including premature and full-term neonates , in healthy adolescent subjects ranging in age from 12 through 17 years, and in pediatric patients ranging in age from 1 week through 12 years.

Table 9. Gender Females have a slightly lower volume of distribution of linezolid than males. Renal Impairment The pharmacokinetics of the parent drug, linezolid, are not altered in patients with any degree of renal impairment; however, the two primary metabolites of linezolid accumulate in patients with renal impairment, with the amount of accumulation increasing with the severity of renal dysfunction see Table Table Antibacterial Drugs Aztreonam : The pharmacokinetics of linezolid or aztreonam are not altered when administered together.

Antioxidants The potential for drug-drug interactions with linezolid and the antioxidants Vitamin C and Vitamin E was studied in healthy volunteers. Strong CYP 3A4 Inducers Rifampin: The effect of rifampin on the pharmacokinetics of linezolid was evaluated in a study of 16 healthy adult males. Monoamine Oxidase Inhibition Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Adrenergic Agents Some individuals receiving ZYVOX may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents.

Serotonergic Agents Dextromethorphan: The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Resistance In vitro studies have shown that point mutations in the 23S rRNA are associated with linezolid resistance. Interaction with Other Antimicrobial Drugs In vitro studies have demonstrated additivity or indifference between linezolid and vancomycin, gentamicin, rifampin, imipenem-cilastatin, aztreonam, ampicillin, or streptomycin.

Gram-positive bacteria Enterococcus faecium vancomycin-resistant isolates only Staphylococcus aureus including methicillin-resistant isolates Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes The following in vitro data are available, but their clinical significance is unknown.

Gram-positive bacteria Enterococcus faecalis including vancomycin-resistant isolates Enterococcus faecium vancomycin-susceptible isolates Staphylococcus epidermidis including methicillin-resistant isolates Staphylococcus haemolyticus Viridans group streptococci.

Gram-negative bacteria Pasteurella multocida. Complicated Skin and Skin Structure Infections Adult patients with clinically documented complicated skin and skin structure infections were enrolled in a randomized, multi-center, double-blind, double-dummy trial comparing study medications administered intravenously followed by medications given orally for a total of 10 to 21 days of treatment.

Linezolid will not treat a viral infection flu or a common cold. Store all forms of linezolid at room temperature away from moisture, heat, and light. Do not freeze. Throw away any liquid not used within 21 days. Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Health Topics. Health Tools. Reviewed: September 23, You should not use linezolid if you are allergic to it. Tell your doctor if you have ever had: high blood pressure; a thyroid disorder; a carcinoid tumor; bone marrow suppression or a weak immune system; kidney or liver disease; pheochromocytoma adrenal gland tumor ; diabetes; seizures; or if you use a catheter.

Tell your doctor if you are pregnant or breastfeeding. Side Effects. Call your doctor at once if you have: vision problems, changes in color vision; severe stomach pain, diarrhea that is watery or bloody; a seizure; sweating, feeling anxious or shaky may be signs of low blood sugar ; lactic acidosis --unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or low blood cell counts --fever, chills, tiredness, weakness, confusion, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include: nausea, vomiting, diarrhea; rash; anemia low red blood cells ; or headache, dizziness. Based on FDA pregnancy categories. Avoid foods that have a high level of tyramine, such as: [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] You should be very familiar with the list of foods you must avoid while you are using linezolid. Linezolid tablets or liquid can be taken with or without food.

Linezolid injection is given in a vein. Do not use in larger or smaller amounts or for longer than recommended. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Gently mix the oral suspension liquid by turning the bottle upside down 3 to 5 times. Do not shake. Measure a dose with the supplied syringe or a dose-measuring device not a kitchen spoon. Prepare an injection only when you are ready to give it.

Call your pharmacist if the medicine has particles in it. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You will need frequent medical tests. Your vision and blood pressure may also need to be checked often. Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication.

Linezolid will not treat a viral infection flu or a common cold. Store all forms of linezolid at room temperature away from moisture, heat, and light.

Do not freeze. Throw away any liquid not used within 21 days.