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Keep this leaflet even after your treatment with Zyvox is finished. You may need to read it again. Talk to the doctor or pharmacist, if you have any concerns about you or your child being given Zyvox. Also tell the doctor if your or your child's diet contains a lot of mature cheese, yeast extracts, meat extracts, soya bean extracts e.
Other strong inducers of hepatic enzymes e. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic 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. Tyramine: A significant pressor response has been observed in normal adult subjects receiving linezolid and tyramine doses of more than 100 mg. A similar study has not been conducted in hypertensive patients. The interaction studies conducted in normotensive subjects evaluated the blood pressure and heart rate effects of placebo, PPA or PSE alone, linezolid alone, and the combination of steady-state linezolid 600 mg every 12 hours for 3 days with two doses of PPA 25 mg or PSE 60 mg given 4 hours apart.
Heart rate was not affected by any of the treatments. Blood pressure was increased with both combination treatments. Dextromethorphan: The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Subjects were administered dextromethorphan two 20-mg doses given 4 hours apart with or without linezolid.
No serotonin syndrome effects confusion, delirium, restlessness, tremors, blushing, diaphoresis, hyperpyrexia have been observed in normal subjects receiving linezolid and dextromethorphan.
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Not much later, in December of 1997, the popular nonsedating antihistamine terfenadine Seldane was withdrawn due to its risk of causing potentially fatal heart arrhythmias when combined with the macrolide class of antibiotics and because safer alternatives existed. The drug had been in widespread use since its FDA approval 12 years previously. Amazingly, the situation with these two drugs is not unique nor is it rare.
This includes approximately 5,000 brand name, generic and over-the counter drugs. Physicians are encouraged to report adverse effects of medications they have administered, but this reporting is not mandatory.
A major weakness of this optional reporting system is that it is difficult or impossible to estimate reliably how often adverse events are occurring. For example, the toxic effects of the heart medication digoxin are well documented and include a particularly serious heart arrhythmia.
Each year, the FDA receives an average of only 82 adverse reaction reports for digoxin, suggesting that the drug is not particularly dangerous.
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Clinical success rates at the end of study were 57. These results demonstrated that Zyvox achieved a statistically significantly higher clinical success rate compared to vancomycin 95 percent confidence interval for the difference in response rates: 0. Results were consistent for the per-protocol group at end of treatment and for all MRSA pneumonia subjects modified intent-to-treat at end of treatment and end of study.
Microbiologic success was also consistent in both the per-protocol and the modified intent-to-treat groups at both end of treatment and end of study. Treatment-related adverse events reported in 1 percent or more of vancomycin patients were diarrhea 4. Deaths occurred in 18. Adverse events were considered treatment-related for 16. Treatment-related adverse events, serious adverse events and deaths were comparable for Zyvox and vancomycin.
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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 600 mg with a low dose of ZYVOX 200 mg given every 12 hours q12h either intravenously IV or orally for 7 to 28 days.
Both groups received concomitant aztreonam 1 to 2 g every 8 hours IVwhich could be continued if clinically indicated. ZYVOX was studied for the treatment of community-acquired CAP and hospital-acquired HAP pneumonia due to MDRSP by pooling clinical data from seven comparative and non-comparative Phase 2 and Phase 3 studies involving adult and pediatric patients.
The pooled MITT population consisted of all patients with S. 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 IV followed by medications given orally for a total of 10 to 21 days of treatment.
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What To Avoid While Using Zyvox Injection Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
Symptoms of serotonin syndrome or NMS-like reactions include hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes that include extreme agitation progressing to delirium and coma.
Linezolid also belongs to a class of drugs known as MAO inhibitors.
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. Tyramine: A significant pressor response has been observed in normal adult subjects receiving linezolid and tyramine doses of more than 100 mg.
A similar study has not been conducted in hypertensive patients.
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Therefore, adolescents administered 600 mg every 12 hours daily will have similar exposure to that observed in adults receiving the same dosage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.