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The safety of ZYVOX formulations was evaluated in 215 pediatric patients ranging in age from birth through 11 years, and in 248 pediatric patients aged 5 through 17 years 146 of these 248 were age 5 through 11 and 102 were age 12 to 17. These patients were enrolled in two Phase 3 comparatorcontrolled clinical trials and were treated for up to 28 days. In the study of hospitalized pediatric patients birth through 11 years with Gram-positive infections, who were randomized 2 to 1 linezolid: vancomycinmortality was 6.
However, given the severe underlying illness in the patient population, no causality could be established. Of the pediatric patients treated for uSSSIs, 19. For all other indications, 18. Patients 12 years or older received ZYVOX 600 mg by mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
Of the pediatric patients treated for uSSSIs, 1. For all other indications, discontinuations due to drug-related adverse events occurred in 0.
ZYVOX has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hours for up to 28 days. Thrombocytopenia associated with the use of ZYVOX appears to be dependent on duration of therapy generally greater than 2 weeks of treatment.
Superinfection The effects of linezolid therapy on normal flora have not been evaluated in clinical trials. Special populations Linezolid should be used with special caution in patients with severe renal insufficiency and only when the anticipated benefit is considered to outweigh the theoretical risk see sections 4. Clinical trials The safety and effectiveness of linezolid when administered for periods longer than 28 days have not been established.
Potential interactions producing elevation of blood pressure In normotensive healthy volunteers, linezolid enhanced the increases in blood pressure caused by pseudoephedrine and phenylpropanolamine hydrochloride.
Potential serotonergic interactions The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Use with tyramine-rich foods No significant pressor response was observed in subjects receiving both linezolid and less than 100 mg tyramine.
Drugs metabolised by cytochrome P450 Linezolid is not detectably metabolised by the cytochrome P450 CYP enzyme system and it does not inhibit any of the clinically significant human CYP isoforms 1A2, 2C9, 2C19, 2D6, 2E1, 3A4. Rifampicin The effect of rifampicin on the pharmacokinetics of linezolid was studied in sixteen healthy adult male volunteers administered linezolid 600 mg twice daily for 2. Breast-feeding Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breast-feeding should be discontinued prior to and throughout administration.
Fertility In animal studies, linezolid caused a reduction in fertility see section 5. General properties Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones.
The in vitro postantibiotic effect PAE of linezolid for Staphylococcus aureus was approximately 2 hours. Susceptibility The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
As necessary, expert advice should be sought when local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Special populations Renal impairment: After single doses of 600 mg, there was a 7-8 fold increase in exposure to the two primary metabolites of linezolid in the plasma of patients with severe renal insufficiency i.
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Linezolid and Alcohol Avoid drinking alcohol, especially draught beers and wine. Linezolid in Pregnancy Linezolid has been classified by the US FDA as Pregnancy Category C. Linezolid During Breastfeeding Studies have proved that Linezolid and its metabolites are excreted in the milk of lactating rats. Disclaimer The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.
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Contact the applicable plan provider for the most current information. To: By clicking send, you acknowledge that you have permission to email the recipient with this information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay.
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If you have any concerns about you or your child taking Zyvox speak to your doctor or pharmacist. If you are pregnant or breastfeeding, the doctor may decide not to prescribe Zyvox. Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell the doctor if you or your child have been treated with or are taking:any medicine that inhibits monoamine oxidase, e.
How to take Zyvox It is recommended that treatment with Zyvox begin in a hospital. If you do not understand the instructions on the box, ask the doctor or pharmacist for help. Continue taking Zyvox until you or your child finish the tablets or oral suspension unless your doctor recommends otherwise. Do not stop taking Zyvox unless your doctor tells you to, even if you feel better.
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For these reasons, before you start linezolid it is important that your doctor knows:Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them.
It works by killing bacteria or preventing their growth.
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Doses of Linezolid are usually administered every 12 hours.
Linezolid appeared to affect the maturation of rat spermatozoa. Supplementation of testosterone had no effect on linezolid-mediated fertility effects. Epididymal hypertrophy was not observed in dogs treated for 1 month, although changes in the weights of prostate, testes and epididymis were apparent.
Reproductive toxicity studies in mice and rats showed no evidence of a teratogenic effect at exposure levels 4 times or equivalent, respectively, to those in humans.
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The number of MRSA infections, which are highly resistant, is increasing in people with this disease, and is associated with delayed recovery from exacerbations and accelerated decline of lung function in children with CF.
These patients were enrolled in two Phase 3 comparator-controlled clinical trials and were treated for up to 28 days.