Patients who develop recurrent nausea or vomiting, unexplained acidosis , or a low bicarbonate level while receiving ZYVOX should receive immediate medical evaluation.
Convulsions Convulsions have been reported in patients when treated with linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.
Hypoglycemia Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with linezolid, a reversible, nonselective MAO inhibitor. Some MAO inhibitors have been associated with hypoglycemic episodes in diabetic patients receiving insulin or hypoglycemic agents. While a causal relationship between linezolid and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with linezolid.
If hypoglycema occurs, a decrease in the dose of insulin or oral hypoglycemic agent, or discontinuation of oral hypoglycemic agent, insulin, or linezolid may be required. Development Of Drug-Resistant Bacteria Prescribing ZYVOX in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Nonclinical Toicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of linezolid. Neither mutagenic nor clastogenic potential was found in a battery of tests including: Linezolid did not affect the fertility or reproductive performance of adult female rats.
The reversible fertility effects were mediated through altered spermatogenesis. Affected spermatids contained abnormally formed and oriented mitochondria and were non- viable.
Tulburari hematologice si limfatice Mai putin frecvente: Anemie, eozinofilie, leucopenie, neutropenie, trombocitopenie.
Tulburari de metabolism si nutritie Frecvente: Ameteli, hipoestezie, insomnie, parestezii. Organe de sima Mai putin frecvente: Vedere incetosata, tinitus Tulburari cardiovasculare Mai putin frecvente: Hipertensiune arteriala, hipotensiune arteriala. Dureri abdominale, crampe sau distensie; diaree; greata; varsaturi.
Constipatie; gura uscata; dispepsie; gastrita; glosita; sete exacerbata; pancreatita; stomatita; decolorarea sau afectarea limbii Tulburari cutanate Mai putin frecvente: Dermatita, hipersudoratie, prurit, erupaii cutanate, urticarie. Tulburari urogenitale Mai putin frecvente: Candidoza vaginala Afectiuni vulvovaginale, poliurie, vaginita. Anomalii ale analizelor de laborator Biochimice Frecvente: Cresterea bilirubinei totale1, ALAT1, ASAT1, LDH1, fosfatazei alcaline1, BUN1, creatinkinazei1, lipazei1, amilazei1 sau glicemiei2; scaderea proteinelor totale3, albuminei3, sodiului4 sau calciului5; cresterea6 sau scaderea5 potasiului sau bicarbonatului.
Cresterea creatininei1, sodiului7, calciului6; scaderea glicemiei8; cresterea6 sau scaderea5 clorului. Cresterea neutrofilelor9 sau eozinofilelor10; scaderea hemoglobinei11, hematocritului11 sau a numarului de hematii11; cresterea12 sau scaderea11 numarului plachetelor sanguine sau leucocitelor. Cresterea numarului de reticulocite1; scaderea numarului de neutrofile Nu se cunoaste nici un antidot specific. Nu s-au raportat cazuri de supradozaj.
Superinfection The effects of linezolid therapy on normal flora have not been evaluated in clinical trials. The use of antibiotics may occasionally result in an overgrowth of non-susceptible organisms. Clinical trials The safety and effectiveness of linezolid when administered for periods longer than 28 days have not been established.
Controlled clinical trials did not include patients with diabetic foot lesions, decubitus or ischaemic lesions, severe burns or gangrene. Excipients Each ml of the solution contains Each ml of solution also contains 0. Potential interactions producing elevation of blood pressure In normotensive healthy volunteers, linezolid enhanced the increases in blood pressure caused by pseudoephedrine and phenylpropanolamine hydrochloride.
Similar studies in hypertensive subjects have not been conducted. 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 mg tyramine.
Zyvox should not be used in patients receiving drugs that inhibit monoamine oxidase A and b e. Except when there is an opportunity for close monitoring and blood pressure monitoring. Zyvox should not be administered to patients with these comorbid clinical conditions or concomitant reception of the following drugs: Adequate and controlled studies of the drug Zyvox in pregnant women not conducted.
Zyvox should be used during pregnancy only if absolutely indicated, i. It is unknown if linezolid penetrates into breast milk, so you should exercise extra caution when using the drug in breastfeeding. Interaction with other medications and alcohol:
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