Servalin Injection Special Precautions

The drug is administered cautiously in the following patients: Patients with preexisting myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia), those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy, and who receive linezolid for longer than two weeks; Patients with severe renal insufficiency; Patients who weigh less than 40 kg (no clinical experience).
General precautions: Lactic acidosis has been reported with the use of LINEZOLID. In reported cases, patients experienced repeated episodes of nausea and vomiting. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving Linezolid should receive immediate medical evaluation.
Thrombocytopenia has been reported with the use of LINEZOLID. The platelet counts should be monitored in patients who received Linezolid particularly in those who receive Linezolid for longer than two weeks or those with an increase hemorrhagic risk, thrombocytopenia, or receiving concomitant drugs that decrease platelet count or function.
The use of antibiotics may promote the overgrowth of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
LINEZOLID has not been studied in patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism.
The safety and efficacy of LINEZOLID formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Peripheral and optic neuropathy have been reported in patients treated with LINEZOLID, primarily those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is recommended.
If peripheral or optic neuropathy occurs, the continued use of LINEZOLID in these patients should be weighed against potential risks.
Patients should inform their physician if taking medications containing pseudoephedrine or phenylpropanolamine, such as cold remedies and decongestants, if taking serotonin re-uptake inhibitors or other antidepressants or if they have a history of hypertension.
Prescribing LINEZOLID 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.
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. Patients should inform their physician if they have a history of seizures.
Renal Impairment: The pharmacokinetics of the parent drug, linezolid, are not altered in patients with any degree of renal insufficiency; however, the two primary metabolites of linezolid may accumulate in patients with renal insufficiency, with the amount of accumulation increasing with the severity of renal dysfunction. The clinical significance of accumulation of these two metabolites has not been determined in patients with severe renal insufficiency.
Because similar plasma concentrations of linezolid are achieved regardless of renal function, no dose adjustment is recommended for patients with renal insufficiency. However, given the absence of information on the clinical significance of accumulation of the primary metabolites, use of linezolid in patients with renal insufficiency should be weighed against the potential risks of accumulation of these metabolites.
Both linezolid and the two metabolites are eliminated by dialysis. No information is available on the effect of peritoneal dialysis on the pharmacokinetics of linezolid. Approximately 30% of a dose was eliminated in a 3-hour dialysis session beginning 3 hours after the dose of linezolid was administered; therefore, linezolid should be given after hemodialysis.
Hepatic Impairment: The pharmacokinetics of linezolid are not altered in patients with mild-to-moderate hepatic insufficiency. On the basis of the available information, no dose adjustment is recommended for patients with mild-to-moderate hepatic insufficiency. The pharmacokinetics of linezolid in patients with severe hepatic insufficiency have not been evaluated.
Use in Children: The C_max and the volume of distribution (V_ss) of linezolid are similar regardless of age in pediatric patients. However, linezolid clearance is a function of age. Excluding neonates less than a week of age, clearance is most rapid in the youngest age groups ranging from >1 week old to 11 years, resulting in lower single-dose systemic exposure (AUC) and shorter half-life as compared with adults. As age of pediatric patients increases, the clearance of linezolid gradually decreases, and by adolescence, means clearance values approach those observed for the adult population. There is wider inter-subject variability in linezolid clearance and in systemic drug exposure (AUC) across all pediatric age groups as compared with adults.
Similar mean daily AUC values were observed in pediatric patients from birth to 11 years of age dosed q8h relative to adolescents or adults dose q12h. Therefore, the dosage for pediatric patients up to 11 years of age should be 10 mg/kg q8h. Pediatric patients 12 years and older should receive 600 mg q12h.
Use in the Elderly: Of the 2046 patients treated with LINEZOLID in Phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.