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Linezolid Suspension Dosage |
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Patients whose therapy is started with Linezolid Suspension injection may be switched to Linezolid Suspension tablets or Linezolid Suspension for oral suspension, with no dosage adjustment.
Duration of treatment is variable, depending on the pathogen isolated, site of infection and its severity. To date, the maximum duration of treatment has been 28 days.
Pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid Suspension clearance values and larger AUC values than many full-term neonates and older infants. By day 7 of age, Linezolid Suspension clearance and AUC values are similar to those of full-term neonates and older infants.
Elderly patients: No dose adjustment is required.
Patients with Renal Insufficiency: No dose adjustment is required. Patients with severe renal insufficiency (ie, creatinine clearance <30 mL/min): No dose adjustment is required. Due to the unknown clinical significance of higher exposure (up to 10-fold) to the 2 primary metabolites of Linezolid Suspension in patients with severe renal insufficiency, Linezolid Suspension should be used with special caution in these patients and only when the anticipated benefit is considered to outweigh the theoretical risk.
As approximately 30% of a Linezolid Suspension dose is removed during 3 hrs of hemodialysis, Linezolid Suspension should be given after dialysis in patients receiving such treatment. The primary metabolites of Linezolid Suspension are removed to some extent by hemodialysis, but the concentrations of these metabolites are still very considerably higher following dialysis than those observed in patients with normal renal function or mild to moderate renal insufficiency.
Therefore, Linezolid Suspension should be used with special caution in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk.
To date, there is no experience of Linezolid Suspension administration to patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than haemodialysis).
Patients with Hepatic Insufficiency: No dose adjustment is required. However, there are limited clinical data and it is recommended that Linezolid Suspension should be used in such patients only when anticipated benefit is considered to outweigh the theoretical risk.
Children: Recommended dosages for pediatric patients, see Table 2.
Linezolid Suspension Injection: Administer Linezolid Suspension injection by IV infusion over a period of 30-120 min. Do not use the IV infusion bag in series connections. Do not introduce additives into the IV solution. If Linezolid Suspension injection is to be given concomitantly with another drug, each drug should be given separately, in accordance with the recommended dosage and route of administration for each product.
During your treatment with Linezolid Suspension, do not start or stop using any other medications unless your doctor tells you to.
If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.
Many other drugs can interact with Linezolid Suspension, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Drugs Metabolized by Cytochrome P-450: Linezolid Suspension is not detectably metabolised by the cytochrome P-450 (CYP) enzyme system and it does not induce or inhibit the activities of clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Therefore, no CYP450-induced drug interactions are expected with Linezolid Suspension. Drugs eg, warfarin and phenytoin, which are CYP2C9 substrates, may be given with Linezolid Suspension without changes in dosage regimen.
Antibiotics: The pharmacokinetics of Linezolid Suspension were not altered when administered together with either aztreonam or gentamicin. The effect of rifampin on the pharmacokinetics of Linezolid Suspension was studied in 16 healthy adult male volunteers administered Linezolid Suspension 600 mg twice daily for 2.5 days with and without rifampin 600 mg once daily for 8 days. Rifampin decreased the Linezolid Suspension Cmax and AUC by a mean 21% (90% CI, 15, 27) and a mean 32% (90% CI, 27, 37) respectively. The mechanism of this interaction and its clinical significance are unknown.
Monoamine Oxidase Inhibition: Linezolid Suspension is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid Suspension has the potential for interaction with adrenergic and serotonergic agents.
Adrenergic Agents: A significant pressor response has been observed in normal adult subjects receiving Linezolid Suspension and tyramine doses of >100 mg. Therefore, patients receiving Linezolid Suspension need to avoid consuming large amounts of foods or beverages with high tyramine content (eg, mature cheese, yeast extracts, undistilled alcoholic beverages and fermented soya bean products eg, soy sauce).
A reversible enhancement of the pressor response of either pseudoephedrine HCl (PSE) or phenylpropanolamine HCl (PPA) is observed when Linezolid Suspension is administered to healthy normotensive subjects. 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 Suspension alone, and the combination of steady-state Linezolid Suspension (600 mg every 12 hrs for 3 days) with 2 doses of PPA (25 mg) or PSE (60 mg) given 4 hrs apart. Heart rate was not affected by any of the treatments.
Blood pressure was increased with both combination treatments. Maximum blood pressure levels were seen 2-3 hrs after the 2nd dose of PPA or PSE and returned to baseline 2-3 hrs after peak. The results of the PPA study follow, showing the mean (and range) maximum systolic blood pressure in mm Hg: Placebo=121 (103-158); Linezolid Suspension alone=120 (107-135); PPA alone=125 (106-139); PPA with Linezolid Suspension=147 (129-176). The results from the PSE study were similar to those in the PPA study. The mean maximum increase in systolic blood pressure over baseline was 32 mm Hg (range: 20-52 mm Hg) and 38 mm Hg (range: 18-79 mm Hg) during co-administration of Linezolid Suspension with pseudoephedrine or phenylpropanolamine, respectively. Initial doses of adrenergic agents eg, dopamine or dopamine agonists, should be reduced and titrated to achieve the desired response.
Serotonergic Agents: The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Subjects were administered dextromethorphan (two 20-mg doses given 4 hrs apart) with or without Linezolid Suspension. No serotonin syndrome effects (confusion, delirium, restlessness, tremors, blushing, diaphoresis, hyperpyrexia) have been observed in normal subjects receiving Linezolid Suspension and dextromethorphan. The effects of other serotonin re-uptake inhibitors have not been studied. However, very rare spontaneous reports of serotonin syndrome with co-administration of Linezolid Suspension and serotonergic agents have been reported.
Incompatibilities: Injection: Additives should not be introduced into this solution. If Linezolid Suspension is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, if the same IV line is to be used for sequential infusion of several drugs, the line should be flushed prior to and following Linezolid Suspension administration with a compatible infusion solution.
Linezolid Suspension solution for infusion is known to be physically incompatible with the following compounds: Amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium and sulfamethoxazole/trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.
Compatible Infusion Solutions: 5% dextrose injection; 0.9% sodium chloride injection; lactated ringer's injection (Hartmann's solution for injection).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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