LIZOLID (vial)
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Chemical Name:
Linezolid -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Oxazolidinone -
Pharmaceutical Form:
Vial -
Composition:
Linezolid 200mg/100ml
LIZOLID
Dry powder for Oral suspension & Liquid Vial
Linezolid
1-PHARMACOLOGY:
Linezolid is an oxazolidinone antibiotic with activity against gram-positive organisms, including those resistant to other antimicrobials,
Linezolid is rapidly and extensively absorbed after oral dosing. Maximum plasma concentrations are reached approximately 1 to 2 hours after dosing, and the absolute bioavailability is approximately 100%. 1
Linezolid readily distributes to well-perfused tissues. The plasma protein binding of Linezolid is approximately 31% and is concentration-independent.
Linezolid is primarily metabolized by oxidation, which results in two inactive carboxylic acid metabolites.
Nonrenal clearance accounts for approximately 65% of the total clearance of Linezolid.
2-INDICATIONS:
LIZOLID is indicated for the treatment of the following infections:
Community-acquired pneumonia caused by streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible strains only). Alternatives must be considered before initiating treatment in the outpatient setting.
Nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant strains), or streptococcus pneumoniae (penicillin-susceptible strains only). Combination therapy may be clinically indicated if the presumptive pathogens include gram-negative organisms.
Complicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible and -resistant strains), streptococcus pyogenes, or streptococcus agalactiae. Combination therapy may be clinically indicated if the presumptive pathogens include gram-negative organisms.
Uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible strains only) or streptococcus pyogenes.
Vancomycin-resistant enterococcus faecium infections, including cases with concurrent bacteremia.
3-CONTRA-INDICATIONS:
This drug is contraindicated for use in patients who have known hypersensitivity to Linezolid.
4-SIDE EFFECTS:
Diarrhea, headache, nausea, dyspepsia, localized abdominal pain, tongue discoloration, pruritus, moniliasis, and hypertension
5-PRECAUTIONS:
Pseudomembranous colitis has been reported with nearly all antibacterial
agents, Therefore, it is important to consider this diagnosis in patients who present
with diarrhea subsequent to the administration of antibacterial agents.
The use of antibiotics may result in overgrowth of nonsusceptible organisms-
particularly yeasts. Should superinfections occur, appropriate measures should be
taken as indicated by the clinical situation.
Platelet counts should be monitored in patients who are at increased risk for bleeding, who have pre-existing thrombocytopenia, who receive concomitant medications that may decrease platelet count or function, or who may require longer than 2 weeks of Linezolid therapy.
The patients should inform their physician if they have a history of hypertension, pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism and if taking serotonin re-uptake inhibitors or other antidepressants and any medication containing pseudoephedrine or phenylpropanolamine, such as cold remedies and decongestants ( Possible drug-interactions).
Large quantities of foods with high tyramine content should be avoided while taking Linezolid. such as cheeses.
Linezolid for Oral Suspension contains phenylalanine. The other Linezolid formulations do not contain phenylalanine.
Pregnancy & Lactation Pregnancy Category C: This drug should be used during pregnancy only if clearly needed. Caution should be exercised when this drug is administered to a nursing woman.
6-DRUG INTERACTIONS:
Drugs such as warfarin and phenytoin, may be given with Linezolid without changes in dosage regimen.
The pharmacokinetics of Linezolid or aztreonam are not altered when administered together.
The pharmacokinetics of Linezolid or gentamicin are not altered when administered together.
Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.
7-DOSAGE & ADMINISTRATION:
Oral and Intravenous dosage of LIZOLID is similar :
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INFECTION
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DOSAGE AND ROUTE OF ADMINISTRATION
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RECOMMENDED DURATION OF TREATMENT (CONSECUTIVE DAYS)
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PEDIATERIC PATIENTS (BIRTH THROUGH 11 YEARS OF AGE)
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ADULTS AND ADOLESCENTS(12 YEARS AND OLDER)
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COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
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10 mg/kg IV or oral q8h
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600mg IV or oral q8h
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10 to 14
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COMMUNITY-ACQUIRED PNEUMONIA,INCLUDING CONCURRENT BACTEREMIA
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NOSOCOMIAL PNEUMONIA
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VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM INFECTIONS,INCLUDING CONCURRENT BACTEREMIA
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10 mg/kg IV or oral q8h
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600mg IV or oral q8h
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14 to 28
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UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
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<5 yrs:10 mg/kg IV or oral q8h
5-11 yrs:10 mg/kg IV or oral q12h
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ADULTS: 400mg oral q12h
ADOLESCENTS: 600mg oral q12h
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10 to 14
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NEONATES :>7 days: these neonates should be initiated with a dosing regimen of 10mg /kg q12h . the dose should be change to 10mg /kg q8h after 7 days.
8-PACKAGING & COMPOSITION:
LIZOLID- Dry powder for Oral Suspension
Bottle of 100 ml
Each 5 ml contains: Linezolid 100 mg
LIZOLID- Injection
Vial of 100 ml
Each 1 ml contains: Linezolid 2 mg
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