VENO TAVOX (vial)
-
Chemical Name:
Levofloxacin -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Quinolone - Respiratory Fluoroquinolone 3th -
Pharmaceutical Form:
Vial -
Composition:
Levofloxacin 500mg/100ml
VENO-TAVOX
Vial
Levofloxacin
Antibacterial
1-PHARMACOLOGY:
Levofloxacin is board spectrum antibacterial agent, its mechanism of action involves inhibition of DNA gyrase.
Levofloxacin is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Fluoroquinolones differ in chemical structure and mode of action from b-lactam antibiotics. Fluoroquinolones may, therefore, be active against bacteria resistant to b-lactam antibiotics.
2-PHARMACOKINETIKS:
The plasma concentration profile after IV administration is similar to that observed for oral Levofloxacin when equal doses are administered. Therefore, the oral and IV routes of administration can be considered interchangeable. Levofloxacin is approximately 24 to 38% bound to serum proteins. Levofloxacin is mainly bound to serum albumin. Levofloxacin binding to serum proteins is independent of the concentration.
Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged in urine.
The mean terminal plasma elimination half-life ranges from approximately 6 to 8 hours following single or multiple doses of Levofloxacin. Renal clearance in excess of the glomerular filtration rate suggests that tubular secretion of Levofloxacin occurs in addition to its glomerular filtration
3-INDICATIONS:
VENO-TAVOX is indicated for the treatment of adults (18 years of age) with mild, moderate, and severe infections
Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlarnydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, or Streptococcus pyoganes.
Complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
4-CONTRAINDICATIONS:
Levofloxacin is contraindicated in persons with a history of hypersensitivity to it, or to any quinolone antimicrobial agents.
5-SIDE EFFECTS:
Skin reaction and general allergic reactions :
itching and rash general allergic reactions (anaphylactic/ anaphylactoid reactions)
Gastro-intestinal Tract:
nausea, diarrhea loss of appetite, vomiting, pain in the abdominal region, dyspepsia.
Effect on the nervous system
headache, dizziness, drowsiness, tingling in the hands, trembling, restlessness, anxiety, convulsions and confusion.
Effect on the cardiovascular system
abnormally rapid beating of the heart, drop of blood pressure.
Very rare effect : circulatory collapse.
Effect on muscles, tendon, bones
tendon pain including inflammation, joint pain or muscle pain.
Effect on the liver and Kidney
increased levels of liver enzymes .
Effect on the blood
eosinophilia, leucopenia.
Other reactions
pain, reddening of the infusion site and inflammation of the vein.
6-PRECAUTIONS:
Although Levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of a highly concentrated urine.
Administer Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observations and appropriate laboratory studies should be performed prior to and during therapy since elimination of Levofloxacin may be reduced. In patients with impaired renal function (creatinine clearance >80 ml/min), adjustment of the dosage regimen is necessary to avoid the accumulation of Levofloxacin .
Excessive exposure to sunlight should be avoided.
Therapy should be discontinued in case of phototoxicity.
As with other quinolones, Levofloxacin should be used with caution in any patient with a known or suspected CNS disorder that may predispose to seizures the or in the presence of other risk factors that may predispose to seizures.
In Diabetic patients, careful monitoring of blood glucose is recommended.
As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy.
Patients should be advised: to drink fluids liberally;
Patients should be careful before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination.
Pregnancy and Lactation :
Pregnancy Category C :
Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the potential for serious adverse reactions from Levofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
7-DRUG INTERACTIONS:
There are indications of a pronounced lowering of the cerebral seizure threshold when quinolones are given concurrently with other agents which lower the seizure threshold (e.g. theophlylline). This applies also to the concomitant administration of quinolones and fenbufen or on non-steroidal antiphlogistics (drugs for the treatment of rheumatic diseases).
Levofloxacin should be given carefully when it is coadministered with drug that effect tubular secretion such as probenicid and cimetidine. This applies especially to patients with impaired renal function.
The half-life of cyclosporin was slightly increased when coadminstered with Levofloxacin.
8-OVERDOSAGE:
Levofloxacin exhibits a low potential for acute toxicity.
In the event of an acute overdosage. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis .
9-DOSAGE AND ADMINISTRATION:
Veno-Tavox is administered by I.V. infusion once or twice daily. The dose is determined by the type and severity of the infection and the sensitivity of the suspected causative pathogen. The following dosage- recommendations can be given for patients with normal renal function (creatinin-clearance>50 mL/min):
Pneumonia: 500 mg Veno-Tavox 1 to 2 times daily
Urinary tract infections: 250 mg Veno-Tavox once daily (consideration should be given to increasing the dose in cases of sever infection)
Skin and soft tissue infections: 500 mg Veno-Tavox twice daily.
As Veno-Tavox is eliminated predominantly by the kidneys the dosage should be reduced in patients with renal insufficiency as given in the following table:
|
|
250 mg/24 h
|
500 mg/24 h
|
500 mg/12 h
|
|
Creatinine clearance
|
First dose
250 mg
|
First dose
500 mg
|
First dose
500 mg
|
|
50-20 ml/min
|
Then:
125mg/24h
|
Then:
250mg/24h
|
Then:
250mg/12h
|
|
19-10 ml/min
|
Then:
125mg/48h
|
Then:
125mg/24h
|
Then:
125mg/12h
|
|
<10 ml/min (including hemodialysis )
|
Then:
125mg/48h
|
Then:
125mg/24h
|
Then:
125mg/24h
|
Veno -Tavox is administered by Slow intravenous infusion. The infusion time for 1 bottle Veno -Tavox (100 ml solution for infusion with 500 mg Levofloxacin) should not be less than 60 minutes.
Veno -Tavox is compatible with the following solutions for infusion: 0.9% NaCl solution, 5% dextrose solution, 2.5% dextrose in ringer solution, combination solution for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Veno -Tavox must not be mixed with heparin or alkaline solution (e.g. sodium hydrogen carbonate).
The duration of treatment is determined according to the disease and is not longer than 14 days. As with other antibacterial agents, treatment with Veno-Tavox should be contained for a last 48 to 72 hours after body temperature has returned to normal or the pathogens have been demonstrably eradicated.
10-PACKAGING & COMPOSITION:
Pack of 1 Vial .
Each Vial 100 ml contains : Levofloxacin 500 mg
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