LEE FLOX 750MG 7TAB

63.00 EGP

Levofloxacin hydrochloride hemihydrate 844.5 mg Eq. to 750 mg levofloxacin.

LEE FLOX 750MG 7TAB; levofloxacin, antibacterials .

ACTIVE-INGREDIENT OF LEE FLOX 750MG 7TAB

Levofloxacin hydrochloride hemihydrate 844.5 mg Eq. to 750 mg levofloxacin.

INDICATION OF LEE FLOX 750MG 7TAB

LEE-FLOX Tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed ib this section. 1.1 Nosocomial Pneumonia : LEE-FLOX is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Esherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Psedomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal ß-lactam is recommended. 1.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen: LEE-FLOX is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP] , Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumonia. MDRSP isolates are isolates resistant to two or more of the following antibacterials: Penicillin (MIC ≥ 2 mcg/mL). 2nd generation Cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5- day Treatment Regimen: LEE-FLOX is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant Streptococcus pneumoniae [MDRSP] , Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae , or Chlamydophila pneumoniae. 1.4 Complicated skin and skin structure infections: LEE-FLOX is indicated for the treatment of Complicated skin and skin structure infectionsdue to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis. 1.5 Uncomplicated skin and skin structure infections: LEE-FLOX is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate ) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic bacterial prostatitisLEE-FLOX is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis. 1.7 Inhalation Anthrax (Post-Exposure): LEE-FLOX is indicated for Inhalation Anthrax (Post-Exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of LEE-FLOX is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEE-FLOX has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEE-FLOX in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEE-FLOX therapy should only be used when the benefit outweighs the risk. 1.8 Plague: LEE-FLOX is indicated for the treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEE-FLOX could not be conducted in humans with plague for eithical and feasibility reasons. Therefore, approval of theis indication was based on an efficacy study conducted in animals. 1.9 Complicated Urinary tract infections: 5-day treatment regimen: LEE-FLOX is indicated for the treatment of Complicated Urinary tract infections due to Eschericia coli, Klebsiella pneumoniae, or Proteus mirabilis. 1.10 Complicated Urinary tract infections: 10-day treatment regimen: LEE-FLOX is indicated for the treatment of Complicated Urinary tract infections ( mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Eschericia coli, Klebsiella pneumoniae, or Proteus mirabilis or Pseudomonas aeruginosa. 1.11 Acute Pyelonephritis: 5 to 10-day treatment regimen: LEE-FLOX is indicated for the treatment of Acute Pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia. 1.12 Uncomplicated Urinary Tract Infections: LEE-FLOX is indictated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Esherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including LEE-FLOX, have been associated with serious adverse reactions and for some patients uncomplicated urinary tract infection is self-limiting, reserve LEE-FLOX for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis: LEE-FLOX is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB)due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae , Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 1.14 Acute Bacterial Sinusitis: 5-day and 10-14 day treatment regimens: LEE-FLOX is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Because fluroquinolones, including LEE-FLOX, have been associated with serious adverse reactions for some patients ABS is self-limiting, reverse LEE-FLOX for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage: To reduce the development of drug-resistant bacteria and maintain the effectivness of LEE-FLOX and other antibacterial drugs, LEE-FLOX should be used only to treat or prevent infections thet are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, They should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing: Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with LEE-FLOX may be initiated before results of these are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly repidly during treatment with LEE-FLOX, Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also thr possible emergence of bacterial resistance .

DOSAGE OF LEE FLOX 750MG 7TAB

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

2.1 Dosage in adult patients with normal renal function: The usual dose of LEE-FLOX Tablets is 500, or 750 mg administered orally every 24 hours, as indicated by infection and described below. These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance 50 KG * (Drug administartion should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin olasma concentrations achieved in humans are reasonably likely to predict clinical benefit. The safety of LEE-FLOX inadults for durations of therapy beyond 28 days or in pediatric patients for adult durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients . Prolonged LEE-FLOX therapy should only be used when the benefit outweighs the risk) : 500 mg every 24 hours for 60 days (*3) . In case of Pediatric patients 50 kg *(Drug administration should begin as sson as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of LEE-FLOX typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated) : 500 mg every 24 hours for 10-14 days. In case of Pediatric patients 50 kg * : dose is 500 mg once every 24 hr for 60 days ( sequential therapy (intravenous to oral ) may be instituated at the discretion of the physician) . In case of Inhalation Anthrax (post-exposure) (Drug administartion should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin olasma concentrations achieved in humans are reasonably likely to predict clinical benefit. The safety of LEE-FLOX inadults for durations of therapy beyond 28 days or in pediatric patients for adult durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients . Prolonged LEE-FLOX therapy should only be used when the benefit outweighs the risk) * Pediatric patients 50 kg * : dose is 500 mg once every 24 hr for 10-14 days. In case of Inhalation Anthrax (post-exposure) * Pediatric patients OVER-DOSAGE OF LEE FLOX 750MG 7TAB

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. Levofloxacin exhibits a low potential for acute toxicity.

CONTRA-INDICATION OF LEE FLOX 750MG 7TAB

LEE-FLOX is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials.

STORAGE OF LEE FLOX 750MG 7TAB

LEE-FLOX Tablets should be stored at a temperature not exceeding 30 °C, in dry place.
PACK OF LEE FLOX 750MG 7TAB
Carton box containing (Al/white opaque PVC) strip of 7 film coated tablets + insert leaflet.
LEE FLOX 750MG 7TAB MANUFACTURED BY
PHARAONIA PHARMACEUTICALS (PHARO PHARMA ) NEW BORG EL-ARAB – 3rd Industrial Zone – Block No 16 – ALEXANDRIA – Egypt.

https://www.drugs.com/mtm/levofloxacin.html

https://www.gardeniapharmacy.com/category/medicine-2/

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