The Leflox (Levofloxacin)
250mg, 500mg, 750mg Tablets.
The Leflox (Levofloxacin) is a synthetic broad-spectrum antibacterial agent Chemically levofloxacin, a chiral fluorinated carboxyquinolone, is the pare (-)-(S)-enantiomer of the racemic drug substance ofloxacin with a chemical name of (-)-(5)-9-fluoro-2. 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido (1.2.3.-de] [1.4] benzoxazine 6-carboxylic acid. Its molecular formula is CHFN,O, and the structural formula is:
The Leflox (Levofloxacin) QUALITATIVE AND QUANTITATIVE COMPOSITION
The Leflox (Levofloxacin) is available for oral administration as:
1. Leflox Tablets 250mg Each film-coated tablet contains:
2. Leflox Tablets 500mg Each film-coated tablet contains:
Levofloxacin USP 500mg
3. Lellax Tablets 750mg Each film-coated tablel contains:
Levofloxacin USP 750mg
Mechanism of Action:
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent.
The Leflox (Levofloxacin) Commonly susceptible species:
Aerobic Gram-positive bacteria
The Staphylococcus aureus methicillin-susceptible, Staphylococcus saprophylicus, Streptococci group C and G. Streptococcus agalactine. Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic Gram-negative bacteria
The for as Burkholderia cepacia, Eikenelia corrodens, Haemophilus influenzae, Haemophilus para-influenzae, Klebsiella oxytoca . Klebsiella pneumoniae. Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri.
Anaerobic bactena Peptostreptococcus
Other
Also Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomalis, Legionella pneumophila, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum.
The Leflox (Levofloxacin) Species for which acquired resistance may be a problem:
Aerobic Gram-positive bacteria
Enterococcus faecalis, Staphylococcus aureus methicillin-resistant. Coagulase negative.
Staphylococcus spp.
Acinetobacter baumannii. Citrobacter freundii, Enterobacter aarogenes. Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Morganella morganii, Proteus mirabilis,
Aerobic Gram-negative bacteda
Also Providencia stuartii, Pseudomonas aeruginosa, Serratia marcascens.
Bacteroides fragilis. Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgatus, Clostridium difficile.
The Levofloxacin has been shown to be sclive against Bacillus anthracis in vitro.
Leflox Pharmacokinetics:
Also bound to plasma proteins.
Special Population:
Also for the Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance
Renal Insufficiency<50mL/min), requiring dosage adjustment in such patients to avoid accumulation. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin.are not required following hemodialysis or CAPD.
ليفلوكس
THERAPEUTIC INDICATIONS:
Lelax (Levofloxacin) is indicated for this treatment of adults (18 years of age) with mild. moderate, and severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below:
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis Comrisunity acquired pneumonia and nosocomial pneumonia
- Complicated skin and skün structure infections Uncomplicated skin and skin structure infections
- Chronic bacterial prostatitis
- Complicated urinary tract infections
- Uncomplicated urinary tract infections
- Acute pyelonephritis
- Inhalational anthrax, post-exposure
- Plague
DOSAGE AND ADMINISTRATION:
There are 24 hours efox (Levofloxacin) Tablets 250mg, 500mg and 750mg administered orally every The dosage depends on the types and severity of the infections and the sensitivity of the presumed, causalive pathogen. Leffox (Levofloxacin) should be swallowed without crushing and with sufficient amount of liquid. The Leflox (Levofloxacin) Tablets can be administered without regard to food Leflox (Levofloxacin) Tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal calions such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution. The dosage guidelines as per the infection are given as under for the Also :
ADVERSE REACTIONS:
The Levofloxacin is usually well tolerated.
me therapy Common Moniliasis, is, insomnia, headache, dizziness, dyspnea, nausea, diarrhea, constipation.
abdominal pan, vomiting, dyspepsia, rash, pruritus, vaginitis, edema and chest pain Less common Genital monitiasis, anemia, thrombocytopenia, granulocytopenia, allergic reaction.
hyperglycemia, hypoglycemia, hyperkalemia, anxiety, agitation, confusion, depression. hallucination, nightmare, sleep disorder, anorexia, abnormal dreaming, tremor, convulsions. paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope, epistaxis, cardiac arrest, palpitation, ventricular tachycardia, ventricular arrhythmia, phlebitis, gastritis. stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembraneous/C. difficile colitis, abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase, urticaria, arthralgia, tendonitis, myalgia, skeletal pain, abnormal renal function and acute renal failure
The Leflox (Levofloxacin) CONTRAINDICATIONS:
Also the for as the Levofloxacin is contraindicated in patients with a history of hypersensitivity to this drug and/or other quinolone antibacterial or to any excipient of the product.
ARE YOU SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE. PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS.
Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reaction that have occurred together, including 1 Tendinitis and tendon rupture.
The Peripheral Neuropathy Central nervous system affects Discontinue levofloxacin immediately and avoid the use of Fluoroquinolones, including.
The levofloxacin in patients who experience any of these serious adverse reactions Fluoroquinolones, including levofloxacin may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with known history of myasthenia gravis.
Acule exacerbation of chronic bronchitis
Acute sinusitis 3 Acute uncomplicated
Discontinue levofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their physician. Avoid levofloxacin in patients who have been history of tendon disorders or tendon rupture.
Also Avoid fluoroquinolones, including levofloxacin, in patients who have previously expenenced penpheral neuropathy Also Fluoroquinolonés may also cause central nervous system stimulation. Suicidal thoughts, for attempted or completed suicide may also occur, especially in patients with a medical history of depression, or an for underlying risk factor for depression. If The these reactions occur in patients receiving levofloxacin, discontinue levofloxacin, and institute appropriate measures.
Exacerbation of Myasthenia Gravis: The Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness has patients with myasthenia gravis. Avoid levofloxacin, was patients with a known history of myasthenia gravis.
The Also for exmpale Discontinue levofloxacin immediately at the first appearance of skin rash jaundice, or any other sign of hypersensitivity and institute supportive measures.
- Uncorrected electrolyte imbalance (eg hypokalemia, hypomagnesemia)
- Elderly and women
- Cardiac disease in g heart failure, myocardial infarction, bradycardia)
Oplates: The patients treated with levofloxacin, determination of
positive results. It may be nec be necessary opiates in unne may give false to confirm positive opiate screens by roore specific method
Risk of Aortic Aneurysm and Dissection: The patients with a known aortic aneurysm or patientsalternative antibacterial treatments available
Pregnancy: There are for adequate and well-controlled studies in pregnant women.
DRUG INTERACTIONS:
The Also Antacids, Sucralfate Metal Cations, Multivitamins Concurrent administration of levofloxacin with Warfann We have been reports in patients that levofloxacin enhances the effects of warfarin.
OVERDOSAGE: The also nAntacids may be used for protection of gastric mucosa. Haemodialysis, including peritoneal dialysis and CAPD, are not affective in removing levofloxacin from the body. No specific antidote exists
Do not store above 30°C
The Protect from sunlight & moisture
The expiration date refers to the product correctly stored at the required conditions
HOW SUPPLIED:
Leflox (Levofloxacin) Tablets 250mg are available in blister pack of 10’s.
Leflox (Levofloxacin) Tablets 500mg are available in blister pack of 10’s.
Lefiox (Levofloxacin) Tablets 750mg are available in blister pack of 10’s.
Keep out of reach of children.
Manufactured by:
GGetz
Plot No. 01, Sector 25, Korangi Industrial Area, Karachi Pakistan
PAK-200014712
www.getxpharma.com