VENO TAVOX 500
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Chemical Name:
Levofloxacin -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Quinolone - Respiratory Fluoroquinolone 3th -
Pharmaceutical Form:
Tablets -
Composition:
Levofloxacin 500mg
VENO TAVOX
Film Coated Tablet
Levofloxacin
1-COMPOSITION:
VENO TAVOX -500 F.C.Tablets: Each film coated tablet contains Levofloxacin 500mg.
VENO TAVOX -750 F.C.Tablets: Each film coated tablet contains Levofloxacin 750mg.
Excipients
VENO TAVOX -500
Microcrystalline cellulose
Magnesium stearate
Crospovidone
Hydroxy propyl Methylcellulose
Poly Ethylene Glycol
Titanium dioxide
Polysorbate 80
Yellow iron oxide
Red iron oxide
VENO TAVOX -750
Microcrystalline cellulose
Magnesium stearate
Crospovidone
Hydroxy propyl Methylcellulose
Poly Ethylene Glycol
Titanium dioxide
Polysorbate 80
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WARNING
Fluoroquinolones, including LEVOFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants
Fluoroquinolones, including LEVOFLOXACIN, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid LEVOFLOXACIN in patients with a known history of myasthenia gravis.
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2-MECHANISM OF ACTION:
Levofloxacin is a member of the fluoroquinolone class of antibacterial agents.
The mechanism of action of levofloxacin and other fluoroquinolone involves inhibition of bacterial topoisomerase IV and DNA gyrase, enzymes required for DNA replication, transcription, repair and recombination
3-PHARMACOKINETICS:
Absorption: Levofloxacin is rapidly and completely absorbed after oral administration. Peak plasma concentrations are usually attained one to two hours after oral dosing. The absolute bioavailability of levofloxacin is approximately 99%.
Metabolism and Excretion: Levofloxacin undergoes limited metabolism in humans, it is excreted largely as unchanged drug in the urine. The mean terminal plasma elimination half-life ranges from approximately 6 to 8 hours.
4-INDICATIONS:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin tablets, should be used only to treat or prevent infections that 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.
Levofloxacin 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 below.
Nosocomial Pneumonia: Levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended
Community-Acquired Pneumonia: 7-14 day Treatment Regimen: Levofloxacin tablets, are indicated for the treatment of community-acquired pneumonia due tomethicillin-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 strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2mcg/mL), 2nd generation cephalosporins, macrolides, tetracyclines andtrimethoprim/sulfamethoxazole).
Community-Acquired Pneumonia: 5-day Treatment Regimen: Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumonia.
Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens: Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute Bacterial Exacerbation of Chronic Bronchitis: Levofloxacin tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Complicated Skin and Skin Structure Infections: Levofloxacin tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis.
Uncomplicated Skin and Skin Structure Infections: Levofloxacin tablets are 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.
Chronic Bacterial Prostatitis: Levofloxacin tablets are indicated for the treatment of chronic bacterial prostatitis due toEscherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis.
Complicated Urinary Tract Infections: 5-day Treatment Regimen: Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
Complicated Urinary Tract Infections: 10-day Treatment Regimen: Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild tomoderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
Acute Pyelonephritis : 5 or 10-day Treatment Regimen: Levofloxacin tablets are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia
Uncomplicated Urinary Tract Infections: Levofloxacin tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Inhalational Anthrax (Post-Exposure): Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin 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 levofloxacin therapy should only be used when the benefit outweighs the risks.
Plague: Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals.
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 levofloxacin tablets may be initiated before results of these tests 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 rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.
5-CONTRAINDICATIONS:
LEVOFLOXACIN is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterial.
6-SIDE EFFECTS:
-The most common adverse drug effects leading to discontinuation of the drug were: gastrointestinal primarily nausea, vomiting, dizziness and headache.
-The most common adverse drug effects (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness
-Common Adverse effects ( ≥ 1%): moniliasis, insomnia, headache, Dizziness, dyspnea, nausea, diarrhea, constipation, abdominal pain, vomiting, dyspepsia, rash, pruritus, vaginitis, edema, injection site reaction, chest pain.
-Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine.
7-WARNINGS AND PRECAUTIONS:
Tendinopathy and Tendon Rupture: Fluoroquinolones, including LEVOFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. LEVOFLOXACIN should be discontinued 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 doctor regarding changing to a non-quinolone antimicrobial drug.
Exacerbation Of Myasthenia Gravis: Fluoroquinolones, including LEVOFLOXACIN, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis.
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including levofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. LEVOFLOXACIN should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity.
Other Serious And Sometimes Fatal Reactions: Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including levofloxacin. These events may be severe and generally occur following the administration of multiple doses.
Clinical manifestations may include one or more of the following:
-Fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens - Johnson syndrome).
-vasculitis; arthralgia; myalgia; serum sickness
-allergic pneumonitis;
-interstitial nephritis; acute renal insufficiency or failure;
-hepatitis; jaundice; acute hepatic necrosis or failure;
-anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.
Hepatotoxicity: Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with levofloxacin; Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis.
Central Nervous System Effects: Convulsions, toxic psychoses, increased intracranial pressure have been reported in patients receiving fluoroquinolones, including levofloxacin. Fluoroquinolones may also cause central nervous system stimulation. If these reactions occur in patients receiving levofloxacin, the drug should be discontinued and appropriate measures instituted. As with other fluoroquinolones, levofloxacin should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).
Clostridium difficile-Associated Diarrhea: Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including levofloxacin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
Peripheral Neuropathy: Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including levofloxacin. LEVOFLOXACIN should be discontinued immediately if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation.
Prolongation of the QT Interval: Some fluoroquinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electro-cardiogram and infrequent cases of arrhythmia. LEVOFLOXACIN should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Blood Glucose Disturbances: As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with levofloxacin, it should be discontinued and appropriate therapy should be initiated immediately.
Photosensitivity/Phototoxicity: Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light, can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs.
8-PREGNANCY: CATEGORY C
No adequate and well-controlled studies in pregnant women. LEVOFLOXACIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
9-LACTATION:
Based on data on other fluoroquinolones and very limited data on levofloxacin, it can be presumed that levofloxacin will be excreted in human milk. 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.
10-PEDIATRIC USE:
An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) has been observed in pediatric patients receiving levofloxacin. Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals.
Levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure) and for treatment of plague.
The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. The safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied.
Safety and effectiveness in pediatric patients below the age of six months have not been established.
11-GERIATRIC USE:
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out since the drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function
12-RENAL IMPAIRMENT:
Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance < 50 mL/min), requiring dosage adjustment in such patients to avoid accumulation.
13-HEPATIC IMPAIRMENT:
Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.
14-DRUG INTERACTIONS:
Chelation Agents : Antacids , Sucralfate, Metal Cations , Multivitamins: Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral levofloxacin tablet administration
Warfarin: there have been reports during the post-marketing experience that levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin use have been associated with episodes of bleeding. Prothrombin time, INR, or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
Anti-diabetic Agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an anti-diabetic agent. Therefore, careful monitoring of blood glucose is recommended during the concomitant administration.
Non-Steroidal Anti-Inflammatory Drugs: The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVOFLOXACIN, may increase the risk of CNS stimulation and convulsive seizures
Theophylline: concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered.
Interactions with Laboratory or Diagnostic Testing: Some fluoroquinolones, including levofloxacin, may produce false-positive urine screening results for opiates using immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.
15-DOSAGE AND ADMINISTRATION:
Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min):
The usual dose of levofloxacin tablets administered as described below
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Type of Infection
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Dosed Every 24 hours
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Duration (days)
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
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Nosocomial Pneumonia
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750 mg
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7–14
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Community Acquired Pneumonia
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500 mg
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7–14
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Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumoniae, or Mycoplasma pneumoniae
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Community Acquired Pneumonia
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750 mg
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5
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Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae,or Chlamydophila pneumoniae
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Acute Bacterial Sinusitis
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750 mg
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5
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500 mg
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10-14
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Acute Bacterial Exacerbation of Chronic Bronchitis
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500 mg
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7
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Complicated Skin and Skin Structure Infections (SSSI)
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750 mg
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7–14
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Uncomplicated SSSI
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500 mg
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7–10
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Chronic Bacterial Prostatitis
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500 mg
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28
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Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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750 mg
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5
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This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
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Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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250 mg
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10
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This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli
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Uncomplicated Urinary Tract Infection
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250 mg
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3
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Inhalational Anthrax (Post-Exposure) in adult
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500 mg
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60
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Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. The safety of levofloxacin in adults for durations of therapy beyond 28 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risks.
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Plague in adult
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500 mg
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10 to 14
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Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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Dosage in Pediatric Patients: The dosage in pediatric patient's ≥ 6 months of age is described below
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Type of Infection
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Dose
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Freq. Once
every
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Duration
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
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Inhalational Anthrax (post-exposure): Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
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Pediatric patients > 50 kg
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500 mg
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24 hr
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60 days
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Pediatric patients < 50 kg and ≥ 6 months of age
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8 mg/kg (not to exceed 250 mg per dose)
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12 hr
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60 days
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Plague: Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis
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Pediatric patients > 50 kg
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500 mg
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24 hr
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10 to 14 days
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Pediatric patients < 50
kg and ≥ 6 months of age
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8 mg/kg (not to exceed 250 mg per dose)
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12 hr
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10 to 14 days
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Dosage Adjustment in Adults with Renal Impairment: Administer levofloxacin tablets, with caution in the presence of renal insufficiency. Careful clinical observation 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 <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin
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Dosage in Normal Renal Function Every 24 hours
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Creatinine Clearance 20 to 49 mL/min
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Creatinine Clearance 10 to 19 mL/min
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Hemodialys is or Chronic Ambulatory Peritoneal Dialysis (CAPD)
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750 mg
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750 mg every 48 hours
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750 mg initial dose, then 500 mg every 48 hours
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750 mg initial dose, then 500 mg every 48 hours
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500 mg
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500 mg initial dose, then 250 mg every 24 hours
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500 mg initial dose,
then 250 mg every 48 hours
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500 mg initial dose, then 250 mg every 48 hours
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250 mg
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No dosage adjustment required
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250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
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No information on dosing adjustment is available
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Levofloxacin Tablets can be administered without regard to food.
16-OVERDOSE:
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.
17-PACKAGING:
VENO TAVOX -500 F.C.Tablets: A pack of 10 F.C.Tablets.
VENO TAVOX -750 F.C.Tablets: A pack of 10 F.C.Tablets.
18-STORAGE CONDITIONS:
Store at temperature between (15-30)0C, Protect from light.
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