Xovell

Xovell

levofloxacin

Manufacturer:

Saga Lab

Distributor:

Pasteur Pharma

Marketer:

PrimeDrug
Full Prescribing Info
Contents
Levofloxacin hemihydrate.
Description
Each film-coated tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Levofloxacin is the L-isomer of the racemate, a quinolone antibacterial agent. The antibacterial activity of Ofloxacin resides primarily in the L-isomer. The mechanism of action of Levofloxacin and other fluoroquinolone antimicrobials involved inhibition of bacterial topoisomerase, enzyme required for DNA replication, transcription, repair and recombination. Levofloxacin has in-vitro activity against a wide range of gram-negative and gram-positive microorganism. Levofloxacin is often bactericidal at concentrations equal to or slightly greater than inhibitory concentration.
Pharmacokinetics: Absorption: Levofloxacin is rapidly and essentially completely absorbed after oral administration. Peak plasma concentrations are usually attained one to two hours after oral dosing. The absolute bioavailability of a 500 mg tablet and a 750 mg tablet of levofloxacin are both approximately 99% demonstrating complete oral absorption of levofloxacin. Oral administration of 500 mg Levofloxacin with food prolongs the time to peak concentration by approximately 14% following tablet administration. Therefore Levofloxacin tablet can be administered without regard to food.
Distribution: The mean volume of distribution of Levofloxacin generally range from 74-112 L after single and multiple 500 mg or 750 mg doses, indicating widespread distribution to body tissues. Levofloxacin reaches its peak level in the skin tissue and in blister fluid or healthy subject at approximately 3 hours after dosing. The skin tissue biopsy to plasma AUC ratio is approximately 1 following multiple once-daily oral administration of 750 mg and 500 mg Levofloxacin, respectively to healthy subjects. Levofloxacin also penetrates well in the lung tissue. Levofloxacin is mainly bound to serum albumins in human. Levofloxacin binding to serum protein is independent of the drug concentration.
Metabolism: Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin. Levofloxacin undergoes limited metabolism in humans and primarily excreted as unchanged drug in the urine. Following oral administration approximately 87% of an administered dose was recovered as unchanged drug in urine within 48 hours, whereas less than 4% of the dose was recovered in feces in 72 hours. Less than 5% of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites have little relevant pharmacological activity.
Excretion: Levofloxacin is excreted largely as unchanged drug in the urine. The mean terminal plasma elimination half-life of Levofloxacin ranges from approximately 6-8 hours following single or multiple doses of Levofloxacin given orally. The mean apparent total body clearance and renal clearance range from approximately 144-226 mL/min and 96-142 mL/min, respectively.
Indications/Uses
Levofloxacin tablet is indicated for treatment of adult with mild, moderate, severe infection caused by susceptible strains of the designated microorganism in the condition listed as follows.
Acute bacterial sinusitis due to Strep. pneumonia, Haemophilus influenzae or Moraxella catarrhalis.
Acute bacterial exacerbation of chronic bronchitis due to methicillin susceptible Staph. aureus, Strep. pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or Moraxella catarrhalis.
Nosocomial Pneumonia due to methicillin susceptible Staph. aureus, Pseudomonas aeruginosa, Serratia marcescens, E. coli, Klebsiella pneumoniae, Haemophilus influenzae or Strep. pneumoniae. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal b-lactam is recommended.
Community-acquired pneumonia due to methicillin-susceptible Staph. aureus, Strep. pneumoniae (including multi drug resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumonia. MDRSP (multi drug resistant Strep. pneumoniae) isolates are strain resistant to two or more of the following antibiotics: penicillin, 2nd gen. Cephalosporin (cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole).
Complicated skin and skin structure infections due to methicillin susceptible Staph. aureus, Enterococcus faecalis, Strep. pyogenes or Proteus mirabilis.
Uncomplicated skin and skin structure infection (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infection due to methicillin susceptible Staph. aureus or Strep. pyogenes.
Chronic Bacterial Prostatitis due to E. coli, Enterococcus faecalis, or methicillin-susceptible Staph. epidermidis.
Complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, E. coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa.
Acute Pyelonephritis (mild to moderate) caused by E. coli.
Uncomplicated Urinary Tract Infection (mild-moderate) due to E. coli, Klebsiella pneumoniae, Staph. saprophyticus.
Dosage/Direction for Use
Adult: Respiratory, uncomplicated skin infection and chronic prostate infection: Usual dose is 500 mg once a day. For certain types of pneumonia, the dose is 750 mg once a day.
Treatment of respiratory infection typically last 5-14 days; for uncomplicated skin infection except 7-10 days of treatment; for chronic prostate infection treatment last for 28 days.
Complicated Skin Infection: The usual dose is 750 mg once a day. Treatment typically lasts for 7-14 days.
Kidney and Urinary Infection: The usual dose is 250 mg once a day. Treatment last for 3-10 days.
Not for children. Levofloxacin might damage developing bones and joints.
Overdosage
Symptoms of Levofloxacin overdosage include the following: breathlessness, lack of movement, poor coordination, tremors, convulsions, collapse.
Contraindications
Levofloxacin is contraindicated to persons with hypersensitivity to Levofloxacin, quinolone antimicrobial agents or any other components of this product.
Warnings
Convulsion and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucination, paranoia, depression, nightmare, insomnia and rare suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Levofloxacin the drug should be discontinued and appropriate measures instituted. Levofloxacin should be discontinued immediately at the first appearance of skin rash or any other sigh of hypersensitivity.
Special Precautions
General: Prescribing Levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Although Levofloxacin is more soluble than other quinolone, adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of a highly concentrated urine. As with other quinolone, Levofloxacin should be used with caution in any patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g. Severe cerebral arteriosclerosis, epilepsy) or in the presence of the risk factors that may predispose to seizure or lower the seizure threshold (e.g. Certain drug therapy, renal dysfunction). As with other quinolones, disturbances of blood glucose including symptomatic hyper/hypoglycemia, have been reported usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. Glyburide/glibenclamide) 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 immediately and appropriate therapy should be initiated immediately. Torsades de Pointes: Some quinolone including levofloxacin have been associated with prolongation of the QT interval on the electrocardiogram and frequent cases of arrhythmia. Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones including Levofloxacin. Levofloxacin should be avoided in patients with known prolongation QT interval, patient with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), class III (amiodarone, sotalol) antiarrhythmic agents.
Use in Children: Quinolones including Levofloxacin cause arthropathy and osteochondrosis in juvenile animals and several species.
Use in Elderly: Elderly patients may be more susceptible to drug associated effects on the QT interval. Therefore precaution should be taken when using Levofloxacin with concomitant drugs that can result in prolongation of QT interval (e.g. Class IA, Class III) anti-arrhythmic or in patients in risk factor for Torsade de Pointes (e.g. Known QT prolongation, uncorrected hypokalemia).
Use In Pregnancy & Lactation
Pregnancy: Teratogenic effects/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.
Nursing Mothers: Levofloxacin has not been measured in human milk. Based upon data from Ofloxacin. It can be presumed that Levofloxacin will be excreted in the human milk. Because for the potential serious adverse reaction from Levofloxacin in nursing infants, a decision should be made whether to discontinue the drug taking into the account the importance of the drug to the mother.
Adverse Reactions
General Disorders: Ascites, allergic reaction, asthenia, edema, fever, headache, hot flashes, influenza like symptoms, leg pain, malaise, rigors, substernal chest pain, syncope, multiple organ failure, changed temperature sensation, withdrawal syndrome.
Cardiovascular Disorder, General: Cardiac failure, hypertension, aggravation of hypertension, hypotension, postural hypotension.
CNS and PNS disorder: Convulsion (seizure), hyperesthenia, hyperkinesia, hypertonia, hypoesthenia, involuntary muscle contraction, migraine, paresthesia, paralysis, speech disorder, stupor, tremor, vertigo, encephalopathy, abnormal gait, leg cramps, intracranial hypertension, ataxia.
Gastro-Intestinal System Disorders: Dry mouth, dysphagia, esophagitis, gastroesophageal reflux disease, GI hemorrhage, glossitis, intestinal obstruction, pancreatitis, tongue edema, melena, stomatitis.
Liver and Biliary System Disorder: Abnormal hepatic function, cholecystitis, cholelithiasis, hepatic enzyme increase, hepatic failure, jaundice.
Respiratory System Disorder: Airways obstruction, aspiration, asthma, bronchitis, bronchospasm, chronic obstructive airways disease, coughing, hemoptysis, epistaxis, hypoxia, laryngitis, pleural effusion, pleurisy, pneumonitis, pneumonia, pneumothorax, pulmonary edema.
Drug Interactions
Antacid, Sucralfate, Metal Cations, Multivitamins: While the chelation by divalent cations is less than with other quinolones concurrent administration of Levofloxacin tab. With antacid con't. Magnesium, Aluminum as well as Sucralfate, Metal cation such as iron and multivitamins with zinc content may interfere its absorption, concentration may be lowered. Interval of 1-2 hours must be taken in consideration.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 500 mg x 30's.
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