Veflox

Veflox

levofloxacin

Manufacturer:

Community Pharm PCL

Distributor:

Community Pharm PCL
Full Prescribing Info
Contents
Levofloxacin.
Description
1 film-coated tablet contains Levofloxacin 500 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Levofloxacin, inhibits DNA-gyrase in susceptible organisms thereby inhibits relaxation of the supercoiled DNA and promotes breakage of DNA standards. DNA gyrase (topoisomerase II), is an essential bacterial enzyme that maintains the superhelical structure of DNA and is required for DNA replication and transcription, DNA repair, recombination, and transposition.
Levofloxacin has been shown to be active against various strains of microorganisms in clinical infections as described in the INDICATIONS section.
Pharmacokinetics: Absorption: Levofloxacin is rapidly and completely absorbed after oral administration. Peak plasma concentrations are usually attained 1-2 hours after oral dosing. The absolute bioavailability is approximately 99%, demonstrating complete oral absorption of levofloxacin.
Distribution: The mean volume of distribution of levofloxacin generally ranges from 74 to 112 L; CSF concentrations ~15% of serum levels; high concentrations are achieved in prostate, lung, and gynecological tissues, sinus, saliva. Levofloxacin is approximately 24% to 38% bound to serum proteins primarily albumin.
Metabolism: Levofloxacin is minimally metabolized by liver. The elimination half-life of Levofloxacin range from approximately 6 to 8 hour.
Excretion: Following oral administration, approximately 87% of an administered dose was recovered unchanged drug in urine within 48 hours, whereas less than 4% of dose was recovered in feces in 72 hours. Less than 5 % of an administered dose was recovered in urine as the metabolites.
Indications/Uses
Veflox are indicated for the treatment of adults with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows.
Acute sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute exacerbation of chronic bronchitis due to Staphylococus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophillus parainfluenzae or Moraxella catarrhalis.
Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae (including penicillin-resistant strains), Haemophilus influenzae, Heamophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pheumoniae, Legionella pneumophila or Mycoplasma pneumoniae.
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.
Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections due to Staphylococcus aureus and Streptococcus pyogenes.
Complicated skin and skin structure infections (mild to moderate) due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes or Proteus mirabilis.
Urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa or Staphylococcus saprophyticus.
Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis.
Pyelonephritis (mild to moderate) caused by Escherichia coli.
Dosage/Direction for Use
Recommended Dose: See Table.

Click on icon to see table/diagram/image

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance. (See Equation.)

Click on icon to see table/diagram/image

The serum creatinine should represent a state of renal function.
Patients with impaired liver function: No adjustment of dosage is required since levofloxacin is not metabolized to any relevant extent by liver and is mainly excreted by kidney.
Elderly patient: No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function.
Mode of Administration: Oral tablets may be administered without regard to meals. Take 2 hours before or 2 hours after multiple vitamins, antacids, or other products containing magnesium, aluminum, iron, or zinc.
Overdosage
Symptoms include acute renal failure and seizures. Treatment should include GI decontamination and supportive care. Levofloxacin cannot be removed by peritoneal or hemodialysis.
Contraindications
Patients hypersensitive to levofloxacin, any component of the formulation, or any other quinolones.
Special Precautions
Do not use in patients who are hypersensitive to levofloxacin or any other quinolone antimicrobial agents.
If skin rash, or muscle pain or tendon pain (e.g. at the wrist or ankle) occurs, discontinue levofloxacin and consult a physician immediately.
Levofloxacin could be harmful to the liver and kidneys.
Do not use, or if necessary, use with special precaution in patients with CNS disorder that predispose to seizures in a dose related manner.
Levofloxacin may prolong the QT interval therefore, use with cautions in patients at risk to develop prolongation of the QT interval such as elderly, patients with heart diseases, especially arrhythmia, patients with hypertension and patients with uncorrected hypokalemia, etc.
Avoid coadministration with drugs that cause prolongation of the QT interval such as antiarrhythmic class IA (e.g. quinidine, procainamide), class III (e.g. amiodarone), cisapride, erythromycin, antipsychotics drugs, tricyclic antidepressants, etc.
Levofloxacin may cause phototoxicity reaction or a severe rash, such as Toxic Epidermal Necrolysis, Steven-Johnson syndrome, Erythema Multiforme, etc.
Levofloxacin may affect blood sugar levels. Carefully use in diabetic patients.
Coadministration of this drug with warfarin may increase the effect of warfarin.
Use in Pregnancy & Lactation: Avoid using levofloxacin in pregnant and breast-feeding women.
Use in Children: Levofloxacin may used be for inhalational anthrax (post exposure) in adolescents and children 6 months of age or older. Safety and efficacy do not established for any other indication in this age group. There is reported that levofloxacin causes arthropathy in juvenile animals use of so, fluoroquinolones may be justified in children younger than 18 years old.
Use In Pregnancy & Lactation
Use in Pregnancy: Avoid using levofloxacin in pregnant and breast-feeding women.
Pregnancy category C. Levofloxacin crosses the placenta. Quinolone exposure during human pregnancy has been reported with other agents. To date, no specific teratogenic effect or increased pregnancy risk has been identified; however, because of concerns of cartilage damage in immature animals exposed to quinolones and the limited levofloxacin specific data, levofloxacin should only be used during pregnancy if a safer option is not available.
Use in Lactation: Enters breast milk, not recommended.
Adverse Reactions
1% to 10%: Cardiovascular: Chest pain (1%), edema (1%).
Central nervous system: Headache (6%), insomnia (4%), dizziness (3%), fatigue (1%), pain (1%).
Dermatologic: Rash (2%), pruritus (1%).
Gastrointestinal: Nausea (7%). diarrhea (5%), constipation (3%), abdominal pain (2%), dyspepsia (2%), vomiting (2%).
Genitourinary: Vaginitis (1%).
Local: Injection site reaction (1%).
Respiratory: Pharyngitis (4%), dyspnea (1%).
Miscellaneous: Monilias (1%).
<1%: Limited to important or life-threatening: Acute renal failure, agitation, agranulocytosis; allergenic reaction (including anaphylaxis, angioedema, pneumonitis rash, pneumonitis, and serum sickness); anaphylactoid reaction, arrhythmia (including atrial/ventricular tachycardia/fibrillation and torsade de pointes), aplastic anemia, arthralgia, ascites, bradycardia, bronchospasm, carcinoma, cardiac failure, cholecystitis, cholelithiasis, confusion, depression, EEG abnormalities, encephalopathy, eosinophilia, erythema multiforme, GI hemorrhage, granulocytopenia, hallucination, heart block, hemolytic anemia, hemoptysis, hepatic failure (some fatal), hepatitis, hyper-/hypoglycemia, hyperkalemia, hyperkinesias, hyper-/hypotension, infection, INR increased, intestinal obstruction, intracranial hypertension, involuntary muscle contractions, jaundice, leukocytosis, leukopenia, leucorrhea, lymphadenopathy, MI, migraine, multiple organ failure, myalgia, nephritis (interstitial), palpitation, pancreatitis, pancytopenia, paralysis, paresthesia, peripheral neuropathy, photosentivity (<0.1%), pleural effusion, pneumonititis, postural hypotension, prothrombin time increased/decreased, pseudomembraneous colitis, psychosis, pulmonary edema, pulmonary embolism, purpura, QTc prolongation, respiratory depression, rhabdomyolysis, seizure, skin disorder, somnolence, speech disorder, Stevens-Johnson syndrome, stupor, suicide attempt/ideation, syncope, tendonitis, tendon rupture, tongue edema, toxic epidermal necrolysis, transaminases increased, thrombocythemia, thrombocytopenia, tremor, urticaria, WBC abnormality.
Drug Interactions
Antacid, Sucralfate, Metal Cations, Multivitamins: While the chelation by divalent cations is less marked than with other quinolones, concurrent administration of Veflox with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken least two hours before of two hours after levofloxacin administration.
Theophylline, Non-steroidal anti-inflammatory drugs: No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. However there are indications of a pronounced lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs that lower the seizure threshold (e.g. theophylline) or with fenbufen or similar non-steroidal anti-inflammatory drugs.
Antidiabetic agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when this agents are co-administered.
Anticoagulant drug (warfarin): Coadministration with warfarin has been reported that the effect of warfarin was potentiated (hepatic metabolism of warfarin may be inhibited, or free warfarin may be increased by competitive displacement from the protein binding site) and therefore prothrombin time prolonged.
Storage
Stored at room temperature (below 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 (pale yellowish-white, oblong, biconvex, one-side scored, with letter "VF" and "500" on the scored side and the letters "Rx" on the other) x 1 x 10's.
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