COMPOSITION :
Each F/C caplet contains : Levofloxacin hemihydrate USP equivalent to levofloxacin 500 mg. DESCRIPTION :
Levoxine (Levofloxacin) is a synthetic broad spectrum antibacterial agent of the fluoroquinolone class and it is L-isomer of ofloxacin. Levoxine, orally, inhibits the bacterial DNA gyrase topoisomerase IV and it is rapidly and almost completely absorbed with peak plasma concentration being obtained within 1- 2 hours, and the absolute bioavailability of Levofloxacin is approximately 100%. About 30 - 40% of Levofloxacin are bound to serum protein and only small amount are metabolised to inactive metabolites. Levofloxacin is widely distributed into body tissues including bronchial mucosa and lungs. The elemination half life is 6 - 8 hours and is prolonged in patients with renal impairment. It is excreted primarily in urine. INDICATIONS :
Levoxine is indicated for the treatment of the following cases :
- Acute sinusitis.
- Acute exacerbation of chronic bronchitis.
- Community-acquired pneumonia.
- Uncomplicated urinary tract infections and prostatitis.
- Complicated urinary tract infections including pyelonephritis.
- Skin and soft tissue infections.
- Septicemia and bacterimia.
- Intra-abdominal infections.
DOSAGE & ADMINISTRATION :
Levoxine should be taken with sufficient amount of liquid during or between meals as follows :
- In adults with normal renal function ( Creatinine clearance > 50 ml / min. ).
Dosage & Duration (According to severity of infection) 500 mg once daily for 10 - 14 days.
Indications Acute Sinusitis
Acute exacerbation of chronic bronchitis 250 - 500 mg once daily for 7 - 10 days. 500 - 1000 mg once or twice daily for 7 - 14 days. 250 mg once daily for 3 days.
Community-acquired pneumonia Uncomplicated urinary tract infections
Complicated urinary tract infections including pyelonephritis
Prostatitis
Skin and soft tissues infections
Septicemia and Bacteriemia Intra-abdominal infections
250 mg once daily for 7 - 10 days.
500 mg once daily for 28 days.
250 mg once daily for 7 - 14 days
or 500 - 1000 mg once or twice daily for 7 - 14 days
500 - 1000 mg once or twice daily for 10 - 14 days. 500 mg once daily for 7 - 14 days.
- In adults with impaired renal function ( Creatinine clearance < 50 ml / min. ).
50 - 20 ml / min. First dose : 250 mg. Then : 125 mg / 24 hrs.First dose : 500 mg. Then : 250 mg / 24 hrs. First dose : 500 mg. Then :250 mg / 12 hrs. Then :125 mg / 12 hrs. Then :125 mg / 24 hrs. Then : 125 mg / 24 hrs. First dose : 500 mg. Then :125 mg / 24 hrs. First dose : 500 mg. First dose : 250 mg. Then : 125 mg / 48 hrs. First dose : 500 mg. Then : 125 mg / 48 hrs. First dose : 500 mg. 19 - 10 ml / min. < 10 ml / min. (including heamodialysis and CAPD*) First dose : 250 mg. * Continuous Ambulatory Peritoneal Dialysis Creatinine Clearance Dosage & Duration (According to severity of infection)
RESTRICTIONS ON USE : Contraindications
- Hypersensitivity to levofloxacin or other quinolones.
- History of tendon disorders related to fluoroquinolone administration.
- During pregnancy and breast feeding. - Children or adolescents. - Epilepsy. Precautions
- Dose of Levofloxacin should be adjusted in patients with renal impairment (creatinine clearance < 50 ml / min.).
- Avoid excessive exposure to strong sunlight or artificial UV rays .
- Avoid using Levofloxacin for patient with G6PD defeciency .
- Superinfection may occur during prolonged therapy.
- Tendinitis may rarely occur and if it is suspected, treatment with Levofloxacin must be stopped.
- Levofloxacin should be used with extreme caution in patients predisposed to seizures.
- Diarrhea persistent and / or bloody may be symptomatic of pseudomembranous colitis and if it is suspected, Levofloxacin must be stopped immediately.
- Careful monitoring of blood glucose of diabetic patients is recommended when they use Levofloxacin.
- Caution is recommended if Levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
- Caution should be taken when using Levofloxacin in patients with risk factors for QT prolongation. Effect on the capacity to drive vehicles or use machines
Levofloxacin may cause dizzines /vertigo , drowsiness , visual disturbances which may impair the ability to drive vehicles or use machines. Use in pregnancy and lactation Levofloxacin must not be used in pregnant women and due to its distribution into breast milk, it should be avoided during lactation.
DRUG INTERACTION :
- There is no interaction between Levofloxacin and theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs . However, a pronounced lowering of the cerebral seizure threshold may occur. Levofloxacin concentration increases in the presence of fenbufen.
- Co-administrated of Levofloxacin with cimetidine and probenecid lead to significant effect on the elimination of Levofloxacin by reducing its renal clearance level.
- Levofloxacin increases the half-life of ciclosporin when co-administrated with each other but no need for ciclosporin dose adjustment.
- Use of Levofloxacin in combination with vitamin K antagonist (e.g. warfarin) will increase coagulation test (PT/INR) and/or bleeding.Therefore , coagulation test should be monitored.
- Iron salts, magnesium or aluminium containing antacids should not be taken 2 hours before or after Levofloxacin.
- Sucralfate should be taken 2 hours after Levofloxacin administration due to it is significant reduce in Levofloxacin bioavailability.
- Levofloxacin may inhibit the growth of mycobacterium tuberculosis and may give false-negative results in the bacteriological diagnosis of tuberculosis.
- Levofloxacin should be used with caution in patients recieving drugs known to prolong the QT interval (class IA and III anti-arrythmics, tricyclic antidepressants, macrolides, antipsychotics). ADVERSE EFFECTS :
- Common adverse effects :
Nausea, diarrhea, increase in liver enzymes (e.g. ALT/AST).
- Uncommon adverse effects :
Pruritis, rash, anorexia, vomiting, abdominal pain, dyspepsia, headache, dizziness / vertigo, drowsiness, insomnia , eosinophilia, leukopenia, asthenia, fungal over growth and proliferation of other resistant micro-organisms, increase in blood bilirubin and serum creatinine.
- Rare and very rare adverse effects :
Urticaria, bronchospasm, hypotension, photosensitization, bloody diarrhea, hypoglycemia( particular in diabetic patients), depression, anxiety , psychotic reactions, paraesthesia, confusion, convulsion, visual and auditory disturbance, arthralgia, myalgia, hepatitis, acute kidney failure, thrombocytopenia and neutropenia. OVER DOSAGE :
In case of acute overdose of Levofloxacin, some symptoms appear like confusion, dizziness, impairment of consciousness and convulsive seizure, increase in QT interval, nausea and mucosal erosions. There is no specific antidote for Levofloxacin overdose, but the pateint should be carefully observed (including ECG monitoring ) and symptomatic treatment should be implemented, also gastric lavage should be considered and antacids may be used for protection of the gastric mucosa. Hemodialysis including peritoneal dialysis and CAPD (continuous ambulatory peritoneal dialysis) are not effective in removing Levofloxacin. STORAGE INSTRUCTION : Store below 30°C, in a dry place.
PRESENTATIONS :
Levoxine Caplets : Pack of 10 caplets and hospital packs of different sizes.
INSTRUCTIONS TO THE PATIENT
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Council of Arab Health Ministers