Each film-coated tablet contains: Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg.
Pharmacology: Pharmacokinetics: Levofloxacin is rapidly and almost completely absorbed after oral use with peak plasma concentrations achieved within 1 hour of a dose. It is distributed into body tissues including the bronchial mucosa and lungs, but penetration into CSF is relatively poor. Levofloxacin is about 30 to 40% bound to plasma proteins. It is only metabolised to a small degree to inactive metabolites. The elimination half-life of levofloxacin is 6 to 8 hours, although this may be prolonged in patients with renal impairment. Levofloxacin is excreted largely unchanged, primarily in the urine. It is not removed by haemodialyiss or peritoneal dialysis.
Used for the treatment of urinary tract infections, chronic bacterial prostatitis, complicated skin and soft-tissue infections, hospital-acquired pneumonia, acute sinusitis and acute pyelonephritis.
Levofloxacin is given as the hemihydrate but doses are expressed in terms of the base; levofloxacin hemihydrate 256 mg is equivalent to about 250 mg of the base. Usual doses range from 250 mg once daily for 3 days for uncomplicated urinary-tract infections to 250 or 500 mg once or twice daily for 10 to 14 days for most other susceptible infections. A 28-day course of treatment with a dose of 500 mg daily should be given for chronic bacterial prostatitis. An alternative regimen of 750 mg once daily for 7 to 14 days may be used for complicated skin infections and for hospital-acquired pneumonia; a shorter course of 750 mg once daily for 5 days may be given for community-acquired pneumonia or for acute bacterial sinusitis. Dosing should be reduced in patients with renal impairment.
In patients hypersensitive to levofloxacin or any other quinolone or any of the excipients; in patients with epilepsy; in patients with history of tendon disorder related to fluoroquinolone administration; during pregnancy; in breastfeeding women.
No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for R- and S-warfarin was detected in a clinical study involving healthy volunteers.
Antidiabetic Agents: Disturbances of blood glucose, including hyperglycemia and hypoglycaemia, have been reported in patients treated concomitantly with quinolone and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.
Non-Steroidal Anti-Inflammatory Drugs: The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Theophylline: No significant effect of Levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers.
Cyclosporine: No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers.
Digoxin: No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Levofloxacin absorption and disposition kinetics were similar in the presence of absence of digoxin.
Probenecid and Cimetidine: No significant effect of probenecid or cimetidine on the Cmax of levofloxacin was observed in a clinical study involving healthy volunteers.
Paediatric use: Levofloxacin is not indicated for paediatric patients (less than 18 years of age).
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.
Pregnancy: 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 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.
Confusion, difficulty breathing, irregular heartbeat, palpitations or chest pain, joint, muscle or tendon pain, nightmares, changes in thought process, redness, blistering, peeling or loosening of the skin, including inside the mouth, seizure, severe or watery diarrhea, skin rash, itching, swelling of the face or neck, tremor or restlessness, vision changes, vomiting.
Side effects that usually do not require medical attention: Constipation or diarrhea, difficulty sleeping, dizziness or drowsiness, headache, intestinal gas or bloating, nausea or stomach upset.
Antacids: Tablets with antacids containing magnesium, aluminium, as well as sucralfate, metal cations such as iron, and multivitamins 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 administration. There are no data concerning an interaction of intravenous quinolone with oral antacids, sucralfate, multivitamins, didanosine, or metal cations.
Store at temperatures not exceeding 30°C.
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.