CELEVO Levofloxacin 500mg Film-Coated Tablet 1's
RXDRUG-DRP-3158-01-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
May be taken with or without food: Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Contraindications
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.
Warnings
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.
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.
Use In Pregnancy & Lactation
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.
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.
Adverse Reactions
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.
Storage
Store at temperatures not exceeding 30°C.
Action
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.
MedsGo Class
Quinolones
Features
Brand
Celevo
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Levofloxacin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Levofloxacin
Dosage Form
Film-Coated Tablet
Registration Number
DRP-3158-01
Drug Classification
Prescription Drug (RX)
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