Ovel (Levofloxacin)
Therapeutic Group : Antibiotic
Presentation:
Ovel Tablet: Each film coated tablet contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 500 mg.
Pharmacology:
Levofloxacin is a fluoroquinolone antimicrobial that shows antibacterial activity by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV enzymes required for DNA replication, transcription, repairing and recombination. Levofloxacin has wide spectrum of activities against different Gram-positive bacteria e.g., Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococci Group C/F, Streptococci Group G, Viridans group streptococci and Gram-negative bacteria e.g., Pseudomonas aeruginosa, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.
Indications:
Ovel is indicated for the treatment of adults with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
• Acute maxillary sinusitis
• Acute exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated skin and soft tissue infections
• Complicated skin and soft tissue infections
• Uncomplicated urinary tract infections
• Complicated urinary tract infections
• Acute pyelonephritis
• Enteric fever
Dosage & Administration:
| Indication | Recommended dose | Duration |
|---|---|---|
| Acute sinusitis | 500 mg daily | 10-14 days |
| Acute exacerbation of chronic bronchitis | 250-500 mg daily | 7-10 days |
| Community-acquired pneumonia | 500 mg once or twice daily | 7-14 days |
| Uncomplicated skin and soft tissue infections | 500 mg daily | 7-10 days |
| Complicated skin and soft tissue infections | 750 mg daily | 7-14 days |
| Uncomplicated urinary tract infections | 250 mg daily | 3 days |
| Complicated urinary tract infections | 250 mg daily | 7-10 days |
| Acute pyelonephritis | 250 mg daily | 10 days |
| Enteric fever | 500 mg daily | 14 days |
| Chronic bacterial Prostitis | 500 mg daily | 28 days |
| Travellers diarrhoea | 500 mg single dose | |
| Obstetric & gynecological infections | 250-750 mg once daily | 3-14 days |
| Bacterial enteritis | 250 mg daily | 3-5 days |
| Gonococcal urethritis | 500 mg daily | 3 days |
| Uterine cervicitis | 500 mg once daily | 7 days |
| Pharyngitis | 500 mg once daily | 14 days |
| Acute otitis media | 500 mg once daily | 5-10 days |
Contrainidications:
Levofloxacin is contraindicated in persons with a history of hypersensitivity of Levofloxacin, quinolone antimicrobial agents, or any other component of this product.
Warning & Precautions:
Adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of highly concentrated urine.
In patients with impaired renal function (creatinine clearance < 50 ml/min), adjustment of the dosage regimen is necessary to avoid the accumulation of Levofloxacin.
Moderate to severe phototoxicity reactions have been observed in less than 0.1% of patients exposed to direct sunlight while receiving Levofloxacin. Excessive exposure to sunlight should be avoided.
Levofloxacin should be used with caution in any patients with known or suspected CNS disorder that may predispose to seizures or lower the seizure the threshold (e.g., severe cerebral arteiosclerosis, epilepsy).
Side effects:
Levofloxacin is generally well tolerated. Side effects include nausea, vomiting, dyspepsia, abdominal pain, diarrhea, headache, dizziness and asthenia; rarely tremor, anxiety, tachycardia, hypotension, hypoglycaemia, pneumonitis, rhabdomyolysis etc.
Drug interaction:
Concurrent administration of Levofloxacin with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations (such as iron) and multi-vitamin preparations with zinc may interfere with the gastrointestinal absorption of Levofloxacin resulting in systematic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after Levofloxacin administration.
Use in special groups:
Use in pregnancy: Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: 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, taking into account the importance of the drug to the mother.
Use in paediatric patients: Levofloxacin can be given to children 6 months of age and above. The safety of Levofloxacin in pediatric patients treated for more than 14 days has not been studied.
Storage:
Store below 30°C, keep in dry place & protect from light.
Packing:
Ovel-500 Tablet: Each box contains 30’s tablets in blister pack.
