OMNIVOX TABLET 500MG

Description

OMNIVOX TABLET 500MG

Description
Each Film-Coated tablet contains: Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg.
Excipients/Inactive Ingredients: q.s.
Colour: Yellow Oxide of Iron NF and Titanium Dioxide BP.

Action
Pharmacology: Mechanism of action: Levofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It functions by inhibiting DNA gyrase, a type II topoisomerase, and topoisomerase iv, which is an enzyme necessary to separate replicated DNA, thereby inhibiting cell division.

Pharmacokinetics: Absorption: Levofloxacin is rapidly and essentially completely absorbed after oral administration. Peak plasma concentrations are usually attained one to two hours after oral dosing. The absolute bioavailability of a 500 mg tablet is approximately 99%. Steady-state conditions are reached within 48 hours following a 500 mg once-daily dosage regimen.
Distribution: The mean volume of distribution of levofloxacin generally ranges from 74 to 112 L after single and multiple 500 mg doses. Levofloxacin reaches its peak levels in skin tissues and in blister fluid of healthy subjects at approximately 3 hours after dosing. Levofloxacin also penetrates well into lung tissues.

Metabolism: Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin. Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine. Following oral administration, approximately 87% of an administered dose was recovered as unchanged drug in urine within 48 hours, whereas less than 4% of the dose was recovered in feces in 72 hours. Less than 5% of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites, the only metabolites identified in humans. These metabolites have little relevant pharmacological activity.

Excretion: Levofloxacin is excreted largely as unchanged drug in the urine. The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of levofloxacin given orally. Concomitant administration of either cimetidine or probenecid results in approximately 24% and 35% reduction in the levofloxacin renal clearance, respectively, indicating that secretion of levofloxacin occurs in the renal proximal tubule. No levofloxacin crystals were found in any of the urine samples freshly collected from subjects receiving levofloxacin.

Indications/Uses
Levofloxacin is from a group of antibiotics known as quinolones. It is used to treat lung, sinus, skin and urinary tract infections caused by certain life threatening bacteria.

Dosage/Direction for Use
Dosage is according to doctor’s instructions only.
Do not exceed the recommended dosage.
Do not chew. Swallow the medicine with a glass of water.
The medicine can be taken either with or between meals.
Missed Dose: If the patient misses a dose of this medicine, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

Overdosage
Symptoms: Levofloxacin tablets do not seem to be especially toxic in the case of an overdose.
Treatment: The treatment for a Levofloxacin tablets overdose will vary. If the overdose is recent, the healthcare provider may administer certain medicines or place a tube into the stomach to “pump the stomach”. Treatment also involves supportive care, which consists of treating the symptoms that occur as a result of the overdose.
Supportive treatment options may include: Fluids through an intravenous line (IV), if necessary.
Close monitoring of vital signs, such as heart rate and breathing.
Other treatments based on the complications that occur.
It is important to seek medical attention immediately if the patient believes that he/she may have overdosed on Levofloxacin tablets.

Contraindications
Patients hypersensitive to levofloxacin or other quinolones or any of the excipients.

Patient with epilepsy.
Patient with history of tendon disorders related to fluoroquinolone administration.
Children or growing adolescents.

During pregnancy.
Breast-feeding women.

Additional information