Omnivox

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.

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.

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 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.

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.

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.

Tendon Effects: Ruptures of the shoulder, hand, or Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.
That peripheral neuropathies have been associated with levofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, they should discontinue treatment and contact their physicians.
Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones, including levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy.
Information for Patients: That peripheral neuropathies have been associated with levofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, they should discontinue treatment and contact their physicians.
Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using levofloxacin with concomitant drugs that can result in prolongation of the QT interval (e.g. class IA or class III antiarrhythmic) or in patients with risk factors for Torsades de pointes (e.g. known QT prolongation, uncorrected hypokalemia).
The pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration. However since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Serious adverse events may occur with therapeutic use or with acute overdose. At therapeutic doses adverse events may include: Irreversible peripheral neuropathy, central nervous system toxicity, cardiovascular toxicity, tendon/articular toxicity, and hepatic toxicity. Toxic epidermal necrolysis, coagulation abnormalities and pancytopenia are other possible adverse effect of levofloxacin. Children and the elderly are believed to be at a greater risk. Adverse reactions may manifest during, as well as after fluoroquinolone therapy. Liver damage and dysglycemia has been associated with levofloxacin. Another serious adverse effect is autoimmune hemolytic anemia. Older patients may have an increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use and such patients may also be more susceptible to prolongation of the QT interval. Patients with known prolongation, those with hypokalemia, or being treated with other drugs that prolong the QT interval should avoid the use of levaquin. Hematologic reactions (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses.
Post-Marketing Adverse Reaction: Additional adverse events reported from worldwide post-marketing experience with levofloxacin include: allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, hemolytic anemia, multi-system organ failure, increased International Normalized Ratio (INR)/prothrombin time, peripheral neuropathy, rhabdomyolysis, Stevens-Johnson Syndrome, tendon rupture, torsades de pointes, vasodilation.

Effect of other medicinal products on Levofloxacin tablets: Iron salts, magnesium- or aluminum-containing antacids: Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminum-containing antacids are administered concomitantly with Levofloxacin tablets. It is recommended that preparations containing iron salts, or magnesium-or aluminum-containing antacids should not be taken 2 hours before or after Levofloxacin tablet administration. No interaction was found with calcium carbonate.
Sucralfate: The bioavailability of levofloxacin tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and Levofloxacin tablets, it is best to administer sucralfate 2 hours after the Levofloxacin tablet administration.
Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs: A pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other agents which lower the seizure threshold. Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Probenecid and cimetidine: Probenecid and cimetidine has statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin is reduced by cimetidine (24%) and probenecid (34%). Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients.
Other relevant information: Pharmacokinetics of levofloxacin is not affected when coadministered with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.
Effect of Levofloxacin tablets on other medicinal products: Ciclosporin: The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Vitamin K antagonists: Increased coagulation tests (PT/INR) and/or bleeding have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests should be monitored in patients treated with vitamin K antagonists.
Drugs known to prolong QT interval: Levofloxacin should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides).
Other forms of interactions: Meals: There is no clinically relevant interaction with food.

Store at temperatures not exceeding 30°C.

Quinolones

J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

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