KINVOX-750

COMPOSITION:

Each film coated Tablet contains:

Levofloxacin Hemihydrate equivalent to

Levofloxacin 750 mg.

Excipients q.s.

Colour: Titanium Dioxide B.P.

DRUG DESCRIPTION:

Levofloxacin is a quinolone antibiotic. It works by killing the bacteria that cause infections in body.

INDICATIONS:

Used to treat infections of the:

Ø Nasal sinuses.

Ø Lungs, in people with long-term breathing problems or pneumonia.

Ø Urinary tract, including your kidneys or bladder.

Ø Prostate gland, where you have a long lasting infection.

Ø Skin and underneath the skin, including muscles. This is sometimes called 'soft tissue'.

PHARMACOLOGICAL ACTION:

MECHANISM OF ACTION:

The  mechanism of action of Levofloxacin and other fluoroquinolone  antimicrobials involves inhibition of bacterial topoisomerase IV and DNA  gyrase (both of which are type II topoisomerases), enzymes required for  DNA replication, transcription, repair and recombination.

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. Kinvox Tablets can be administered without  regard to food.

Distribution:

The  mean volume of distribution of levofloxacin generally ranges from 74 to  112 L after single and multiple 750 mg doses, indicating widespread  distribution into body tissues. 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

axtivity.

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. The mean apparent total body clearance and renal

clearance range from approximately 144 to 226 mL/min and 96 to 142 mL/min, respectively.

CONTRAINDICATIONS:

KINVOX-750 is contraindicated in persons with known hypersensitivity to Levofloxacin, or

other quinolone antibacterial.

Marketed by :KINGZY PHARMACEUTICALS LTD.

142 Okporo Road, Port Harcourt,

Rivers State, NIGERIA