LEFLOXCIN FILM-COATED TABLET 500mg

Levofloxacin

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

(-)-Ofloxacin | (3S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid | (S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid | (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid | (S)-Ofloxacin | L-Ofloxacin | Levofloxacin anhydrous | Levofloxacine | Levofloxacino | Levofloxacinum | Ofloxacin S-(-)-form | Levofloxacin |

Description

A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

Indication

For the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species, Staphylococus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Groups C/F/G), Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.

Mechanism of Action

Levofloxacin inhibits bacterial type II topoisomerases, topoisomerase IV and DNA gyrase. Levofloxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing; DNA replication and transcription is inhibited.

Pharmacodynamics

Levofloxacin, a fluoroquinolone antiinfective, is the optically active L-isomer of ofloxacin. Levofloxacin is used to treat bacterial conjunctivitis, sinusitis, chronic bronchitis, community-acquired pneumonia and pneumonia caused by penicillin-resistant strains of Streptococcus pneumoniae, skin and skin structure infections, complicated urinary tract infections and acute pyelonephritis.

Pharmacokinetics

Absorption:

Absorption of ofloxacin after single or multiple doses of 200 to 400 mg is predictable, and the amount of drug absorbed increases proportionately with the dose.

Distribution:

Not Available

Metabolism:

Mainly excreted as unchanged drug (87%); undergoes limited metabolism in humans.

Elimination:

Mainly excreted as unchanged drug in the urine.

Half-life

6-8 hours

Clearance

Not Available

Toxicity

Side effects include disorientation, dizziness, drowsiness, hot and cold flashes, nausea, slurring of speech, swelling and numbness in the face

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

LEFLOXCIN FILM-COATED TABLET 500mg was registered with Health Science Authority of Singapore by PAN-MALAYAN PHARMACEUTICALS PTE LTD. It is marketed with the registration number of SIN15180P with effective from 2017-02-27.

This product contains 500mg of Levofloxacin in the form of TABLET, FILM-COATED.

The medicine was manufactured by PT Novell Pharmaceutical Laboratories in INDONESIA

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: J01MA12

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