PHARMACOLOGY

Pharmacotherapeutic Group: Fluoroquinolones Antibiotics

 Pharmacodynamic Properties:

Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits topoisomerase IV and DNA gyrase enzymes, which is essential in reproduction of bacterial DNA.

 Pharmacokinetics:

The maximum reported plasma concentration of ciprofloxacin Eye/Ear Solution was less than 5 ng/mL.

Absorption: Rapidly and well absorbed from the gastrointestinal tract with peak plasma concentration after 2 hour

Distribution:Bile (high concentrations), CSF (10% of those in plasma in the absence of meningitis); crosses the placenta and enters the breast milk. Protein-binding: 20-40%.

Metabolism: Converted to oxociprofloxacin, sulfociprofloxacin and other active metabolites

Excretion: Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug.

 INDICATIONS

Conjuntivitis, Bacterial Corneal Ulcer, Bacterial Ear Infection, Endopthalmititis, Prophylaxis in the occular surgery

 DOSAGE & ADMINISTRATION

For ear infection: Instilled into the affected ear twice or thrice daily (approximately 12 hours apart) for 7 days.

For eye infection:

Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes forthe remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

 ADVERSE DRUG REACTIONS

For eyes: Local burning or discomfort, white crystalline precipitation, lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation, corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

For ear:Site pain, ear pruritus, fungal ear superinfection, and headache

 PRECAUTIONS

Should not be used for injection, for inhalation

 CONTRAINDICATIONS

Hypersensitivity

 PRESENTATION

CIFROX E/E DROPS: Each vial contains 5ml of solution