Generic Name

Composition

Therapeutic Category

Division

Ciprofloxacin E/E Drops

Ciprofloxacin 0.3% w/v Eye/Ear Drops

Fluoroquinolone Antibiotic

TIME

    BRAND COMPOSITION DESCRIPTION
     CIFROX E/E Drops  Each 5ml contains:
    Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin    0.3%w/v

    Clear Colourless solution filled in a 10.25 ml overflow capacity gamma sterilized Lupolene vials plugged with gamma sterilized inner seal and capped with gamma sterilized caps.

     

     
     
     
     

    PATIENT INFORMATION

    Pregnancy:Category C

    Storage: Store below 25 °C. Store away from heat, moisture, and light.

    Missed dose: Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

    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 sensationitchingconjunctival 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 painear pruritusfungal 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