Ciloxan - Ciprofloxacin Hydrochloride ointment

CILOXAN^® (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below:

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  Gram-Positive:
  
  
  
  Staphylococcus aureus
  
  
  
  Staphylococcus epidermidis
  
  
  
  Streptococcus pneumoniae
  
  
  
  Streptococcus
  Viridans Group

Apply a ½ inch ribbon into the conjunctival sac three times a day on the first two days, then apply a ½ inch ribbon two times a day for the next five days.

The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN^® (ciprofloxacin ophthalmic ointment) 0.3%: discomfort and keratopathy. Other reactions associated with ciprofloxacin therapy occurring in less than 1% of patients included allergic reactions, blurred vision, corneal staining, decreased visual acuity, dry eye, edema, epitheliopathy, eye pain, foreign body sensation, hyperemia, irritation, keratoconjunctivitis, lid erythema, lid margin hyperemia, photophobia, pruritus, and tearing. Systemic adverse reactions related to ciprofloxacin therapy occurred at an incidence below 1% and included dermatitis, nausea and taste perversion.

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  Drug Interactions:
  Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

CILOXAN^® (ciprofloxacin ophthalmic ointment) 0.3% is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 385.82 g/mol. Its empirical formula is C₁₇H₁₈FN₃O₃•HCl•H₂O and its chemical structure is as follows:

Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position.

Each gram of CILOXAN^® (ciprofloxacin ophthalmic ointment) 0.3% contains: