Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep

Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep is a prescription medicine used for the treatment of steroid responsive inflammatory ocular conditions, otitis media, otitis externa, ocular inflammation associated with infection, post-operative inflammation of ear and eye, corneal ulcers, and bacterial conjunctivitis. Ciprofloxacin is an antibiotic that inhibits bacterial DNA synthesis, and Hydrocortisone is a corticosteroid that reduces inflammation and swelling.

• Steroid responsive inflammatory ocular conditions
• Otitis media
• Otitis externa
• Ocular inflammation associated with infection
• Post-operative inflammation of ear and eye
• Corneal Ulcers
• Bacterial Conjunctivitis

Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA. Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.

Ciprofloxacin inhibits DNA gyrase, preventing bacterial DNA synthesis. Hydrocortisone reduces inflammation by suppressing leukocyte migration and decreasing capillary permeability.

Eye Dose (Corneal Ulcers - Adult): 2 drops every 15 minutes for first 6 hours, then 2 drops every 30 minutes for remainder of first day; 2 drops hourly on 2nd day; 2 drops every 4 hours on days 3-14. May continue after 14 days if corneal re-epithelialization has not occurred.

Eye Dose (Bacterial Conjunctivitis - Adult): 1-2 drops every 2 hours for first 2 days, then 1-2 drops every 4 hours for next 5 days.

Ear Dose (Acute Otitis Externa - Adult): 4 drops into affected ear twice daily for 7 days.

Pediatric Dose (Ear): Established for patients 6 months and older (4 drops twice daily).

Pediatric Dose (Eye): Not established.

Ear Drop: Warm the suspension by holding the bottle in hand for 1-2 minutes to avoid dizziness. Patient should lie with the affected ear upward, instill the suspension, and maintain position for 60 seconds. Repeat for opposite ear if necessary.

Eye Drop: Shake well before use. Hold the dropper close to the eye without touching it and place the medicine inside the lower eyelid.

If you miss a dose of Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep, use it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

Common Side Effects:

• Transient ocular burning or discomfort
• Stinging
• Redness
• Itching
• Periocular/facial edema
• Foreign body sensation
• Photophobia
• Blurred vision
• Tearing
• Dryness
• Eye pain
• Dizziness (rare)

Steroid Component Side Effects: Elevated intraocular pressure, glaucoma, optic nerve damage, posterior sub-capsular cataract formation, delayed wound healing.

• Prolonged use may result in overgrowth of nonsusceptible organisms including fungi.
• Monitor intraocular pressure (risk of glaucoma and optic nerve damage).
• Patients wearing contact lenses must not use the drops during the time the lenses are worn.
• Caution during pregnancy and lactation.
• Contraindicated in herpes simplex, viral conditions, mycosis, glaucoma, and newborn babies.

• Hypersensitivity to any ingredient of the product
• Herpes simplex and other viral conditions
• Mycosis (fungal infections)
• Glaucoma
• Newborn babies
• Fungal diseases of ocular or auricular structures

May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption with oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg.

No food interactions have been found or established.

[CONSULT YOUR DOCTOR] Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep may be unsafe to use during pregnancy. Pregnancy Category C. Excretion in breast milk unknown; not recommended.

[CONSULT YOUR DOCTOR] Information regarding the use of Ciprofloxacin 0.3% + Hydrocortisone Acetate 1% E/E prep during breastfeeding is not available. Excretion in breast milk unknown; not recommended.

Safety and effectiveness for eye application in pediatric patients have not been established. Safety and effectiveness for ear application have been established in pediatric patients 6 months of age and older.

Limited information is available regarding dose adjustment for elderly patients.

For topical use, no dose adjustment is required in renal or hepatic impairment.

Information on overdosage is not available. Consult a physician if overdose is suspected.

Store in a cool and dry place, away from light and out of reach of children.

Ciprofloxacin + Hydrocortisone Acetate