Aprocin 0.3%

Description

Indications

Aprocin 0.3% ophthalmic solution is indicated for the treatment of:

• Corneal ulcers
• Conjunctivitis
• Blepharitis These conditions are caused by susceptible strains of bacteria.

Use as directed by a registered physician.

Composition

Each ml of Aprocin ophthalmic solution contains:

• Active Substance: Ciprofloxacin Hydrochloride BP, equivalent to Ciprofloxacin 3 mg.
• Preservative: Benzalkonium Chloride 0.06 mg.

Pharmacology

Ciprofloxacin is an antibiotic with broad-spectrum in vitro activity against both Gram-negative and Gram-positive organisms. It works by inhibiting the A subunits of DNA gyrase (topoisomerase), an essential enzyme for bacterial DNA replication, making it bactericidal.

Dosage & Administration

• For Corneal Ulcers:
  • Instill 2 drops into the affected eye every 15 minutes for the first 6 hours.
  • After 6 hours, instill 2 drops every 30 minutes on the first day.
  • On the second day, instill 2 drops every hour.
  • From the third to the fourteenth day, instill 2 drops every 4 hours. Treatment may continue beyond 14 days if corneal re-epithelialization has not occurred.
• For Bacterial Conjunctivitis/Blepharitis:
  • Instill 1 drop into the conjunctival sac(s) every 2 hours for the first 2 days.
  • For the next 5 days, instill 1 drop every 4 hours.
• Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.

Use as directed by a registered physician.

Interaction

Specific drug interaction studies have not been conducted with Aprocin ophthalmic solution. However, systemic administration of some quinolones, including Ciprofloxacin, may:

• Elevate plasma concentrations of theophylline
• Interfere with caffeine metabolism
• Enhance the effects of the oral anticoagulant warfarin and its derivatives
• Be associated with transient elevations in serum creatinine when used with cyclosporine

Contraindications

Aprocin is contraindicated in:

• Patients with a history of hypersensitivity to Ciprofloxacin or any other components of the product.
• Patients with hypersensitivity to other quinolones (e.g., Nalidixic acid).

Side Effects

The most common side effect is local burning or discomfort. In corneal ulcer studies, white crystalline precipitates were seen in about 17% of patients. Less common side effects (in less than 10% of patients) include:

• Lid margin crusting
• Crystals/scales
• Foreign body sensation
• Itching
• Conjunctival hyperemia (redness)
• Bad taste after instillation

Rare side effects (in less than 1% of patients) include:

• Corneal staining
• Keratopathy/keratitis (corneal inflammation)
• Allergic reactions
• Lid edema (swelling)
• Tearing
• Photophobia (sensitivity to light)
• Corneal infiltrates
• Nausea
• Decreased vision

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin ophthalmic solution should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

• General: As with other anti-infective medications, prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If a superinfection occurs, discontinue the medication and begin alternative therapy.
• Discontinue Aprocin at the first appearance of a skin rash or any other signs of a hypersensitivity reaction.

Overdose Effects

A topical overdose of Aprocin eye drops can be flushed from the eye(s) with warm tap water.

Therapeutic Class

Aural Anti-bacterial Preparations, Ophthalmic Antibacterial Drugs

Storage Conditions

Store at room temperature, protected from light. It is advisable to use the contents within one month after first opening the bottle.