Ciprofloxacin HCL Ophthalmic Solution 0.3%, 5mL

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Description

NDC: 59390-217-05

Ciprofloxacin HCl 0.3% Ophthalmic Solution, 5 mL — Altaire Pharmaceuticals

Active ingredients Ciprofloxacin hydrochloride equivalent to 3 mg/mL base (0.3%)
Dosage form Ophthalmic solution
Route Topical ophthalmic
Size 5 mL
Manufacturer Altaire Pharmaceuticals
NDC 59390-217-05

Indications and Usage

Indicated for the treatment of corneal ulcers and bacterial conjunctivitis caused by susceptible strains of bacteria, including Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.

Dosage and Administration

For corneal ulcers, instill two drops into the affected eye every 15 minutes for the first six hours, then every 30 minutes for the remainder of the first day; on day two instill two drops hourly, and on days three through fourteen instill two drops every four hours. For bacterial conjunctivitis, instill one or two drops every two hours while awake for two days, then one or two drops every four hours while awake for the next five days.

Warnings and Precautions

  • Not for injection into the eye
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with systemic quinolones; discontinue at the first sign of rash or allergic reaction
  • A white crystalline precipitate may form in patients with corneal ulcers; it does not preclude continued use and resolves over time
  • Remove contact lenses before use; do not wear during infection

Contraindications

Contraindicated in patients with a history of hypersensitivity to ciprofloxacin, any component of the product, or other quinolones.

Adverse Reactions

The most frequent adverse reaction is local burning or discomfort. Other reactions include white crystalline precipitate, lid margin crusting, foreign body sensation, itching, conjunctival hyperemia, and a bad taste following instillation.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Protect from light and keep tightly closed.

How Supplied

Supplied as a sterile ophthalmic solution in a plastic dropper bottle.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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