Ciprofloxacin 0.3% 10mL

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Sandoz Inc.SKU: RX-1042

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Description

NDC: 61314-656-10

Ciprofloxacin HCl 0.3% Ophthalmic Solution, 10 mL — Sandoz

Active ingredient Ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin base per mL (0.3%)
Dosage form Ophthalmic solution
Route Topical ophthalmic
Size 10 mL
Manufacturer Sandoz
NDC 61314-656-10

Indications and Usage

Treatment of corneal ulcers and bacterial conjunctivitis caused by susceptible strains of designated microorganisms.

Dosage and Administration

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

Warnings and Precautions

  • Not for injection into the eye
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with quinolones, sometimes after the first dose
  • Remove contact lenses before use
  • Prolonged use may cause overgrowth of nonsusceptible organisms, including fungi; discontinue at first sign of skin rash or hypersensitivity

Contraindications

Contraindicated in patients with a history of hypersensitivity to ciprofloxacin or any component; a history of hypersensitivity to other quinolones may also preclude use.

Adverse Reactions

The most common adverse reaction is local burning or discomfort; in corneal ulcer studies a white crystalline precipitate occurred in about 17% of patients. Other reactions include lid margin crusting, foreign body sensation, itching, and conjunctival hyperemia.

Storage and Handling

Store at 2°C to 25°C (36°F to 77°F); protect from light.

How Supplied

Sterile solution in a plastic dropper dispensing system, supplied in a 10 mL size.

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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