Ciprofloxacin HCl Ophthalmic

Product Type: HUMAN PRESCRIPTION DRUG

Route: OPHTHALMIC

Dosage Form:

NDC: 59390-217

Application: ANDA204613

Effective: 20221028

INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution, USP 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group)* Conjunctivitis: Haemophilus influenza Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred. Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days. How Supplied: As a sterile ophthalmic solution the dispensing system consists of a natural low density polyethylene bottle with tip and a tan polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. Ciprofloxacin Ophthalmic Solution USP, 0.3% - each mL containing 3.5 mg ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin is available in: 2.5 mL fill in 7.5cc bottles ….. NDC #59390-217-02 5 mL fill in 7.5cc bottles ….. NDC #59390-217-05 10 mL fill in 15cc bottles ….. NDC #59390-217-10

CONTRAINDICATIONS A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

WARNINGS NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.

ADVERSE REACTIONS The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients [ see Precautions ] . Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision. TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .