DESCRIPTION
id: 1f7efdaf-6f41-4ef7-8cf8-59105abff755
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:
Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position.
Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: acetic acid, edetate disodium 0.05%, mannitol 4.6%, purified water, sodium acetate, hydrochloric acid and/or sodium hydroxide may be used to adjust pH. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.
INDICATIONS AND USAGE
id: 57263f67-e8c8-4d73-9484-0fe5e516e6fb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
CONTRAINDICATIONS
id: dc02cb0f-9870-4efb-b863-0a186935a4c8
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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
id: 237fb15c-622b-452b-b6eb-2d69f5dfee49
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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
id: c5b1dff8-eb58-421a-af25-976586bf9da1
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
OVERDOSAGE
id: 2ff88400-2266-4e81-b3ba-cf5d1c96ce64
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
A topical overdose of Ciprofloxacin Ophthalmic Solution may be flushed from the eye(s) with warm tap water.
HOW SUPPLIED
id: b5ab5479-15f6-4db9-861f-d3ac774caf63
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
As a sterile ophthalmic solution: 5 mL in plastic controlled drop-tip dispensers.
5 mL – 68788-9944-5
STORAGE
id: 20df2f53-0790-4699-ae9a-1e17fafe7af4
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from light.
ANIMAL PHARMACOLOGY
id: 171034f8-c45e-4dbc-82fc-0e109a3b422e
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one-month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions.
Rx Only
Manufactured by:
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 282:02 1/09 MG #18143
Relabeled by Preferred Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL
id: e8ff94ff-aa40-4c74-a11d-d9bac4ee24d1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Ciprofloxacin Ophthalmic Solution
(0.3 % as base)
Sterile
10 mL
Rx only
