DESCRIPTION
id: f320953e-937a-4f17-9e51-9edbe366f9b9
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: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.
INDICATIONS AND USAGE
id: 8db9f136-efdd-44fa-b1e2-2f121de30528
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: cd7bfa10-8edd-4510-9bf3-ddd3429d35e2
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: 62cb49e3-aff5-4175-b2d4-bbd7c8098b20
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: 5863c8dd-9c9d-4f88-b791-a68f45af3ce0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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: 9694c7eb-286d-4951-a4c8-58c64f577285
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: 302c8a94-1247-4216-9558-7ad25145155e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
As a sterile ophthalmic solution: 5 mL and 10 mL mLin translucent LDPE plastic ophthalmic dispensers with a tan polystyrene cap
5 mL – NDC 16571-135-50
10 mL – NDC 16571-135-10
STORAGE
id: 03b7e36d-4adc-4c12-8650-25acb092768f
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Retain in carton until contents are used and protect from light.
ANIMAL PHARMACOLOGY
id: fbd95ad7-f27b-49ea-a77a-4dfc47dc2286
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
Distributed by:
PACK Pharmaceuticals, LLC
1110 W.Lake Cook Rd., Ste 152 Buffalo Grove,
IL60089
Manufactured by
FDC Limited
B-8, M.I.D.C. Waluj, Dist. Aurangabad 431 136
Maharashtra State, India
Revision 07/10
5 mL Carton Label
id: 3b6862a3-a66f-4918-86bc-05e4321d4577
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 16571-135-50
PACK PHARMACEUTICALS, LLC
Ciprofloxacin
Ophthalmic Solution USP
0.3% as base
Rx Only
Sterile 5 mL
