CIPROFLOXACIN OPHTHALMIC SOLUTION, USP, 0.3% AS BASE

DESCRIPTION

id: 4f9013c6-0ded-4297-98b2-dc2536417cb3
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•HCI•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 Hydrochloride 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: 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

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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: e720041c-84a1-4157-9ba1-da296d0e3191
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: c21079b3-7866-4933-bae5-239f820e967e
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: 6df2aa6d-f625-4be6-bf8f-a599a5999a43
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

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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

A topical overdose of ciprofloxacin ophthalmic solution may be flushed from the eye(s) with warm tap water.

HOW SUPPLIED

id: 7b090fbc-ba29-4e8f-a8c6-60fb1a560f93
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

As a sterile ophthalmic solution in natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Do not use if tamper evident seal is not intact or missing. 2.5 mL in 7.5mL bottle – NDC 40042-015-52
5 mL in 7.5mL bottle – NDC 40042-015-05
10 mL in 10mL bottle – NDC 40042-015-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 2.5 mL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

CONTAINER NDC-40042-015-52

Sterile

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

2.5 mL

Rx Only
FOR TOPICAL USE ONLY.

INGREDIENTS:  Each mL contains: Active: ciprofloxacin hydrochloride 3.5 mg
equivalent to 3 mg base.  Preservative: benzalkonium chloride 0.006%.
Inactives: sodium acetate, acetic acid, mannitol, edetate disodium,
hydrochloric acid and/or sodium hydroxide (to adjust pH) and
water for injection.  USUAL DOSAGE: Read enclosed insert.
STORAGE:  Store at 2° to 25°C (36° to 77°F). Protect from light.
Retain in carton until contens are used.

Manufactured by:
PharmaForce, Inc.
Columbus, OH  43229

Manufactured by:
PhamaForce, Inc.
Hilliard, OH  43026

RN1023-00
Rev. 10/08 CARTON NDC 40042-015-52

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

STERILE

FOR TOPICAL OPHTHALMIC USE ONLY

2.5 mL

PharmaForce

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 5 mL

id: a2645456-b6e9-4ec3-9409-16968c598264
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

CONTAINER NDC-40042-015-05

Sterile

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

5 mL

Rx Only
FOR TOPICAL USE ONLY.

INGREDIENTS:  Each mL contains: Active: ciprofloxacin hydrochloride 3.5 mg
equivalent to 3 mg base.  Preservative: benzalkonium chloride 0.006%.
Inactives: sodium acetate, acetic acid, mannitol, edetate disodium,
hydrochloric acid and/or sodium hydroxide (to adjust pH) and
water for injection.  USUAL DOSAGE: Read enclosed insert.
STORAGE:  Store at 2° to 25°C (36° to 77°F). Protect from light.
Retain in carton until contens are used.

Manufactured by:
PharmaForce, Inc.
Columbus, OH  43229

Manufactured by:
PhamaForce, Inc.
Hilliard, OH  43026

RN1024-00
Rev. 10/08

CARTON

NDC 40042-015-05

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

STERILE

FOR TOPICAL OPHTHALMIC USE ONLY

5 mL

PharmaForce

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 10 mL

id: 3ba8e0d2-1104-4454-b485-9c4567c19e02
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

CONTAINER NDC-40042-015-10

Sterile

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

10 mL

Rx Only
FOR TOPICAL USE ONLY.

INGREDIENTS:  Each mL contains: Active: ciprofloxacin hydrochloride 3.5 mg
equivalent to 3 mg base.  Preservative: benzalkonium chloride 0.006%.
Inactives: sodium acetate, acetic acid, mannitol, edetate disodium,
hydrochloric acid and/or sodium hydroxide (to adjust pH) and
water for injection.  USUAL DOSAGE: Read enclosed insert.
STORAGE:  Store at 2° to 25°C (36° to 77°F). Protect from light.
Retain in carton until contens are used.

Manufactured by:
PharmaForce, Inc.
Columbus, OH  43229

Manufactured by:
PhamaForce, Inc.
Hilliard, OH  43026

RN1025-00
Rev. 10/08

CARTON

NDC 40042-015-10

CIPROFLOXACIN
Ophthalmic
Solution, USP

0.3% as base

STERILE

FOR TOPICAL OPHTHALMIC USE ONLY

10 mL

PharmaForce