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ALBALON Label and ALBALON General Information

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albalon (naphazoline hydrochloride)  solution 
[Allergan Inc.]

Sterile

DESCRIPTION

Naphazoline hydrochloride, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as a white, odorless crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is represented by the structural formula:

Chemical Name:

2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride

Contains:

Active: naphazoline HCl 0.1%. Preservative: benzalkonium chloride 0.004%.
Inactives: citric acid, monohydrate; edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium citrate, dihydrate; and sodium hydroxide to adjust the pH. It has a shelf life pH range of 5.5 to 6.5.

CLINICAL PHARMACOLOGY

Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha-adrenergic receptors in the arterioles of the conjunctiva, resulting in decreased conjunctival congestion. Naphazoline belongs to the imidazoline class of sympathomimetics.

INDICATIONS AND USAGE

ALBALON® (naphazoline hydrochloride ophthalmic solution, USP) 0.1% is indicated for use as a topical ocular vasoconstrictor.

CONTRAINDICATIONS

ALBALON® ophthalmic solution is contraindicated in the presence of an anatomically narrow angle or in narrow-angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.

WARNINGS

Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

PRECAUTIONS

General:

Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or injury.

Patient Information:

Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.

To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.

Drug Interactions:

Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. (See WARNINGS.)

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been
conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established. See “ WARNINGS.” and “ CONTRAINDICATIONS.”

ADVERSE REACTIONS

Ocular: Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.

Systemic: Dizziness, headache, nausea, sweating , nervousness, drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.

DOSAGE AND ADMINISTRATION

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.

HOW SUPPLIED

ALBALON® (naphazoline hydrochloride ophthalmic solution, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

      15 mL in 15 mL bottle –NDC 11980-154-15

Note: Store between 15° to 25°C (59° to 77°F).

Rx Only

© 2003 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® Marks owned by Allergan, Inc.

4701X

71583US10M

ALBALON (naphazoline hydrochloride)

PRODUCT INFO Product Code 11980-154 Dosage Form SOLUTION Route Of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength naphazoline hydrochloride (naphazoline) Active 1 MILLIGRAM  In 1 MILLILITER citric acid, monohydrate Inactive   edetate disodium Inactive   polyvinyl alcohol Inactive   water Inactive   sodium chloride Inactive   sodium citrate, dihydrate Inactive   benzalkonium chloride Inactive   sodium hydroxide Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 11980-154-15 15 MILLILITER In 1 BOTTLE, PLASTIC None

Revised: 05/2006