DOSAGE & ADMINISTRATION SECTION.


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

DRUG INTERACTIONS SECTION.


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 severe hypertensive crisis if given sympathomimetic drug. (See WARNINGS.).

GENERAL PRECAUTIONS SECTION.


General:. For topical ophthalmic use only. Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or injury.

ADVERSE REACTIONS SECTION.


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.

HOW SUPPLIED SECTION.


HOW SUPPLIED. Naphazoline Hydrochloride Ophthalmic Solution, USP) is supplied as sterile 0.1% solution in 15 mL plastic dropper bottles. NDC 17478-216-12Storage: Store at 20 to 25C (68 to 77F). Keep container tightly closed.Rx OnlyManufactured by: Akorn Inc.Lake Forest, IL 60045Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as topical ocular vasoconstrictor.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation 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.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. 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.

DESCRIPTION SECTION.


DESCRIPTION. Naphazoline hydrochloride, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as white, odorless crystalline powder having 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 mg (0.1%). Preservative: benzalkonium chloride 0.1mg (0.01%). Inactives: Boric acid; edetate disodium; purified water; sodium chloride; sodium carbonate; and hydrochloric acid may be added to adjust the pH (5.5 to 7.0).. Chemical Structure.

INFORMATION FOR PATIENTS SECTION.


Patient Information:. Patients should be advised to discontinue the drug and consult 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.

NURSING MOTHERS SECTION.


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 nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel. AK-Con 0.1%.

PEDIATRIC USE SECTION.


Pediatric Use:. Safety and effectiveness in pediatric patients have not been established. See WARNINGS. and CONTRAINDICATIONS..

PRECAUTIONS SECTION.


PRECAUTIONS. General:. For topical ophthalmic use only. 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 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 severe hypertensive crisis if given 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 pregnant woman or can affect reproduction capacity. Naphazoline should be given to 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 nursing woman.. Pediatric Use:. Safety and effectiveness in pediatric patients have not been established. See WARNINGS. and CONTRAINDICATIONS..

PREGNULLNCY SECTION.


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 pregnant woman or can affect reproduction capacity. Naphazoline should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.


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