Naphazoline

Generic Name: Naphazoline hydrochloride
Dosage Form: ophthalmic solution

Naphazoline Hydrochloride
Ophthalmic Solution USP, 0.1%

Rx only

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:

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Chemical Name:

2-(1-naphthylmethyl)-2-imidazole monohydrochloride

Each mL contains:

Active: Naphazoline Hydrochloride 1 mg (0.1%).

Inactives: Boric Acid, Edetate Disodium, Sodium Carbonate, Sodium Chloride and Hydrochloric Acid may be added to adjust pH (5.5 to 7.0), and Purified Water USP.

Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Naphazoline Hydrochloride Ophthalmic Solution, USP, 0.1% is a sterile solution with a pH between 5.5 and 7.0.

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.

INDICATIONS AND USAGE:

Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as a topical ocular vasoconstrictor.

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.

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

Patient Information: Patients should be advised to discontinue the drug and consult the 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 any surface, 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 also 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 harm when administered to a pregnant women or can affect reproduction capacity. Naphazoline should be given to a pregnant women 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 women.

Pediatric Use: Safety and effectiveness in the pediatric population 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:

Naphazoline Hydrochloride Ophthalmic Solution, USP, is supplied as a sterile 0.1% solution in 15 mL plastic dropper bottles. NDC 17478-216-12

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Keep container tightly closed.

Akorn

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

GNH00N Rev. 12/11

Principal Display Panel Text for Container Label:

NDC 17478-216-12

Naphazoline

Hydrochloride

Ophthalmic

Solution, USP

0.1%

15 mL

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Carton Label:

NDC 17478-216-12

Naphazoline

Hydrochloride

Ophthalmic

Solution, USP

0.1%

15 mL

Sterile

Rx only Akorn Logo

Naphazoline 
Naphazoline hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-216
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid  
Edetate Disodium  
Sodium Carbonate  
Sodium Chloride  
Hydrochloric Acid  
Water  
Benzalkonium Chloride  
Packaging
# Item Code Package Description
1 NDC:17478-216-12 1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083590 12/19/1995
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 063434679 LABEL(17478-216), PACK(17478-216)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 155135783 MANUFACTURE(17478-216), ANALYSIS(17478-216), STERILIZE(17478-216)
Revised: 03/2012
 
Akorn, Inc.



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