Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%

NAPHAZOLINE HYDROCHLORIDE - naphazoline hydrochloride solution/ drops 
Bausch & Lomb Incorporated

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Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%

STERILE OPHTHALMIC SOLUTION

 

Rx only

FOR OPHTHALMIC USE ONLY.

 

DESCRIPTION:

Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%, a sterile solution, is an ocular vasoconstrictor and 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 following structural formula:

Naphazoline Hydrochloride (structural formula)

C14H14N2·HCl

Mol. Wt 246.74

Chemical Name:
2-(1-naphthylmethyl)-2-imidazoline monohydrochloride

Each mL Contains: ACTIVE: Naphazoline Hydrochloride, 1 mg (0.1%); INACTIVES: Boric Acid, Sodium Chloride, Edetate Disodium, Sodium Carbonate, Purified Water. Sodium Carbonate and/or Hydrochloric Acid may be added to adjust pH (5.5 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

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:

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:

NOT FOR INJECTION INTO THE EYE - FOR TOPICAL USE ONLY.

Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in pediatric patients, 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.

Information for Patients:

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:

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 effect 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 into the conjunctival sac(s) every three to four hours as needed.

HOW SUPPLIED:

Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%, is available in a plastic squeeze bottle with controlled drop tip in the following size:

15 mL bottle - Prod. No. 04611

Storage:

Store between 15°- 30°C (59°-86°F).

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

MANUFACTURING INFORMATION:

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

XO50131 (Folded)

XM10028 (Flat)

REV.12/03-62

Package/Label Principal Display Panel

NDC 24208-725-06  Bausch & Lomb  Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%  [icon- eye]  STERILE  Rx only  15 mL

NDC 24208-725-06 Bausch & Lomb Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1% [icon- eye] STERILE Rx only 15 mL


NAPHAZOLINE HYDROCHLORIDE 
naphazoline hydrochloride   solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)24208-725
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
HYDROCHLORIC ACID 
WATER 
SODIUM CARBONATE 
SODIUM CHLORIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
124208-725-061 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
115 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (24208-725-06)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04007305/25/199406/01/2006

Labeler - Bausch & Lomb Incorporated (807927397)
Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated807927397ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE
Revised: 06/2010Bausch & Lomb Incorporated