Naphazoline

Naphazoline
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Naphazoline is a Alpha-Adrenergic Agonist that is FDA approved for the treatment of as a topical ocular vasoconstrictor. Common adverse reactions include Mydriasis, increased redness, increased intraocular pressure, irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

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

Dosage

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naphazoline in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naphazoline in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Naphazoline in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naphazoline in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naphazoline in pediatric patients.

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

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

Adverse Reactions

Clinical Trials Experience

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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Naphazoline in the drug label.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Naphazoline in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Naphazoline during labor and delivery.

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

Geriatic Use

There is no FDA guidance on the use of Naphazoline with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Naphazoline with respect to specific gender populations.

Race

There is no FDA guidance on the use of Naphazoline with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Naphazoline in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Naphazoline in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Naphazoline in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Naphazoline in patients who are immunocompromised.

Administration and Monitoring

Administration

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

Monitoring

There is limited information regarding Monitoring of Naphazoline in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Naphazoline in the drug label.

Overdosage

There is limited information regarding Overdose of Naphazoline in the drug label.

Pharmacology

Mechanism of Action

• 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.

Structure

• 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:

This image is provided by the National Library of Medicine.

• 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.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Naphazoline in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Naphazoline in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Naphazoline in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Naphazoline in the drug label.

How Supplied

• Naphazoline Hydrochloride Ophthalmic Solution, USP, is supplied as a sterile 0.1% solution in 15 mL plastic dropper bottles.

15mL dropper bottle - 68788-0446-1

Storage

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

Keep container tightly closed.

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Naphazoline Hydrochloride Ophthalmic Solution, USP 0.1%

15 mL

Sterile

Rx only

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling 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.

Precautions with Alcohol

• Alcohol-Naphazoline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• AK-Con®

Look-Alike Drug Names

There is limited information regarding Naphazoline Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.