Vasocon

VASOCON- naphazoline hydrochloride solution
CIBA Vision

VA SO CON REGULAR

NAPHAZOLINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1%

DESCRIPTION

Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:

Image from Drug Label Content
(click image for full-size original)

Chemical Name:

2-(1-naphthylmethyl)-2-imidazoline monohydrochloride

VA SOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL naphazoline hydrochloride in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.

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. Naphalozine belongs to the imidazoline class of sympathomimetics.

Vasocon Indications and Usage

VA SOCON REGULAR 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

Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.

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 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

If 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 children 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

VA SOCON REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).

CAUTION: Federal law prohibits dispensing without prescription.

Mfd. by OMJ Pharmaceuticals, Inc.,

San Germán, P.R., 00683 for:

CIBA Vision

Ophthalmics®

___________________

Atlanta, Georgia 30155

6072-A

VASOCON
naphazoline hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58768-844
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naphazoline hydrochloride (naphazoline) naphazoline 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride
edetate disodium
hydrochloric acid
polyethylene glycol 8000
polyvinyl alcohol
water
sodium chloride
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58768-844-15 15 mL (15 MILLILITER) in 1 BOTTLE, DROPPER None
Labeler — CIBA Vision

Revised: 08/2006 CIBA Vision

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.