Vasocon

CIBA Vision

Vasocon

FULL PRESCRIBING INFORMATION

VASOCON REGULAR

NAPHAZOLINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1%

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

Chemical Name:

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

VASOCON 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.

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 REGULAR is indicated for use as a topical ocular vasoconstrictor.

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.

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.

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

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.

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).

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.

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.

Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.

Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.

Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.

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

VASOCON 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