: EPIFRIN® (epinephrine, USP) sterile ophthalmic solution is a topical sympathomimetic agent for ophthalmic use.

Chemical Name: 1,2-Benzenediol,4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-.

Contains:

Active: epinephrine, USP ..... 0.5%, 1%, 2%

Inactives: sodium metabisulfite; edetate disodium; hydrochloric acid; and purified water.

Clinical Pharmacology : Epinephrine is an adrenergic agonist that stimulates (alpha)- and (beta)-adrenergic receptors. The capacity of EPIFRIN® (epinephrine, USP) to decrease the aqueous inflow in open-angle glaucoma has been well documented. Studies have also shown that prolonged topical epinephrine therapy offers significant improvement in the coefficient of aqueous outflow.

EPIFRIN® is effective alone in reducing intraocular pressure and is particularly useful in combination with miotics or beta-adrenergic blocking agents for the difficult-to-control patients. The addition of EPIFRIN® to the patient' regimen often provides better control of intraocular pressure than the original agent alone.

and Usage : EPIFRIN® is indicated for the treatment of chronic simple glaucoma.

Contraindications : EPIFRIN® should not be used in patients who have had an attack of narrow-angle glaucoma, since dilation of the pupil may trigger an acute attack. Do not use if hypersensitive to any ingredient.

1. EPIFRIN® should be used with caution in patients with a narrow angle, since dilation of the pupil may trigger an acute attack of narrow-angle glaucoma.

2. Use with caution in patients with hypertensive cardiovascular disease or coronary artery disease.

3. Epinephrine has been reported to produce reversible macular edema in some aphakic patients and should be used with caution in these patients.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions :

General: Epinephrine in any form is relatively uncomfortable upon instillation. However, discomfort lessens as the concentration of epinephrine decreases. EPIFRIN® is not for injection.

Carcinogenesis, mutagenesis and impairment of fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Pregnancy Category C: Animal reproduction studies have not been conducted with epinephrine. It is also not known whether epinephrine can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions : Undesirable reactions to topical epinephrine include eye pain or ache, browache, headache, conjunctival hyperemia and allergic lid reactions.

Adrenochrome deposits in the conjunctiva and cornea after prolonged epinephrine therapy have been reported. Topical epinephrine has been reported to produce reversible macular edema in some aphakic patients.

Overdosage : Accidental ingestion will not cause problems because pharmacologically active concentrations of epinephrine cannot be achieved orally in man. Should accidental overdosage in the eye(s) occur, flush eye(s) with water or normal saline.

Dosage and Administration : The usual dosage is 1 drop in the affected eye(s) once or twice daily. However, the dosage should be adjusted to meet the needs of the individual patients. This is made easier with EPIFRIN® (epinephrine, USP) sterile ophthalmic solution available in three strengths.

How Supplied : EPIFRIN® is available on prescription only in plastic dropper bottles in the following concentrations and sizes:

0.5% 15 mL--NDC 11980-119-15

1% 15 mL--NDC 11980-122-15

2% 15 mL--NDC 11980-058-15

Note: Protect from light and excessive heat. If the solution discolors or a precipitate forms, it should be discarded.