Propine (Dipivefrin Hydrochloride Ophthalmic) - Indications and Dosage

INDICATIONS

PROPINE^® (dipivefrin HCI ophthalmic solution, USP) is indicated as initial therapy for the control of intraocular pressure in chronic open-angle glaucoma. Patients responding inadequately to other antiglaucoma therapy may respond to addition of PROPINE^®.

In controlled and open-label studies of glaucoma, PROPINE^® ophthalmic solution demonstrated a statistically significant intraocular pressure-lowering effect. Patients using PROPINE^® twice daily in studies with mean durations of 76-146 days experienced mean pressure reductions ranging from 20-24%.

Therapeutic response to PROPINE^® ophthalmic solution twice daily is somewhat less than 2% epinephrine twice daily. Controlled studies showed statistically significant differences in lowering of intraocular pressure between PROPINE^® and 2% epinephrine. In controlled studies in patients with a history of epinephrine intolerance, only 3% of patients treated with PROPINE^® ophthalmic solution exhibited intolerance, while 55% of those treated with epinephrine again developed intolerance.

Therapeutic response to PROPINE^® twice daily therapy is comparable to 2% pilocarpine 4 times daily. In controlled clinical studies comparing PROPINE^® ophthalmic solution and 2% pilocarpine, there were no statistically significant differences in the maintenance of IOP levels for the two medications. PROPINE^® does not produce miosis or accommodative spasm which cholinergic agents are known to produce. Night blindness often associated with miotic agents is not present with PROPINE^® therapy. Patients with cataracts avoid the inability to see around lenticular opacities caused by constricted pupil.

DOSAGE AND ADMINISTRATION

Initial Glaucoma Therapy. The usual dosage of PROPINE^® is one drop in the eye(s) every 12 hours.

Replacement with PROPINE ^® ophthalmic solution. When patients are being transferred to PROPINE^® from antiglaucoma agents other than epinephrine, on the first day continue the previous medication and add one drop of PROPINE^® ophthalmic solution in each eye every 12 hours. On the following day, discontinue the previously used antiglaucoma agent and continue with PROPINE^®.

In transferring patients from conventional epinephrine therapy to PROPINE^® ophthalmic solution, simply discontinue the epinephrine medication and institute the PROPINE^® regimen.

Addition of PROPINE ^® ophthalmic solution. When patients on other antiglaucoma agents require additional therapy, add one drop of PROPINE^® every 12 hours.

Concomitant Therapy. For difficult to control patients, the addition of PROPINE^® ophthalmic solution to other agents such as pilocarpine, carbachol, echothiophate iodide or acetazolamide has been shown to be effective.

Note: Not for injection.

HOW SUPPLIED

PROPINE^® (dipivefrin HCI ophthalmic solution, USP) 0.1%, is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with purple polystyrene caps as follows:

	10 mL in 10 mL bottle	- NDC 0023-9208-10
	15 mL in 15 mL bottle	- NDC 0023-9208-15

Note: Store in a tight, light-resistant container at 15° to 25°C (59° to 77°F).

Rx Only

Revised December 2005
© 2006 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
7592X
71738US11T