PROPINE SUMMARY
PROPINE®
(dipivefrin hydrochloride ophthalmic solution, USP) 0.1%
PROPINE® contains dipivefrin hydrochloride in a sterile, isotonic solution. Dipivefrin HCI is a white, crystalline powder, freely soluble in water with an osmolality of approximately 250 - 330 mOsmol/kg.
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.
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