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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® (dipivefrin) .
In controlled and open-label studies of glaucoma, PROPINE® (dipivefrin) ophthalmic solution demonstrated a statistically significant intraocular pressure-lowering effect. Patients using PROPINE® (dipivefrin) twice daily in studies with mean durations of 76-146 days experienced mean pressure reductions ranging from 20-24%.
Therapeutic response to PROPINE® (dipivefrin) 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® (dipivefrin) and 2% epinephrine. In controlled studies in patients with a history of epinephrine intolerance, only 3% of patients treated with PROPINE® (dipivefrin) ophthalmic solution exhibited intolerance, while 55% of those treated with epinephrine again developed intolerance.
Therapeutic response to PROPINE® (dipivefrin) twice daily therapy is comparable to 2% pilocarpine 4 times daily. In controlled clinical studies comparing PROPINE® (dipivefrin) ophthalmic solution and 2% pilocarpine, there were no statistically significant differences in the maintenance of IOP levels for the two medications. PROPINE® (dipivefrin) 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® (dipivefrin) 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® (dipivefrin) is one drop in the eye(s) every 12 hours.
Replacement with PROPINE® (dipivefrin) ophthalmic solution
When patients are being transferred to PROPINE® (dipivefrin) from antiglaucoma agents other than epinephrine, on the first day continue the previous medication and add one drop of PROPINE® (dipivefrin) ophthalmic solution in each eye every 12 hours. On the following day, discontinue the previously used antiglaucoma agent and continue with PROPINE® (dipivefrin) .
In transferring patients from conventional epinephrine therapy to PROPINE® (dipivefrin) ophthalmic solution, simply discontinue the epinephrine medication and institute the PROPINE® (dipivefrin) regimen.
Addition of PROPINE® (dipivefrin) ophthalmic solution
When patients on other antiglaucoma agents require additional therapy, add one drop of PROPINE® (dipivefrin) every 12 hours.
For difficult to control patients, the addition of PROPINE® (dipivefrin) ophthalmic solution to other agents such as pilocarpine, carbachol, echothiophate iodide or acetazolamide has been shown to be effective.
Note: Not for injection.
PROPINE® (dipivefrin HCI ophthalmic solution, USP) 0.1%, is supplied sterile in plastic dropper bottles as follows: 5 mL - 0023-9208-05; 10 mL - 0023-9208-10; 15 mL - 0023-9208-15.
Note: Store in tight, light-resistant containers.
Allergan, Inc. Irvine, CA 92612, U.S.A. Revised December 2000. FDA Rev date: 4/12/2002This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/9/2008
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