July 31, 2015
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Propine

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Propine




Indications
Dosage
How Supplied

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® (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.

Concomitant Therapy

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.

HOW SUPPLIED

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: 4/12/2002

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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