Dipivefrin Hydrochloride label

Dipivefrin Hydrochloride

Dipivefrin Hydrochloride Recall

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Side Effects & Adverse Reactions

NOT FOR INJECTION – FOR OPHTHALMIC USE ONLY.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Dipivefrin hydrochloride ophthalmic solution 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 dipivefrin.

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

Therapeutic response to 0.1% dipivefrin twice daily is somewhat less than 2% epinephrine twice daily. Controlled studies showed statistically significant differences in lowering of intraocular pressure between 0.1% dipivefrin and 2% epinephrine. In controlled studies in patients with a history of epinephrine intolerance, only 3% of patients treated with dipivefrin exhibited intolerance, while 55% of those treated with epinephrine again developed intolerance.

Therapeutic response to 0.1% dipivefrin twice daily is comparable to 2% pilocarpine 4 times daily. In controlled clinical studies comparing 0.1% dipivefrin and 2% pilocarpine, there were no statistically significant differences in the maintenance of IOP levels for the two medications.

Dipivefrin does not produce miosis or accommodative spasm which cholinergic agents are known to produce. The blurred vision and night blindness often associated with miotic agents are not present with dipivefrin therapy. Patients with cataracts avoid the inability to see around lenticular opacities caused by constricted pupil.

History

There is currently no drug history available for this drug.

Other Information

Dipivefrin Hydrochloride Ophthalmic Solution USP, 0.1% is a sterile, isotonic solution. Dipivefrin hydrochloride is a white, crystalline powder, freely soluble in water. It is classified as a sympathomimetic agent and has the following structural formula:

Image from Drug Label Content

Chemical Name: (±) -3, 4-Dihydroxy-a- [(methylamino) methyl] benzyl alcohol 3, 4-dipivalate hydrochloride.

Contains: Active: Dipivefrin hydrochloride, 0.1% (1 mg/mL). Preservative: Benzalkonium chloride 0.005%. Inactive Ingredients: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH to 2.5 to 3.5), Purified Water. DM-00

Dipivefrin Hydrochloride Manufacturers

  • Falcon Pharmaceuticals, Ltd
    Dipivefrin Hydrochloride | Falcon Pharmaceuticals, Ltd
    No Recall

    Dipivefrin Hydrochloride | Falcon Pharmaceuticals, Ltd

    Dipivefrin Hydrochloride | Falcon Pharmaceuticals, Ltd

    Initial Glaucoma Therapy. The usual dosage of dipivefrin hydrochloride ophthalmic solution, 0.1%, is one drop in the eye(s) every 12 hours.

    Replacement With Dipivefrin Hydrochloride Ophthalmic Solution: When patients are being transferred to dipivefrin from antiglaucoma agents other than epinephrine, on the first day continue the previous medication and add one drop of dipivefrin to each eye(s) every 12 hours. On the following day, discontinue the previously used antiglaucoma agent and continue with dipivefrin.

    In transferring patients from conventional epinephrine therapy to dipivefrin, simply discontinue the epinephrine medication and institute the dipivefrin regimen.

    Addition of Dipivefrin Hydrochloride Ophthalmic Solution: When patients on other antiglaucoma agents require additional therapy, add one drop of dipivefrin every 12 hours.

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

    Note: Not for injection.