Dipivefrine

Dipivefrine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Dipivefrine is a Ophthalmologic Agent that is FDA approved for the treatment of of intraocular pressure in chronic open-angle glaucoma. Common adverse reactions include Burning sensation in eye, injection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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.

Dosage

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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dipivefrine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dipivefrine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Dipivefrine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dipivefrine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dipivefrine in pediatric patients.

Contraindications

• Dipivefrin hydrochloride should not be used in patients with narrow angles since any dilation of the pupil may predispose the patient to an attack of angle-closure glaucoma. This product is contraindicated in patients who are hypersensitive to any of its components.

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dipivefrine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dipivefrine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dipivefrine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dipivefrine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dipivefrine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dipivefrine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dipivefrine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dipivefrine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dipivefrine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dipivefrine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dipivefrine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dipivefrine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dipivefrine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Dipivefrine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Dipivefrine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Dipivefrine in the drug label.

Pharmacology

There is limited information regarding Dipivefrine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dipivefrine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dipivefrine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dipivefrine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dipivefrine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dipivefrine in the drug label.

How Supplied

Storage

There is limited information regarding Dipivefrine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dipivefrine in the drug label.

Precautions with Alcohol

• Alcohol-Dipivefrine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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