Diclofenac (ophthalmic)

Diclofenac (ophthalmic)
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];

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Diclofenac (ophthalmic) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diclofenac (ophthalmic) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diclofenac (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Diclofenac (ophthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diclofenac (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diclofenac (ophthalmic) in pediatric patients.

Contraindications

Diclofenac Sodium Ophthalmic Solution, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.

Warnings

With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Precations

General

It is recommended that Diclofenac Sodium Ophthalmic Solution, 0.1%, like other NSAIDs, be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications that may prolong bleeding time.

Diclofenac Sodium Ophthalmic Solution, 0.1% may slow or delay healing.

Results from clinical studies indicate that Diclofenac Sodium Ophthalmic Solution, 0.1% has no significant effect upon intraocular pressure, however, elevations in intraocular pressure may occur following cataract surgery.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Diclofenac (ophthalmic) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Diclofenac (ophthalmic) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Diclofenac (ophthalmic) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Diclofenac (ophthalmic) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diclofenac (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Diclofenac (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Diclofenac (ophthalmic) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Diclofenac (ophthalmic) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Diclofenac (ophthalmic) in geriatric settings.

Gender

There is no FDA guidance on the use of Diclofenac (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Diclofenac (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Diclofenac (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Diclofenac (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Diclofenac (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Diclofenac (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Diclofenac (ophthalmic) Administration in the drug label.

Monitoring

There is limited information regarding Diclofenac (ophthalmic) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Diclofenac (ophthalmic) and IV administrations.

Overdosage

There is limited information regarding Diclofenac (ophthalmic) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Diclofenac (ophthalmic) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Diclofenac (ophthalmic) Mechanism of Action in the drug label.

Structure

There is limited information regarding Diclofenac (ophthalmic) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Diclofenac (ophthalmic) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Diclofenac (ophthalmic) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Diclofenac (ophthalmic) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Diclofenac (ophthalmic) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Diclofenac (ophthalmic) How Supplied in the drug label.

Storage

There is limited information regarding Diclofenac (ophthalmic) 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 Diclofenac (ophthalmic) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Diclofenac (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Diclofenac (ophthalmic) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Diclofenac (ophthalmic) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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