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Diclofenac (Ophthalmic)

Pronunciation

Pronunciation

(dye KLOE fen ak)

Index Terms

  • Diclofenac Sodium

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic, as sodium:

Voltaren: 0.1% (5 mL [DSC]) [contains cremophor el, edetate disodium]

Generic: 0.1% (2.5 mL, 5 mL)

Brand Names: U.S.

  • Voltaren [DSC]

Pharmacologic Category

  • Nonsteroidal Anti-inflammatory Drug (NSAID)
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic

Pharmacology

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties.

Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Absorption

Negligible

Use: Labeled Indications

US labeling:

Ocular pain/photophobia: Temporary relief of pain and photophobia in patients undergoing corneal refractive surgery

Postoperative ocular inflammation: Treatment of postoperative inflammation following cataract extraction

Canadian labeling:

Ocular pain/photophobia: Treatment of nonchronic posttraumatic inflammation in nonpenetrating wounds

Postoperative ocular inflammation: Treatment of postoperative inflammation following cataract surgery

Contraindications

Hypersensitivity to diclofenac or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity (eg, asthma, urticarial, acute rhinitis, other allergic manifestations) to acetylsalicylic acid or other drugs with prostaglandin synthesis inhibiting activity. There is a potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents (NSAIDS).

Dosing: Adult

US labeling:

Postoperative ocular inflammation: Cataract surgery: Ophthalmic: Instill 1 drop into affected eye 4 times/day beginning 24 hours after cataract surgery and continuing for 2 weeks.

Ocular pain/photophobia: Corneal refractive surgery: Ophthalmic: Instill 1 to 2 drops into affected eye within the hour prior to surgery, within 15 minutes following surgery, and then continue for 4 times/day, up to 3 days.

Canadian labeling:

Postoperative ocular inflammation: Cataract surgery: Instill 1 drop into affected eye up to 5 times during the 3 hours preceding surgery, at 15, 30, and 45 minutes following surgery, then 1 drop 3 to 5 times/day for up to 4 weeks.

Nonchronic post-traumatic ocular inflammation (nonpenetrating wounds): Note: Obtain wound culture prior to initiation then instill 1 drop 4 to 5 times/day, based on disease severity.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

For ophthalmic use only; avoid contact of bottle tip with skin or eye. Instill drops into conjunctival sac; nasolacrimal occlusion or closing the eye for 2 minutes after administration may limit systemic absorption and increase local activity. In postoperative patients, separate bottles should be used for each eye if both eyes require treatment. Soft contact lenses should be removed prior to administration and should not be reinserted for at least 15 minutes afterwards. Wait at least 5 minutes before administering other types of eye drops.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Drug Interactions

Corticosteroids (Ophthalmic): NSAID (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Exceptions: Loteprednol. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Transient burning or stinging in the eyes (15%)

Ophthalmic: Lacrimation (incisional refractive surgery: 30%), keratitis (cataract patients: 28%; includes patients with keratitis prior to surgery), increased intraocular pressure (cataract patients: 15%)

1% to 10%:

Cardiovascular: Facial edema (≤3%)

Central nervous system: Chills (≤3%), dizziness (≤3%), headache (≤3%), insomnia (≤3%), pain (≤3%)

Dermatologic: Pruritus (≤10%)

Gastrointestinal: Abdominal pain (≤3%), nausea (≤3%), vomiting (≤3%)

Infection: Viral infection (≤3%)

Neuromuscular & skeletal: Weakness (≤3%)

Ophthalmic: Abnormal lacrimation (≤10%), blurred vision (≤10%), conjunctivitis (≤10%), corneal deposits (≤10%), corneal edema (≤10%), corneal lesions (≤10%), corneal opacity (≤10%), eye discharge (≤10%), eye irritation (≤10%), eyelid edema (≤10%), eye pain (≤10%), eye redness (≤10%), iritis (≤10%), ocular allergy (≤10%), transient postoperative increased intraocular pressure (≤10%), visual disturbance (≤10%)

Respiratory: Rhinitis (≤3%)

Miscellaneous: Fever (≤3%)

<1% (Limited to important or life-threatening): Allergic conjunctivitis, asthma, conjunctival hyperemia, corneal disease, corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulcer, cough, dyspnea, eczema, erythema, hypersensitivity reaction, ocular hyperemia, skin rash, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy. The Canadian labeling contraindicates use in these patient populations.

• Bleeding and/or healing delay: May slow/delay healing or prolong bleeding time following surgery. Use caution in patients at risk of bleeding or taking concomitant medication that may increase risk of bleeding and in patients receiving concomitant topical steroid therapy due to risks for impaired/delayed healing and corneal complications.

• Keratitis: Use of topical ophthalmic NSAIDs may be associated with keratitis. Continued use may be associated with sight-threatening complications, including corneal perforation. Discontinue use of topical NSAIDs in any patient with evidence of corneal epithelial breakdown.

Disease-related concerns:

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision. Onset or progression of ocular infections may be masked during therapy; monitor for development of infection and if necessary, initiate concurrent antimicrobial therapy.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Post-surgical patients: To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Other warning/precautions:

• Follow up/monitoring: Monitor patients for 1 year following application of ophthalmic drops for corneal refractive procedures. Patients using diclofenac ophthalmic drops should not wear soft contact lenses.

• Prolonged use: Use of topical ophthalmic NSAIDs for more than 24 hours prior to surgery and greater than 14 days after ocular surgery has been associated with an increased risk of more frequent and severe corneal adverse events.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have not been observed in animal studies; therefore, the manufacturer classifies diclofenac ophthalmic as pregnancy category C. When administered orally, diclofenac crosses the placenta. Refer to the Diclofenac (Systemic) monograph for details. The amount of diclofenac available systemically following topical application of the ophthalmic drops is significantly less in comparison to oral doses; however, because it may cause prenatal constriction of the ductus arteriosus, the manufacturer recommends that the use of diclofenac ophthalmic drops late in pregnancy be avoided.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, stinging, or change in tears. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, eye discharge, bleeding in eye, or edema of eye or eyelid (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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