Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic, as sodium:
Generic: 0.1% (2.5 mL, 5 mL)
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Absorption
Negligible
Use: Labeled Indications
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
Voltaren Ophtha [Canadian product]:
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).
Dosage and Administration
Dosing: Adult
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.
Voltaren Ophtha [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.
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): Nonsteroidal Anti-Inflammatory Agents (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
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). 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%, postmarketing, and/or case reports: 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.
- 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
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies. The amount of diclofenac available systemically following application of the ophthalmic drops is estimated to be below quantifiable limits. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988). 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
What is this drug used for?
- It is used to treat swelling and pain after cataract surgery.
- It is used to treat pain and sun sensitivity in patients who have had cornea surgery.
Frequently reported side effects of this drug
- Burning
- Stinging
- Change in tears
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Eye discharge
- Bleeding in eye
- Eye or eyelid swelling
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
