Version May 2024
Ocular pain/photophobia: Ophthalmic:
US labeling: Corneal refractive surgery: Instill 1 to 2 drops into operative 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 (Voltaren Ophtha): Nonchronic posttraumatic ocular inflammation (nonpenetrating wounds): Obtain wound culture prior to initiation, then instill 1 drop 4 to 5 times/day, based on disease severity.
Postoperative ocular inflammation: Cataract surgery: Ophthalmic:
US labeling: Instill 1 drop into affected eye 4 times/day beginning 24 hours after cataract surgery and continuing for 2 weeks.
Canadian labeling (Voltaren Ophtha): 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.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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
Hypersensitivity to diclofenac or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity (eg, asthma, urticaria, 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).
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.
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)
Yes
Solution (Diclofenac Sodium Ophthalmic)
0.1% (per mL): $3.50 - $14.61
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic, as sodium:
Voltaren Ophtha: 0.1% (0.3 mL, 2.5 mL, 5 mL, 10 mL) [contains edetate (edta) disodium, polyoxyl/peg-35 castor oil(cremophor el)]
Generic: 0.1% (2.5 mL, 5 mL, 10 mL)
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.
Ocular pain/photophobia:
US labeling: Temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
Canadian labeling: Treatment of nonchronic posttraumatic inflammation in nonpenetrating wounds.
Postoperative ocular inflammation: Treatment of postoperative inflammation following cataract extraction.
Diclofenac may be confused with Diflucan
Diclofenac may be confused with Duphalac brand name for lactulose [multiple international markets]
Flexin: Brand name for diclofenac [Argentina], but also the brand name for cyclobenzaprine [Chile] and orphenadrine [Israel]
Flexin [Argentina] may be confused with Floxin brand name for flunarizine [Thailand], norfloxacin [South Africa], ofloxacin [US, Canada], and pefloxacin [Philippines]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
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. Risk C: 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). Risk C: Monitor therapy
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.
It is not known if diclofenac is present in breast milk following ophthalmic use. The amount of diclofenac available systemically following application of the ophthalmic drops is estimated to be below quantifiable limits.
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
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