Sofenac Eye Drop

Sofenac Eye Drop:

Sofenac Eye Drops is a sterile ophthalmic solution available in a 5 ml bottle. Each ml of the solution contains Diclofenac Sodium IP 1 mg (0.1% w/v) as the active ingredient, along with Sarcosine 0.2% w/v as a preservative and sterile aqueous base q.s. The product is strictly for external ophthalmic use only and must not be injected or ingested. It is a topical non-steroidal anti-inflammatory drug (NSAID) used primarily for the management of post-operative eye pain and inflammation. The product is packaged in a white rectangular box with a vertical orange stripe on the right side, featuring the brand name “SOFENAC” displayed prominently in large bold orange letters, with the text “Diclofenac Sodium Ophthalmic Solution” and “5 ml” printed in black sans-serif font.

Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID) belonging to the phenylacetic acid derivative class. Its mechanism of action is based on its ability to inhibit both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are natural chemicals in the body that mediate inflammation, pain, and swelling. By blocking their production, diclofenac effectively reduces intraocular inflammation, pain, and redness following eye surgery or other ocular conditions. The drug also inhibits the release of other inflammatory mediators and suppresses the migration of inflammatory cells to the site of injury. In the ophthalmic formulation, diclofenac achieves therapeutic concentrations in the aqueous humor (the fluid inside the eye), providing sustained anti-inflammatory and analgesic effects. Unlike systemic NSAIDs, the topical ophthalmic formulation delivers the drug directly to the ocular surface with minimal systemic absorption, reducing the risk of gastrointestinal and cardiovascular side effects.

The primary indications for Sofenac Eye Drops are the treatment of postoperative eye pain and inflammation following ophthalmic procedures such as cataract extraction, refractive surgery (LASIK, PRK), and other anterior segment surgeries. It is used to prevent and treat the pain, redness, swelling, and discomfort that commonly occur after these procedures. In some clinical settings, it is also used off-label for the management of non-infectious anterior uveitis, episcleritis, and as an adjunct in the treatment of diabetic macular edema following cataract surgery. The product is intended for use in adults and should only be used under the supervision of a qualified ophthalmologist.

The recommended dosage is 1 drop instilled into the affected eye(s) 4 times daily (every 6 hours), beginning 1 day prior to surgery or at the onset of symptoms, and continued for 7 to 14 days post-operatively as directed by the ophthalmologist. For non-surgical indications, the dosage may be adjusted based on the severity of the condition. The anti-inflammatory and analgesic effect is noticeable within 30 minutes to 1 hour of instillation. Patients should not use more drops than directed, and the course of treatment should be completed as prescribed. The solution should be used within one month after opening the container.

The most common side effects include mild to moderate burning or stinging sensation in the eye immediately upon instillation, eye discomfort, and temporary blurred vision. Other common side effects include eye redness, itching, dry eye, foreign body sensation, and increased tearing. These effects are generally mild and transient, resolving within a few minutes to a few hours. Uncommon side effects may include headache, dizziness, nausea, and taste disturbance (dysgeusia).

Serious but rare side effects include corneal erosion, corneal ulceration, keratitis punctata (punctate keratitis), corneal epithelial discontinuity, corneal edema, increased intraocular pressure, and severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing). In patients with pre-existing corneal problems, diabetes, or those who have undergone multiple eye surgeries in a short period, the risk of corneal complications is increased. The use of this medicine may increase the risk of corneal adverse effects in diabetic patients, which can result in vision loss. Patients should seek immediate medical attention if they experience severe eye pain, sudden vision loss, persistent redness, or signs of a severe allergic reaction.

Important precautions include removing contact lenses before instilling the drops and waiting at least 15 minutes before reinserting them, as the preservative may be absorbed by soft contact lenses. If using other eye medications simultaneously, a gap of at least 5 minutes should be maintained between different drops. Patients should avoid driving or operating heavy machinery until their vision is clear after application, as temporary blurred vision is common. The product should not be used in patients with a known hypersensitivity to diclofenac or other NSAIDs. It should be used with caution in patients with a history of peptic ulcer, gastrointestinal bleeding, or cardiovascular disease. The product is not recommended during pregnancy as animal studies have shown harmful effects on the developing baby. The dropper tip should not be touched to the eye or any surface to maintain sterility. The product should not be used if the solution changes color or becomes cloudy.

The product should be stored below 30 degrees Celsius in a cool and dry place away from direct sunlight and kept out of reach of children. The bottle should be tightly closed after each use. The product is available in India at a price of approximately 35 rupees per 5 ml bottle and is available through major online pharmacy platforms and offline pharmacies with a valid prescription