Nevanac® [Nepafenac]

Brand Alcon

In stock 672 Items

Available since: 2019-09-19

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Clinical Pharmacology

Nepafenac is a precursor of the active form of nonsteroidal anti-inflammatory drugs with anti-inflammatory and analgesic effects. When applied topically, Nepafenac penetrates the cornea of the eye, where with the help of hydrolases it is transformed into amphenac, the active form. Amphenac inhibits the action of cyclooxygenase (prostaglandin H-synthase), an enzyme necessary for the production of prostaglandins.

When applied topically, Nepafenac reduces swelling of eye tissue and pain, and does not have a significant effect on intraocular pressure.

Indications

Treatment, as well as prevention of postoperative pain and inflammation during cataract surgeries.

Composition

1 ml contains:

Active substance: Nepafenac 1 mg

Excipients: benzalkonium chloride (as a 50% solution) 0.05 mg, carbomer 974P 5.0 mg, tyloxapol 0.1 mg, disodium edetate 0.1 mg, mannitol 24.0 mg, sodium chloride 4.0 mg, sodium hydroxide and / or hydrochloric acid to bring the pH, purified water to 1 ml.

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Dosage and Administration

Locally. Shake the bottle before use.

1 drop in the conjunctival sac of the eye (s) 3 times a day. Treatment begins 1 day before surgery for cataract removal and continues for the first 2 weeks of the postoperative period (including the day of surgery). 30-120 minutes before the operation, you need to drop an extra drop of the drug.

Adverse reactions

Local:in 1-10% of cases there is point keratitis, pain and itching in the eye, blurred vision, dry conjunctiva, foreign body sensation, formation of crusts at the edges of the eyelids. In 0.1-1% of cases - iritis, keratitis, deposits in the cornea, choroidal effusion, eye discharge, photophobia, eye irritation, allergic conjunctivitis, bleeding from the eyelids, discomfort in the eyes, increased tearing, conjunctival hyperemia.

Systemic side effects: in 1-10% of cases - a headache. In 1-4% of cases - increased blood pressure, nausea, vomiting, sinusitis. In 0.1-1% of cases - dry mouth, skin elasticity (dermatochalasis), increased sensitivity.

Post-marketing observations (frequency unknown): ulcerative keratitis, defect / disease of the corneal epithelium, corneal damage, formation of inflammatory infiltrate in the anterior chamber of the eye, deterioration of the cornea healing process, reduced visual acuity, scar on the cornea, corneal clouding.

Patients with signs of corneal damage should immediately discontinue use of the drug and carefully examine the state of the cornea. Experience with nonsteroidal anti-inflammatory drugs for topical use suggests that patients with complications from surgical ophthalmic interventions, cornea denervation, corneal epithelial defects, diabetes, superficial eye diseases (eg, dry eye syndrome), rheumatoid arthritis, or repeated surgical interventions performed during short periods of time, there may be an increased risk of corneal adverse reactions that may create threat of vision loss.

Contraindications

bronchial asthma, COPD, urticaria, or acute rhinitis, which are caused by taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
children under 18;
body hypersensitivity;
pregnancy, lactation.

Drug interactions

In in-vitro studies, neither; Nepafenac or amphenac does not inhibit the metabolic activity of human cytochrome P450 (isoenzyme CYP1A2, 2C9, 2C19, 2D6, 2E1 and ZA4) at concentrations up to 300 ng / ml. Therefore, with simultaneous use with other drugs, interaction involving cytochrome P450 isoenzymes is unlikely. Interactions mediated by binding to plasma proteins are also unlikely.

Data on the simultaneous use of the drug Nevanac and prostaglandin analogues are not available. Given the mechanisms of their action, simultaneous use is not recommended.

If necessary, it can be used in combination with other ophthalmic preparations for local use. In this case, the interval between their use should be at least 5 minutes.

Pregnancy and Lactation

Not recommended for use during pregnancy and lactation. If you need an appointment during lactation, breastfeeding is recommended to stop at the time of treatment.

Animal tests revealed reproductive toxicity. When studying the effects of Nepafenac on the reproductive organs of rats, taking toxic doses of> 10 mg / kg resulted in dystocia, an increase in the number of spontaneous abortions at the post-implantation stage, a decrease in body weight and embryo growth, a decrease in embryo survival. In pregnant rabbit, the administration of low-toxic doses of 30 mg / kg led to an increase in the developmental defects of the offspring.

Special instructions

Patients should avoid exposure to sunlight.

The use of NSAIDs for local use can lead to the development of keratitis. In some susceptible patients, long-term use of nonsteroidal anti-inflammatory drugs for local use can cause epithelial cell rupture, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These side effects may create a risk of vision loss. Patients with signs of corneal epithelial cell rupture should immediately discontinue use of the drug, and be monitored, the purpose of which is to monitor the state of the cornea.

The use of NSAIDs for local use can slow down or delay the healing process. It is also known that topical glucocorticosteroids slow down or delay healing. Simultaneous use of NSAIDs for local use and GCS for local use can slow down or delay the healing process.

Experience with the use of NSAIDs for topical use suggests that patients with complications from surgical ophthalmologic interventions, cornea denervation, corneal epithelium defects, diabetes mellitus, superficial eye diseases (for example, dry eye syndrome), rheumatoid arthritis or repeated surgical interventions carried out during a short period time, there may be an increased risk of corneal adverse reactions, which may create a risk of loss of vision. NSAIDs for topical use should be used with caution when treating such patients. Prolonged use may increase the risk and severity of corneal adverse reactions.

The use of NSAIDs for topical use in combination with eye surgery can cause intense bleeding in the eye tissue (including hyphema). Nevanac should be used with caution in patients whose history has a tendency to bleed, or if patients are receiving other medications that can increase blood clotting time.

Data on the simultaneous use of prostaglandin analogues and the drug Nevanac are missing. Given the mechanisms of their action, simultaneous use is not recommended.

The drug contains preservative benzalkonium chloride, which can cause eye irritation and discoloration of soft contact lenses. In addition, the wearing of contact lenses is not recommended during the postoperative period after surgery for cataracts. It is not recommended to use contact lenses when treating Nevanac.

Studies have shown that benzalkonium chloride, which is contained in the Nevanac preparation, can cause acne keratitis and / or toxic ulcerative keratitis. Therefore, with frequent or prolonged use of the drug requires careful medical observation of the patients.

The use of NSAIDs for topical administration may interfere with the timely recognition of signs of an acute eye infection, because they do not possess any antimicrobial properties. In the event of an eye infection, the use of nonsteroidal anti-inflammatory drugs for local use simultaneously with antibacterial agents should be carried out with the observance of precautionary measures.

Cross sensitivity

When using Nepafenac, there is the possibility of developing cross-sensitivity to acetylsalicylic acid, derivatives of fenl acetic acid, as well as other NSAIDs.

Do not touch the tip of the dropper bottle to any surface to avoid contamination of the bottle and its contents.

The bottle must be closed after each use.

Influence on ability to drive motor transport and control mechanisms

After the use of the drug, a temporary decrease in the clarity of visual perception is possible, and until it is restored, it is not recommended to drive a car and engage in activities requiring increased attention and reaction.

Overdosage

Data overdose of the drug is not available. If an excessive amount of the drug gets into the eyes, it is recommended to wash the eyes with warm water.