Nevanac eye drops 0.1% 5ml

Nevanak eye drops - is an anti-inflammatory and analgesic drug used to treat post-operative pain and inflammation due to cataract removal.

Nevanac eye drops reduce the synthesis of substances activating and supporting inflammation (prostaglandins) in the lesion, rapidly reducing pain, reducing inflammatory edema. Diclofenac is superior in its anti-inflammatory activity ibuprofen, butadione and acetylsalicylic acid (aspirin).

In the cornea and conjunctiva, the active substance reaches its maximum concentration 30 minutes after instillation of the drug. In the systemic circulation in significant concentrations of Diclofenac is not detected. Penetrates into the anterior chamber of the eye.

Nepaphenac is a precursor of the active form of non-steroidal anti-inflammatory drugs with anti-inflammatory and analgesic action. With topical application, nepafenac penetrates through the cornea of the eye, where hydrolases convert it into amphenac, an active form. Amfenac inhibits the action of cyclooxygenase (prostaglandin-H-synthase), an enzyme necessary for the production of prostaglandins.

With topical application, nepafenac reduces the swelling of the eye tissues and pain, does not have a significant effect on intraocular pressure.

Nevanac is rapidly absorbed through the cornea of the eye. Three times daily instillation of the drug Nevanac in both eyes in the blood plasma revealed low measured concentrations of napafenac and amfenac after 2 and 3 hours, respectively. Cmax of nepafenac in plasma after topical application is 0.310 ± 0.104 ng / ml; Cmax amfenac - 0.422 ± 0.121 ng / ml.

Cmax of napafenac on average in aqueous humor is observed after 1 hour.

Distribution

Amfenac has a high affinity for serum albumins. In vitro binding to rat albumin, human albumin and human serum was 98.4%, 95.4%, and 99.1%, respectively.

Studies in rats have shown that radiolabeled substances associated with the active substance are widely distributed in the body after a single and repeated use of oral doses of 14C-napafenac.

Metabolism

With topical application under the influence of intraocular hydrolases, napafenac undergoes rapid hydrolysis to amphenac.

Further metabolism of amfenac proceeds by hydroxylation of the aromatic ring, which leads to the formation of conjugates with glucuronic acid. Radiographic chromatographic analysis performed before and after hydrolysis involving P-glucuronidase showed that all metabolites were presented in the form of conjugates with glucuronic acid, with the exception of amfenac. Amphenac was the main metabolite in plasma - this substance accounted for about 13% of the total radioactivity detected in the plasma. The second on the occurrence in the plasma was a metabolite of 5-hydroxynapaphenac with 9% of the total radioactivity at Cmax.

Excretion

Nepaphenac is excreted mainly by the kidneys (about 85% of the radioactive label when oral administration of 14C-napafenac is found in the urine, about 6% in the feces), but the concentrations of nepafenac and amfenac in the urine are not quantifiable.

Indications:

Treatment, as well as the prevention of postoperative pain and inflammation in surgical operations for cataracts.

Contraindications:

• bronchial asthma, COPD, urticaria or acute rhinitis, which are caused by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• children under 18;
• hypersensitivity of the body;
• pregnancy, lactation.

Special instructions:

Patients should avoid exposure to sunlight.

The use of NSAIDs for topical application can lead to the development of keratitis. In some susceptible patients, prolonged use of non-steroidal anti-inflammatory drugs for topical use can cause a rupture of epithelial cells, thinning of the cornea, erosion of the cornea, the formation of an ulcer on the cornea, or perforation of the cornea. These side effects can create a risk of vision loss. Patients with signs of rupturing the corneal epithelium should immediately stop using the drug, and be monitored to monitor the condition of the cornea.

The use of NSAIDs for topical application may slow or delay the healing process. It is also known that glucocorticosteroids for topical application slow or delay healing. Simultaneous application of NSAIDs for topical application and SCS for local administration may slow or delay the healing process.

The experience with topical application of NSAIDs suggests that patients with complications following surgical ophthalmic interventions, denervation of the cornea, defects in the corneal epithelium, diabetes mellitus, superficial eye diseases (eg, dry eye syndrome), rheumatoid arthritis or repeated surgical interventions for a short period time, may have an increased risk of developing side effects from the cornea, which can create a threat of vision loss. NSAIDs for topical use should be used with caution in the treatment of such patients. Long-term use may increase the risk of occurrence and severity of adverse reactions from the cornea.

The use of NSAIDs for topical use in combination with a surgical procedure on the eyes can cause intense bleeding in the eye tissues (including hyphema). The drug Nevanac should be used with caution in patients who have a history of bleeding tendency, or if patients receive other medications that can increase clotting time.

Data on the simultaneous use of prostaglandin analogs and the drug Nevanak are absent. Given the mechanisms of their action, simultaneous use is not recommended.

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

Studies have shown that benzalkonium chloride, which is contained in the drug Nevanac, can cause point keratitis and / or toxic ulcer keratitis. Therefore, with frequent or prolonged use of the drug, careful medical supervision of the patients' condition is necessary.

The use of NSAIDs for topical application may interfere with the timely recognition of signs of acute eye infection. they do not possess any antimicrobial properties. In the case of ocular infection, the use of non-steroidal anti-inflammatory drugs for topical administration concomitantly with antibacterial agents should be carried out with precautionary measures.

Cross-sensitivity

With the use of nepafenac, it is possible to develop cross-sensitivity to acetylsalicylic acid, derivatives of fennulfacetic acid, as well as other NSAIDs.

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

The bottle must be closed after each use.

Impact on the ability to drive vehicles and manage mechanisms

After application of the drug, a temporary decrease in the clarity of visual perception is possible, and before its restoration it is not recommended to drive and engage in activities requiring increased attention and reaction.

Suggested Use:

Locally. Shake the bottle before use.

1 drop in the conjunctival sac of the eye (eye) 3 times a day. Treatment is started 1 day before surgery for cataract removal and continues for the first 2 weeks of the postoperative period (including the day of the operation). For 30-120 minutes before the operation, it is necessary to drip an additional drop of the drug.

Packaging:

• Comes in original packaging. Item is brand new and unopened.

Storage:

• Keep away from direct sunlight.
• Keep locked and away from children.
• Store in dry place at room temperature.
• Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!