Index of drugs

Prevention and treatment of postoperative pain and inflammation associated with the surgical removal of cataracts. In addition, a 1 mg / ml formulation: reducing the risk of postoperative macular edema associated with cataract surgery in patients with diabetes mellitus.

1 ml of suspension contains 1 mg or 3 mg of nepafenac. The preparation contains benzalkonium chloride.

Nepafenac is a precursor to a non-steroidal anti-inflammatory drug. After topical application to the eye, the drug penetrates the cornea and is converted by the hydrolase present in the tissue of the eye into amfenac - a non-steroidal anti-inflammatory drug. Amfenac inhibits the action of H synthase of prostaglandins (cyclooxygenase), an enzyme necessary for the production of prostaglandins. After administration of the 1 mg / ml formulation in both eyes 3 times a day or 3 mg / ml once a day for 4 days, the presence of low but determinable plasma concentrations of nepafenac and amfenac was observed in most volunteers, respectively 2 and 3 hours after serving. Amfenac has a high affinity for serum albumin. Nepafenac is relatively rapidly bioactivated to amfenac with the participation of hydrolases localized within the eye. Subsequently, the amphine is subjected to an intense metabolism leading to the formation of more polar metabolites, including the hydroxylation of the aromatic ring, leading to the formation of glucuronidic connections. The second most important metabolite identified in the plasma was 5-hydroxynepafenac. Urinary excretion is the main route of excretion (85% of the dose), approximately 6% of the dose is excreted in the faeces. After administration of the preparation to patients undergoing cataract surgery, a single dose of the preparation had the maximum mean concentrations in the aqueous humor after 1 hour. These data indicate that the cornea is rapidly penetrating the drug.

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to other NSAIDs. Patients with Acetylsalicylic acid or other NSAIDs cause asthma attacks, urticaria or acute rhinitis.

Avoid sun during treatment with the preparation. With continuous use of NSAIDs, some sensitive patients may experience: epithelial damage, corneal thinning, corneal erosions, corneal ulceration or corneal perforation - these events can be a threat to vision; Patients with evidence of corneal epithelial destruction should immediately discontinue use and be carefully monitored for corneal conditions. Topical NSAIDs and corticosteroids may slow down or delay the healing process - simultaneous use may increase the risk of healing disorders; caution should be exercised when co-administered with the preparation and corticosteroids, especially in patients at high risk of adverse reactions within the cornea. Due to the increased risk of adverse reactions from the cornea, caution should be used in patients after complicated ocular surgical procedures, with corneal denervation, corneal epithelial abnormalities, diabetes mellitus, ocular surface disorders (eg dry eye syndrome), rheumatoid arthritis or in patients undergoing eye surgery repeatedly in a short period of time. Prolonged use of topical NSAIDs may increase the risk of corneal adverse reactions and their severity. In diabetic patients prescribed nepafenac for the prevention of macular edema following cataract surgery, the existence of additional risk factors should lead to a re-evaluation of the benefit-risk balance and intensified monitoring of the patient. It has been reported that NSAIDs used for the eyes may cause increased bleeding of the eye tissues (including hemorrhages to the anterior chamber of the eye) in connection with surgical procedures on the eye - the preparation should be used with caution in patients with known bleeding tendencies or other drugs that may increase the time bleeding. The use of topical anti-inflammatory drugs to the eye may mask the symptoms of acute eye infection - in the case of eye infection, the use of NSAIDs with anti-infectives should be undertaken with caution.There is the possibility of cross-sensitivity to nepafenac and Acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. The use of contact lenses is not recommended in the postoperative period after cataract removal; patients should not wear contact lenses unless advised by a doctor. The product contains benzalkonium chloride, which may cause irritation and discolour soft contact lenses. If contact lenses should be used during treatment, patients should remove contact lenses prior to instillation and wait at least 15 minutes before putting them on again. It has been reported that benzalkonium chloride may cause punctate keratopathy and / or toxic ulcerative keratopathy - careful monitoring of patients who use the product frequently or for a long time is required. The 3 mg / ml formulation should not be used to reduce the risk of postoperative macular edema associated with cataract surgery, as the efficacy and safety of the use of this strength in this indication has not been studied. There are no data on the safety and efficacy of the preparation in children and adolescents.

There are no adequate data from the use of nepafenac during pregnancy. As the systemic exposure of non-pregnant women is negligible, the risks associated with pregnancy may be considered low. However, due to the fact that inhibition of prostaglandin synthesis may have a negative impact on pregnancy and / or fetal development and / or delivery and / or postnatal development, the preparation is not recommended for use during pregnancy. Do not use the preparation in women of childbearing potential not using contraception. It is not known whether nepafenac is excreted in human milk. However, no effects are to be expected in a breast-fed child, since systemic exposure to nepafenak of a breast-feeding woman is negligible - the preparation can be used during breastfeeding.

Uncommon: keratitis, point keratitis, corneal epithelial defects, feeling of a foreign body in the eyes, scabs on the edges of the eyelids. Rare: hypersensitivity, dizziness, iritis, choroidal effusion, corneal deposits, eye pain, eye discomfort, blepharitis, pruritus of the eye, discharge from the eye, allergic conjunctivitis, increased tearing, conjunctival congestion, nausea, flaccid skin (dermatochalasis), allergic dermatitis. Not known: headache, corneal perforation, healing disorder (cornea), corneal opacity, corneal scarring, decreased visual acuity, eye irritation, swollen eyes, ulcerative keratitis, corneal thinning, blurred vision, vomiting, increased blood pressure. In addition, drops with a concentration of 3 mg / mi uncommon: hypertension. As part of the experience collected after placing on the market of the 1 mg / ml preparation, cases of defect and / or corneal epithelium disorder were identified. The severity of these cases varies, ranging from a mild impact on the integrity of corneal epithelial tissue to more serious events for which surgery and / or other treatments have been required to regain clear vision. Post-marketing experience with topically applied NSAIDs indicates that patients with complicated ocular surgery, corneal denervation, corneal epithelium abnormalities, diabetes, ocular surface conditions (e.g. dry eye syndrome), rheumatoid arthritis or undergoing multiple eye surgery in a short period of time. In diabetic patients prescribed nepafenac for the prevention of macular edema following cataract surgery, the existence of additional risk factors should lead to a reassessment of the anticipated benefit-risk balance and enhanced patient monitoring.Patients with diabetes (only 1 mg / ml). The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients (often); in addition: corneal epithelial defects and allergic dermatitis (uncommon). Eye reactions in patients with diabetes may occur more frequently than those observed in the general population.

Adults.Nevanac 1 mg / ml. Prevention and treatment of postoperative pain and inflammation associated with the surgical removal of cataracts: 1 drop into the conjunctival sac of the affected eye (eyes) 3 times a day. The use of the drug begins on the day before the cataract surgery, continues on the day of surgery and up to 21 days of the post-operative period, as recommended by the doctor. At 30-120 minutes before the procedure, an additional drop of the preparation should be given.Reduction of the risk of postoperative macular edema associated with cataract surgery in patients with diabetes mellitus: 1 drop into the conjunctival sac of the affected eye (eyes) 3 times a day starting from the first day before cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period, as recommended by the doctor. At 30-120 minutes before the procedure, an additional drop of the preparation should be given.Nevanac 3 mg / ml. Prevention and treatment of postoperative pain and inflammation associated with the surgical removal of cataracts: 1 drop into the conjunctival sac of the affected eye (eyes) once a day. The use of the drug begins on the day before the cataract surgery, continues on the day of surgery and up to 21 days of the post-operative period, as recommended by the doctor. At 30-120 minutes before the procedure, an additional drop of the preparation should be given. No dosage adjustment is necessary for elderly patients or patients with impaired hepatic or renal function. If the patient uses more than one topical eye medicine, each drug should be administered separately, with at least a 5-minute break; eye Ointment should be used at the end. The bottle should be well shaken before use.