Ophthal Dexa 1mg/ml 5ml

Form

tsvetebi

Dosage mg

1მგ/

Pack

1

International Nonproprietary Name: (11 beta, 16 alpha) – 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione Dosage Form: Eye drops. Content per 1 ml of solution: Active substances: Dexamethasone sodium phosphate – 1 mg/ml (calculated as dexamethasone) Excipients: Benzalkonium chloride, boric acid, borax, disodium edetate, water for injection. Description: Colorless transparent solution. Pharmacotherapeutic group: Topical glucocorticosteroid. Indications for use: Acute and chronic inflammatory processes: - Non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis, and blepharitis; - Scleritis and episcleritis; - Iritis, iridocyclitis, and uveitis of various origins; - Superficial corneal lesions of various etiologies (chemical, physical, and immune mechanisms) after complete corneal epithelialization; - Inflammation of the posterior segment of the eye (choroiditis, chorioretinitis); - Sympathetic ophthalmia. Allergic diseases of the eyes: - Allergic conjunctivitis and keratoconjunctivitis. Prevention and treatment of inflammatory events in the postoperative and post-traumatic periods. Contraindications: - Keratitis caused by herpes simplex or varicella, as well as other viral diseases of the cornea and conjunctiva. - Ocular mycobacterial infections. - Ocular fungal diseases. - Acute purulent diseases of the eye with damage to the corneal epithelium. - Corneal epitheliopathy. - Increased intraocular pressure. - Hypersensitivity to any component of the preparation. Use during pregnancy and lactation: To date, there are no clinical trial data on the use of the preparation during pregnancy and lactation or in infants. However, its use is possible if the potential benefit to the mother outweighs the potential risk to the fetus. Dosage and administration: Instill 1-2 drops of Oftan Dexamethasone eye drops into the conjunctival sac 3-5 times a day. The duration of treatment with Oftan Dexamethasone eye drops should not exceed 2-3 weeks. The decision to continue treatment is based on objective data, including the effectiveness of the preparation, the severity of symptoms, and the possibility of side effects. Side effects: When instilling Oftan Dexamethasone eye drops, a burning sensation may occur. Prolonged use can lead to secondary glaucoma and steroid cataracts; therefore, when using the preparation for more than 2 weeks, and also in patients with a history of glaucoma, regular monitoring of intraocular pressure is recommended. In case of side effects, discontinue the use of the preparation and consult an ophthalmologist immediately. Overdose: Overdose is unlikely with local use of Oftan Dexamethasone. Interaction with other drugs: Interaction with other drugs is mainly determined by the participation of the same cytochrome-containing enzymes in the elimination process. Dexamethasone can enhance the effects of phenytoin, barbiturates, and warfarin. It induces the isoenzyme CYP3A4, thereby reducing the effectiveness of calcium channel blockers, quinidine, and erythromycin. With the usual regimen of local use, the dose is insufficient to cause induction or saturation of liver enzymes. Special instructions: The use of the preparation while wearing contact lenses is not recommended. Contact lenses should be removed before using the preparation and reinserted no less than 15 minutes after administration. With prolonged use of eye drops, an increase in intraocular pressure may occur. If the preparation is used for 2 or more weeks, intraocular pressure should be measured regularly. Corticosteroid therapy can mask an ongoing bacterial or fungal infection. In case of infection, appropriate antimicrobial therapy should be carried out along with the use of eye drops. Due to possible tearing upon instillation, it is not recommended to take it immediately before driving or operating mechanical devices. Form of release: 5 ml polyethylene plastic dropper bottle with a screw cap. The bottle is placed in a cardboard box along with the instructions for use. Shelf life: 2 years. Use within 1 month after opening the bottle. Do not use after the expiry date indicated on the packaging. Storage conditions: List B. Store at a temperature of +2 to +8ºC, out of reach of children. Dispensing condition: By prescription. Manufacturer: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland