Oftan-dexamethasone eye drops 0.1% 5ml
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Active ingredients
Dexamethasone
Release form
Drops
Composition
1 ml: dexamethasone sodium phosphate 1.32 mg, which corresponds to the content of dexamethasone 1 mg. Excipients: benzalkonium chloride, boric acid, sodium tetraborate, disodium edetate, water d / and.
Pharmacological effect
Synthetic fluorinated GCS for local use in ophthalmology. The drug has a pronounced anti-inflammatory and antiallergic effect. Dexamethasone interacts with specific protein receptors in target tissues, thus regulating the expression of corticosteroid-dependent genes and affecting further protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes and inhibits the release of enzymes. Inhibits kinin synthesis, mitosis and leukocyte migration. Inhibits the synthesis of antibodies and violates the recognition of antigen. All these mechanisms are involved in the suppression of the inflammatory response in the tissues in response to mechanical, chemical or immune damage. The duration of the anti-inflammatory action after instillation of 1 drop of the drug is 4-8 hours.
Pharmacokinetics
Absorption When applied topically, systemic absorption is low. After instillation into the conjunctival sac penetrates well into the corneal epithelium and conjunctiva. At the same time, therapeutic concentrations are achieved in the aqueous humor; in case of inflammation or damage to the mucous membrane, the rate of penetration increases. Distribution and metabolism About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins. Metabolized in the liver by the action of the CYP3A4 isoenzyme. ExcretionMetabolites are excreted through the intestine. T1 / 2 averages 3.6 ± 0.9 h.
Indications
Acute and chronic inflammatory processes: - non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis, and blepharitis; - inflammation of the posterior segment of the eye (choroiditis, chorioretinitis); - swelling, inflammation (including in the postoperative period); - sympathetic ophthalmia. Allergic eye diseases: - allergic conjunctivitis and keratoconjunctivitis. Prevention and treatment of inflammation in the postoperative and post-traumatic period.
Contraindications
keratitis associated with herpes simplex, chicken pox and other viral diseases of the cornea and conjunctiva; - eye tuberculosis; - mycobacterial eye infections; - fungal eye diseases; - acute purulent eye diseases; - corneal epithelium damage (including condition after removal cornea foreign body); - corneal epitheliopathy; - increased intraocular pressure; - glaucoma; - age up to 18 years (due to the lack of data on the efficacy and safety of using the drug in children and adolescents under 18); yield to the components of the drug.
Use during pregnancy and lactation
To date, clinical trials data regarding the use of the drug Oftan Dexamethasone during pregnancy and lactation are not available. Oftan Dexamethasone can be used during pregnancy and during breastfeeding only as prescribed by the attending physician, if the expected therapeutic effect justifies the potential risk to the fetus and the baby. The duration of therapy is not more than 7-10 days.
Dosage and administration
In acute conditions, 1-2 drops are prescribed in the conjunctival sac every 1-2 hours. After reducing the inflammation, the drug is instilled 1-2 drops in the conjunctival sac 3-5 times / day. The duration of treatment should not exceed 2-3 weeks. the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.
Side effects
On the part of the organ of vision: after instillation, perhaps a transient burning sensation, allergic reactions. With prolonged use may develop secondary glaucoma and steroid cataracts, as well as ulceration, turbidity, thinning and / or perforation of the cornea; rarely - the spread of bacterial or herpes infections. The drug contains in its composition the preservative benzalkonium chloride, which can cause eye irritation.
Overdose
Overdose with topical application of eye drops Oftan Dexamethasone is unlikely. Symptoms: local irritation is possible. Treatment: there is no specific antidote. The drug should be discontinued and prescribe symptomatic therapy.
Interaction with other drugs
Interaction with other drugs, mainly due to the participation in the elimination of dexamethasone CYP3A4 isoenzyme. Dexamethasone induces a CYP3A4 isoenzyme, thereby reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. In the usual mode of topical administration, the dose of the drug is insufficient to induce or saturate the liver enzymes. With prolonged use with iodoxuridine, destructive processes in the corneal epithelium may increase.
special instructions
Oftan Dexamethasone contains a preservative benzalkonium chloride, which can be absorbed by soft contact lenses and cause a change in their color and have an adverse effect on eye tissue. If it is necessary to use contact lenses during treatment with Oftan Dexamethasone, they should be removed before using the drug and, if necessary, be installed no earlier than 15 minutes after instillation. .Corticosteroid therapy may mask a current bacterial or fungal infection. In the presence of infection, it is necessary to combine the use of drops with appropriate antimicrobial therapy. The effect on the ability to drive vehicles and control mechanisms. Due to the possible tearing after instillation, the drug is not recommended to be used immediately before driving or operating mechanical equipment.