Dexamethasone-ROMFARM eye drops 0.1% 10ml
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Active ingredients
Dexamethasone
Release form
Drops
Composition
On 1 ml: dexamethasone 1 mg. Excipients: polysorbate 80, hypromellose (hydroxypropyl methylcellulose 4000), disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, disodium edetate dihydrate, benzalkonium chloride, purified water.
Pharmacological effect
GKS for local use in ophthalmology. It has a pronounced anti-inflammatory, antiallergic and antiexudative action. Interacting with specific protein receptors in target tissues, regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Reduces the formation, release and activity of inflammatory mediators (including histamine, kinin, prostaglandins, lysosomal enzymes). Inhibits cell migration to the site of inflammation. Reduces vasodilation and increased vascular permeability in the inflammation. Stabilizes lysosomal enzymes of leukocyte membranes. Suppresses the synthesis of antibodies and violates the recognition of antigen. Slows down the release of interleukin 1 and interleukin 2, γ-interferon from lymphocytes and macrophages. Induces the formation of lipocortin, inhibits the release of inflammatory mediators by eosinophils and stabilizes the membranes of mast cells. All these effects are involved in suppressing the inflammatory response in the tissues in response to mechanical, chemical or immune damage. The duration of the anti-inflammatory effect of the drug after instillation of 1 drop of solution is from 4 to 8 hours.
Pharmacokinetics
Absorption and distribution After instillation into the conjunctival sac, dexamethasone penetrates well into the corneal epithelium and conjunctiva, and therapeutic concentrations are achieved in the aqueous humor. When inflammation or damage to the mucous membrane, the rate of penetration increases. The systemic absorption of the drug is minimal. About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins. Metabolism and excretion Dexamethasone is metabolized in the liver by the action of cytochrome-containing enzymes. Metabolites are excreted in the feces. T1 / 2 averages 3 hours.
Indications
Conjunctivitis (non-purulent and allergic); keratitis; keratoconjunctivitis (without damage to the epithelium); blepharitis; scleritis; episcleritis; chorioretinitis; uveitis; blepharoconjunctivitis; optic neuritis; sympathetic ophthalmia; prevention and treatment of inflammation after surgery and injuries; restoration of corneal transparency and reduction of neovascularization after keratitis, burns.
Contraindications
- viral eye diseases; - fungal eye diseases; - purulent eye diseases (without concomitant antimicrobial therapy); - trachoma; - increased intraocular pressure; - damage to the integrity of the cornea epithelium; - eye tuberculosis; - children under 6 years old; - pregnancy; lactation period (breastfeeding); - hypersensitivity to the drug.
Use during pregnancy and lactation
The use of the drug during pregnancy during lactation (breastfeeding) is contraindicated.
Dosage and administration
For adults with acute inflammatory processes, the drug is instilled into the conjunctival sac, 1-2 drops 4-5 times a day for 2 days; in the future, the drug is used 1-2 drops 3-4 times / day for 4-6 days. In chronic inflammatory processes, the drug is instilled 2 times / day for 3-6 weeks. The maximum duration of the drug use is 6 weeks. In allergic diseases eye preparation is instilled into the conjunctival sac 1-2 drops 4-5 times / day for 2 days with gradual withdrawal within 1-2 weeks. In case of damage to the eyeball as a result of injuries or during surgical interventions after anti-glaucoma filtering surgery, the drug is used dailysurgery or the next day. After a cataract extraction operation, surgery for strabismus, retinal detachment, and after injury, the drug is used starting from the 8th day. Depending on the severity of symptoms of inflammation, the drug should be instilled 1-2 drops 2-4 times / day for 2-4 weeks. Children aged 6 to 12 years old when treating allergic and inflammatory conditions are instilled 1 drop 2-3 times. / day for 7-10 days. If necessary, treatment is continued after a fluorescein test is performed on day 10 (to check the integrity of the corneal epithelium).
Side effects
Basically, the drug is well tolerated. Local reactions: immediately after instillation of the drug, a rapidly passing burning sensation, tearing, blurred vision. With prolonged use of the drug (more than 2 weeks), intraocular pressure may develop, glaucoma develops with damage to the optic nerve, and reduction in acuity vision and loss of visual fields, as well as the formation of posterior subcapsular cataract, thinning and perforation of the cornea; very rarely - the spread of herpes and bacterial infections. In patients with hypersensitivity to dexamethasone or benzalkonium chloride, allergic conjunctivitis and blepharitis can develop. It may develop itching, palpebral or conjunctival erythema. infections. With long-term use, there may be an increase in the risk of systemic side effects characteristic of GCS. From the endocrine system : decrease in glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome. On the part of the digestive system: nausea, vomiting, increased or decreased appetite, exacerbation of chronic diseases of the gastrointestinal tract. On the side of the cardiovascular system: arrhythmia, bradycardia, increased blood pressure. For the central nervous system: increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, headache.
Overdose
Overdose when used in ophthalmology is unlikely. Symptoms: local manifestations are possible. There is no specific antidote. The drug should be canceled and prescribed symptomatic therapy. Prolonged use of the drug or the use in high doses can increase the systemic absorption of dexamethasone, and may also develop ocular hypertension and certain diseases of the cornea or lens.
Interaction with other drugs
Long-term use of dexamethasone with idoxuridine may increase the destructive processes in the corneal epithelium. Dexamethasone may increase the effect of barbiturates. Combined use of phenytoin with dexamethasone leads to a decrease in the concentration of the latter. Varfarin in combination with dexamethasone increases the risk of bleeding.to induce or saturate hepatic enzymes. Dexamethasone with diuretics (especially thiazide and carbonic anhydrase inhibitors) and amphotericin B can be used to increase potassium excretion and increase the risk of heart failure. Simultaneous use of dexamethasone with cardiac glycosides worsens their tolerance and increases development of ventricular extrasystole (due to induced hypokalemia). With simultaneous use of dexamethasone with ethanol and NSAIDs increase the risk of erosive and ulcerative lesions of the gastrointestinal tract. Estrogens and oral estrogen-containing contraceptives reduce the clearance of dexamethasone, which may be accompanied by increased severity of its action. Combined use of antiarrhythmic drugs with dexamethasone can reduce the effect of the latter.
special instructions
The product is intended for topical use only. It should not be used for intraocular injection. Before use, the drug should be shaken. If there is no improvement after 3-4 days of treatment, additional local or systemic treatment should be prescribed. The drug contains antimicrobial preservative benzalkonium chloride, which can be adsorbed by soft contact lenses. Therefore, you can not use the drug while wearing soft contact lenses. It is necessary to remove the lenses before applying the drug and install no earlier than 15 minutes after instillation. When using the drug in combination with other ophthalmic drops, it is necessary to maintain an interval between instillation of at least 15 minutes. Treatment with the drug can mask the picture of a bacterial or fungal infection, therefore during treatment Infectious diseases of the eye, the drug should be combined with adequate antimicrobial therapy. Dexamethasone can lead to a false-positive test result for doping. Effects on ability to drive vehicles and control mechanisms Taking into account the possibility of tearing after instillation of the drug, it should not be used immediately before driving or working with mechanisms.Within 30 minutes after instillation of the drug should refrain from classes that require attention.