Expiration date: 01/2025
Release form and composition:
Eye drops, 1 ml contains:
the ketotifen gidrogumat 345 mcg
EMCO corresponds to the contents of ketotifen 250 mcg
Excipients: glycerol, sodium hydroxide 1N, water d/and benzalkonium chloride (as preservative).5 ml - polyethylene bottles (1) with the dropper - packs of cardboard.
Pharmacological action: anti-Allergic drug.The mechanism of action associated with stabilization of membranes of mast cells and decrease release of their histamine, leukotrienes and other biologically active substances. Suppresses caused by platelet-activating factor in the accumulation of eosinophils. Prevents the manifestation of allergic reactions of immediate type. Blocks histamine H1-receptors.
Pharmacokinetics: Satyanarayana the ketotifen in the blood after instillation in the conjunctival cavity for 14 days in 18 adult - less than 20 PG/ml (minimum detectable concentration).Metabolism and excretion of the Main metabolite is ketotifen-N-glucuronide is practically inactive.About 1% of the drug is excreted unchanged by the kidneys within 48 h, 60-70% - as metabolites (glucuronides).
Indications:- prophylaxis and treatment of allergic conjunctivitis.
Dosing regimen: Adults and children over 12 years: 1 drop 2 times/day in both eyes. Duration of use - no more than 6 weeks.Side effects:organ: rare (less than 2%) - decreased visual acuity, dry eyes, in some cases, the feeling of hurt when backfilling, the feeling of pain in the eyes, photophobia, subconjunctival hemorrhage, conjunctivitis.Dermatological reactions: rarely - skin rash in some cases - eczema, allergic reactions.Other: rarely - headache, fatigue, in some cases, dry mouth.
Contraindications: individual hypersensitivity to ketotifen.
Pregnancy and lactation: No clinical data on the safety of use of eye drops Zaditen during pregnancy.The use of the drug during lactation (breastfeeding) is possible only under strict medical supervision.
Special instructions:the product contains as a preservative benzalkonium chloride, which is able to penetrate into the material of soft contact lenses, so it is recommended to remove lenses prior to instillation of the drug Zaditen and wear no earlier than 15 minutes after instillation.It should not be used Zaditen when wearing contact lenses the irritation or inflammation of the eyes.While the appointment of the drug Zaditen with other eye drops you need to take a break between instillation for at least 5 min. effects on ability to drive vehicles and management mekhanizmami period of drug treatment Zaditen should refrain from potentially hazardous activities associated with the need for increased attention and rapid psychomotor reactions.
Overdose: Data on drug overdose Zaditen do not exist.
Drug interactions: none noted drug interactions Zaditen with other drugs.
Terms and conditions of storage: the Drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 2 years. The drug should not use after the expiry date.After opening the bottle of eye drops should be used within one month
