Composition, form of production and packaging
Eye drops 1 ml
ketotifen hydrofumarate 345 Ојg,
which corresponds to a content of ketotifen 250 Ојg
Excipients: glycerol, sodium hydroxide 1n, water d / u, benzalkonium chloride (as a preservative).
5 ml - polyethylene bottles (1) with a dropper - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Anti-allergic drug.
The mechanism of action is associated with stabilization of mast cell membranes and a decrease in the release of histamine, leukotrienes and other biologically active substances from them. Suppresses the accumulation of eosinophils caused by the platelet activating factor. Prevents the occurrence of allergic reactions of immediate type. It blocks histamine H 1 -receptors.
PHARMACOKINETICS
Suction
The concentration of ketotifen in the blood after instillation into the conjunctival cavity for 14 days in 18 adults is less than 20 pg / ml (the minimum detectable concentration).
Metabolism and excretion
The main metabolite of ketotifen-N-glucuronide is practically inactive.
About 1% of the drug is excreted unchanged by the kidneys within 48 hours, 60-70% - in the form of metabolites (glucuronides).
INDICATIONS
- prevention and treatment of allergic conjunctivitis.
DOSING MODE
Adults and children over 12 years: 1 drop 2 times / day in both eyes. Duration of application - no more than 6 weeks.
SIDE EFFECT
From the side of the organ of vision: rarely (no more than 2%) - reduced visual acuity, dry eyes; in some cases - the feeling of rezi during instillation, a feeling of pain in the eyes, photophobia, subconjunctival hemorrhages, conjunctivitis.
Dermatological reactions: rarely - skin rash; in some cases - eczema, allergic reactions.
Other: rarely - headache, fatigue; in some cases - dry mouth.
CONTRAINDICATIONS
- increased individual sensitivity to ketotifen.
PREGNANCY AND LACTATION
There are no clinical data on the safety of Zaditen eye drops during pregnancy.
The use of the drug during lactation (breastfeeding) is possible only under the strict supervision of a doctor.
APPLICATION FOR CHILDREN
The drug is prescribed for children over 12 years.
SPECIAL INSTRUCTIONS
The drug contains benzalkonium chloride as a preservative, which is able to penetrate into the material of soft contact lenses, therefore it is recommended to remove the lenses before instillation of the Zaditen preparation and to put on not earlier than 15 minutes after instillation.
Do not use Zaditen when wearing contact lenses, with irritation or inflammation of the eyes.
With the simultaneous administration of Zaditen with other eye drops, it is necessary to take a break between instillations for at least 5 minutes.
Impact on the ability to drive vehicles and manage mechanisms
During the period of Zaditen's treatment, it is necessary to refrain from potentially dangerous activities related to the need for increased attention and rapid psychomotor reactions.
OVERDOSE
Data on the overdose of Zaditen are absent.
DRUG INTERACTION
No interaction of Zaditen with other drugs was noted.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years. The drug should not be used after the expiration date.
After opening the bottle, eye drops should be used within one month.
