2010/06/23

Zaditen

Composition, structure and packing

Eye drops 1 ml ketotifen gidrofumarat 345 mg, which corresponds to the content of ketotifen 250 mcg Other ingredients: glycerol, sodium hydroxide, 1N, water d /, and benzalkonium chloride (as preservative).

Clinico-pharmacological group: antiallergic drug for local use in ophthalmology.

Pharmacological action

Antiallergic drug. The mechanism of action is associated with stabilization of the membranes of mast cells and reduced release of their histamine, leukotrienes and other biologically active substances. Inhibits factor induced activation of platelets accumulation of eosinophils. Prevents allergic reactions of immediate type. Blocks histamine H1 receptors.

Pharmacokinetics

Absorption

The concentration of ketotifen in the blood after instillation in the conjunctival cavity for 14 days in 18 adults - less than 20 pg / ml (minimum detectable concentration).

Metabolism and excretion

The major metabolite ketotifen-N-glucuronide is virtually inactive. About 1% of the drug excreted unchanged in the kidneys within 48 h, 60-70% - in the form of metabolites (glucuronide).

Statement
prevention and treatment of allergic conjunctivitis.

Dosage regimen

Adults and children over 12 years: 1 drop 2 times / day in both eyes. Duration of treatment - no more than 6 weeks.

Side effect
On the part of the organ of vision: rare (less than 2%) - decrease of visual acuity, dry eyes, and in some cases - the feeling of rubber with instillation, feeling pain in his eyes, photophobia, subkonyunktivalnye hemorrhage, conjunctivitis.

Dermatological reactions: seldom - skin rash, and in some cases - eczema, allergic reactions.

Other: rarely - headache, fatigue, and in some cases - a dry mouth.

Contraindications
increased individual sensitivity to ketotifenu.

Pregnancy and lactation

No clinical data on the safety of Zaditen eye drops during pregnancy.

Use during lactation (breast feeding) is possible only under strict medical supervision.

Cautions

The product contains the preservative benzalkonium chloride, which is able to penetrate into the material of soft contact lenses, so it is recommended to remove lenses before instillation of the drug Zaditen and put on no earlier than 15 minutes after instillation. Do not use Zaditen wearing contact lenses, if irritation or inflammation of the eye. With simultaneous use of the drug with other Zaditen eye drops need to take a break between the instillation of not less than 5 minutes.

Effects on ability to drive vehicles and management mechanisms

During treatment with Zaditen should refrain from potentially dangerous activities associated with the necessity of increased attention and rapid psychomotor reactions.

Overdose

Data on drug overdose Zaditen absent.

Drug Interactions

There was no drug interaction Zaditen with other drugs.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2 years. The drug should not be used after the expiration date. After opening a bottle of eye drops should be used within a month.