Ketotifen pills 1mg, 30pcs – Ozon

Composition

Composition for 1 tablet: Active ingredient: ketotifen fumarate-1.38 mg (corresponds to ketotifen-1.00 mg); Excipients: microcrystalline cellulose – 112.22 mg, calcium hydrophosphate-20.00 mg, corn starch-5.00 mg, magnesium stearate-1.40 mg

Pharmacological action

Anti – allergic agent-stabilizer of mast cell membranes ATX: S. 01. G. X. 08

Pharmacodynamics :

Stabilizer of mast cell membranes, has moderate H1-histamine blocking activity, inhibits the release of histamine, leukotrienes from basophils and neutrophils, reduces the accumulation of eosinophils in the respiratory tract and the reaction to histamine, suppresses early and late asthmatic reactions to allergen. Prevents the development of bronchospasm, does not have a bronchodilating effect. It inhibits phosphodiesterase, which increases the cAMP content in adipose tissue cells.

The therapeutic effect is fully manifested in 1.5-2 months from the start of therapy.

Pharmacokinetics:

Absorption is almost complete, bioavailability is about 50% (due to the presence of the “first pass” effect through the liver). The time to reach the maximum concentration (TMAX) is 2-4 hours, and the binding to plasma proteins is 75%. Passes through the blood-brain barrier. Penetrates into breast milk.

It is metabolized in the liver. It is excreted by the kidneys in the form of metabolites (the main metabolite-ketotifen N-glucuronide is pharmacologically inactive).

Within 48 hours, the main part of the dose is excreted by the kidneys (1% – unchanged and 60-70% – in the form of metabolites). Elimination – two-phase: the half-life of the first phase is 3-5 hours, the second-21 hours.

Pharmacokinetics in children older than 3 years does not differ from adults.

Indications

Atopic bronchial asthma, hay fever, allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria.

Contraindications

Hypersensitivity, pregnancy, lactation, children under 3 years of age.

With caution :

Epilepsy, liver failure.

Side effects

From the nervous system: drowsiness, dizziness, slowing of the reaction rate (disappear after a few days of therapy), sedation, fatigue; rarely-anxiety, sleep disorders, nervousness (especially in children).

From the digestive system: dry mouth, increased appetite, nausea, vomiting, gastralgia, constipation.

From the urinary system:  dysuria, cystitis.

Other: thrombocytopenia, weight gain, allergic skin reactions.

Interaction

Increases the effect of sleeping pills, antihistamines, and ethanol.

In combination with hypoglycemic drugs, the likelihood of developing thrombocytopenia increases.

How to take, course of use and dosage

Inside, with meals, adults – 1 mg 2 times a day in the morning and evening. If necessary, the dose is increased to 2 mg 2 times a day.

Children from 3 years and older – 1 mg 2 times a day.

Duration of treatment – at least 3 months.

Discontinuation of therapy is carried out gradually, over 2-4 weeks.

Overdose

Symptoms: drowsiness, confusion, disorientation, brady or tachycardia, low blood pressure, shortness of breath, cyanosis, convulsions, increased excitability, coma.

Treatment: gastric lavage (if a short time has passed since taking it), symptomatic treatment, with the development of convulsive syndrome – barbiturates or benzodiazepines. Dialysis is ineffective.

Description

Tablets are white in color, flat-cylindrical with a chamfer, odorless or slightly odorless.

Special instructions

It is not desirable to abruptly cancel the previous treatment with beta-adrenostimulants, glucocorticosteroids, ACTH in patients with bronchial asthma and bronchospastic syndrome after joining ketotifen therapy, cancellation is carried out for at least 2 weeks, gradually reducing the dose.

Treatment is stopped gradually, within 2-4 weeks (possible relapse of asthmatic symptoms).

People who are sensitive to sedation, in the first 2 weeks, the drug is prescribed in small doses.

It is not intended for relieving an attack of bronchial asthma.

In patients receiving concomitant oral hypoglycemic agents, the peripheral blood platelet count should be monitored.

Impact on the ability to drive a vehicle :

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets,1 mg.

Storage conditions

Store in a dry place protected from light, at a temperature not exceeding 25°C.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Ketotifen

Conditions of release from pharmacies

By prescription

Dosage form

Tablets