Ketotifen-OBL - instructions for use, dose, side effects, contraindications

Stabilizer of mast cell membranes,has moderate H1-histaminoblocking activity, inhibits the release of histamine, leukotrienes from basophils and neutrophils, reduces the accumulation of eosinophils in the respiratory tract and the response to histamine, suppresses early and late asthmatic reactions to the allergen. It prevents the development of bronchospasm, does not have bronchodilator effect. Inhibits phosphodiesterase, resulting in increased cAMP content in adipose tissue cells.

Therapeutic effect is fully manifested after 1,5-2 months from the beginning 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 (TFROM_mOh) - 2-4 h, the connection with plasma proteins - 75%. Passes through the blood-brain barrier. Penetrates into breast milk.

Metabolised 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 kidneys display the bulk of the dose (1% in unchanged form and 60-70% in the form of metabolites). The elimination is biphasic: the half-life of the first phase is 3-5 h, the second - 21h.

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

Indications:

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

Contraindications:

Hypersensitivity, pregnancy, lactation, children under 3 years.

Carefully:

Epilepsy, hepatic insufficiency.

Dosing and Administration:

Inside, with food, inadult - 1 mg 2 times a day in the morning and evening. If necessary, increase the dose 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.

The abolition of therapy is carried out gradually, within 2-4 weeks.

Side effects:

From the nervous system: drowsiness, dizziness, slow reaction (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.

Overdose:

Symptoms: drowsiness, confusion, disorientation, brady- or tachycardia, lowering of blood pressure, dyspnea, cyanosis, convulsions, increased excitability, coma.

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

Interaction:

Strengthens the effect of hypnotics, antihistamines, ethanol.

In combination with hypoglycemic drugs, the probability of thrombocytopenia increases.

Special instructions:

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

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

Persons sensitive to sedation, in the first 2 weeks, the drug is prescribed in small doses.

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

In patients concomitantly receiving oral hypoglycemic agents should monitor the number of platelets in the peripheral blood.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Tablets, 1 mg.

Packaging:

For 10 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N001378 / 01

Date of registration:19.11.2007

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp07.01.2018

Illustrated instructions

Instructions

Ketotifen-OBL (Ketotifen-OBL)