Ketotifen tablets 1 mg, 30 pcs. (Ketotifen)

Release form

Tablets.

Packing

30 pcs.

Pharmacological action of

Ketotifen has a pronounced antihistamine, slightly antiserotonin effect, without anticholinergic effect. At higher doses, it has a slightly inhibitory effect on the central nervous system.

Pharmacodynamics

The mechanism of action of Ketotifen is associated with the ability to inhibit the release of histamine and other inflammatory mediators from mast cells due to membrane stabilization and also due to blockade of histamine H1 receptors.

Ketotifen inhibits the phosphodiesterase enzyme, resulting in increased levels of cyclic adenosine monophosphate in mast cells. The drug reduces or inhibits the reaction of the skin and bronchi caused by the antigen, which causes its use for prophylactic purposes.

When used as monotherapy does not stop asthma attacks, but leads to a decrease in the number, duration and intensity of these attacks, and in some cases they completely disappear. Reduces eosinophilia, reduces the need and frequency of use of anti-asthma drugs: corticosteroids, bronchodilators, etc.

Pharmacokinetics

The drug is characterized by good and rapid resorption, without the danger of cumulation in the body. Bioavailability is approximately 50%, which is associated with metabolism during the first passage through the liver. The time to reach maximum plasma concentration is 2-4 hours, and binding to plasma proteins is 75%.

Removal from the body proceeds in two phases, and within 48 hours, the main part of the single dose taken is excreted in the urine. The therapeutic effect develops after 2 weeks of the course of taking the drug.

Contraindications

Pregnancy, lactation (to stop breastfeeding), increased individual sensitivity to ketotifen, children - up to 3 years.

Special instructions

In the early days of treatment, motor coordination reactions may be slowed down. Patients should be warned about the need to refrain from activities requiring increased concentration of attention and good motor coordination, including driving vehicles.

Composition

1 tablet contains: active substance:

ketotifen hydrofumarate 1.38 mg (corresponding to 1 mg ketotifen)

Dosage and administration of

Ketotifen is taken orally. Assign to adults - twice a day (morning and evening), 1 tablet (1 mg) with meals. If necessary, the daily dose can be increased to 4 mg (divided into 2 doses).

For children over 3 years of age, ketotifen tablets are prescribed as follows: with a body weight of up to 25 kg - twice a day (morning and evening) 1/2 tablet more than 25 kg - twice a day, 1 tablet. With insufficient therapeutic effect after a 4-week treatment of children with body weight less than 25 kg, the dose can be increased to 1 tablet 2 times a day.

Side effects

In the first days of admission, drowsiness, dry mouth, slight dizziness, and tiredness, which usually pass spontaneously, are possible. In such cases, the dose to adults is reduced to 1 mg per day.

In rare cases, thrombocytopenia, weight gain, and allergic skin reactions are possible.

Drug Interactions

It is advisable to avoid the combined use of ketotifen with oral antidiabetic agents due to possible reversible thrombocytopenia. It is also possible to potentiate the effect of sedatives, narcotic drugs and alcohol, therefore, such combinations should be avoided.

Overdose

Overdose phenomena are observed when the concentration of ketotifen in blood plasma is 5–122 ng / ml (therapeutic concentration is 1–4 ng / ml). Symptoms: weakness, disorientation, confusion, dyspnea, tachycardia or bradycardia, convulsions, severe hypotension.

Treatment: symptomatic therapy. There is no specific antidote.

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

Dosage form

table tki

Indications

Allergic conjunctivitis, allergies, hay fever, asthma, hives, dermatitis, allergic rhinitis

Possible product names

KETOTIFEN 0.001 N30 TABLE / IRBITSK HFZ

Ketotifen 1 mg Tab. X30

Ketotifen 1mg No. 30

KETOTIFEN TAB. 1MG No. 30

Ketotifen tablets 1 mg 30 pcs.

Irbitskij HFZ, Russia



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