Ketotifen, syrup, 100ml

Composition

5 ml of syrup contains: Active ingredient: ketotifen hydrofumarate 1.38 mg (corresponds to 1 mg of ketotifen). auxiliary substances: sorbitol; methyl parahydroxybenzoate; propyl parahydroxybenzoate; citric acid monohydrate; sodium hydrophosphate dodecahydrate; ethanol 96%; sodium saccharinate; strawberry flavor (liquid essence “Strawberry”); purified water.

Pharmacological action

Ketotifen has a pronounced antihistamine, weakly antiserotonin effect, without an anticholinergic effect. In higher doses, it has a slightly depressing 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, as well as due to the blockade of histamine H1 receptors. Ketotifen inhibits the enzyme phosphodiesterase, which increases the level of cyclic adenosine monophosphate in mast cells.

The drug reduces or suppresses skin and bronchial reactions caused by the antigen, which causes its use for preventive purposes. When used as monotherapy, it 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-asthmatic drugs: corticosteroids, bronchodilators, etc.

The drug is characterized by good and fast resorption, without the risk of accumulation in the body. Bioavailability is approximately 50%, which is associated with metabolism during the” first pass ” through the liver. The time to reach the maximum plasma concentration is 2-4 hours, and the binding to plasma proteins is 75%. Elimination 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 a course of taking the drug.

Indications

• Atopic bronchial asthma, allergic rhinitis,
• allergic conjunctivitis, hay fever
• Ketotifen Sopharma effectively prevents attacks of bronchial asthma, other manifestations of allergic reactions of immediate type

Use during pregnancy and lactation

Although no effect on pregnancy and peri-and postnatal development was observed in animal studies when Ketotifen was administered in animal – tolerated doses, its safety in human pregnancy has not been established.

Therefore, during pregnancy, Ketotifen can only be prescribed in cases of extreme necessity.

It is believed that ketotifen is also excreted in women’s breast milk, so mothers taking Ketotifen should not breastfeed their children.

Contraindications

There are no absolute contraindications.

Do not take the drug during pregnancy, at the same time as taking oral antidiabetic drugs, which can lead to thrombocytopenia; with sedatives and alcohol.

Hypersensitivity to the components of the drug.

Side effects

In the first few days, you may experience drowsiness, dry mouth, mild dizziness, fatigue, and slow mental reactions, which usually disappear after a few days. It is recommended to use a lower dose (5 ml per day) during the first week. Less often, there is an increase in appetite and the associated increase in body weight.

Patients taking ketotifen should refrain from potentially dangerous attention-seeking activities (such as driving a car).

The drug can be used during lactation only if necessary, since it penetrates into breast milk.

Interaction

The use of ketotifen in patients who have systematically taken corticosteroids requires a gradual reduction in previous corticosteroid therapy, since there is a risk of developing adrenal insufficiency.

Combination with oral antidiabetic agents sometimes leads to the development of thrombocytopenia.

Concomitant use of Ketotifen and sedatives, sleeping pills, antihistamines, and alcohol may increase their effects.

How to take, course of use and dosage

Inside, while eating.

Adults — 5 ml of syrup 2 times a day (morning and evening). For patients who have a significant sedative effect, it is recommended to slowly increase the dose during the first week, starting with 0.5 mg (2.5 ml of syrup) in the evening before bedtime, until the therapeutic dose is gradually reached.

Children older than 3 years — 5 ml of syrup 2 times a day (morning and evening); from 6 months to 3 years — 2.5 ml of syrup (0.5 mg) 2 times a day, morning and evening.

Duration of treatment. Treatment is long-term, and the therapeutic effect is achieved after several weeks of therapy. Treatment should be carried out for at least 2-3 months, especially in patients who did not have an effect in the first weeks. Discontinue treatment with ketotifen gradually, over 2-4 weeks.

Overdose

When the dose is increased, there may be a slight tremor of the extremities, anxiety and tachycardia, which disappear after reducing the dose.

Special instructions

Patients taking ketotifen should refrain from potentially dangerous attention-seeking activities (such as driving a car). The drug can be used during lactation only if necessary, since it penetrates into breast milk.

Form of production

Syrup

Storage conditions

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

Shelf life

3 years

Active ingredient

Ketotifen

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral use

Description

Pregnant women in the second and third trimester as prescribed by a doctor, Children older than 6 months, Adults as prescribed by a doctor, Children as prescribed by a doctor

Indications

Allergic Conjunctivitis, Bronchial Asthma, Pollinosis, Urticaria, Allergic Rhinitis, Allergy, Dermatitis