Ketotifen for children: reviews and instructions for use. Complete instructions for the use of ketotifen syrup for children

Allergies in children can manifest as skin rashes and problems with the respiratory system. In order to prevent the development of its complications (eczema, asthma, autoimmune diseases), it is important not to delay treatment. This helps Ketotifen, which is often prescribed by doctors. Before giving the drug to a child, parents should study the instructions and strictly follow the treatment plan.

Ketotifen: the composition of the drug and the principle of action

Ketotifen is a drug that can relieve allergic manifestations. It is effective for long-term therapeutic and prophylactic use, but is not able to relieve acute bronchospasm. The drug blocks histamine receptors, which leads to a decrease in the production of histamine (a substance that provokes allergic reactions). Additionally, the components of the drug inhibit bronchial hyperactivity and prevent spasms.

The drug is produced by a number of domestic companies, there is a Bulgarian remedy "Ketotifen Sopharma". The medicine is presented in two forms:

Syrup. Viscous liquid with strawberry or vanilla aroma. Packaged in bottles of 50 and 100 ml.
Pills. Small round tablets packed in blisters of 10 pieces. One pack can contain up to 6 blisters.

The active substance of the drug is ketotifen fumarate (hydrofumarate). In terms of ketotifen, its volume in one serving of syrup or tablet is 1 mg. Auxiliary components of the drug (in the form of tablets) are potato starch, calcium phosphate, magnesium stearate. The syrup formula varies slightly depending on which pharmaceutical company makes it. Usually it contains citric acid, sodium saccharinate, flavors.

When taken, the drug is completely absorbed, the maximum concentration in the body is observed after 3 hours. It is excreted in the urine within two days. The kidneys are responsible for excretion by 60% and the liver by 30%.

The shelf life of Ketotifen is up to 3 years. The temperature of 5-15 degrees is suitable for storing syrup, the tablets are kept in a dry place at a temperature of 5-25 degrees.

Syrup "Ketotifen" refers to the antihistamine group of drugs for symptomatic use. Pharmacological features - blocking of histamine receptors, inhibition of bronchial hyperactivity and complete suppression of foci of inflammation of the respiratory tract. It does not have a bronchodilator effect. The therapeutic effect develops very slowly - the result is visible after the first month of use.

Instructions for use syrup "Ketotifen" contains instructions for use, dosage, duration of treatment and indications and contraindications.

Indications for the use of syrup "Ketotifen"

Preventive treatment of bronchial asthma, allergic rhinitis and conjunctivitis, hay fever, allergic dermatitis, urticaria and hay fever.
The syrup "Ketotifen" produced by the Borshchagovsky Pharmaceutical Plant is absolutely similar to the Swiss drug "Zaditen", which indicates the effectiveness of treatment with this drug.
The course of treatment of bronchial asthma is quite long - up to two months, so it is not recommended to suddenly stop taking the medicine.
It is necessary to reduce the dose of the drug taken within 4 weeks, while a recurrence of asthma symptoms may occur.
For preventive purposes, it is enough to take the remedy for 20 days.
As a result of clinical studies of the syrup, the effectiveness of the treatment of allergic diseases, the improvement of clinical indicators and the well-being of patients, as well as a decrease in the frequency of recurrence of diseases, were revealed.

Forms of release of the drug and dosage

The drug is available in the form of tablets and syrup in vials of 100 ml and 50 ml. The composition of the syrup includes:

Ketotifen hydrofumarate,
lemon acid,
sodium saccharin,
glycerol
banana flavor.

Physical features - a colorless thick liquid with a specific taste. Syrup "Ketotifen" is indicated for oral use in children and adults.

Attention! A doctor's consultation is required!

Dose for adults - 5 ml after breakfast and dinner. If necessary, a single dose is doubled to 10 ml, which corresponds to 20 ml per day.

Children - from 6 months to 3 years - should consume 0.25 ml in the morning and evening for each kilogram of body weight. Example: for a child weighing 10 kg, a single dose is 2.5 mg or ½ teaspoon.

For children aged 3 years and older, the dose is increased to 5 ml (1 tablespoon) twice - in the morning and in the evening.

For greater effectiveness of the drug during treatment, an increase in the dose is allowed. For young children under the age of 6 months, the drug is contraindicated. For the elderly, the dosage of the drug is similar to the dosage for adults.

In the case of the use of Ketotifen syrup by patients with bronchial asthma, remember that this medicine is not intended to eliminate an immediate asthma attack.

Contraindications for use

While taking the drug with diabetic drugs, the level of platelets in the blood should be monitored.
At the beginning of treatment, there is no need to cancel anti-asthma drugs due to the possible development of renal failure.
Patients with liver problems and epileptics should be extremely careful.
Prolonged use of syrup can cause the development of caries.
Avoid drinking alcohol while taking this drug.
if it is not possible to cancel treatment with the drug, it must be used with great care.
the baby should be weaned.
At the beginning of the course of treatment, the drug "Ketotifen" reduces the speed of reaction and may be the cause of the driver's inattention while driving.
Syrup "Ketotifen" is contraindicated for those who have a complete intolerance to the drug, as well as for patients with advanced forms of infectious diseases.

Interaction with other medicines and unwanted effects

The drug "Ketotifen" enhances the effect on the body of sleeping pills, sedatives, antihistamines and alcohol.

Interaction with atropine-like drugs can lead to increased dry mouth, urinary retention and constipation.

Side effects are mild, occur in the first days of taking the drug and disappear in a short time. Symptoms may include vomiting, nausea, increased drowsiness, nervous agitation, insomnia, weight gain, hunger, cystitis, and hepatitis.

Pharmacological kinetics

When taken orally, Ketotifen is absorbed almost completely. The main component of Ketotifen, y-glucuronide, is almost non-toxic to the body. Peak plasma concentration will be reached after 3 hours. It is excreted from the body in a two-phase way. The first - after 5 hours, the second after 21 hours. 60% is excreted by the kidneys, 30% - by the liver and 10% - unchanged. Completely excreted within two days with urine.

Terms and conditions of storage of syrup "Ketotifen"

The shelf life is indicated on the packaging and is 3 years. At the end of the expiration date, the medicinal product must be destroyed.

Conditions - in a dry, dark place at a temperature of 5 ° C to 15 ° C.

Remember! All medications must be kept out of the reach of children!

active substance: ketotifen hydrofumarate;

5 ml syrup contains 1 mg ketotifen hydrofumarate (calculated as ketotifen and 100% dry matter)

Excipients: sodium benzoate (E 211), liquid maltitol, sodium saccharin, sodium phosphate dodecahydrate, citric acid monohydrate, fumaric acid, glycerin, hydroxyethyl cellulose, banana flavor, purified water.

Dosage form

Basic physical and chemical properties: colorless or slightly yellowish transparent viscous liquid with a specific smell.

Pharmacological group

Antihistamines for systemic use.

ATX code

Pharmacological properties

Pharmacological. Ketotifen has a membrane-stabilizing, anti-allergic, antihistamine effect. The mechanism of action of ketotifen is due to inhibition of the release of biologically active substances of mast cells and basophils (histamine, leukotrienes), inhibition of eosinophil sensitization by cytokines, blocking their migration to inflammation foci. The drug inhibits the development of airway hyperreactivity due to platelet activation under the influence of platelet activating factor (PAF) or allergens. The drug inhibits phosphodiesterase, increases the level of cAMP in cells. Ketotifen causes non-competitive blockade of H 1 -histamine receptors. Effectively prevents bronchospasm, reduces the need for the use of corticosteroids, bronchodilators. It has no bronchodilator effect. The therapeutic effect of the drug develops slowly, within 1-2 months.

Pharmacokinetics. when taken orally, ketotifen is absorbed almost completely. The main metabolite of ketotifen, N-glucuronide, is practically non-toxic. The maximum plasma concentration is reached after 2-4 hours. Protein binding is about 75%. The withdrawal of ketotifen from the body has a two-phase character: the first half-life is 3-5 hours, the second - 21 hours. 60-70% of the drug is excreted by the kidneys and 20-30% - by the liver in the form of metabolites, 10% is excreted unchanged. Within 48 hours, the main part of the accepted single dose of the drug is excreted in the urine.

Indications

Preventive treatment of bronchial asthma, especially atopic.

Symptomatic treatment of allergic conditions, including allergic rhinitis and conjunctivitis.

Contraindications

Hypersensitivity to ketotifen or other components of the drug.
The simultaneous use of ketotifen and oral antidiabetic agents (risk of reversible thrombocytopenia) should be avoided until this phenomenon has been sufficiently studied.

Interaction with other medicinal products and other forms of interaction

Atropine (atropine-like agents): increases the risk of adverse reactions such as urinary retention, constipation, dry mouth.

Sedatives, sleeping pills: Ketotifen may enhance the effects of other drugs that depress the central nervous system.

Antihistamines: can lead to mutual potentiation of their effects.

Ethanol: enhances the depressive effect of ketotifen on the central nervous system.

Oral antidiabetic agents: may cause reverse thrombocytopenia.

The use of ketotifen may reduce the need for beta-agonists, corticosteroids And Methylxanthine .

Application features

The drug is not intended for the urgent treatment of an attack of bronchial asthma!

When using the drug Ketotifen, the need for corticosteroids and bronchodilators in patients with bronchial asthma may decrease.

At the beginning of treatment with Ketotifen, anti-asthma drugs, especially systemic glucocorticosteroids, should not be abruptly discontinued due to the possible development of adrenal insufficiency. In these cases, the period of return of the normal reaction of the hypothalamic-pituitary-adrenal glands to stress can last up to 1 year.

Caution should be exercised when using ketotifen in patients with impaired liver function.

To prevent a sedative effect, the drug can be started in the first days with a half dose.

People with impaired carbohydrate tolerance (for example, glucose-galactose malabsorption), patients with diabetes should be aware that the drug contains carbohydrates (syrup contains 0.06 g of carbohydrates per 1 ml). The syrup contains maltitol (hydrated glucose syrup) in a liquid state. Patients with rare hereditary fructose intolerance should not take this medicine.

Frequent and prolonged use of the syrup can be harmful to the teeth (development of caries).

When taken simultaneously with hypoglycemic drugs, it is necessary to control the level of platelets in the peripheral blood (transient thrombocytopenia is possible).

Ketotifen should be used with caution in persons with a tendency to convulsions (for example, with a history of epilepsy), since the drug may lower the seizure threshold.

Experience with ketotifen suggests that no special recommendations are required for the elderly.

Clinical observations are consistent with the pharmacokinetic features and indicate that a higher dose of the drug per kilogram of body weight may be required to obtain an optimal result in children than in adults. Such high doses are as well tolerated by children as the minimum doses.

During treatment with ketotifen, alcohol should be avoided!

Use during pregnancy or lactation.

The use of the drug is possible during pregnancy only in cases where the expected benefit outweighs the potential risk to the fetus.

Ketotifen passes into breast milk, so breastfeeding should be stopped while taking the drug.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

At the beginning of treatment, the drug Ketotifen can slow down the rate of reactions, requires the patient to be extra careful when driving vehicles and working with mechanisms.

Dosage and administration

Children from 6 months to 3 years prescribe syrup in a single dose of 0.25 ml (0.05 mg of ketotifen) per 1 kg of body weight, the frequency of administration is 2 times a day (morning and evening). Measure the required dose with a dosing spoon.

For example, a child weighing 10 kg can use 2.5 ml (according to the label of the dosing spoon) 2 times a day (with morning and evening meals).

Children over 3 years old prescribe 5 ml / 1 mg of ketotifen (1 dosing spoon) syrup 2 times a day (morning and evening during meals).

The therapeutic effect of the drug develops gradually, after 2-4 weeks from the start of treatment, so the course of treatment should be long (from 2-3 months). Stop treatment should be gradual, within 2-4 weeks, and during this period there may be a relapse of asthma symptoms.

Children.

The drug should be used in children over 6 months of age.

Overdose

Symptoms. It can be manifested by severe sedation (including severe drowsiness), languor, confusion, disorientation, nystagmus, headache, tachycardia, bradycardia, arrhythmia, depression of the respiratory center, arterial hypotension, coma; possible symptoms of stimulation of the central nervous system (especially in children): irritability, convulsions.

Compound

each tablet contains: active substance- ketotifen (as ketotifen fumarate) - 1 mg; Excipients - microcrystalline cellulose, croscarmellose sodium, magnesium stearate, anhydrous colloidal silicon dioxide, lactose monohydrate.

Description

Tablets are white or almost white, biconvex.

pharmachologic effect

Pharmacological action - membrane-stabilizing, anti-allergic, antihistamine, anti-asthma. It inhibits the release of histamine and other mediators (such as the slow reacting substance of anaphylaxis, lymphokines) from mast cells and basophils. It non-competitively blocks H 1 -histamine receptors, inhibits phosphodiesterase, increases the level of cyclic adenosine monophosphate in cells, blocks calcium channels of cells, and is a functional leukotriene antagonist. Suppresses the sensitization of eosinophils by cytokines, prevents eosinophilic infiltration in places of allergic inflammation in the respiratory tract. Prevents the development of symptoms of airway hyperreactivity due to platelet activating factor or exposure to allergens. Prevents the development of bronchospasm (does not have a bronchodilatory effect). It has a depressing effect on the central nervous system.

Pharmacokinetics

Absorption is almost complete, bioavailability is about 50% (due to the presence of the “first pass” effect through the liver). Simultaneous food intake does not affect the degree of absorption (bioavailability) of ketotifen. The time to reach maximum plasma concentration is 2-4 hours, the connection with plasma proteins is 75%. Passes through the blood-brain barrier. Penetrates into breast milk. Metabolized in the liver. It is excreted by the kidneys in the form of metabolites (the main metabolite is ketotifen N-glucuronide, which is pharmacologically inactive). Within 48 hours, the main part of the dose taken is excreted by the kidneys (1% - unchanged and 60-70% - in the form of metabolites). Elimination is biphasic: the half-life of the first phase is 3-5 hours, the second is 21 hours.

Peculiarities of pharmacokinetics in children. The metabolism of ketotifen in children is the same as in adults, but the clearance is higher in children. Therefore, for children older than 3 years, the same daily dose is required as for adults.

Features of pharmacokinetics in patients with impaired liver function. Special studies of the pharmacokinetics of ketotifen in this group of individuals have not been conducted. Since ketotifen is metabolized in the liver by glucuronidation, people with severely impaired liver function may slow down metabolism and increase the concentration of ketotifen in the blood.

Features of pharmacokinetics in patients with impaired renal function. Special studies of the pharmacokinetics of ketotifen in this group of individuals have not been conducted. Given that 60-70% of the drug is excreted in the urine as metabolites, severe renal dysfunction may be accompanied by an increase in the concentration of metabolites in the blood and an increase in the risk of developing their undesirable effects.

Indications for use

Prevention and treatment of multisystem allergic diseases:

Chronic idiopathic urticaria (eg, cold urticaria);

Allergic rhinitis with or without concomitant bronchial asthma;

allergic conjunctivitis;

Atopic dermatitis.

The use of Ketotifen does not replace treatment with corticosteroids (inhaled or systemic) if corticosteroids are indicated for the treatment of bronchial asthma.

Contraindications

Hypersensitivity to any of the components of the drug, pregnancy, lactation (if necessary, the use of the drug should stop breastfeeding), children under 3 years of age, history of epilepsy and convulsions.

Carefully: liver failure.

Pregnancy and lactation

Although there is no evidence of a teratogenic effect, taking ketotifen during pregnancy is not recommended. Ketotifen is excreted in breast milk, so mothers receiving ketotifen should not breastfeed their baby.

Dosage and administration

The drug is taken orally during meals.

Adults appoint 1 mg (1 tablet) twice a day (morning and evening).

In patients prone to sedation, a slow increase in dose during the first week is recommended. It is recommended to start taking 1 tablet once a day in the evening and increase the dose over 5 days to the full daily dose. If necessary, the daily dose can be increased to 4 mg (4 tablets) and divided into two doses. When using higher doses, a faster onset of effect can be expected.

Children over 3 years of age appoint 1 mg (1 tablet) twice a day (morning and evening). Given that the study of pharmacokinetics has established a high rate of metabolism of ketotifen, children may need to prescribe higher doses of the drug in terms of kilograms of body weight to achieve the optimal effect. At the same time, the tolerance of such doses remains good.

Simultaneous use of bronchodilators. When taking ketotifen, the frequency of taking bronchodilators may be reduced.

Use in the elderly. When prescribing ketotifen to the elderly, dose adjustment is not required.

Duration of therapy

It takes several weeks to achieve the full therapeutic effect of ketotifen. If within a few weeks the patient does not have a reaction to taking ketotifen, its further use to achieve a lasting effect should continue for at least 2-3 months. Cancellation of ketotifen should be carried out gradually over 2-4 weeks, while exacerbation of the symptoms of an allergic disease is possible.

Side effect

The incidence of side effects is given in the following gradation: very often (> 1/10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000); неизвестно (по имеющимся данным определить частоту встречаемости не представляется возможным).

From the side of the central nervous system: infrequently - dizziness, slow reaction rate (disappear after a few days of therapy), sedation, feeling of fatigue; rarely - anxiety, sleep disturbances, nervousness (especially in children); unknown - convulsions, drowsiness, headache.

From the immune system: very rarely - erythema multiforme, Stevens-Johnson syndrome, severe skin reactions.

From the side of the skin: unknown - rash, urticaria.

From the hematopoietic system: very rarely - thrombocytopenia.

From the digestive system: infrequently - increased appetite, dryness of the oral mucosa; rarely - dyspeptic phenomena; unknown - nausea, vomiting, constipation, diarrhea.

From the side of the liver: very rarely - hepatitis, increased levels of liver enzymes.

From the side of metabolism: rarely - weight gain.

From the urinary system: infrequently - dysuria, cystitis.

Overdose

Symptoms: drowsiness, nystagmus, confusion, disorientation, bradycardia or tachycardia, lowering blood pressure, shortness of breath, cyanosis, convulsions, irritability (especially in children), coma may develop.
Treatment: induction of vomiting, gastric lavage (if a little time has passed since ingestion), the appointment of activated charcoal, saline laxatives; symptomatic treatment, with the development of a convulsive syndrome - short-acting barbiturates and benzodiazepines. Dialysis is ineffective.

Interaction with other drugs

Enhances the effect of sedatives, hypnotics, antihistamines, ethanol.
When taking ketotifen and oral hypoglycemic drugs together, it is necessary to control the platelet count due to an increased likelihood of developing thrombocytopenia.

Precautionary measures

It is undesirable to abruptly cancel the previous treatment with beta-agonists, glucocorticosteroids, adrenocorticotropic hormone preparations 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.

The active substance is ketotifen as ketotifen fumarate .

Ketotifen tablets contain 1 mg of active ingredient. Additional substances: lactose monohydrate, starch, magnesium stearate.

The syrup contains 1 mg/5 ml of the active ingredient.

The eye drops contain 0.25 mg / ml of the active substance. Additional substances: sodium hydroxide, chloride benzalkonium , trilon B, , chloride sodium, purified water, citric acid.

Release form

The drug is available in the form of syrup, tablets and eye drops.

pharmachologic effect

The drug has a pronounced antihistamine effect . This is a tool from the group anti-asthma non-bronchodilator drugs.

Pharmacodynamics and pharmacokinetics

The drug acts as follows: it slows down the release of histamine, as well as other mediators from mast cells, it also blocks histamine H1 receptors while inhibiting the PDE enzyme. As a result of these actions, mast cells increase the level cAMP. Ketotifen acts suppressively on the effects of platelet-activating factor. If the drug is used alone, then the attacks bronchial asthma are not bought. At the same time, the drug prevents their occurrence and significantly reduces the intensity and duration of these attacks. In some cases, they stop completely. In plasma, the maximum concentration of the drug is observed after 2-4 hours. Most of the dose is metabolized in the liver.

Indications for the use of Ketotifen

What are these pills from, and what are the syrup and eye drops for?

The drug is used as an additional agent in the process of long-term atopic therapy. Also an indication for the use of Ketotifen are a number of allergic conditions, including conjunctivitis and.

Contraindications

Do not use the drug in patients who are highly sensitive to the active or auxiliary components of Ketotifen. It is forbidden to take the drug in the first trimester of pregnancy, as well as during breastfeeding.

Side effects

During the period of treatment with this drug, some side effects may develop. Quite often there is a state of drowsiness, dry mouth, increased drowsiness, dizziness. There may be problems with the gastrointestinal tract - nausea, vomiting. These phenomena disappear spontaneously during treatment. Also, in view of the increased appetite, weight may increase. Less commonly, symptoms of irritability and arousal, hypersensitivity. Children may have seizures. Quite rarely, it can occur jaundice , dark color of urine. Overdose may cause drowsiness, hypotension , dizziness, vomiting and nausea, convulsions in children. In this situation, urgent gastric lavage and symptomatic treatment are necessary.

Instructions for use Ketotifen (Method and dosage)

Ketotifen tablets, instructions for use

Consume during meals, drink a small amount of water. One tablet contains 1 mg of the drug. Adults take one tablet twice a day. Those patients who have a pronounced sedative effect should gradually increase the dose of the drug. This is done for seven days, you need to start with 0.5 mg. This dose is taken at bedtime, and gradually the amount of the drug rises to a therapeutic dose. Children over three years old take 1 tablet twice a day - in the morning and in the evening. The drug is taken in the same way during meals.

Ketotifen Sopharma is used similarly.

Syrup Ketotifen, instructions for use

Children from one to three years old can take Ketotifen exclusively in the form of a syrup, which is prescribed at a dose of 0.25 ml per kg of the child's weight twice a day. Children from 3 years old should take 5 ml of syrup twice a day with meals.

Instructions for eye drops

Starting from 3 years old, one drop can be instilled twice a day into the conjunctival sac.

Treatment with Ketotifen takes a long period. In this case, a noticeable effect after taking it will be achieved after 2-3 weeks of therapy. The general course of treatment can be two to three months. A particularly long period should take this drug for those patients who have not observed a visible effect after a few weeks of taking the medication. Treatment with this remedy is stopped gradually, over several weeks. This is done to avoid recurrence of asthmatic symptoms .

Overdose

There are no data on overdose. After taking 20 mg of the drug, no serious symptoms were noticed.

Interaction

It can significantly enhance the effect of sleeping pills, as well as antihistamines and ethyl alcohol.

Terms of sale

Requires a prescription.

Storage conditions

In a dry, dark place inaccessible to children at a temperature not exceeding 25 degrees Celsius.

Best before date

Not more than 3 years.

special instructions

The drug is not used for stop asthma attacks. When starting therapy with this remedy, treatment with other anti-asthma drugs should not be abruptly stopped. Especially it concerns systemic GCS. People who are steroid dependent may develop adrenal insufficiency.

This drug has the ability to lower the seizure threshold, therefore, it is carefully prescribed to those patients who develop convulsions. During pregnancy, this drug is prescribed only when there are direct indications, and the benefits of taking it outweigh the risk to the woman and the fetus. When taking the drug, you need to stop breastfeeding. In view of the possible manifestation of drowsiness, ketotifen is recommended to be used very carefully by drivers and people working with potentially dangerous units.

According to the Sportviki website, the drug increases the sensitivity of beta-2 adrenergic receptors, as a result of which it is often used in bodybuilding and for weight loss. We advise you to consult your doctor about the possibility of such use of the medication.

For children

Instruction

At the age of one to three, the drug is prescribed in the form of a syrup at a dose of 0.25 ml per kg of the child's weight twice a day. Children over 3 years of age are prescribed to take 5 ml of syrup or 1 tablet in the morning and evening.

Reviews about Ketotifen for children

The drug is effective when used in children. The medication relieves allergy attacks, but long-term use is required. Side effects, such as drowsiness, are also possible.

Alcohol compatibility

During the period of drug therapy, you should not drink alcoholic beverages due to the fact that alcohol significantly increases the depressive effect on the central nervous system.

Ketotifen's analogs

Coincidence in the ATX code of the 4th level:

An analogue can be called a medicine.

Reviews about Ketotifen

The drug is considered an inexpensive effective remedy for allergic reactions. Of the minuses, it should be noted the duration of the course and side effects, especially increased drowsiness after using the medication.