Zaditen - description of the drug, instructions for use, reviews. Medicinal reference book geotar Zaditen syrup instructions for use

Depending on the form of release, the amount of active substance and additional ingredients may differ:

Drops Zaditen contains 0.345 mg in each milliliter ketotifen , which corresponds to 0.250 mg of the active substance. As excipients, drops contain glycerol, a molar solution of hydroxide, and water for injection.
Syrup Zaditen 5 ml contains 1 mg of the active substance (contained in the form hydrofumarate ). Additional ingredients: ; propyl parahydroxybenzoate and methyl parahydroxybenzoate (sodium salts), banana flavor, citric acid, sodium hydrogen phosphate, hydrogenated glucose syrup, demineralized water.
Tablets Zaditen contains 1 mg ketotifen present in the form fumarate , as well as excipients: lactose monohydrate, corn starch, magnesium stearate.

Release form

The drug is available in three forms:

Eye drops . It is a clear yellowish solution with no odor. Drops are sold in 5 ml polyethylene bottles with droppers. Each bottle is placed in a separate cardboard box.
Syrup . Characteristic banana smell. The syrup is poured into bottles of 100 ml.
Tablets . The color of the tablets is white, with a yellowish or grayish tint. The shape is round, flat. The edges are bevelled and one side is notched. Tablets are placed in blisters, 3 packs are placed in boxes.

pharmachologic effect

Antiallergic drug with antihistamine action. Depending on the form of release, the application can be local or systemic.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The effect of the drug is associated with several facets of the action of ketotifen:

contributes to the stabilization of membranes in mast cells;
inhibits phosphodiesterase;
reduces the release of histamine and leukotrienes and other inflammatory mediators;
interferes with the accumulation of eosinophils;
blocks receptors sensitive to histamine.

Pharmacokinetics

When Zaditen is taken orally, it is completely absorbed. Bioavailability is approximately 50%. The maximum plasma concentration is reached after 2-4 hours. The drug binds to plasma proteins by 75%. happens in the liver. It is excreted from the body in the urine in two phases.

When applied topically (eye drops), in most cases the concentration of the drug is very low to be measurable.

Indications for use

Zaditen drops are prescribed for for the purpose of treatment and prevention.

Indications for the use of syrup and tablets:

(for the prevention of seizures);
prevention ;
prevention and treatment of polysystemic diseases caused by ( , , conjunctivitis , ).

The drug does not help stop the attack asthma .

Contraindications

Contraindication to the use of Zaditen is excessive sensitivity to the active substance or other ingredients of the preparations.

It is forbidden to prescribe the drug in the form of tablets to children under 3 years of age, drops are not used until 12 years of age.

Side effects

Possible undesirable effects in the treatment of drops:

burning in the eyes;
feeling of pain when instilled;
punctate epithelial ;
decreased visual clarity after instillation of drops;
dry eyes;
eyelid damage;
conjunctivitis ;
soreness in the eyeballs;
increased photosensitivity;
small subconjunctival hemorrhages;
dry mouth ;
high fatigue ;
skin rashes;
allergic reactions.

Side effects of syrup and Zaditen tablets:

sedative effect at the beginning of treatment;
dryness in the mouth;
insignificant ;
in children, irritation of the central nervous system is possible, which is manifested by agitation, irritability, ;
weight gain.

Zaditen, instructions for use (Method and dosage)

Drops are prescribed for adults and children after 3 years. They need to be instilled 1 drop 2 times a day into the lower conjunctival sac. It is important to ensure that the tip of the dispenser does not touch the eye or other parts of the face, which could contaminate the solution.

Instructions for using the syrup:

age from 6 months to 3 years - 0.25 ml / kg twice a day;
from 3 years - 5 ml twice a day.

Application of tablets:

adults take a tablet in the morning and evening; it is possible to increase the dose by 2 times;
children from 3 years old are given a tablet in the morning and in the evening.

Tablets and syrup are taken with meals. It is necessary to stop taking these pharmacological forms gradually over several weeks.

Overdose

Data on cases of overdose of drops have been reported.

Symptoms of an overdose of tablets or syrup:

depression of consciousness drowsiness to full ;
increased heart rate;
sharp decline;

It is necessary to wash the stomach (if a little time has passed after taking the medicine), give it. The treatment is mainly symptomatic. At mean barbiturates or benzodiazepines.

Interaction

With the simultaneous use of Zaditen and bronchodilators, it is necessary to reduce the dosage of bronchodilators.

Zaditen may enhance the effect of antihistamines, alcohol and substances that have a suppressive effect on the central nervous system.

Zaditen - a drug to combat the manifestations of allergies.

Release form and composition of Zaditen

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

The main active ingredient of Zaditen is ketotifen.

Auxiliary substances are:

In Zaditen eye drops - glycerol, sodium hydroxide solution, benzalkonium chloride, water for injection;
In Zaditen tablets - lactose monohydrate, magnesium stearate, corn starch;
Zaditen syrup contains fumaric acid, citric acid, banana flavor, propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium hydrogen phosphate, hydrogenated glucose syrup, demineralized water.

Pharmacological action of Zaditen

Ketotifen, which is the main active ingredient of the drug, suppresses the action of inflammatory mediators. It also inhibits the release of histamine and leukotrienes, the entry of eosinophils into areas of inflammation, and the development of airway hyperreactivity.

Zaditen is a potent drug that blocks histamine H 1 receptors and thereby helps relieve allergy symptoms.

Zaditen prevents the manifestation of immediate allergic reactions.

Indications for use Zaditena

According to the instructions, Zaditen is used for:

Bronchial asthma to prevent its attacks;
Hay fever with asthmatic symptoms;
Allergic bronchitis, rhinitis, conjunctivitis;
Acute and chronic urticaria;
Atopic dermatitis.

Contraindications

According to the instructions, Zaditen is not used if patients have hypersensitivity to the components included in the drug.

Method of application and dosage of Zaditen

Zaditen tablets are intended for oral administration. They are taken 2 times a day, 1 mg with breakfast and dinner.

If the patient has a tendency to develop a sedative effect, then in this case it is recommended to start taking the drug with 0.5 mg 2 times a day with a gradual increase in dosage over 7 days.

The daily dose of Zaditen may be increased to 4 mg.

Cancellation of Zaditen tablets should be carried out gradually over 14-28 days.

The tablet form of the drug is not used until the age of 3 years.

Children from 6 months to 3 years of age are prescribed Zaditen in the form of a syrup at a dosage of 0.25 ml per kilogram of body weight 2 times a day in the morning and evening. Children over the age of 3 years syrup is prescribed 5 ml 2 times a day with breakfast and dinner.

Zaditen drops are indicated for use by adults and children over the age of 12 years 2 times a day, 1 drop in each eye. The maximum duration of use is 6 weeks.

Side effects of Zaditen

The drug can cause adverse reactions in the form of: dry mouth, sedation, dizziness, irritability, irritability, skin reactions, weight gain, insomnia.

The use of Zaditen drops can cause: dry eyes, decreased visual acuity, pain and pain in the eyes when instilled, photophobia, conjunctivitis, subconjunctival hemorrhages.

Overdose

An overdose of the drug is manifested by: drowsiness, disorientation and clouding of consciousness, arterial hypotension and tachycardia, increased excitability, convulsions, reversible coma.

For the treatment of overdose, gastric lavage and activated charcoal are used, as well as symptomatic therapy with monitoring of cardiovascular parameters. For agitation and convulsions, benzodiazepines or short-acting barbiturates are prescribed.

Interaction with other drugs

The drug may enhance the effects of drugs that suppress the central nervous system, alcohol and antihistamines.

special instructions

Before instillation of Zaditen drops, it is necessary to remove contact lenses and do not wear them for at least 15 minutes after the procedure, since the drug contains benzalkonium chloride, which has the ability to penetrate into the material of soft lenses.

If Zaditen drops are prescribed simultaneously with other eye drops, then the interval between instillations should be at least 5 minutes.

Starting therapy with Zaditen, it is not necessary to cancel symptomatic and prophylactic anti-asthma drugs.

In patients taking antidiabetic drugs, it is necessary to control the level of platelets in the blood.

The drug is carefully prescribed to patients with epilepsy, since Zaditen may lower the seizure threshold.

Storage conditions for Zaditen

This product is stored at a temperature not exceeding 25 ºС.

Eye drops after opening the bottle can be stored for a month.

Zaditen is an antiallergic and antihistamine drug of systemic action. Zaditen contains ketotifen, a substance that inhibits the activity of endogenous substances involved in the mechanism of the development of an inflammatory reaction. Ketotifen also blocks H1-histamine receptors.

Ketotifen does not have a direct bronchodilating effect.

Studies have identified a number of effects of ketotifen that allow it to be used as an anti-asthma drug (excluding acute asthma attacks):

inhibition of the release of histamine, leukotrienes and prostaglandins;
decrease in the primary effect of the antigen on eosinophils (decrease in the flow of eosinophils into the focus of inflammation);
decrease in airway hyperreactivity due to platelet activation under the influence of PAF or neurogenic activation due to the intake of sympathomimetics and contact with allergens;

Zaditen is an anti-allergic drug with a pronounced effect, which can be used to prevent the development and reduce the severity of allergic-type reactions that have already developed. Zaditen is not used to relieve acute conditions (in particular, bronchospasm).

Pharmacokinetics

After oral administration, the bioavailability of ketotifen reaches 50% (due to the first passage through the liver), absorption in the gastrointestinal tract is almost complete.

Peak serum levels of ketotifen following oral administration are reached in 2 to 4 hours. Up to 75% of ketotifen is bound to serum proteins.

In the body, ketotifen is converted to N-glucuronide, which has no pharmacological activity. In children, the metabolism of ketotifen is similar to adults, but the overall clearance is slightly higher (children are often prescribed the same dosages of Zaditen as adult patients).

Ketotifen is excreted in 2 stages: the half-life for the first stage is 3-5 hours, for the second - 21 hours.

Within 48 hours, most of the accepted dosage is excreted: up to 70% in the form of a metabolite, about 1% unchanged.

Food does not affect the bioavailability of ketotifen.

Indications for use

Zaditen is used in the treatment and prevention of allergic diseases, including chronic and acute urticaria, atopic dermatitis, allergic conjunctivitis and rhinitis.

Zaditen can be used in prophylactic treatment of bronchial asthma, including in cases of bronchial asthma associated with manifestations of atopy. Zaditen is not used to relieve acute attacks of bronchial asthma.

Mode of application

Tablets Zaditen

Zaditen tablets are taken orally with food. It is often suggested to take 1 Zaditen tablet twice a day. If a patient develops a sedative result while taking Zaditen tablets, the dose should be gradually increased to the recommended therapeutic dose, and therapy should be started with 1/2 Zaditen tablet twice a day.

Given the patient's condition and the effectiveness of therapy, the dose of ketotifen can be increased to 4 mg per day (2 Zaditen tablets twice a day). When using high doses, the therapeutic result comes faster.

When prescribing the drug Zaditen to patients with bronchial asthma, it is possible to reduce the number of bronchodilators taken (dosage adjustment should be carried out exclusively by a specialist). The withdrawal of Zaditen should be carried out gradually (withdrawal time 2-4 weeks): it should be borne in mind that during the period of withdrawal of ketotifen in patients with bronchial asthma, relapses are possible.

For children from 3 years of age, ketotifen is prescribed in adult doses (1 tablet of Zaditen twice a day). It should be borne in mind that, based on 1 kg of weight, children require higher dosages than adult patients. There is no deterioration in tolerability when prescribing high doses of ketotifen (in the therapeutic dose corridor).

Children under 3 years of age should be prescribed Zaditen in the form of a syrup.

Elderly patients do not need to adjust the dose of ketotifen.

Syrup Zaditen

The syrup is taken orally with food. Dosing of the syrup should be carried out using a measuring device attached to the syrup. The syrup is taken undiluted.

Children from 6 months to 3 years of age are offered ketotifen 0.05 mg (0.25 ml syrup)/kg body weight twice a day. In particular, a child weighing 10 kg should be given 2.5 ml of Zaditen syrup twice a day.

Children over 3 years of age are prescribed 5 ml of Zaditen syrup twice a day or ketotifen in the form of tablets (according to dosing recommendations).

Features of therapy with Zaditen

At the beginning of therapy with ketotifen, it is not necessary to cancel symptomatic anti-asthma drugs, as well as drugs that the patient receives for prevention. Particular attention is needed when canceling systemic glucocorticosteroids (due to the possible presence of adrenal insufficiency in patients receiving steroids) - such patients may require a long withdrawal period to normalize adrenal function (the withdrawal period can last up to 1 year).

Side effects

At the beginning of therapy with Zaditen, patients are likely to experience dizziness, dry mouth and sedation (in general, these side effects resolve on their own without discontinuation of ketotifen).

Also, while taking ketotifen, patients are likely to experience agitation, insomnia and increased irritability. Adverse events from the side of the central nervous system were more often recorded in children.

There are rare reports of weight gain during ketotifen therapy.

When taking Zaditen syrup, patients also infrequently recorded the development of cystitis, Stevens-Johnson syndrome, erythema multiforme, and an increase in the level of liver enzymes in the serum.

In isolated cases, during therapy with Zaditen in patients receiving antidiabetic drugs, the development of a reversible decrease in platelet levels was recorded (such patients need regular monitoring of platelet levels).

Contraindications

It is impossible to prescribe Zaditen tablets and syrup to patients with intolerance to ketotifen or auxiliary components of the drug.

Zaditen should be used with caution in patients with a tendency to develop seizures, as well as indications of a history of epileptic seizures.

At the beginning of therapy, it is necessary to abandon activities that require a high speed of psychomotor reactions. In the future, if the patient develops undesirable effects from the central nervous system, potentially unsafe activities are prohibited.

Pregnancy

In the course of animal studies, no teratogenic, mutagenic and embryotoxic effects of ketotifen were detected. But studies of ketotifen in pregnant women have not been conducted, therefore, ketotifen should be prescribed to pregnant women only if absolutely necessary.

In animal studies, ketotifen passes into breast milk. If necessary, the appointment of ketotifen during lactation should stop breastfeeding.

drug interaction

Zaditen with combined use potentiates the effect of drugs that depress the central nervous system, as well as other antihistamines and ethyl alcohol.

Overdose

With an overdose of ketotifen, patients develop drowsiness, depression of consciousness, disorientation, confusion, arterial hypotension and tachycardia. In general, children are likely to experience increased excitability and seizures. In rare cases, with severe overdose, a reversible coma is possible.

In case of intoxication with ketotifen, symptomatic agents are prescribed. If no more than 1 hour has passed from taking an overdose, the stomach is washed and oral administration of sorbent agents is prescribed.

Zaditen refers to systemic antihistamines.

Release form and composition

Zaditen is available in the following dosage forms:

Tablets containing 1 mg of ketotifen (in the form of hydrogen fumarate) and excipients (lactose monohydrate, magnesium stearate, corn starch). One package contains 30 tablets of white, grayish-white or yellowish-white color;
Syrup for children, 5 ml of which contains 1 ml of ketotifen (in the form of hydrogen fumarate). Sold in bottles of 100 ml;
Eye drops, 1 ml of which contains 250 mcg of ketotifen. Are issued in bottles on 5 ml.

Indications for use

Zaditen is used for the treatment and prevention of allergic diseases such as allergic rhinitis, urticaria, allergic dermatitis, hay fever, allergic bronchitis, atopic bronchial asthma.

Zaditen drops are used in the treatment and prevention of allergic conjunctivitis.

Contraindications

Pregnancy;
lactation period;
Increased individual sensitivity to the components of the drug.

With caution, the drug should be taken by patients suffering from liver failure and epilepsy.

Method of application and dosage

Zaditen tablets and syrup for children are taken orally with meals.

Adult tablets are prescribed 1 pc. (1 mg) morning and evening. If the patient has a tendency to develop a sedative effect, it is recommended to slowly increase the dosage during the first week of therapy, starting with ½ tablet 2 times a day and leading up to the full dose. If necessary, the daily dose is increased to 4 tablets, that is, 2 tablets in the morning and in the evening. When using a higher dosage, the effect occurs much faster.

Children are prescribed pills from the age of 3 years. The recommended dose is 1 tablet in the morning and evening.

For children under 3 years old, Zaditen is used in the form of a syrup. Its dosage depends on the age of the child:

Up to 6 months - 0.05 mg / kg twice a day;
6 months - 3 years - 0.5 mg twice a day;
After 3 years - 1 mg twice a day.

The duration of the course of therapy is at least 3 months. If it is necessary to cancel Zaditen, this is done gradually. During this period, relapses of diseases are possible.

Zaditen drops are prescribed for adults and children over 12 years of age. Recommended dosage: 1 drop in each eye in the morning and evening. The duration of use should not exceed 6 weeks.

Side effects

At the beginning of treatment with Zaditen, side effects such as mild dizziness, increased drowsiness, slowing down of mental reactions may develop. These symptoms usually disappear after a few days.

Also, possible side effects include: increased appetite, sometimes dry mouth and dyspeptic symptoms; weight gain, cystitis, dysuria, thrombocytopenia.

The use of Zaditen drops can lead to the development of the following side effects:

On the part of the visual system: dry eyes, decreased visual acuity, sometimes - photophobia, pain in the eyes, conjunctivitis, subconjunctival hemorrhage, a feeling of pain when instilled;
Allergic reactions: sometimes - skin rashes, in some cases - eczema;
Other symptoms: sometimes - increased fatigue, headache, in some cases - dry mouth.

special instructions

The therapeutic effect of Zaditen develops gradually, within 1-2 months.

In the initial period of long-term therapy with Zaditen, it is impossible to immediately stop taking anti-asthmatic symptomatic and prophylactic drugs that the patient is taking. This is especially true for systemic glucocorticoids.

With the simultaneous use of Zaditen and bronchodilators, the dosage of the latter should sometimes be reduced.

In patients taking antidiabetic agents, when prescribing Zaditen, it is necessary to control the level of platelets in the peripheral blood.

When prescribing this drug to patients with a history of epilepsy, caution should be exercised, since Zaditen may lower the seizure threshold.

Zaditen is able to enhance the effectiveness of drugs that suppress the central nervous system, as well as antihistamines and alcohol.

Zaditen drops contain the preservative benzalkonium chloride, which can penetrate the material of soft contact lenses. To prevent such exposure, it is recommended to remove contact lenses before administering the drug and put them on after at least 15 minutes have passed after instillation.

In the case of using Zaditen drops simultaneously with other eye drops, it is important to take a break between their instillations for at least 5 minutes.

Do not use Zaditen drops for irritation or inflammation of the eyes.4.6 Rating: 4.6 - 5 votes

Zaditen (Zaditen)

Compound

1 tablet Zaditen contains:

Ketotifen fumarate - 1 mg;

Excipients: magnesium stearate, corn starch, lactose monohydrate.

5 ml of Zaditen syrup contains:

Ketotifen hydrofumarate - 5 mg;

Other ingredients: sodium propylparaben, sodium methylparaben, banana flavor, anhydrous citric acid, liquid maltitol, anhydrous disodium hydrogen phosphate, purified water.

pharmachologic effect

Ketotifen does not have a direct bronchodilating effect.

Studies have identified a number of effects of ketotifen that allow it to be used as an anti-asthma drug (excluding acute asthma attacks):

inhibition of the release of histamine, leukotrienes and prostaglandins;
decrease in the primary effect of the antigen on eosinophils (decrease in the flow of eosinophils into the focus of inflammation);
decrease in airway hyperreactivity due to platelet activation under the action of PAF or neurogenic activation due to the intake of sympathomimetics and contact with allergens;

Pharmacokinetics

After oral administration, the bioavailability of ketotifen reaches 50% (due to the first passage through the liver), absorption in the gastrointestinal tract is almost complete.

Peak serum levels of ketotifen following oral administration are reached in 2 to 4 hours. Up to 75% of ketotifen is bound to serum proteins.

In the body, ketotifen is converted to N-glucuronide, which has no pharmacological activity. In children, the metabolism of ketotifen is similar to adults, but the overall clearance is slightly higher (children are usually prescribed the same doses of Zaditen as adult patients).

Ketotifen is excreted in 2 stages: the half-life for the first stage is 3-5 hours, for the second - 21 hours.

Within 48 hours, most of the dose taken is excreted: up to 70% as a metabolite, about 1% unchanged.

Food does not affect the bioavailability of ketotifen.

Indications for use

Zaditen is used in the treatment and prevention of allergic diseases, including chronic and acute urticaria, atopic dermatitis, allergic conjunctivitis and rhinitis.

Mode of application

Tablets Zaditen

Zaditen tablets are taken orally with food. It is usually recommended to take 1 tablet of Zaditen twice a day. If a patient develops a sedative effect while taking Zaditen tablets, the dose should be gradually increased to the recommended therapeutic dose, and therapy should be started with 1/2 Zaditen tablet twice a day.

When prescribing Zaditen to patients with bronchial asthma, the number of bronchodilators taken can be reduced (dose adjustment should be carried out exclusively by a specialist). Cancellation of the drug Zaditen should be carried out gradually (withdrawal time 2-4 weeks): it should be borne in mind that during the period of withdrawal of ketotifen in patients with bronchial asthma, relapses are possible.

For children from 3 years of age, ketotifen is prescribed in adult doses (1 tablet Zaditen twice a day). It should be borne in mind that, based on 1 kg of weight, children require higher doses than adult patients. There is no deterioration in tolerability when prescribing high doses of ketotifen (in the therapeutic dose corridor).

Children under 3 years of age should be prescribed Zaditen in the form of a syrup.

For elderly patients, the dose of ketotifen is not adjusted.

Syrup Zaditen

The syrup is taken orally with food. Dosing of the syrup must be carried out using a measuring device attached to the syrup. The syrup is taken undiluted.

Children over 3 years of age are prescribed 5 ml of Zaditen syrup twice a day or ketotifen in the form of tablets (according to dosing recommendations).

Features of therapy with Zaditen

At the beginning of therapy with ketotifen, symptomatic anti-asthma drugs, as well as drugs that the patient receives for prophylaxis, should not be canceled. Particular attention is needed when canceling systemic glucocorticosteroids (due to the possible presence of adrenal insufficiency in patients receiving steroids) - such patients may require a long withdrawal period to normalize adrenal function (the withdrawal period can last up to 1 year).

Side effects

At the beginning of therapy with Zaditen, patients may experience dizziness, dry mouth and sedation (as a rule, these side effects resolve on their own without discontinuation of ketotifen).

Also, while taking ketotifen, patients may experience agitation, insomnia and increased irritability. Adverse events from the side of the central nervous system were more often recorded in children.

There are rare reports of weight gain during ketotifen therapy.

When taking Zaditen syrup in patients, the development of cystitis, Stevens-Johnson syndrome, erythema multiforme, and an increase in the level of liver enzymes in serum were also rarely recorded.

Contraindications

It is forbidden to prescribe Zaditen tablets and syrup to patients with intolerance to ketotifen or auxiliary components of the drug.

Zaditen should be used with caution in patients with a tendency to develop seizures, as well as indications of a history of epileptic seizures.

Pregnancy

In the course of animal studies, no teratogenic, mutagenic and embryotoxic effects of ketotifen were detected. However, studies of ketotifen in pregnant women have not been conducted, therefore, ketotifen should be prescribed to pregnant women only if absolutely necessary.

In animal studies, ketotifen passes into breast milk. If necessary, the appointment of ketotifen during lactation should stop breastfeeding.

drug interaction

Zaditen, when combined, potentiates the effect of drugs that depress the central nervous system, as well as other antihistamines and ethyl alcohol.

Overdose

With an overdose of ketotifen, patients develop drowsiness, depression of consciousness, disorientation, confusion, arterial hypotension and tachycardia. Mostly in children, increased excitability and seizures may occur. In rare cases, with severe overdose, a reversible coma is possible.

In case of an overdose of ketotifen, the patient should be under the supervision of medical personnel, the function of the cardiovascular system and central nervous system should be especially carefully monitored. With the development of excitement and convulsions, the appointment of barbiturates (it is necessary to choose short-acting drugs) or benzodiazepines is recommended.

Release form

Zaditen tablets in blister plates, 30 pieces in a pack.

Syrup Zaditen 100 ml in bottles, in a cardboard box 1 bottle and a measuring device.

Storage conditions

Zaditen tablets and syrup should be kept away from children at room temperature.