Ketotifen - Instructions For Use, Price, Reviews, Tablets, Syrup

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ketotifen

Ketotifen: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ketotifen

ATX code: S01GX08

Active ingredient: ketotifen (ketotifen)

Producer: Irbitsky Khimfarmzavod (Russia), Rozpharm, LLC (Russia), Sopharma (Bulgaria), Update PFC (Russia), Balkanpharma (Bulgaria)

Description and photo update: 2019-16-08

Prices in pharmacies: from 38 rubles.

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Ketotifen - antiallergic agent, stabilizer of mast cell membranes.

Release form and composition

Dosage forms:

• Tablets: round, flat-cylindrical, white, with a chamfer and a dividing line, with a slight odor or without it (10 pcs. In a blister strip, in a cardboard box 1, 2, 3, 4 or 5 packages);
• Syrup (100 ml in dark glass bottles, in a cardboard box 1 bottle complete with a measuring cup).

The active substance is ketotifen fumarate:

• 1 tablet - 1.3 mg, which corresponds to 1 mg of ketotifen;
• 5 ml of syrup - 1 mg.

Auxiliary components in the composition of tablets: lactose monohydrate (milk sugar), potato starch, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Ketotifen belongs to the group of cycloheptathiophenones and has a pronounced antihistamine effect. It is not a bronchodilating anti-asthma drug.

The mechanism of action of the drug consists in inhibiting the release of histamine and other mediators released by mast cells, blocking histamine H ₁ receptors, inhibiting the enzyme phosphodiesterase. As a result of this effect, the level of cyclic adenosine monophosphate (cAMP) in mast cells increases. Ketotifen suppresses the effects of platelet-activating factor (PAF).

Prevents the appearance of asthmatic attacks, but does not stop them, therefore, when taking the drug, a decrease in the intensity and duration of attacks is noted, and in some cases, their complete disappearance. The full therapeutic effect is manifested 1.5–2 months after the start of treatment.

Pharmacokinetics

It is absorbed almost completely in the gastrointestinal tract, bioavailability is about 50% due to metabolism during passage through the liver ("first pass" effect). The maximum concentration in blood plasma is reached after 2–4 hours. About 75% binds to plasma proteins. It is excreted into breast milk, crosses the blood-brain barrier. The volume of distribution is 2.7 l / kg.

Approximately 60% of the taken dose of the drug is metabolized in the liver by demethylation, N-glucuronic conjugation and N-oxidation. As a result, the following metabolites are formed: ketotifen-N-glucuronide (inactive), nor-ketotifen (pharmacologically active with an action similar to that of ketotifen), 10-hydroxy-ketotifen, and ketotifen N-oxide (pharmacological activity not determined).

About 70% is excreted by the kidneys in the form of inactive metabolites, 0.8% - in unchanged form. Withdrawal is two-phase: the half-life of the first phase is from 3 to 5 hours, the second is about 21 hours.

In children over 3 years of age, the metabolism does not differ from the analogous process in adults, however, a faster clearance is observed. As a result, patients 3 years of age and older must be prescribed a daily dose for adults.

Indications for use

According to the instructions, Ketotifen in tablet form is used to treat the following diseases:

• Atopic bronchial asthma;
• Seasonal allergic rhinoconjunctivitis (hay fever);
• Atopic dermatitis;
• Allergic conjunctivitis;
• Allergic rhinitis;
• Hives.

The drug in the form of a syrup is taken for the prevention of the above and other allergic diseases, including allergic bronchitis.

Contraindications

• Breastfeeding period;
• Hypersensitivity to drug components.

In addition, a contraindication to the use of tablets is:

• Pregnancy period;
• Age up to 3 years.

Do not administer syrup to infants under 6 months of age.

It is recommended to prescribe with caution:

• Tablets: for liver failure and patients with epilepsy;
• Syrup: during pregnancy, especially in the first trimester.

Instructions for the use of Ketotifen: method and dosage

• Tablets: taken orally, morning and evening with meals. The recommended dosage for adults and children is 1 tablet 2 times a day, in severe cases it is allowed to increase the dose for adults up to 2 mg 2 times a day. The treatment period is 3 or more months. The drug should be withdrawn gradually over 2-4 weeks;
• Syrup: taken orally in the morning and evening with meals. Dosage for adults and children over the age of 3 years - 1 mg (5 ml) 2 times a day; for children from 6 months to 3 years old - 0.5 mg 2 times a day. The daily dose for adults can be increased to 4 mg if necessary.

Side effects

The use of Ketotifen can cause side effects:

• From the nervous system: dizziness (when taking syrup - light), drowsiness, slowing down of the speed of mental reactions (as a rule, they are temporary and disappear within several days of use);
• From the urinary tract: cystitis, dysuria;
• From the side of metabolism: an increase in body weight;
• From the hematopoietic system: thrombocytopenia.

In addition, when taking pills, you may experience:

• From the nervous system: feeling tired, sedative; rarely - sleep disturbances, anxiety, nervousness (especially often in children);
• From the digestive system: nausea, dry mouth, vomiting, constipation, increased appetite, gastralgia;
• Others: allergic skin reactions.

When taking syrup, side effects can also be:

From the digestive system: possibly increased appetite; rarely - dry mouth, dyspeptic symptoms

Overdose

Symptoms: confusion, drowsiness, dizziness, irritability, nystagmus, disorientation, arterial hypotension, tachycardia or bradycardia, nausea, vomiting, cyanosis, shortness of breath, coma, seizures may occur in children.

Treatment: gastric lavage (with a short period of time from the moment of taking the drug), symptomatic treatment. For seizures, benzodiazepines or barbiturates are recommended. If necessary, symptomatic treatment with control of cardiac activity is carried out. In case of overdose, dialysis is ineffective.

special instructions

The therapeutic effect of Ketotifen occurs after 1-2 months of use.

The previous use of glucocorticosteroids, beta-adrenostimulants, adrenocorticotropic hormones (ACTH) in patients with bronchospastic syndrome and bronchial asthma should be continued after the appointment of ketotifen for 2 or more weeks before discontinuation, gradually reducing the dose.

Abrupt withdrawal of ketotifen can cause a relapse of asthmatic symptoms, so it is recommended to stop taking it gradually, over 2 to 4 weeks.

With simultaneous use with syrup, a decrease in the dose of bronchodilators is allowed.

Tablets are not intended to relieve attacks of bronchial asthma.

With the simultaneous administration of tablets with oral hypoglycemic agents, it is recommended in patients to control the platelet count in the peripheral blood.

With sensitivity to sedation, the first 2 weeks of treatment, patients are advised to take the drug in small doses.

During the period of use of Ketotifen, it is necessary to refrain from driving vehicles and mechanisms, as well as engaging in those types of activities, the implementation of which requires a high concentration of attention and quick psychomotor reactions.

Application during pregnancy and lactation

Ketotifen in syrup form is prohibited during pregnancy and lactation.

Ketotifen tablets are prohibited for use in the first trimester of pregnancy, and in the second and third trimesters, the drug is prescribed with caution only in cases where the perceived risk to the fetus is lower than the potential benefit to the mother.

If necessary, the use of tablets during lactation, breastfeeding should be discontinued.

Pediatric use

Ketotifen syrup should not be used to treat patients under the age of 6 months.

Ketotifen tablets are prohibited for the treatment of patients under the age of 3 years.

For violations of liver function

In case of liver failure, the drug in the form of syrup and tablets should be used with caution.

Use in the elderly

When treating elderly patients, dose adjustment is not required.

Drug interactions

When combined with antihistamines, hypnotics and ethanol, Ketotifen enhances their effect.

Simultaneous use of each of the dosage forms with oral hypoglycemic drugs: the risk of thrombocytopenia increases.

The syrup increases the activity of sedatives.

Analogs

Analogs of Ketotifen are: Zaditen, Ketotifen Sopharma, Ketotifen-Ros.

Terms and conditions of storage

Store in a dry, dark place at temperatures up to 25 ° C.

Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ketotifen

Reviews of Ketotifen indicate that this drug is an inexpensive, effective antihistamine. As disadvantages, users indicate the duration of the course of therapy and the side effects (in particular, increased drowsiness).

The price of Ketotifen in pharmacies

The approximate price for Ketotifen is: tablets (30 pcs. In a package) - 55–70 rubles, syrup (100 ml in a bottle) - 80 rubles.

Ketotifen: prices in online pharmacies

Drug name Price Pharmacy

Ketotifen 1 mg tablets 30 pcs. RUB 38 Buy

Ketotifen 1 mg tablets 30 pcs. RUB 50 Buy

Ketotifen Sopharma 1 mg tablets 30 pcs. RUB 63 Buy

Ketotifen Sopharma tablets 1mg 30 pcs. RUB 64 Buy

Ketotifen Sopharma 1 mg / 5 ml syrup 100 ml 1 pc. RUB 69 Buy

Ketotifen tablets 1mg 30 pcs. RUB 72 Buy

Ketotifen sofarma syrup 1mg / 5ml 100ml 93 rbl. Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!