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

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

Ketotifen Sopharma

Ketotifen Sopharma: 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 Sopharma

ATX code: R06AX17

Active ingredient: ketotifen (Ketotifen)

Manufacturer: Sopharma AD (Bulgaria)

Description and photo update: 2019-12-07

Prices in pharmacies: from 63 rubles.

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Ketotifen Sopharma is an anti-allergic drug, stabilizer of mast cell membranes.

Release form and composition

Dosage forms of Ketotifen Sopharma:

• syrup: viscous, transparent, from light yellow to colorless, with a specific strawberry smell (in a cardboard box 1 bottle of dark glass or dark polyethylene terephthalate containing 100 ml of syrup, with a 5 ml measuring spoon or a 20 ml measuring cup included);
• tablets: white or white with a grayish tinge, flat, round, odorless, with a chamfer and a notch on one side (in a pack of cardboard 3 blisters containing 10 tablets each).

Each pack also contains instructions for the use of Ketotifen Sopharma.

Composition of 5 ml syrup:

• active substance: ketotifen hydrofumarate - 1.38 mg (corresponds to the content of ketotifen - 1 mg);
• auxiliary components: sodium saccharinate - 1 mg, ethanol 96% - 100 mg, sodium hydrogen phosphate dodecahydrate - 30 mg, citric acid monohydrate - 9 mg, propyl parahydroxybenzoate - 1 mg, methyl parahydroxybenzoate - 5 mg, sorbitol - 1750 mg, strawberry flavor (liquid essence "Strawberry") - 15 mg, purified water - up to 5 ml.

Composition of 1 tablet:

• active substance: ketotifen hydrofumarate - 1.38 mg (corresponds to the content of ketotifen - 1 mg);
• auxiliary components: magnesium stearate - 1.4 mg, wheat starch - 5 mg, calcium hydrogen phosphate anhydrous - 20 mg, microcrystalline cellulose (type 200) - 112.22 mg.

Pharmacological properties

Pharmacodynamics

Ketotifen belongs to the group of cycloheptathiophenones, has a pronounced antihistamine effect. The drug does not belong to a bronchodilating anti-asthma drug.

Its mechanism of action is associated with inhibition of the enzyme phosphodiesterase (due to which the level of cyclic adenosine monophosphate in mast cells increases), blocking of histamine H ₁ receptors and inhibition of the release of histamine and other mediators from mast cells.

Ketotifen Sopharma does not stop asthmatic attacks, but prevents their development, leads to a decrease in their intensity and duration, and in some cases contributes to their complete disappearance. Ketotifen facilitates sputum production, suppresses the effects of platelet-activating factor.

Pharmacokinetics

• absorption and distribution: ketotifen is almost completely absorbed from the gastrointestinal tract (GIT), due to the effect of the first passage through the liver, its bioavailability is 50%. The maximum plasma level of the drug is observed between 2–4 hours. Its binding to plasma proteins is approximately 75%, and the volume of distribution is 2.7 liters per 1 kg. The substance passes through the blood-brain barrier and enters breast milk;
• metabolism: after oral administration, almost 60% of ketotifen is metabolized in the liver in three ways - N-glucuronic conjugation, N-oxidation and demethylation. As a result, metabolites are formed - 10-hydroxy-ketotifen and ketotifen N-oxide (their pharmacological activity is unknown), norketotifen (its pharmacological activity is similar to that for ketotifen) and ketotifen-N-glucuronide (pharmacologically inactive). In children, the metabolism of the drug does not differ, except for a faster clearance, and therefore, patients over the age of 3 years are prescribed the drug in a daily dose intended for adults;
• excretion: ketotifen is excreted by the kidneys unchanged by 0.8%, in the form of metabolites - by 70%. Its elimination consists of two phases. The half-life of the first phase varies from 3 to 5 hours, the second is approximately 21 hours.

Indications for use

• combined treatment of atopic bronchial asthma;
• conjunctivitis;
• allergic rhinitis.

Contraindications

Absolute:

• glucose-galactose malabsorption, fructose intolerance, isomaltase / sucrase deficiency;
• I trimester of pregnancy;
• period of breastfeeding;
• children's age: syrup - under 6 months, tablets - under 3 years;
• individual intolerance to the components of the drug.

Relative (syrup and tablets Ketotifen Sopharma are prescribed under medical supervision):

• liver failure;
• a history of seizure episodes;
• epilepsy;
• II and III trimesters of pregnancy (provided that the expected benefit to the mother exceeds the potential risk to the fetus).

Ketotifen Sopharma, instructions for use: method and dosage

Syrup Ketotifen Sopharma is taken orally, with meals. The recommended daily dose, depending on the patient's age, is:

• children from 6 months to 3 years: 0.5 mg (2.5 ml) 2 times a day, in the morning and evening (syrup in this age group of patients should be used in accordance with the doctor's recommendations);
• children from 3 to 18 years old, adult patients: 1 mg (5 ml) 2 times a day, in the morning and evening.

Ketotifen Sopharma tablets are taken orally, at the same time with food, with water.

The recommended dose for children aged 3 years and older is 1 tablet 2 times a day, in the morning and evening.

If adult patients have a significant sedative effect, the dose of Ketotifen Sopharma is increased slowly over the first 7 days, starting with taking 0.5 mg (2.5 ml) of syrup or ½ tablet in the evening before bedtime, until the therapeutic dose is gradually reached. If necessary, the dose can be increased to 4 mg (20 ml) of syrup or 4 tablets per day - 2 mg (10 ml) of syrup or 2 tablets 2 times a day. In this case, a more rapid onset of the therapeutic effect can be expected.

The treatment is carried out over a long period, since the effect of the drug is achieved after several weeks from the start of taking the syrup / tablets. The minimum period of therapy should be 2–3 months, especially in cases where no effect was observed in the first weeks of taking Ketotifen Sopharma.

With the combined use of ketotifen and β ₂ -adrenomimetics, the frequency of use of bronchodilators can be reduced.

In order to avoid the likelihood of exacerbation of bronchial asthma, treatment cancellation should be carried out gradually, over a period of 14-28 days.

Correction of the dosage regimen of Ketotifen Sopharma for elderly patients is not required.

Side effects

Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, including isolated messages - very rare):

• infections: infrequently - cystitis;
• immune system: very rarely - exudative erythema multiforme, severe skin reactions, Stevens-Johnson syndrome;
• metabolism and nutrition: rarely - increased body weight;
• mental disorders: often - anxiety, insomnia, irritability, agitation;
• nervous system: infrequently - headache, dizziness; rarely - sedative effect (slowing down reactions, relaxation); very rarely - convulsions;
• Gastrointestinal tract: infrequently - nausea, diarrhea, vomiting, dry mouth;
• hepatobiliary system: very rarely - hepatitis, increased activity of liver enzymes.

At the beginning of taking the syrup / tablets, dizziness and dry mouth may occur, which usually disappear spontaneously during therapy. Rarely are manifestations of stimulation of the central nervous system (CNS) in the form of anxiety, insomnia, irritability and excitement (especially in children), drowsiness, fatigue and nervousness.

Overdose

The main symptoms: hyperexcitability, nausea, vomiting, drowsiness, shortness of breath, dizziness, confusion, arterial hypotension, disorientation, bradycardia / tachycardia, cyanosis, nystagmus, coma, seizures in children.

Therapy: if a little time has passed since taking the drug, gastric lavage is performed. If necessary, patients are prescribed symptomatic treatment, and cardiac activity is monitored. If there is a convulsive syndrome, activated charcoal, benzodiazepines, or barbiturates are prescribed. Dialysis is ineffective.

special instructions

Ketotifen Sopharma is not used to relieve an attack of bronchial asthma.

At the beginning of taking syrup / tablets, abrupt withdrawal of other anti-asthma drugs, in particular systemic glucocorticosteroids, should be avoided. With steroid dependence, this can lead to the development of adrenal insufficiency.

Patients with intercurrent infection should receive specific anti-infective treatment.

After adding ketotifen to the treatment, the cancellation of the previous therapy is carried out for 14 days (minimum) with a gradual decrease in doses.

Ketotifen Sopharma lowers the threshold of seizure activity, and therefore, if there is a history of seizure episodes, it is prescribed with extreme caution.

In the presence of sensitivity to sedation, Ketotifen Sopharma is taken in small doses in the first 14 days.

The syrup contains auxiliary components propyl and methyl parahydroxybenzoates, due to which allergic reactions (possibly of a delayed type) can develop. It also contains sorbitol (up to 3.5 g in 10 ml), which, with rare hereditary fructose intolerance, can cause diarrhea and stomach irritation (taking this dosage form in such cases is not recommended).

Patients suffering from alcoholism should take into account that the syrup contains 2.46% by volume of alcohol (ethanol). It is also important to take into account when using the syrup in children with a high risk group (with epilepsy or liver pathologies) during pregnancy in the II and III trimesters.

Wheat starch, which is part of the Ketotifen Sopharma tablets, may contain only traces of gluten, and therefore it is considered safe for patients with gluten enteropathy (celiac disease).

Influence on the ability to drive vehicles and complex mechanisms

During the period of taking Ketotifen Sopharma, it is recommended to refrain from driving vehicles and conducting potentially hazardous activities, the implementation of which requires the speed of psychomotor reactions and increased attention.

Application during pregnancy and lactation

Ketotifen Sopharma is not prescribed in the first trimester of pregnancy. It is used with caution in the II and III trimesters of pregnancy, provided that the potential benefit of therapy to the mother outweighs the predicted risks to the fetus.

Since ketotifen is excreted in breast milk, if it is necessary to use the drug during lactation, breastfeeding is stopped.

Pediatric use

The appointment of Ketotifen Sopharma in the form of a syrup is contraindicated in children under 6 months, in the form of tablets - under 3 years.

For violations of liver function

For patients with hepatic impairment, the drug is prescribed with caution.

Use in the elderly

Correction of the dosage regimen for elderly patients is not required.

Drug interactions

Possible interactions of ketotifen with other substances / drugs:

• oral antidiabetic agents: the development of reversible thrombocytopenia is possible (during the period of treatment it is important to monitor the number of platelets);
• other drugs that suppress the central nervous system (hypnotics / sedatives): their effects may increase;
• other antihistamines: mutual enhancement of effects is possible;
• alcohol: enhances the inhibitory effect of ketotifen on the central nervous system (during the period of therapy, it is recommended to avoid drinking alcohol).

Analogs

The analogues of Ketotifen Sopharma are: Ketotifen-OBL, Stafen, Ketotifen Stada, Frenasma, Ketotifen tablets, Positan, Zaditen SRO, Ketotifen fumarate, Daltifen, Ketof, Zaditen, Ketotifen.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

After the first opening of the syrup bottle, the drug should be used within 1 month.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ketotifen Sopharma

According to reviews, Ketotifen Sopharma is a safe, effective and affordable drug used to treat asthma and allergies. Its advantages also include the absence of addiction, despite the long period of therapy, the cumulative effect, the possibility of using the drug in the form of a syrup in young children (from 6 months) and its pleasant taste.

Among the disadvantages most often appear the development of drowsiness and lethargy after taking Ketotifen Sopharma, the presence of wheat starch in the tablets, the need for long-term use of the drug and its gradual withdrawal.

Price for Ketotifen Sopharma in pharmacies

The approximate price for Ketotifen Sopharma in tablets (30 pcs in a package) is from 60 to 74 rubles, in the form of a syrup (in a bottle of 100 ml) - from 56 to 75 rubles.

Ketotifen Sopharma: prices in online pharmacies

Drug name Price Pharmacy

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

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

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