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

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

Epistatus

Epistat: 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. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Epistat

ATX code: R03DX03

Active ingredient: fenspiride (fenspiride)

Producer: Gedeon Richter-RUS (Russia), Gedeon Richter Romania A. O. (Romania)

Description and photo updated: 22.11.2018

Epistat is an anti-inflammatory and anti-bronchoconstrictor agent.

Release form and composition

• prolonged-release film-coated tablets: round, biconvex, engraved with "R33" on one side, white or almost white, slight surface roughness is possible (15 pcs. in blisters, in a cardboard box 2, 4 or 6 blisters);
• syrup: clear orange liquid with a characteristic odor (150 ml each in light-protective bottles, in a cardboard box 1 bottle complete with a plastic dosing cup, graduated from 2.5 to 20 ml).

Composition of 1 tablet:

• active substance: fenspiride hydrochloride - 80 mg;
• auxiliary components: hypromellose-2208, magnesium stearate, povidone-K29-32, calcium hydrogen phosphate dihydrate, colloidal silicon dioxide;
• composition of the film shell: opadry II white 85F18422, including talc, macrogol-3350, titanium dioxide (E 171), polyvinyl alcohol.

Composition of 1 ml of syrup:

• active substance: fenspiride hydrochloride - 2 mg;
• auxiliary components: licorice root extract, glycerol, propyl parahydroxybenzoate, sodium saccharinate, potassium sorbate, citric acid solution, methyl parahydroxybenzoate, vanilla and honey flavors, sunset yellow dye (E 110), water.

Pharmacological properties

Pharmacodynamics

Fenspiride has anti-inflammatory and anti-bronchoconstrictor properties. The mechanism of its action is due to the ability to reduce the production of cytokines (in particular, tumor necrosis factor α), free radicals and derivatives of arachidonic acid - biologically active substances that play an important role in the development of bronchospasm and inflammation.

The process of inhibition of the metabolism of arachidonic acid is enhanced by the H1-antihistamine effect of fenspiride, since histamine promotes the metabolism of arachidonic acid and the subsequent formation of prostaglandins and leukotrienes.

The drug blocks α-adrenergic receptors, when stimulated, the secretion of the bronchial glands increases.

Thus, Epistat reduces the effect of a number of factors contributing to the development of inflammation and obstruction of the bronchi, and also has an antispasmodic effect.

Pharmacokinetics

After oral administration, fenspiride is well absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is observed on average after 6 hours, then gradually decreases.

T1 / 2 - about 12 hours.

Fenspiride does not accumulate in tissues. It is excreted: by the kidneys - 90%, through the intestines - 10%.

Indications for use

According to the instructions, Epistat is used to treat the following diseases of the lower and upper respiratory tract:

• laryngitis;
• rhinopharyngitis;
• bronchitis, including against the background of chronic respiratory failure;
• sinusitis and otitis media of various etiologies;
• tracheobronchitis;
• infectious diseases of the respiratory tract, accompanied by a cough (in cases where standard antibiotic therapy is indicated);
• respiratory symptoms (sore throat, hoarseness, cough) with flu, whooping cough, measles;
• bronchial asthma (as part of complex therapy).

Contraindications

• pregnancy and lactation;
• glucose-galactose malabsorption, fructose intolerance, sucrase / isomaltase deficiency - for syrup;
• age up to 2 years - for syrup, up to 18 years - for tablets;
• hypersensitivity to any component of the drug.

Epistat syrup should be used with caution in patients with diabetes mellitus (it contains sucrose).

Instructions for the use of Epistat: method and dosage

Pills

In the form of tablets, Epistat should be taken orally at the beginning of a meal: swallowed whole and washed down with a little water.

Adults are prescribed 1 pc. 80 mg 2-3 times a day. Do not exceed the maximum daily dose of 240 mg.

The duration of therapy is determined individually, depending on the indication and the severity of the disease.

Syrup

Epistat syrup should be taken orally.

The recommended daily intake is 4 mg per kilogram of body weight:

• children weighing less than 10 kg: 10–20 ml (2–4 tsp *) per day, the syrup can be added to a bottle with baby food;
• children weighing more than 10 kg: 30-60 ml (2-4 tbsp. l. *), taken before meals.

* In 1 tsp. (5 ml of syrup) contains 10 mg of fenspiride hydrochloride and 3 g of sucrose.

** In 1 tbsp. l. (15 ml of syrup) contains 30 mg of fenspiride hydrochloride and 9 g of sucrose.

Adolescents from 16 years old and adults are prescribed 45–90 ml of syrup (3–6 tbsp. L.). The drug should be taken before meals.

The duration of therapy is determined individually, depending on the indication and the severity of the disease.

To get the exact dose, you need to use the included measuring cup - with it you can measure 2.5; 3; five; 7.5; ten; 12.5; 15 and 20 ml of syrup.

Side effects

Gradation of side effects: very often - ≥ 1/10, often - from ≥ 1/100 to <1/10, infrequently - from ≥ 1/1000 to <1/100), rarely - from ≥ 1/10000 to <1 / 1000, very rarely - <1/10000, frequency unknown - based on the available data, it is impossible to estimate the frequency of the effects.

Possible adverse events:

• from the digestive system: often - epigastric pain, nausea, gastrointestinal disorders; frequency unknown * - vomiting, diarrhea;
• on the part of the heart and blood vessels: rarely - moderate tachycardia (its severity decreases with a decrease in the dose of Epistat); frequency unknown * - a decrease in blood pressure and a feeling of palpitations (these reactions are probably due to the development of tachycardia);
• from the central nervous system: rarely - drowsiness; frequency unknown * - dizziness;
• on the part of the skin and subcutaneous tissues: rarely - urticaria, rash, erythema, fixed erythema pigmentosa, angioedema; frequency unknown * - pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• others: frequency is unknown * - increased fatigue, asthenia.

* Data of post-registration use of the drug.

When taking Epistat syrup, the risk of developing hypersensitivity reactions to the dye, sunset yellow, is increased.

Overdose

There are known cases of overdose when taking fenspiride at a dose of more than 2320 mg. Symptoms: nausea, vomiting, agitation or drowsiness, sinus tachycardia.

In case of overdose, seek medical attention immediately. First of all, gastric lavage is performed, further treatment is symptomatic, aimed at maintaining the vital functions of the body, control of the electrocardiogram is necessary.

special instructions

Epistat syrup contains sucrose: in 1 tsp. - 3 g (0.3 XE), in 1 tbsp. l. - 9 g (0.9 XE), which should be taken into account in patients with diabetes mellitus.

In addition, the syrup contains parabens (propyl parahydroxybenzoate and methyl parahydroxybenzoate), which can cause the development of allergic reactions, including the delayed type.

Influence on the ability to drive vehicles and complex mechanisms

Studies of the effect of fenspiride on human cognitive and psychomotor functions have not been conducted. However, it has been established that the drug can cause drowsiness, especially at the initial stage of treatment and while drinking alcohol. In this regard, patients are advised to be careful when driving vehicles and performing activities that require attention and speed of reactions.

Application during pregnancy and lactation

There is not enough data on the use of fenspiride during pregnancy to assess the degree of its safety, therefore Epistat is not recommended for use by pregnant women. There is no need to terminate a pregnancy that occurs during treatment.

It is not known whether fenspiride passes into breast milk, and therefore, Epistat should not be taken by lactating women.

Pediatric use

In the form of a syrup, the drug is contraindicated in children under 2 years of age.

In the form of tablets, Epistat is not prescribed for children and adolescents under the age of 18.

Drug interactions

Special studies on the interaction of fenspiride with other concomitantly used drugs have not been conducted.

Since H1-histamine receptor blockers can enhance the sedative effect, Epistat is not recommended to be combined with sedative drugs and alcohol.

Reception of Epistat is not an obstacle to the appointment of antibiotics.

Analogs

Epistat analogs are Sirep, Fenspirid, Fespalen, Fespalen Solution Tablets, Erespal, Eladon, Erispirus.

Terms and conditions of storage

Keep out of the reach of children at temperatures up to 25 ° C.

Shelf life:

• tablets - 3 years;
• syrup - 2 years, after the first opening of the bottle - 28 days.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Epistat

Reviews about Epistat are contradictory. Some patients confirm its high efficiency in diseases accompanied by cough. Others write about the lack of a therapeutic effect and the development of side effects (including severe weakness, headache, drowsiness, fluctuations in blood pressure, tachycardia), due to which treatment with this remedy had to be interrupted.

The disadvantages of syrup include "unnecessary", according to many patients, components, such as parabens and dyes - chemicals that can cause allergic reactions. Given that Epistat is used in this dosage form to treat children and adolescents, the composition of the syrup causes distrust among parents.

The price of Epistat in pharmacies

Approximate prices for Epistat:

• syrup - 145-185 rubles per bottle of 150 ml;
• film-coated prolonged-release tablets - 180–255 rubles per package 30 pcs.

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!