Epistat syrup 2mg/ml 150ml

Epistat syrup instruction for use

You can buy Epistat syrup here

Form of release, composition and packaging

The syrup is transparent, orange, with a characteristic odor.
1 ml
fenspiride hydrochloride 2 mg
Excipients: sodium saccharinate 0.45 mg, sucrose 600 mg, methylparahydroxybenzoate 0.9 mg, propyl parahydroxybenzoate 0.35 mg, glycerol 225 mg, potassium sorbate 1.9 mg, licorice root extract 0.02 mg, flavor honey 5 mg, tincture of vanilla * - 4 mg, dye sunset yellow sunset (E110) - 0.1 mg, citric acid solution 10% - qs (to adjust the pH), water - up to 1 ml.
* The total ethanol content is not more than 0.785% by volume.
150 ml - vials of light-protective polyethylene terephthalate with a capacity of 150 ml (1) complete with a dispensing cup, graduated from 2.5 ml to 20 ml - packs of cardboard.

pharmachologic effect

The anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is due to a decrease in the production of biologically active substances (cytokines, in particular TNFα), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm.
Inhibition of the metabolism of arachidonic acid by fenspiride is enhanced by the blockade of histamine H1 receptors, since histamine stimulates the metabolism of arachidonic acid followed by the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by increased secretion of bronchial glands. Thus, fenspiride reduces the effect of a number of factors that promote increased secretion of proinflammatory factors, the development of inflammation and bronchial obstruction.
Fenspiride also has an antispasmodic effect.

Pharmacokinetics

Suction and distribution
Fenspiride is well absorbed from the digestive tract. Cmax in blood plasma after oral administration is achieved after 2.3 ± 2.5 h (0.5-8 h).
Epistat syrup does not accumulate in the tissues.
Excretion
T1 / 2 is approximately 12 hours. Fenspiride is excreted mainly by the kidneys (90%), 10% by the intestine.

Indications for Epistat syrup

Diseases of the upper and lower respiratory tract:
- Rhinopharyngitis and laryngitis;
- tracheobronchitis;
- bronchitis (in the background of chronic respiratory failure or without it);
- bronchial asthma (as part of complex therapy);
- respiratory effects (cough, hoarseness, swelling in the throat) in measles, whooping cough, influenza;
- infectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated.
Otitis and sinusitis of various etiologies.

Contraindications for Epistat syrup

- hypersensitivity to the active substance and / or any other component of the drug;
- Pregnancy;
- the period of breastfeeding;
- Children under 2 years;
- patients with fructose intolerance, glucose-galactose malabsorption, sugarase / isomaltase deficiency (due to the presence of sucrose in the formulation of Epistat syrup).

Carefully

Patients with diabetes mellitus (due to the presence of sucrose as part of the drug Epistat syrup).

Dosage

The patient should strictly follow the recommendations of the attending physician.
Inside, take before meals.
The daily dose of the drug should be divided into 3 divided doses.
Epistat syrup is supplied with a measuring cup, with which 2.5 ml, 3 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml or 20 ml can be measured.
Use this measuring cup to get the required dose of the drug.
Children between the ages of 2 and 16
The recommended dose is 4 mg / kg / day.
Body weight less than 10 kg: 10-20 ml syrup / day (2-4 teaspoons), the syrup can be added to a bottle with food.
Body weight more than 10 kg: 30-60 ml syrup / day (2-4 tablespoons).
Adolescents over 16 years of age and adults
45-90 ml of syrup / day (3-6 tablespoons).
The duration of treatment is determined by the doctor.

Side effects of Epistat syrup

The most frequent adverse reactions with fenspiride were observed on the part of the gastrointestinal tract.
The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000), the frequency is unknown (the frequency can not be estimated from the available data).
From the nervous system: rarely - drowsiness; frequency unknown * - dizziness.
From the cardiovascular system: rarely - a moderate tachycardia, the severity of which decreases with a decrease in the dose of Epistat syrup; frequency unknown * - palpitations, decreased blood pressure, possibly associated with tachycardia.
On the part of the digestive system: often - gastrointestinal disorders, nausea, epigastric pain; frequency unknown * - diarrhea, vomiting.
From the skin and subcutaneous tissues: rarely - erythema, rash, hives, angioedema, fixed erythema pigmentosa; frequency unknown * - skin itching, toxic epidermal necrolysis, Stevens-Johnson syndrome.
General reactions: frequency unknown * - asthenia, increased fatigue.
* Data on the registration of fenspiride.
The risk of developing reactions of hypersensitivity to the dye is the sunset yellow, which is part of the preparation.

Overdose

In the case of an overdose (there have been cases of overdose when taking the drug at a dose of more than 2320 mg), the patient should immediately seek medical help.
Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.
Treatment: gastric lavage, ECG monitoring, maintenance of vital body functions.

Drug Interactions

Special studies on the interaction of fenspiride with other drugs have not been conducted.
Given that the use of H1-histamine receptor blockers can enhance sedation, Epistat syrup is not recommended in combination with medications that have a sedative effect, or with ethanol.
Treatment with Epistat syrup should not prevent the initiation of antibiotic therapy.

special instructions for Epistat syrup

When prescribing the drug for patients with diabetes it is necessary to take into account that Epistat syrup contains sucrose: 1 teaspoon (5 ml of syrup) - 3 g of sucrose = 0.3 XE; 1 tbsp. spoon (15 ml of syrup) - 9 g of sucrose = 0.9 XE.
Patients with rare hereditary diseases of fructose intolerance, with impaired absorption of glucose-galactose or with sugar-isomaltase deficiency should not take this drug.
The composition of the drug includes parabens (methyl parahydroxybenzoate and propyl parahydroxybenzoate), so that the use of this drug can provoke the development of allergic reactions, including. deferred.
Epistat syrup contains 0.785% by volume of ethyl alcohol, which corresponds to the content of ethanol in a single dose:
- Children weighing less than 10 kg (5 ml) - 0.031 g;
- Children weighing more than 10 kg (15 ml) - 0.093 g;
- adolescents over 16 years and adults (30 ml) - 0.186 g.
This amount of ethyl alcohol should be taken into account when using the drug in children and patients at high risk: patients with liver disease and epilepsy. Also, the drug should be used with caution in patients with cerebral diseases, patients with a tendency to develop drug dependence.
The drug may have a negative effect on patients suffering from alcoholism.
Impact on the ability to drive vehicles and mechanisms
Studies to study the effect of fenspiride on the ability to drive vehicles and work with mechanisms have not been conducted. Patients should be informed that with the use of Epistat syrup, development of drowsiness is possible, especially at the beginning of therapy or when combined with alcohol intake. Patients should be careful when driving vehicles, as well as when performing work that requires a high rate of psychomotor reactions.

Pregnancy and lactemia

Data on the use of fenspiride in pregnant women are absent or limited. It is not recommended to use Epistat syrup during pregnancy.
Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.
Do not use Epistat syrup during breastfeeding due to the lack of data on the penetration of fenspiride in breast milk.

Application in childhood

Contraindicated in children under 2 years.

Conditions of leave from pharmacies

To buy Epistat syrup you don't need a prescription.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C. Shelf life - 2 years. Do not use after the expiry date printed on the package.
Shelf life after opening the bottle is 28 days.