The drug fenspiride. Fenspiride hydrochloride: trade names, instructions for use Use in childhood

Fenspiride is a modern pharmacological agent, the use of which helps relieve. Has an anti-inflammatory effect. Refers to bronchodilators and is used in the treatment of bronchial asthma and inflammation respiratory tract.

Release form

The drug Fenspiride is available in tablets with film-coated and in the form of syrup. Tablets are packaged in cardboard packaging of 30, 20 or 10 pieces. This medicine is sold in jars containing from 10 to 100 tablets (depending on the packaging format).

The syrup is available in plastic bottles containing 150 ml of medicine. Instructions are attached to the medicine in any form.

Composition of the drug

One tablet contains 80 mg of fenspiride hydrochloride. This is the active substance. The auxiliary components are:

  • calcium dihydrogen phosphate;
  • hypromellose;
  • povidoneK25;
  • colloidal silicon dioxide;
  • Magnesium stearate.

1 ml of syrup contains 2 mg of active substance. Auxiliary components included in this release form:

  • hydrochloric concentrated acid;
  • methyl parahydroxybenzoate;
  • glycerol;
  • sugar;
  • potassium sorbate;
  • propyl parahydroxybenzoate;
  • flavoring

Mechanism of drug action

The drug Fenspiride reduces the production of biological substances that are actively involved in the development of inflammation and bronchospasm. The main property is associated with antagonism with bradykinin, serotonin, histamine (H-1 receptors). Blocks α-adrenergic receptors, which, when stimulated, provoke an increase in the secretion of the bronchial glands. Has an antispasmodic papaverine-like effect.

The instructions for use indicate that Fenspiride does not have an antibacterial effect and cannot replace an antibiotic in cases where there are indications for its use.

Fenspiride is characterized by rather slow absorption when it enters the gastrointestinal tract. Only 6 hours after administration the maximum concentration is reached. Half-life occurs within 12 hours. About 90% of the substance is excreted through the kidneys, another 10% through the intestines.

Indications for use of Fenspiride

The drug Fenspiride is prescribed for the diseases specified in the instructions:

  • asthma;
  • bronchitis (acute and chronic);
  • tonsillitis;
  • sinusitis (acute and chronic);
  • pharyngitis, nasopharyngitis (chronic and acute);
  • rhinitis;
  • tracheitis;
  • laryngitis.








This medicine is used as directed for symptoms of respiratory tract inflammation caused by influenza, whooping cough, or measles. It is a means for maintenance therapy of complicated and isolated bronchial asthma.

Dosage of the drug

The drug Fenspiride is intended for oral use. Dosage depends on dosage form and the age of the patient.

Before using the drug, consult your doctor

Fenspiride tablets are prescribed to adult patients. The standard dose is 1 tablet 2 times a day. This is indicated in the instructions. In case of a complex course of the disease, the doctor may prescribe a third daily dose to enhance the effect. The duration of the course is determined by the doctor, taking into account the type and degree of the disease.

Syrup

Fenspiride syrup is prescribed to both adults and children. Adults are recommended to take about 80 mg of the active substance. This dose corresponds to 50–90 mg of syrup.

When prescribing Fenspiride to children, the dosage is calculated according to the instructions depending on the child’s weight: per 1 kg of weight = 4 mg of syrup. Small children who weigh up to 10 kg are given 10–20 mg of liquid Fenspiride per day. This is 2, 3 or 4 teaspoons. Daily dose for older children, the dose is from 30 to 60 mg of syrup.

For convenience, the liquid product can be diluted in milk or juice. For babies, add the medicine to a bottle of drink or baby food.

Features of application

Fenspiride has an antibronchoconstrictor effect and does not replace antibiotics. If the disease requires antibiotic therapy, it must be started immediately.

To date, there is no reliable data confirming or denying the fact that the components of Fenspiride are excreted in breast milk. Therefore, this medicine is not yet recommended for nursing women.

During the experimental study this tool Undesirable changes in fetal development have been identified in animals. The effect of Fenspiride on human intrauterine development has not yet been determined by research. Pregnant women are currently contraindicated to take this medicine.

Contraindications for use

Fenspiride tablets are contraindicated in children under 14 years of age. In any form, the medicine is contraindicated if you are allergic to the main active ingredient. The instructions also state that the drug should not be used during pregnancy and breastfeeding.

Side effects

Side effects when taking Fenspiride sometimes include nausea, indigestion, and vomiting. In special cases, work is disrupted of cardio-vascular system, which provokes tachycardia. Some patients experience drowsiness or, on the contrary, nervous overexcitation. Allergic reactions are also possible. They can occur in the form of a rash, pigmentation, swelling of the face or limbs, and erythema. Taking Fenspiride, among others side effects, may be accompanied by fatigue and drowsiness.



When taking the syrup, urticaria sometimes occurs as a side effect. The occurrence of negative side effects, regardless of whether they are indicated in the instructions for use or not, means that taking the drug must be stopped immediately. To select an analogue medicine, you should consult a doctor.

Interaction with other pharmaceuticals

Since Fenspiride has a sedative effect, when taking it it is better to discontinue other drugs in this category. If this is not possible, increased sedation should be considered drug group, and do not plan to drive vehicles or other activities that require increased concentration.

Drug overdose

An overdose is accompanied by such phenomena as vomiting, sinus tachycardia, drowsiness or agitation. To eliminate the consequences of an overdose, gastric lavage and medicinal maintenance of vital body functions are necessary. To monitor the patient's condition, ECG monitoring is carried out.

Medicinal analogues

Fenspiride itself, produced by various manufacturers, is sold under other names - Amispiron, Sinuspal, Bronchomax, Inspiron,. There are other drugs to relieve bronchial spasm and treat infections in the mucosa respiratory organs, the active ingredient in which is fenspiride.

A drug with a bronchodilator effect, eliminating swelling of the mucous membrane and inflammation. Produced in tablet form by a Russian manufacturer.

The instructions for use of this drug indicate that it is anti-inflammatory and bronchodilator. Suitable for relieving swelling and inflammation of the bronchial glands. This is an antihistamine with antispasmodic myotropic activity.

Long-acting tablets. According to the instructions, the use of this drug helps with inflammatory diseases of the respiratory tract and bronchial asthma in combination with other pharmaceuticals.

Bronchicum

If Fenspiride is not effective enough in eliminating the inflammatory disease, it can be replaced with a stronger one. This medicine costs more, but is more active. Available in the form of lozenges. Manufacturer – Germany.

A well-known and proven drug for the treatment of respiratory tract inflammation. Available in tablets and syrup form. It has an expectorant and mucolytic effect. The active ingredient is Ambroxol, produced in Russia.

Flavored syrup for the treatment of acute and chronic diseases of the respiratory organs. The instructions for use indicate that its use is approved for relieving inflammation in young children.

This medicine is sold in the form of granules intended for preparation of a suspension immediately before use. The cooking method is described in the instructions. Fluifort is indicated for the treatment of various diseases of the respiratory organs, accompanied by too much mucus secretion.

Tablets with mucolytic, expectorant and bronchodilator effects. The instructions list the following indications for use: bronchial asthma, tuberculosis, pneumoconiosis, whooping cough, pneumonia, bronchitis.

  • Fenspiride

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Release form:

Release form, description and composition

Film-coated tablets light yellow, round, biconvex; on a cross section, the core is white or almost white.

Excipients: calcium hydrogen phosphate dihydrate - 104.5 mg, hypromellose - 100 mg, crospovidone - 12.8 mg, colloidal silicon dioxide - 0.5 mg, magnesium stearate - 2.2 mg.

Shell composition: opadry II yellow 85F32771 (polyvinyl alcohol 35 - 49%, talc - 9.8 - 25%, macrogol 3350 7.35 - 35.2%, titanium dioxide and iron oxide yellow - 15.15 - 30%)

10 pieces. - contour cell packaging (3) - cardboard packs.
15 pcs. - contour cell packaging (2) - cardboard packs.
30 pcs. - bottles made of polyethylene terephthalate (1) - cardboard packs.

Pharmacotherapeutic group:

  • Intermediates

Pharmacological properties:

Pharmacodynamics

A drug with bronchodilator and anti-inflammatory effects. Reduces the manifestations of bronchospasm and inflammation in the respiratory tract. The mechanism of action is associated with antagonistic activity towards histamine H1 receptors and myotropic antispasmodic activity. Reduces the production of a number of biologically active substances involved in the development of inflammation and contributing to increased bronchial tone (including cytokines, TNFα, arachidonic acid derivatives, free radicals).

Pharmacokinetics

Well absorbed from the gastrointestinal tract. Cmax is reached 6 hours after administration and decreases 3 times after 12 hours. It is excreted mainly by the kidneys (90%), through the intestines – 10%. T 1/2 - 12 hours.

Indications for use:

Rhinopharyngitis, laryngitis, otitis, sinusitis, rhinotracheobronchitis, bronchitis, maintenance therapy for isolated and complicated bronchial asthma, respiratory symptoms in measles, whooping cough, influenza.

Refers to diseases:

  • Bronchitis
  • Flu
  • Whooping cough
  • Laryngitis
  • Otitis
  • Sinusitis

Contraindications:

Hypersensitivity to fenspiride, pregnancy, lactation, children under 18 years of age (for tablets), children under 2 years of age (for syrup).

Formula: C15H20N2O2, chemical name: 8-(2-Phenylethyl)-1-oxa-3,8-diazaspiro-decan-2-one (as hydrochloride).
Pharmacological group: intermediates/ histaminergic agents/ histaminolytics/ H1-antihistamines.
Pharmachologic effect: anti-asthmatic, bronchodilator, antihistamine, anti-inflammatory.

Pharmacological properties

Fenspiride blocks H1-histamine receptors and is an antagonist of inflammatory mediators (histamine, serotonin, bradykinin), and has an antispasmodic papaverine-like effect. Fenspiride in high doses reduces the formation of pro-inflammatory agents (tumor necrosis factor alpha, cytokines, free radicals, arachidonic acid metabolites), some of which have a bronchoconstrictor effect. Fenspiride is well absorbed into gastrointestinal tract, the maximum concentration is achieved after 2.3 hours when taking syrup and 6 hours when taking tablets; The half-life of fenspiride is 12 hours. Excreted by the intestines (10%) and kidneys (90%). In experimental studies, a risk of teratogenic effects (development of cleft palate) was found.

Indications

Rhinopharyngitis, rhinotracheobronchitis, laryngitis, sinusitis, otitis, bronchospastic syndrome, chronic bronchitis with respiratory failure, bronchial asthma (maintenance treatment), respiratory disorders due to whooping cough, measles, influenza.

Method of administration of fenspiride and dose

Fenspiride is taken orally. Adults, before meals: 2–3 times a day, 80 mg or 3 times a day, 45–90 ml of syrup. Children (only in the form of syrup) - with a body weight up to 10 kg - 10–20 ml per day (can be added to a bottle with food), with a body weight over 10 kg - 30–60 ml daily, before meals.
Sunset yellow S, which is included in the syrup as a dye, can cause the appearance of allergic reactions, including bronchospasm (especially in people who are hypersensitive to aspirin).

Contraindications for use

Hypersensitivity, for tablets up to 14 years of age.

Restrictions on use

Breastfeeding, pregnancy.

Use during pregnancy and breastfeeding

Taking fenspiride during pregnancy is possible if the expected effects of treatment are higher than the possible risk to the fetus. The use of fenspiride during breastfeeding is not recommended.

Side effects of fenspiride

Nervous system: excitement, drowsiness;
circulatory system: tachycardia (rare);
digestive system: nausea, abdominal pain, dyspepsia, vomiting;
allergic reactions (very rare): Quincke's edema, erythema, rash, fixed erythema pigmentosa, urticaria (due to the presence of parahydroxybenzoate in the syrup).

Interaction of fenspiride with other substances

No data.

Overdose

An overdose of fenspiride causes agitation or drowsiness, sinus tachycardia, nausea, and vomiting. Necessary: ​​gastric lavage, ECG monitoring, maintenance of vital functions.

The same active ingredient may have different trade names. Manufacturers of drugs and their prices also differ. Despite this, the same component has an identical effect on the human body in different medications. This article will discuss a compound such as fenspiride hydrochloride. What it is and what it is used for, we will find out further. We will also find out what this component is called and what method of application they have.

Trade names

Fenspiride hydrochloride is available in different forms. Pharmacy chains offer the purchase of tablets and syrups (suspensions). The trade names of such drugs are as follows:

  • "Erespal";
  • "Siresp";
  • "Eladon";
  • "Erispirus";
  • "Epistat";
  • "Fenspiride";
  • “Codesteam” and so on.

These medications have bronchodilator, expectorant, antihistamine and anti-inflammatory effects. You can purchase the products without a special prescription from a doctor at an affordable price.

Purpose of the active substance and contraindications

Due to the fact that fenspiride hydrochloride is a bronchodilator, it is used for pneumonia, bronchitis, laryngitis and other diseases accompanied by cough. The instructions describe more indications. If you study the information for the previously mentioned medications, you can say that they are prescribed for:

  • otitis media of various origins;
  • tracheitis, rhinotracheobronchitis;
  • bronchial asthma, whooping cough;
  • viral and bacterial infections respiratory tract, flu.

Persons who are hypersensitive to it should avoid therapy with the active substance called fenspiride hydrochloride. Each drug has additional components. If the patient is allergic to them, then this must also be taken into account. The medicine in tablet form is prohibited for use in children under 14 years of age. It is preferable to give children a suspension.

Fenspiride hydrochloride: instructions

The method of using a particular drug depends on the dosage. Adult patients are prescribed 80 mg of the active ingredient per day. This volume can range from 1 to 4 tablets. For children, the dose is selected according to body weight. Always pay attention to how many milligrams of the main substance are in 1 milliliter of the drug.

Effect of the drug: positive and negative

The abstract states that the drug "Fenspiride hydrochloride" (including analogues) can cause adverse reactions. More often it is an allergy. But some patients experience abdominal pain, increased excitability, and insomnia. To eliminate these unpleasant symptoms, it is enough to stop taking the medicine.

After use, the medication is quickly absorbed into the bloodstream. The active substance blocks histamine receptors, relieves inflammation (being an antagonist of mediators). Fenspiride also has an antispasmodic effect.

What do they say about the drug?

Patients often ask the question: “Is fenspiride hydrochloride an antibiotic?” Doctors give a negative answer to it. The drug does not have an antimicrobial effect. He's just filming inflammatory process, eliminates allergic reactions and spasms. As a result, the product does not have a negative effect on the intestinal microflora.

Patients say that the medicine in syrup form contains sweeteners. Due to this, the suspension has a pleasant taste. Children take the drug with pleasure and do not refuse treatment. This is an advantage of the medication.

Using the drug quickly leads to recovery. Improvement becomes noticeable after just a few days of use. At the same time, you should not quit therapy, believing that recovery has occurred. You need to take the drug for the time determined by the specialist.

Doctors say that the active ingredient fenspiride hydrochloride combines well with other medications. It can be taken with antibiotics, antiviral drugs, and vitamin complexes. Often these drugs are used simultaneously with inhalations. A complex prescription allows you to get a quick effect from therapy.

Conclusion

The active substance called fenspiride hydrochloride has different shapes release and names of drugs. It is used for treatment various diseases. The composition of the drug in the form of a suspension includes a dye. Therefore, caution must be exercised with this form of medication. Monitor your child's condition carefully and if allergies occur, consult a doctor. Do not be ill!

Fenspiride (tablet form) corresponds to the group of drugs for the treatment of bronchial asthma. The medicine is characterized by the following application features:

  • Sold only with a doctor's prescription
  • During pregnancy: contraindicated
  • When breastfeeding: contraindicated

Package

Fenspiride is a drug that has anti-inflammatory and antibronchoconstrictor effects.

Release form and composition

Dosage forms:

  • film-coated tablets: round, biconvex, almost white or white; the core on the cross section is almost white or white (in a cardboard pack there are 1–6 or 10 contour strip packs of 10, 20 or 30 tablets or 1 jar of 10, 20, 30, 40, 50, 60 or 100 tablets);
  • syrup: transparent orange or orange with a brown tint; a precipitate may form, which disappears when the bottle is shaken (in a cardboard box there is 1 plastic bottle of 150 ml each).

Composition of 1 tablet:

  • active substance: fenspiride hydrochloride – 80 mg;
  • auxiliary components: calcium hydrogen phosphate dihydrate – 118 mg; hypromellose – 106 mg; povidone K25 – 13 mg; colloidal silicon dioxide – 1 mg; Magnesium stearate – 2 mg;
  • shell: hypromellose – 4.7 mg; macrogol 4000 – 0.9 mg; titanium dioxide – 1.15 mg; Magnesium stearate – 0.25 mg.

Composition of 1 ml syrup:

  • active substance: fenspiride hydrochloride – 2 mg;
  • auxiliary components: concentrated hydrochloric acid, methyl parahydroxybenzoate, glycerin, granulated sugar, potassium sorbate, propyl parahydroxybenzoate, Honey flavor, Orange yellow dye E110, purified water.

Pharmacological properties

Pharmacodynamics

Fenspiride has an anti-inflammatory and antibronchoconstrictor effect, which is associated with a decrease in the production of a number of biologically active substances [cytokines, especially tumor necrosis factor alpha (TNF-α), arachidonic acid derivatives, free radicals], which play an important role in the development of bronchospasm and inflammation.

The suppression of arachidonic acid metabolism by fenspiride is potentiated by its H1-antihistamine effect, since histamine stimulates the formation of its products (leukotrienes and prostaglandins). In addition, the substance blocks α-adrenergic receptors, the stimulation of which occurs with an increase in the secretion of the bronchial glands. Thanks to the use of the drug, the development of inflammation and bronchial obstruction is inhibited.

Fenspiride also has antispasmodic properties.

Pharmacokinetics

Absorption of fenspiride occurs relatively slowly in the gastrointestinal tract. After oral administration, maximum concentration is reached after 6 hours.

The half-life of fenspiride is 12 hours. Excreted mainly by the kidneys (approximately 90%).

Indications for use

  • diseases of the upper and lower respiratory tract: laryngitis, nasopharyngitis; tracheobronchitis; respiratory phenomena (in the form of cough, hoarseness, sore throat) against the background of measles, whooping cough and flu; bronchial asthma (simultaneously with other drugs); bronchitis with/without chronic respiratory failure; infectious diseases respiratory tract, accompanied by cough, in cases where standard antibiotic therapy is indicated;
  • sinusitis and otitis media of various etiologies.

Contraindications

  • pregnancy and breastfeeding;
  • age up to 2 years – syrup;
  • age up to 18 years – tablets;
  • glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase deficiency - syrup;
  • the presence of individual intolerance to the components included in the drug.

Instructions for use of Fenspiride: method and dosage

Fenspiride syrup and tablets should be taken orally, preferably before meals. The bottle of syrup must be shaken before use.

Frequency of application – 2–3 times a day.

Adults are prescribed 1 tablet of Fenspiride, maximum 3 tablets per day.

  • adults and children over 12 years old: 45–90 ml;
  • children 2–12 years old: 4 mg/kg (2 ml/kg): with body weight up to 10 kg – 10–20 ml (can be added to food); more than 10 kg – 30–60 ml.

The duration of therapy is determined by the doctor.

Side effects

Most often, during therapy, the development of disorders of the digestive system is noted.

Possible adverse reactions (> 10% - very common; > 1% and< 10% – часто; >0.1% and< 1% – нечасто; >0.01% and< 0,1% – редко; < 0,01% – очень редко; с неустановленной частотой – в случаях, когда на основании имеющихся данных установить частоту развития adverse reactions it is forbidden):

  • nervous system: rarely – drowsiness; with an unknown frequency – dizziness;
  • heart: rarely - moderate tachycardia (with a decrease in the dose of the drug its severity decreases); with an unknown frequency – feeling of heartbeat, decreased blood pressure(may be associated with tachycardia);
  • digestive system: often – nausea, gastrointestinal disorders, epigastric pain; with unknown frequency – vomiting, diarrhea;
  • skin and subcutaneous tissues: rarely - angioedema, rash, erythema, urticaria, fixed erythema pigmentosa; with an unknown frequency - toxic epidermal necrolysis, pruritus, Stevens-Johnson syndrome;
  • general disorders: with unknown frequency – increased fatigue, asthenia.

The severity and frequency of side effects may vary depending on the dosage form of the drug.

Overdose

There is evidence of cases of overdose when taking Fenspiride in doses greater than 2320 mg.

Main symptoms: agitation/drowsiness, sinus tachycardia, vomiting, nausea.

Therapy: gastric lavage, maintaining vital body functions, electrocardiogram monitoring. In case of overdose, you should seek medical help.

special instructions

Application of Fenspiride antibacterial therapy does not replace. Taking the drug should not be a reason for postponing an adequate prescription medicines with antibacterial effect.

The syrup contains sugar. One teaspoon of the drug contains 3000 mg of sucrose, which corresponds to 0.3 XE (bread units).

Fenspiride syrup contains parabens (propyl parahydroxybenzoate and methyl parahydroxybenzoate), which can lead to the development of allergic reactions, including delayed ones.

Impact on the ability to drive vehicles and complex mechanisms

While taking Fenspiride, patients should take into account the possibility of developing drowsiness, especially at the beginning of the course or in combination with alcohol. You must be careful when driving vehicles.

Use during pregnancy and lactation

According to the instructions, Fenspiride is contraindicated during pregnancy/lactation.

Use in childhood

Fenspiride therapy is contraindicated:

  • syrup – up to 2 years;
  • tablets – up to 18 years of age.

Drug interactions

The combined use of Fenspiride with drugs that have a sedative effect, as well as with alcohol, should be avoided, which is associated with the likelihood of increased sedation.

Analogues

Analogs of Fenspiride are: Epistat, Erispirus, Erespal, Siresp, Eladon, Thespalen.

Terms and conditions of storage

Store in a place protected from light at temperatures up to 25 °C. Keep away from children.

Shelf life – 3 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

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