Instructions for use Inspiron tablets (solution): description, composition, FTG, INN


Release form and composition

Inspiron is available in the form of film-coated tablets and syrup.

Tablets are available in blisters of 10 pieces. One cardboard package contains 3 blisters.

The syrup is available in 150 ml bottles. There is 1 bottle in one cardboard box.

The active ingredient of the drug is fenspiride hydrochloride. 1 tablet contains 80 mg of the active ingredient, 1 ml of syrup - 2 mg.

Excipients in the composition of Inspiron tablets are the following components:

  • Coating mixture;
  • Povidone;
  • Magnesium stearate;
  • Hypromelose;
  • Dihydrate;
  • Colloidal anhydrous silicon dioxide;
  • Calcium hydrophosphate.

In addition to the active ingredient fenspiride hydrochloride, Inspiron syrup also contains the following components:

  • Licorice root extract;
  • Sodium sugar;
  • Vanillin;
  • Glycerol;
  • Purified water;
  • Honey-linden aroma;
  • Rafinated sugar;
  • Potassium sorbate;
  • E 102;
  • E 124;
  • E 216;
  • E 218.

Pharmacological properties

Pharmacodynamics

Inspiron has an anti-inflammatory and antibronchoconstrictor effect, which is based on the following mechanisms:

  • inhibition of histamine H1 receptors, leading to relaxation of bronchial smooth muscles;
  • anti-inflammatory effect, due to which the synthesis of a number of anti-inflammatory factors (cytokines, TNF-a, arachidonic acid metabolites, free radicals, thromboxane, leukotrienes, prostaglandins) that have a bronchoconstrictor effect is reduced;
  • suppression of a1-adrenergic receptors, stimulating the production of viscous mucus by the bronchi.

Pharmacokinetics

The time to reach maximum concentration in the blood after taking the drug is 6 hours. The half-life is 12 hours. The active substance is predominantly excreted from the body in the urine.

Indications for use

According to the instructions, Inspiron is used as part of a complex treatment of inflammatory processes of the respiratory tract and ENT organs in chronic and acute forms, including the following conditions:

  • Sinusitis;
  • Tracheitis;
  • Otitis;
  • Bronchitis;
  • Rhinitis;
  • Rhinopharyngitis;
  • COPD;
  • Bronchial asthma.

Inspiron is used for the symptomatic treatment of pertussis infection, as well as as part of the pathogenetic therapy of respiratory symptoms of infectious diseases of measles and influenza.

The drug is used to treat year-round or allergic seasonal inflammation of the mucous membrane of the nasal cavity, as well as other allergic manifestations of the ENT organs and respiratory tract.

Contraindications

According to the instructions, Inspiron is contraindicated in case of hypersensitivity to one or more components that are part of the tablets or syrup.

Additional contraindications for the use of the product in syrup form are conditions that are accompanied by impaired absorption of sugars. Among them are the following pathologies:

  • Glucose malabsorption;
  • Galactose intolerance;
  • Fructose intolerance;
  • Sucrose intolerance.

Inspiron tablets are contraindicated in children under 14 years of age.

It is not recommended to use the drug during pregnancy and breastfeeding.

Directions for use and dosage

Inspiron in syrup form is intended primarily for children. It should be taken orally before meals after preliminary shaking. It is recommended to divide the daily dose into 2-3 doses. For children under 14 years of age, it should be calculated according to the scheme 4 mg per 1 kg of body weight. It is allowed to mix the drug with baby food. The recommended doses of syrup are as follows:

  • Children weighing up to 10 kg are prescribed a dose of 10-20 ml;
  • For children weighing from 10 to 45 kg, a dose of Inspiron syrup of 75-90 ml is recommended;
  • Adolescents over the age of 14 years and adult patients are usually prescribed the drug in a dose of up to 90 ml.

For adult patients, as a rule, the drug is prescribed in tablet form. They are taken orally before meals. For chronic forms of diseases, a daily dose of 2 tablets is recommended. In this case, the interval between doses should be 12 hours. To enhance the therapeutic effect of Inspiron or in acute forms of illness, it is possible to increase the daily dose of tablets to 3 pieces. In this case, the interval between doses of the drug should be 8 hours.

The duration of treatment with the drug should be determined by the doctor on an individual basis. The minimum course of therapy in cases of acute diseases is 1 week, and in chronic forms of diseases – 2 months.

Inspiron

Name: Inspiron Pharmacological action: Has a pronounced anti-inflammatory effect, prevents bronchial constriction. The anti-inflammatory effect is carried out by reducing the activity of phosphodiesterase A2, inhibiting the synthesis and secretion of pro-inflammatory prostaglandins, leukotrienes and cytokines, suppressing the migration of white blood cells to the site of inflammation and reducing swelling of the respiratory tract mucosa. Binds H1-histamine receptors, has an antispasmodic effect on the smooth muscle layer of the bronchi. Reduces the secretion of mucus from the nose, paranasal sinuses, and the amount of bronchial secretion. Inhibits alpha1-adrenergic receptors, which stimulate the production of viscous mucus.

Indications for use: Complex treatment of inflammatory pathology of the respiratory tract, ENT organs, acute and chronic: rhinitis, sinusitis, otitis, nasopharyngitis, tracheitis, bronchitis, bronchial asthma and COPD. Treatment of allergic seasonal and year-round inflammation of the nasal mucosa, other allergic manifestations of the respiratory tract, ENT organs. Pathogenetic therapy of respiratory symptoms of infectious diseases of influenza, measles. Symptomatic treatment of pertussis infection.

Directions for use: The syrup is taken after preliminary shaking, enterally before meals, dividing the dose into 2-3 doses. For children 0-14 years old, a daily dosage of 4 mg/kg body weight is recommended. Inspiron can be mixed with baby food. Recommended daily doses of syrup for children weighing up to 10 kg are 10-20 ml, for children weighing 10-45 kg - 75-90 ml, for adolescents over 14 years old and adults 75-90 ml. In adults, it is more rational to use the tablet form of Inspiron.

Inspiron tablets are taken enterally before meals. The average therapeutic daily dose for chronic diseases is 2 tablets (the interval between doses is 12 hours). If it is necessary to enhance the effect and/or in case of an acute illness, it is allowed to increase the daily dosage to 3 tablets (administration interval is 8 hours). The duration of the therapeutic course is determined by the doctor. The minimum course of treatment for acute pathologies is one week, for chronic pathologies - two months. Inspiron tablets are intended for adults.

Side effects: Allergic manifestations (very rare): rash, urticaria, erythema, fixed erythema pigmentosa, Quincke's edema. Gastrointestinal manifestations (often): nausea, vomiting, gastric pain, dyspepsia. Cardiovascular manifestations (rare): sinus tachycardia. Manifestations from the nervous system (rare): agitation or drowsiness. General disorders (rare): asthenia, weakness.

Contraindications: Hypersensitivity to the components of Inspiron. For syrup: conditions accompanied by impaired absorption of sugars - fructose, galactose, sucrose, glucose malabsorption. During lactation, use is not recommended.

Pregnancy: Inspiron is not recommended during pregnancy.

Interaction with other drugs: None recorded. Can be used with antibiotics and antipyretics.

Overdose: In case of overdose, nausea, vomiting, dyspepsia, sinus tachycardia, drowsiness, and agitation occur. In case of overdose, discontinue Inspiron, rinse the stomach, carry out symptomatic treatment, and monitor cardiac activity.

Release form: Inspiron syrup in 150 ml bottles. Film-coated tablets, 10 tablets in a blister, packaging - 3 blisters.

Storage conditions: In original packaging at temperatures up to +25 degrees Celsius.

Synonyms: Fenspiride, Erespal.

Composition: 1 ml of syrup contains 2 mg of fenspiride hydrochloride. Excipients: licorice root extract, potassium sorbate, glycerin, sodium saccharin, refined sugar, purified water, vanillin, honey-linden aroma, E 218, E 216, E102, E124.

1 tablet contains fenspiride hydrochloride 80 mg. Additional substances: hypromelose, coating mixture, colloidal anhydrous silicon dioxide, povidone, calcium hydrogen phosphate, dihydrate, magnesium stearate.

Additionally: Inspiron is not a drug that reduces the reaction rate when driving. A teaspoon of syrup contains 3 g of sugar, which is important for those with diabetes and those on a low-calorie diet.

Attention! The description of the drug " Inspiron " on this page is a simplified and expanded version of the official instructions for use. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Side effects

The use of Inspiron in some cases causes the following side effects from the gastrointestinal tract:

  • Nausea;
  • Dyspepsia;
  • Diarrhea;
  • Vomit;
  • Digestive disorder;
  • Epigastric pain.

While using Inspiron, it is possible to develop such a side effect from the cardiovascular system as sinus tachycardia, which goes away after reducing the dose.

On the part of the nervous system, the drug in rare cases causes drowsiness or a state of agitation.

Among the general disorders that can result from the use of Inspiron are weakness and increased fatigue.

The drug can cause the development of the following allergic manifestations:

  • Quincke's edema;
  • Skin rash;
  • Erythema;
  • Hives;
  • Fixed erythema pigmentosa.

Inspiron 80 mg No. 30 tablet p.p.o. extended release.

Instructions for medical use of the drug INSPIRON Trade name Inspiron International nonproprietary name Fenspiride Dosage form Film-coated tablets, prolonged release, 80 mg Composition 1 tablet contains: active substance: fenspiride hydrochloride, calculated as 100% substance 80 mg; excipients: calcium hydrogen phosphate dihydrate; hypromelose (hydroxypropyl methylcellulose); povidone; anhydrous colloidal silicon dioxide; magnesium stearate; shell composition: coating mixture “Opadry II WHITE” 33G28707 (hypromelose (hydroxypropyl methylcellulose); titanium dioxide (E 171); lactose monohydrate; polyethylene glycol (macrogol) 3000; triacetin). Description White film-coated tablets, round in shape, with a biconvex surface. The fracture shows a white or almost white core. Pharmacotherapeutic group Drugs for the treatment of respiratory tract diseases. Other drugs for the treatment of obstructive airway diseases for systemic use. Fenspiride. ATX code R03D X03. Pharmacological properties Pharmacokinetics. Maximum plasma concentrations are achieved on average 6 hours after oral administration. The half-life is 12 hours. Fenspiride is excreted from the body primarily through urine. Pharmacodynamics. Inspiron has bronchodilator and anti-inflammatory properties due to the interaction of several interrelated mechanisms: – blocks H1-histamine receptors and has an antispasmodic effect on the smooth muscles of the bronchi; – has an anti-inflammatory effect, which leads to a decrease in the production of pro-inflammatory factors (cytokines, TNF-a, arachidonic acid derivatives, prostaglandins, leukotrienes, thromboxane, free radicals), some of which also have a bronchoconstrictor effect. Indications for use Cough in diseases of the upper and lower respiratory tract: - nasopharyngitis and laryngitis - otitis and sinusitis - rhinotracheobronchitis - bronchitis - measles - influenza As a maintenance therapy for asthma and its complications. Method of administration and dosage Recommended for use by adults. For oral use. Take before meals. Daily dose. The usual recommended therapeutic dose for the treatment of chronic inflammatory processes is 2 tablets per day (morning and evening). To enhance the effect and/or in case of acute diseases - 3 tablets per day (morning, afternoon and evening). A course of treatment. The duration of treatment depends on the course of the disease and is determined by the doctor individually. For children, the drug is used only in the form of syrup. Side effects According to the frequency of occurrence, adverse reactions are divided into the following categories: very often (>1/10); often (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000). From the cardiovascular system: rarely - moderate sinus tachycardia, which decreases after dose reduction. From the gastrointestinal tract: often - digestive disorders, nausea, stomach pain, frequency unknown - diarrhea, vomiting. From the nervous system: rarely – drowsiness. From the skin and subcutaneous tissue: rarely - erythema, fixed erythema pigmentosa, rash, urticaria, Quincke's edema, frequency unknown - itching. General disorders: asthenia (weakness), fatigue. Contraindications Hypersensitivity to fenspiride or any of the components of the drug. Drug interactions Since fenspiride increases the sedative effect of H1-antihistamines, it is not recommended to combine it with sedatives and alcohol. Special instructions Treatment with the drug does not replace antibiotic therapy. Inspiron should be used with caution in patients with hereditary galactose intolerance, lactase deficiency, or glucose/galactose malabsorption syndrome. Pregnancy and breastfeeding It is not recommended to use the drug during pregnancy or breastfeeding. Use in pediatrics This dosage form is not used in pediatric practice. Peculiarities of the drug's effect on the ability to drive a vehicle or potentially dangerous mechanisms Inspiron may cause drowsiness; caution should be exercised when driving vehicles or other mechanisms, especially at the beginning of therapy. Overdose When taking a large amount of the drug, drowsiness or agitation, nausea, vomiting, and sinus tachycardia may occur. Treatment. It is necessary to rinse the stomach and monitor the electrocardiogram. Apply symptomatic therapy. Release form and packaging 10 tablets each in a blister pack of polyvinyl chloride film and aluminum foil with a varnished print. 3 blister packs together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store in original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life 2 years. Conditions for dispensing from pharmacies By prescription. , Ukraine, 01032, Kyiv, st. Saksaganskogo, 139. Address of the organization that accepts claims from consumers regarding product quality on the territory of the Republic of Kazakhstan: Representative office of the Arterium Corporation in the Republic of Kazakhstan 050060, Almaty, Al-Farabi Avenue, 97, 3rd entrance, office “54” Tel/ Fax;; E-mail

special instructions

The use of Inspiron can be combined with the use of antipyretic drugs and various antibiotics. Concomitant use of the drug with sedatives is not recommended.

In cases where doses recommended in the drug instructions are exceeded, side effects such as nausea and vomiting, agitation or drowsiness, sinus tachycardia and dyspepsia may occur. In such situations, the use of the drug must be stopped, gastric lavage and symptomatic therapy must be carried out.

Inspiron does not affect the ability to drive vehicles or the speed of psychomotor reactions when engaging in potentially hazardous activities.

1 teaspoon of syrup contains 3 g of sugar, which must be taken into account in patients with diabetes and on a low-calorie diet.

The drug is dispensed from pharmacies with a doctor's prescription.

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