Amkesol

Instruction manual

For medical use of the drug

Structure:

Active ingredients: 1 tablet contains: Ambroxol hydrochloride (in terms of 100% substance) 15 mg (mg); ketotifen hydrofumarate (in terms of 100% substance) 1 mg (mg); licorice root dry extract (extracum glycyrrhizae aqua siccum) (4.8–5.5: 1) (extractant - aqueous ammonia) 10 mg (mg), (in terms of glycyrrhizic acid) 0.8 mg (mg); theobromine (in terms of 100% substance) 50 mg (mg);

excipients: microcrystalline cellulose, croscarmellose sodium, potato starch, calcium stearate.

Dosage form.

Tablets.

Basic physico-chemical properties: tablets of a cylindrical shape from light yellow to gray-yellow with a brownish tint; inclusions of different sizes and colors are detected.

Pharmacotherapeutic group.

Antitussive drugs and mucolytics. code atx r05f b01.

Pharmacological properties.

Amkesol is a mucolytic and expectorant bronchodilator with pronounced anti-inflammatory and anti-allergic activity. each component of the drug has certain pharmacological properties.

Ambroxol hydrochloride.

Pharmacodynamics

Ambroxol hydrochloride - a secretolytic and secretory agent from the benzylamine group, stimulates serous cells of the glands of the bronchial mucosa, which leads to increased secretion of mucus and a change in the ratio of serous and mucous components of sputum; activates hydrolytic enzymes and increases motor activity of the ciliated epithelium of the bronchi; promotes the separation of pathological secretion from the walls of the bronchi and its removal from the respiratory tract; increases the content of surfactant in the lungs and prevents its destruction in pneumocytes, which helps to improve the drainage function of the lungs.

Pharmacokinetics

With the oral administration of ambroxol, the hydrochloride is rapidly and completely absorbed, penetrates well into the lung tissue. The maximum concentration of ambroxol hydrochloride in blood plasma is determined 2 hours after oral administration. Metabolized in the liver. The elimination half-life makes 10-12 hours; excreted in the urine.

Ketotifen hydrofumarate.

Pharmacodynamics

Ketotifenum hydrofumarate exhibits antiallergic activity by inhibiting the action of endogenous inflammatory mediators and the release of allergy mediators (histamine, leukotrienes), prevents the sensitization of eosinophils by cytokines, which inhibits the migration of eosinophilic granulocytes to the focus of inflammation, which prevents the development of hypertension and prevents the development of hypertensive factors allergens. Ketotifen hydrofumarate prevents the development of bronchospasm and has anti-asthma properties.

Pharmacokinetics

Ketotifenum hydrofumarate when ingested is absorbed almost completely; bioavailability is 50%. The maximum concentration of ketotifen hydrofumarate occurs in 2–4 hours, the half-life is biphasic and is 3-5 hours and 21 hours, respectively. The metabolism of ketotifen hydrofumarate occurs in the liver.

Licorice root extract.

Licorice root extract has an expectorant, anti-inflammatory and antispasmodic effect. Glycyrrhizic acid has anti-inflammatory properties. Likviritozide (flavonoid glucoside) and 2,4,4-trioxychalcon act as antispasmodics.

Pharmacokinetics

The pharmacokinetics of the extract has not been studied in detail.

Theobromine.

Theobromine - 3,7-dimethylxanthine, an alkaloid of the purine base group. Causes weak stimulation of the central nervous system (CNS), cardiac activity; increases the concentration of CAMP in the tissues, which leads to the expansion of the bronchi, increased mucociliary clearance, improved bronchopulmonary circulation and inhibition of the release of mediators of anaphylactic reactions.

Pharmacokinetics

Theobromine is absorbed quickly and completely. Plasma concentration is reached after 15-45 minutes. It easily penetrates into all body tissues, including the central nervous system. Metabolized in the liver.

Clinical characteristics.

Indications.

Acute and chronic diseases of the respiratory tract, accompanied by difficult separation of viscous sputum.

Contraindications

Amkesol should not be used in patients with a known hypersensitivity to ambroxol hydrochloride or to other components of the drug.

Peptic ulcer of the stomach and duodenum.

Interaction with other drugs and other types of interactions.

The simultaneous use of amkesol increases the effectiveness of ampicillin and amoxicillin in diseases of the respiratory tract by increasing their concentration in lung tissues. Amkesol potentiates the action of theophylline, enhances the effect of sleeping pills, sedatives, antihistamines.

With simultaneous use with oral antidiabetic agents, a reversible decrease in platelet count is possible.

Use with oral antidiabetic agents can lead to thrombocytopenia.

Features of the application.

Before use, consult a doctor.

Treatment of patients with hypertension should be carried out under the supervision of a physician.

Ketotifen can lower the seizure threshold, so it should be used with caution in patients with epilepsy.

Severe skin lesions have been reported: erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis (Lyell syndrome), and acute generalized exanthematous pustulosis associated with the use of ambroxol hydrochloride. If there are signs of progression of the rash on the skin (sometimes associated with the appearance of vesicles or damage to the mucous membrane), immediately stop treatment with Ambroxol hydrochloride and seek medical help.

Also at the initial stage of Stevens-Johnson syndrome or Lyell syndrome, patients may have non-specific symptoms similar to signs of the onset of the flu, such as fever, aches, rhinitis, cough and sore throat. Erroneously, with such nonspecific symptoms similar to signs of the onset of influenza, symptomatic treatment with cough and cold preparations can be used. Therefore, when new lesions of the skin or mucous membranes appear, you should immediately seek medical help and stop treatment with the drug.

Since Ambroxol can enhance mucus secretion, Amkesol, tablets, should be used with caution in case of impaired bronchial motility and increased mucus secretion (for example, with such a rare disease as primary ciliary dyskinesia), due to the possibility of secretion.

Patients with impaired renal function or severe liver failure should take Amkesol tablets, only after consulting a doctor. When Ambroxol is used, like any active substance that is metabolized in the liver and then excreted by the kidneys, the metabolites accumulate in the liver in patients with severe renal failure.

Use during pregnancy or lactation.

The drug is contraindicated during pregnancy or lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

During the use of the drug, one should refrain from driving vehicles, performing work with potentially dangerous mechanisms requiring increased attention and reaction speed.

Dosage and administration.

Recommended for adults and children from 12 years.

For oral use after meals.

Daily dose. The usual recommended therapeutic dose for treatment is 1 tablet 3 times a day (morning, day, evening).

The course of treatment is from 4 to 14 days. The duration of treatment depends on the indications for use, the course of the disease and is determined by the doctor.

Children.

Assign to children from 12 years.

Overdose.

Epigastric pain, nausea, vomiting; drowsiness, disorientation, confusion; tachycardia, arterial hypotension; cramps, especially in children.

Treatment: flush the stomach, consult a doctor. Symptomatic Therapy

Adverse Reactions

General disorders: reactions from the mucous membranes, fever.

From the immune system, skin and subcutaneous tissue: skin rash, urticaria, angioedema, pruritus, anaphylactic reactions, including anaphylactic shock, other allergic reactions, erythema, severe skin lesions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyells syndrome), acute generalized exenthematous pustulosis, angioedema, erythema multiforme.

From the gastrointestinal tract: nausea, vomiting, dyspepsia, abdominal pain, dry mouth, diarrhea, constipation, salivation, possibly increased activity of liver enzymes, increased body weight, dry throat.

From the respiratory system: rhinorrhea, dyspnea (as a hypersensitivity reaction).

From the urinary system: dysuria.

Infections: cystitis.

From the cardiovascular system: slight arterial hypertension is possible.

From the side of the central nervous system: drowsiness, dry mouth and slight dizziness, which on its own disappears with continued treatment, sometimes, very rarely, especially in children, increased irritability, insomnia, irritability, dysgeusia are possible.

Reported Suspected Adverse Reactions

Reporting suspected adverse reactions in the post-registration period of the drug is important because it provides an opportunity to continue monitoring the benefit / risk ratio of the drug. Health professionals are asked to report any suspected adverse reactions.

Shelf life.

3 years.

Do not use after the expiration date indicated on the package.

Storage conditions.

Store at a temperature not exceeding 25 os.

Keep out of the reach of children.

Packaging.

10 tablets in a blister; 2 blisters in a pack of cardboard.

20 tablets per blister; 1 blister in a pack of cardboard.

Vacation category.

On prescription.

Manufacturer.

Pao "chemical farm" red star ".

The location of the manufacturer and the address of the place of business.

61010, Ukraine, Kharkov, st. Gordienkovo, 1.