Reglisam granules for preparation of oral solution for children 25mg, sachets 30pcs

Composition

Composition per packageactive substance: Glycyrama (Ammonium glycyrrhizinate) in terms of 100% substance – 0.025 GW of auxiliary substances: Sodium hydrocitrate (di-substituted) – 0.050 g Potato starch-0.010 g Milk sugar (lactose monohydrate – – 1.215 g Mass of granules in a package-1.3 g

Pharmacological action

Pharmacotherapy group Anti-inflammatory agent Pharmacological properties It has an anti-inflammatory, moderate expectorant effect, stimulates the function of the adrenal cortex.

Indications

Respiratory tract diseases with difficult sputum discharge, including mild forms of bronchial asthma (as part of complex therapy). Allergic dermatitis, eczema, Addison’s disease [diencephalic-pituitary forms, alone and in combination with adrenocorticotropic hormone (ACTH)], asthenic conditions and hypotonic syndrome, hypofunction of the adrenal cortex against the background of long-term therapy with glucocorticosteroids, including prevention of withdrawal syndrome during the period of discontinuation of treatment with glucocorticosteroids or reducing their dosage.

Contraindications

Hypersensitivity to the components of the drug, severe organic lesions of the heart and parenchymal organs, impaired liver and kidney function, age up to 5 months, lactase deficiency, lactose intolerance, glucose-galactose malabsorption. If you have one of these diseases, be sure to consult your doctor before taking the drug.

Side effects

Possible allergic reactions. In this case, the drug should be discontinued. If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

It is possible to increase the effect of drugs that stimulate the function of the adrenal cortex.

How to take, course of use and dosage

Inside 30 minutes after eating in the form of an aqueous solution, which is prepared before use by dissolving the contents of one package (1.3 g) in 1 tablespoon (15 ml) of warm boiled water (single dose). The drug is prescribed to children in accordance with age:

• from 5 months to 3 years-2 times a day;
• from 3 to 5 years-3 times a day;
• from 5 to 10 years-3-4 times a day.

The course of treatment is from 3 to 30 days. Repeated courses are possible in consultation with the doctor. Children over 10 years of age are prescribed 50 mg tablets in dosage form.

Overdose

Possible liver dysfunction. Treatment is symptomatic.

Description

Granules for the preparation of a solution for oral use (orange)are white, homogeneous, without agglomerates, with an orange smell.

Functional features

Suction and distribution

Absorption is high. Oral bioavailability is 10%, which is due to the pronounced effect of “first pass” through the liver. The time to reach_cmax in blood plasma is 1-3 hours.

Binding to plasma proteins is 50%. Penetrates the placental barrier. There are no data on the ability of acetylcysteine to cross the BBB and be excreted in breast milk.

Metabolism and elimination

It is rapidly metabolized in the liver to form a pharmacologically active metabolite-cysteine, as well as diacetylcysteine, cystine and mixed disulfides.

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T_1/2 is about 1 h

. Pharmacokinetics in special clinical cases

Impaired liver function leads to an extension of T_1/2 to 8 hours.

Special instructions

Patients with diabetes mellitus and people on a low-carb diet should take into account that one package of the drug contains about 1.22 g of carbohydrates (0.1 XE). With caution for diabetic patients. Use during pregnancy and lactation is not applicable. The drug is intended for use in children under 10 years of age. The effect on the ability to drive a car and work with mechanisms is not applicable. The drug is intended for use in children under 10 years of age.

Form of production

Granules for the preparation of an oral solution for children 25 mg. 1.3 g each in bags made of polyethylene-coated packaging paper or laminated paper. 10 or 30 bags together with instructions for use in a cardboard pack.

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25 C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Ammonium Glycyrrhizinate

Description

Children older than 6 months, For children

Indications

Bronchial Asthma, Dermatitis, Bronchitis, Eczema