Ambrobene Stopussin drops, 25ml

Dry, irritating, difficult to stop cough of various etiologies; relief of cough in the pre- and postoperative period.

Inside, after eating.

The corresponding number of drops are dissolved in 100 ml of liquid (water, tea, fruit juice). The dose depends on the body weight:

• up to 7 kg - 8 drops 3-4 times a day;

• 7-12 kg - 9 drops 3-4 times a day;

• 12Ц20 kg - 14 drops 3 times a day;

• 20-30 kg - 14 drops 3-4 times a day;

• 30-40 kg - 16 drops 3-4 times a day;

• 40-50 kg - 25 drops 3 times a day;

• 50Ц70 kg - 30 drops 3 times a day;

• 70Ц90 kg - 40 drops 3 times a day.

1 ml of the preparation contains
active ingredients : guaifenesin 0.100 g, butamirate citrate 0.004 g;
excipients : ethanol 96% 0.300 g, floral aroma (alpine flowers aroma) 0.002 g, purified water 0.007 g Polysorbate-80 0.001 g, liquorice extract liquid 0.003 g, propylene glycol up to 1,000 ml.

Hypersensitivity to the components of the drug, children up to 6 months of age, the first trimester of pregnancy, myasthenia gravis.

Pharmacotherapeutic group:

antitussive agent + expectorant

Pharmacological properties

Pharmacodynamics

Combined drug that has an anti-cough and expectorant effect.
Butamirate has a peripheral local anesthetic effect on the sensitive nerve endings of the bronchial mucosa, which provides an antitussive effect.
Guaifenesin increases the secretion of the bronchial glands and reduces the viscosity of mucus. An increase in secretion is caused both by a direct effect on the bronchial glands - by stimulating the secretion of secretions from the bronchial glands and the removal of acidic glycoproteins from acinar cells, and by reflex, when the afferent parasympathetic fibers of the gastric mucosa are irritated and the respiratory center is inhibited. Increasing the tone of the vagus nerve (n. Vagus) stimulates the production of bronchial secretions. The mucus produced by the bronchial glands enhances the activity of the ciliated epithelium, which facilitates the evacuation of mucus from the bronchi and its coughing up.

Pharmacokinetics

When taken orally, butamirate citrate is rapidly and completely absorbed. The connection with plasma proteins is 94%. Undergoes metabolism with the formation of
2 metabolites, which also have an antitussive effect. Metabolites are excreted mainly (90%) by the kidneys and only a small part through the intestines.
The half-life (T?) Is 6 hours.
When taken orally, guaifenesin is rapidly absorbed from the gastrointestinal tract. The connection with plasma proteins is negligible. Guaifenesin is rapidly metabolized, with the formation of inactive metabolites, which are excreted by the kidneys. T? - 1 tsp

Application during pregnancy and during breastfeeding

Controlled clinical studies on the effect of the drug on pregnant women or animal studies have not been conducted.
When taking guaifenesin in the first trimester of pregnancy, more frequent cases of possible inguinal hernia formation in the neonatal period have been described. The drug should not be taken during the first 3 months of pregnancy. The use of the drug in the second and third trimesters of pregnancy is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether butamirate and guaifenesin pass into breast milk. Due to insufficient information on the use of these drugs during breastfeeding, the risk of side effects in infants cannot be ruled out unequivocally. The use of the drug during breastfeeding is possible in cases where the expected benefit to the mother outweighs the potential risk to the baby.

Side effect

Subject to the recommended dosage regimen, patients usually tolerate the drug well. The most commonly reported disorders of digestion (nausea, lack of appetite, pain in the stomach, vomiting, diarrhea), headaches, dizziness and drowsiness, which occur in about 1% of patients. These side effects usually diminish as the dose is reduced. Skin allergic reactions were also observed.
The frequency of the adverse reactions listed below was determined according to the following criteria: very often ( > 1/10); often ( > 1/100 - <1/10); infrequently ( > 1/1000 - <1/100); rarely ( > 1/10000 - <1/1000); very rare (<1/10000), including isolated messages.
From the nervous system: often - anorexia, headache.
On the part of the organ of hearing and balance: often - dizziness.
From the digestive system: often - nausea, pain in the stomach, vomiting, diarrhea.
On the part of the skin and subcutaneous fat: very rarely - rashes, urticaria.
From the side of the kidneys and urinary tract: very rarely - urolithiasis.
In case of any side effects, including effects not indicated in the instructions for use, please inform your doctor about it.

Overdose

Symptoms: In case of an overdose, signs of the toxic effects of guaifenesin predominate: drowsiness, muscle weakness, nausea and vomiting. Development of urolithiasis is possible.
Treatment: In case of overdose, consult a doctor. Guaifenesin has no specific antidote. Prescribe gastric lavage, intake of activated charcoal, symptomatic therapy aimed at supporting cardiovascular, respiratory and renal functions, electrolyte balance.

Interaction with other medicinal products

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid; enhances the sedative effect of alcohol, sedatives, hypnotics and general anesthetics on the central nervous system; enhances the effect of muscle relaxants.
When determining the concentration of vanilyl mandelic acid and 5-hydroxyindoleacetic acid using nitrosonaphthol as a reagent, falsely increased results may be obtained. Therefore, the use of drugs containing guaifenesin should be discontinued 48 hours before urine collection for this test.

special instructions

During treatment with the drug, it is not recommended to consume alcoholic beverages.
If symptoms persist or worsen, seek medical attention.
The drug contains 35.6 vol. % ethanol, the maximum single dose of the drug (40 drops) contains up to 0.322 g of ethanol. This should be taken into account when prescribing the drug to patients suffering from liver disease, epilepsy, pregnant and lactating women and children.
The drug should not be prescribed for productive cough in patients suffering from prolonged or chronic cough (including those caused by smoking), bronchial asthma, chronic bronchitis or pulmonary emphysema.
If you miss a dose, do not increase the next dose to compensate for the missed dose. If you have any questions about taking this medicine, ask your doctor.

Influence on the ability to drive vehicles and mechanisms

The drug can have an adverse effect on activities that require increased concentration of attention and speed of psychomotor reactions (for example, driving, working with mechanisms and working at heights).