Ambrobene Stoptussin, drops 25 ml

Pharmacodynamics
Combined drug with anti-cough and expectorant effect.
Butamirat has a peripheral local anesthetic effect on sensitive nerve endings of the bronchial mucosa, which provides anti-cough effect.
Guaifenesin increases secretion of bronchial glands and decreases mucus viscosity. Increased secretion is caused both by direct action on bronchial glands – stimulation of secretion from bronchial glands and removal of acidic glycoproteins from acinar cells, and by reflex way, when there is irritation of afferent parasympathetic fibers of gastric mucosa and inhibition of respiratory center. Increase of tone of the vagus nerve (n. vagus) stimulates production of bronchial secretion. Mucus produced by bronchial glands increases activity of ciliated epithelium, resulting in easier evacuation of mucus from the bronchi and coughing it up.
Pharmacokinetics
When administered orally butamirate citrate is quickly and completely absorbed. Binding with plasma proteins is 94%. It is metabolized to form
2 metabolites, also having antitussive effect. Metabolites are excreted mainly (90%) by kidneys and only small part is excreted through intestine.
The half-life (T½) is 6 hours.
Guaifenesin when taken orally is quickly absorbed from the gastrointestinal tract. Binding to plasma proteins is insignificant. Guaifenesin is rapidly metabolized, with the formation of inactive metabolites that are excreted by the kidneys. T½ – 1 hour.

Indications

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

Pharmacological effect

Pharmacodynamics
A combined drug that has an antitussive 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 bronchial glands and reduces the viscosity of mucus. An increase in secretion is caused both by a direct effect on the bronchial glands – stimulation of secretion from the bronchial glands and removal of acidic glycoproteins from acinar cells, and by a reflex pathway, when irritation of afferent parasympathetic fibers of the gastric mucosa occurs and depression of the respiratory center. An increase in the tone of the vagus nerve (n. vagus) stimulates the production of bronchial secretions. The mucus produced by the bronchial glands increases the activity of the ciliated epithelium, as a result of which the evacuation of mucus from the bronchi and its coughing are facilitated.
Pharmacokinetics
When taken orally, butamirate citrate is quickly and completely absorbed. Plasma protein binding is 94%. Metabolized to form
2 metabolites that also have an antitussive effect. Metabolites are excreted mainly (90%) by the kidneys and only a small part through the intestines.
Half-life (T½) – 6 hours
Guaifenesin, when taken orally, is rapidly absorbed from the gastrointestinal tract. Communication with plasma proteins is insignificant. Guaifenesin is rapidly metabolized to form inactive metabolites that are excreted by the kidneys. T½ – 1 hour.

Special instructions

During treatment with the drug it is not recommended to drink alcoholic beverages.
If symptoms persist or worsen, you should consult a doctor.
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 diseases, 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 emphysema.
If you miss a dose, do not increase the next dose to make up for the missed dose. If you have any questions about taking this drug, contact your doctor.
Impact on the ability to drive vehicles and machinery
The drug may have an adverse effect on activities that require increased concentration and speed of psychomotor reactions (for example, driving, working with machinery and working at heights).

Active ingredient

Butamirate, Guaifenesin

Composition

1 ml of the drug contains
active ingredients: guaifenesin 0.100 g, butamirate citrate 0.004 g;
excipients: ethanol 96% 0.300 g, floral flavor (aroma of alpine flowers) 0.002 g, purified water 0.007 g polysorbate-80 0.001 g, liquid licorice extract 0.003 g, propylene glycol up to 1.000 ml.

Pregnancy

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 formation of an inguinal hernia 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 unknown 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 definitively excluded. 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.

Contraindications

Hypersensitivity to the components of the drug, children under 6 months, first trimester of pregnancy, myasthenia gravis.
With caution
The drug should be used with caution in patients with a tendency to develop drug dependence, with liver disease, alcoholism, epilepsy, brain diseases, as well as in children and pregnant and lactating women.

Side Effects

If the recommended dosage regimen is followed, patients usually tolerate the drug well. The most commonly reported symptoms are digestive disorders (nausea, lack of appetite, stomach pain, vomiting, diarrhea), headaches, dizziness and drowsiness, which occur in approximately 1% of patients. These side effects usually decrease after the dose is reduced. Allergic skin reactions have also been observed.
The frequency of adverse reactions listed below was determined according to the following criteria: very often (>1/10); often (>1/100 – 1/1000 -1/10000 – <1/1000); very rare (< 1/10000), including isolated reports.
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.
From the skin and subcutaneous fat: very rarely – rashes, urticaria.
From the kidneys and urinary tract: very rarely – urolithiasis.
If any side effects occur, including effects not listed in the instructions for use, please notify your doctor.

Interaction

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 vanillylmandelic acid and 5-hydroxyindoleacetic acid using nitrosonaphthol as a reagent, falsely elevated results may be obtained. Therefore, the use of drugs containing guaifenesin must be stopped 48 hours before collecting urine for this test.

Overdose

Symptoms: In case of overdose, signs of toxic effects of guaifenesin predominate: drowsiness, muscle weakness, nausea and vomiting. Urolithiasis may develop.
Treatment: In case of overdose, consult a doctor. Guaifenesin does not have a specific antidote. Gastric lavage, activated charcoal, and symptomatic therapy aimed at supporting cardiovascular, respiratory and renal functions, and electrolyte balance are prescribed.

Storage conditions

In a place protected from light at a temperature of 10 to 25°C.
Keep out of the reach of children.

Shelf life

5 years.

Manufacturer

Teva Czech Enterprises s.r.o., Czech Republic