Ambrobene Stoptussin drops for oral use, 25ml

Composition

1 ml of the drug contains the active ingredients: guaifenesin 0,100 g, the butamirat citrate 0.004 g; excipients: ethanol 96% 0.300 g, floral flavor (aroma Alpine flowers) 0.002 g, purified water 0,007 g Polysorbate-80 0.001 g, licorice extract liquid 0.003 g, propylene glycol up to 1,000 ml.

Pharmacological action

Pharmacodynamically a drug that has anti-tussive and expectorant action. 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. Increased secretion is caused both by direct action on the bronchial glands-stimulation of secretion from the bronchial glands and removal of acid glycoproteins from acinar cells, and by reflex, when afferent parasympathetic fibers of the gastric mucosa are irritated and the respiratory center is depressed. Increasing the tone of the vagus nerve (n. vagus) stimulates the production of bronchial secretions. Mucus produced by the bronchial glands increases the activity of the ciliated epithelium, which facilitates the evacuation of mucus from the bronchi and its coughing. Pharmacokinetics When butamirate is taken orally, citrate is rapidly and completely absorbed. Binding to plasma proteins is 94%. It is metabolized to form 2 metabolites, which also have an antitussive effect. Metabolites are mainly excreted (90%) by the kidneys and only a small part-through the intestines. The half – life (half-life) is 6 hours. Guaifenesin is rapidly absorbed from the gastrointestinal tract when taken orally. The association with plasma proteins is insignificant. Guaifenesin is rapidly metabolized to form inactive metabolites that are excreted by the kidneys. Half-life-1 hour.

Indications

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

Use during pregnancy and lactation

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 exceeds the potential risk to the fetus. It is not known whether butamirate and guaifenesin pass into human milk. Due to insufficient data on the use of these drugs during breastfeeding, the risk of side effects in children cannot be unequivocally excluded. The use of the drug during breastfeeding is possible in cases where the expected benefit to the mother exceeds the potential risk to the baby.

Contraindications

Hypersensitivity to the components of the drug, children under 6 months of age, first trimester of pregnancy, myasthenia gravis. With caution The drug should be used with caution in patients with a tendency to develop drug dependence, 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. Digestive disorders (nausea, lack of appetite, stomach pain, vomiting, diarrhea), headaches, dizziness, and drowsiness are most commonly reported, occurring in approximately 1% of patients. These side effects usually decrease after a dose reduction. Allergic skin reactions were also observed. The frequency of adverse reactions listed below was determined according to the following criteria: very common (>1/10); often (>>1/100 – >><1/10); infrequently (>1/1000 -<1/10); infrequently (><1/100); rarely (>1/10000 – <1/100); rarely (><1/1000); very rarely ( From the nervous system: often – anorexia, headache. From the side of the organ of hearing and balance: often-dizziness. From the digestive system: often – nausea, stomach pain, vomiting, diarrhea. Skin and subcutaneous fat disorders: very rare-rash, urticaria. From the side of the kidneys and urinary tract: very rarely-urolithiasis. If you experience any side effects, including those not listed in the instructions for use, please inform your doctor.

Interaction

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

How to take, course of use and dosage

The drug is taken after a meal, the corresponding number of drops is dissolved in 100 ml of liquid (water, tea, fruit juice, etc. ). If a syringe is attached to the drug for dosing, you can use it to accurately set the drug. Dose depending on the patient’s body mass:

• up to 7 kg to 8 drops 3-4 times a day,
• 7-12 kg for 9 drops 3-4 times a day,
• 12-20 kg for 14 drops 3 times a day,
• 20-30 kg for 14 drops 3-4 times daily,
• 30-40 kg for 16 drops 3-4 times a day,
• 40-50 kg 25 drops 3 times a day,
• 50-70 kg 30 drops 3 times a day,
• more than 70 kg 40 drops 3 times a day.

If the condition worsens or does not improve within 3 days, you should consult a doctor. You can use the drug without a doctor’s appointment for no more than 7 days.

Overdose

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

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. 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 of the lungs. If you missed a drug, do not increase the next dose to make up for the missed one. If you have any questions about taking this medicine, please contact your doctor. Influence on the ability to drive vehicles and mechanisms The drug may have an adverse effect on activities that require increased concentration of attention and speed of psychomotor reactions (for example, driving a car, working with mechanisms and high-altitude work).

Storage conditions

In a dark place at a temperature of 10 to 25°C. Keep out of reach of children.

Shelf

life is 5 years.

Active ingredient

Butamirate, Guaifenesin

Dosage form

Drops for oral use

Description

Children as prescribed by a doctor, Children over 6 months of age, Pregnant women in the second and third trimester as prescribed by a doctor, For adults

Indications

Cough