Ambrobene Stoptussin drops for oral use, 50ml

Composition

1 ml of the drug contains active substances: guaifenesin 0.100 g, butamirate citrate 0.004 g; excipients: ethanol 96% 0.300 g, floral fragrance (alpine flower fragrance) 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

A 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 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.

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, treatment

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

5 years

Active ingredient

Butamirate, Guaifenesin

Dosage form

oral drops