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

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

Active ingredient

Butamirate, Guaifenesin

Composition

1 ml of the preparation contains:
active ingredients: guaifenesin 0,100 g, butamirate citrate 0,004 g;
excipients: ethanol 96% 0,300 g, floral fragrance (flavor of Alpine flowers) 0,002 g, purified water 0,007 g polysorbate-80 0,001 g, licorice extract liquid 0,003 g, propylene glycol to 1,000 ml.

How to take, the dosage

The drug is taken after meals, the appropriate number of drops is dissolved in 100 ml of liquid (water, tea, fruit juice, etc.). If the drug is supplied with a syringe for dosing, you can use it for accurate intake of the drug.
Dose according to the body weight of the patient:

• under 7 kg at 8 drops 3-4 times a day,
• 7-12 kg at 9 drops 3-4 times a day,
• 12-20 kg at 14 drops 3 times a day,
• 20-30 kg at 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,
• 50-70 kg 30 drops 3 times a day,
• over 70 kg 40 drops 3 times a day.

If the condition worsens or does not improve within 3 days, consult a physician.
Do not use the drug without a prescription for more than 7 days.

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 vanillylmindalic acid and 5-hydroxyindoluacetic acid using nitrosonaphthol as a reagent, falsely elevated results may be obtained. Therefore, the use of preparations containing guaifenesin must be discontinued 48 hours before urine collection for this test.

Special Instructions

It is not recommended to drink alcoholic beverages during treatment with the drug.
If the symptoms persist or intensify, you should consult a doctor.
The drug contains 35.6 vol. % of ethanol, the maximum single dose of the drug (40 drops) contains up to 0.322 g of ethanol. This should be considered when prescribing the drug to patients suffering from liver diseases, epilepsy, pregnant and lactating women and children.
The drug should not be administered in productive cough in patients with prolonged or chronic cough (including that caused by smoking), bronchial asthma, chronic bronchitis or pulmonary emphysema.
If you miss a dose, do not increase the next dose to make up for the one you missed. If you have any questions concerning the drug administration, consult your physician.
Effect on the ability to drive vehicles and mechanisms
The drug may have an adverse effect on activities requiring increased concentration and rapid psychomotor reactions (e.g., driving, working with mechanisms and high-altitude work).

Contraindications

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

Side effects

If the recommended dosing regimen is followed, patients usually tolerate the drug well. Digestive disorders (nausea, lack of appetite, stomach pain, vomiting, diarrhea), headaches, dizziness and somnolence have been reported most frequently in about 1% of patients. These side effects usually decrease after dose reduction. Skin allergic reactions have also been observed.
The frequency of adverse reactions listed below was determined according to the following criteria: very common (>1/10); common (>1/100 to <1/10); infrequent (>1/1000 to <1/100); rare (>1/10000 to <1/1000); very rare (<1/10000), including individual reports.
Nervous system disorders: often – anorexia, headache.
Hearing organ and balance: often – dizziness.
The digestive system: often – nausea, pain in the stomach, vomiting, diarrhea.
Skin and subcutaneous fat: very rarely – rashes, urticaria.
Kidneys and urinary tract: very rare – urolithiasis.
In case of any side effects, including those not specified in the instructions for use, please inform your physician.

Overdose

Symptoms: In overdose there are predominant signs of toxic effects of guaifenesin: drowsiness, muscle weakness, nausea and vomiting. The development of urolithiasis is possible.
Treatment: In case of overdose seek medical attention. Guaifenesin has no specific antidote. Gastric lavage, activated charcoal, symptomatic therapy to support cardiovascular, respiratory and renal functions, electrolyte balance are prescribed.

Pregnancy use

Controlled clinical studies on the effect of the drug on pregnant women or animal studies have not been conducted.
When taking guaifenesin during the first trimester of pregnancy, more frequent cases of possible inguinal hernia formation during the neonatal period have been described. The drug should not be taken during the first 3 months of pregnancy. Administration of the drug in the second and third trimesters of pregnancy is possible in cases when the expected benefits to the mother exceed the potential risk to the fetus.
It is unknown whether butamirate and guaifenesin penetrate into maternal milk. Due to insufficient information on the use of these drugs during breastfeeding, the risk of side effects in infants cannot be unequivocally excluded. Administration of the drug during breastfeeding is possible in cases when the expected benefit to the mother exceeds the potential risk to the infant.