Instructions for Mukotec syrup 100 ml
Composition
active ingredients: 5 ml of syrup contain salbutamol sulfate equivalent to 1 mg of salbutamol, bromhexine hydrochloride 2 mg, guaifenesin 50 mg, menthol (levomenthol) 0.5 mg;
excipients: sodium methyl parahydroxybenzoate (E 219); sodium propyl parahydroxybenzoate (E 217); sucrose; propylene glycol; sodium saccharin; sorbic acid; glycerin; citric acid monohydrate; sorbitol solution, non-crystallizing (E 420); Sunset Yellow FCF dye (E 110); purified water.
Dosage form
Syrup.
Main physicochemical properties: Syrupy orange liquid.
Pharmacotherapeutic group
Remedies used for coughs and colds. Expectorants. Combinations.
ATX code R05C A10.
Pharmacological properties
Pharmacodynamics
MUCOTEC® is a combination drug with bronchodilator, mucolytic and expectorant properties. Thanks to the rational combination of salbutamol, bromhexine hydrochloride, guaifenesin and menthol, it effectively and quickly relieves disorders of the bronchopulmonary system.
Salbutamol - a selective stimulator of b2-adrenoreceptors - effectively and for a long time dilates the bronchi. In therapeutic doses, it does not cause stimulation of cardiac activity. Bromhexine hydrochloride reduces the viscosity of sputum and promotes its evacuation from the bronchi. Guaifenesin relaxes and clears the bronchi of mucus, promotes expectoration. Menthol relieves symptoms of irritation and inflammation in the mucous membrane of the respiratory tract.
Pharmacokinetics
No specific pharmacokinetic studies have been conducted.
Indication
Secretolytic therapy for respiratory diseases accompanied by bronchospasm and the formation of viscous secretions that are difficult to separate: tracheobronchitis, chronic obstructive pulmonary diseases, bronchial asthma, and pulmonary emphysema.
Contraindication
Hypersensitivity to salbutamol, other sympathomimetics, bromhexine, guaifenesin, menthol or any of the other components of the drug. Arrhythmia, severe cardiovascular diseases, hyperthyroidism, severe liver dysfunction, gastric and duodenal ulcers.
Interaction with other medicinal products and other types of interactions
Hypokalemia, which develops as a result of the use of drugs containing salbutamol, may increase with the simultaneous use of diuretics. As a result, the risk of developing arrhythmias increases when used against the background of such treatment with cardiac glycosides. The effects of salbutamol may be reduced with the simultaneous use of β-blockers, especially non-selective (such as propranolol), and may also be enhanced with the simultaneous use of xanthines (such as theophylline).
Salbutamol should not be used simultaneously with inhalation anesthetics, adrenaline, tricyclic antidepressants and corticosteroids.
Bromhexine should not be administered simultaneously with drugs containing codeine. With the simultaneous use of bromhexine and drugs that irritate the digestive tract, mutual enhancement of the irritating effect on the gastric mucosa is possible. Simultaneous administration with antibiotics (amoxicillin, erythromycin, cefuroxime, doxycycline), sulfonamide drugs contributes to an increase in their concentration in bronchial secretions. When administered simultaneously with drugs that suppress the cough center, difficulty in the discharge of thinned sputum (accumulation of bronchial secretions in the respiratory tract) is possible. Simultaneous administration with bronchodilators is possible.
Guaifenesin enhances the effects of central nervous system depressants and ethanol. It may also cause false-positive results in diagnostic tests for 5-hydroxyindoleacetic acid and vanillylmandelic acid in urine.
There is no data on the negative interaction of menthol with other drugs.
Application features
The drug should be used with caution in patients with essential or symptomatic hypertension, ischemic heart disease and other cardiovascular diseases, as well as in patients with subcompensated diabetes mellitus and glaucoma.
Very rarely, severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, occur with the use of bromhexine. If changes appear on the skin and mucous membranes, you should immediately consult a doctor and stop using the drug.
In case of impaired bronchial motility, accompanied by the formation of a large amount of bronchial secretion (malignant cilia syndrome), the drug should be used with extreme caution due to possible stagnation of secretions.
In case of impaired renal function (including severe renal failure) or liver disease (with moderate and mild hepatic failure), it should be used with extreme caution (reducing the dose or increasing the time interval between applications).
Periodic monitoring of liver function is recommended, especially with prolonged use.
The syrup contains sucrose, which should be taken into account by patients with diabetes mellitus and those on a low-calorie diet. Also, due to the sucrose content of the drug, it should not be used in patients with rare hereditary diseases such as fructose intolerance or sucrase-isomaltase insufficiency. Before starting treatment and during treatment, it is necessary to monitor blood glucose levels in such patients.
The product contains sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (possibly delayed).
This medicine contains sorbitol, so patients with rare hereditary problems of fructose intolerance should not take this medicine. Consult your doctor before taking this medicine.
This medicine contains the colouring agent sunset yellow FCF (E 110), which may cause an allergic reaction.
The drug also contains propylene glycol, which can cause symptoms similar to those that occur when drinking alcohol.
Isolated cases of myocardial ischemia have been reported in association with the use of salbutamol. Patients with cardiac disease (e.g. coronary artery disease) treated with salbutamol sulfate should seek medical attention if they experience chest pain or other symptoms suggestive of worsening cardiac disease. Attention should be paid to evaluating symptoms such as shortness of breath and chest pain, which may be due to both cardiac and respiratory disease.
Treatment with β2-agonists may result in severe hypokalemia, and monitoring of serum potassium levels is recommended.
As with other β-adrenergic agonists, salbutamol sulphate may cause reversible metabolic changes, such as increased blood sugar levels. As a result, there have been isolated reports of ketoacidosis in diabetic patients. Concomitant use of corticosteroids may exacerbate this condition.
Do not administer to patients before anesthesia.
The drug should not be used in patients with hypertrophic cardiomyopathy.
If there is a history of gastric bleeding, the syrup should be used under the supervision of a physician. During treatment with the drug, it is necessary to drink a sufficient amount of fluid, which increases the expectorant effect of bromhexine.
Use during pregnancy or breastfeeding
Do not apply.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, it is better to refrain from driving vehicles and performing work that requires precision of movements, speed of reaction, and concentration of attention.
Method of administration and doses
The drug should be used as prescribed and under the supervision of a doctor.
Adults and children over 12 years old should take 10 ml 3 times a day. Children from 6 to 12 years old - 5-10 ml 3 times a day. Children from 2 to 6 years old - 5 ml 3 times a day. The duration of treatment is determined by the doctor individually.
Children.
Do not prescribe the drug to children under 2 years of age due to the lack of experience in using it in this age group of patients.
Overdose
Symptoms: tachycardia, tremor, convulsions, gastrointestinal discomfort, nausea, vomiting, extrasystole, hypotension, chest pain, hypokalemia, ataxia, diplopia, drowsiness, metabolic acidosis, rapid breathing, headache, palpitations, arrhythmia, hyperglycemia, abdominal pain, exacerbation of gastric ulcer, agitation, confusion and respiratory depression.
Treatment: Symptomatic therapy.
Adverse reactions
Immune system disorders: hypersensitivity reactions including rash, pruritus, anaphylactic reactions including anaphylactic shock, angioedema, urticaria, oropharyngeal edema, Lyell's syndrome.
On the part of the digestive tract: dyspeptic phenomena, nausea, vomiting, diarrhea, abdominal pain, exacerbation of gastric ulcer/intestinal ulcer, gastralgia, unpleasant taste in the mouth.
Nervous system: tremor, myalgia, headache, hyperactivity, dysgeusia, dizziness, anxiety, insomnia.
Cardiovascular: tachycardia; peripheral vasodilation; arrhythmia, including ventricular fibrillation, supraventricular tachycardia and extrasystole; hypotension or hypertension; palpitations; myocardial ischemia; collapse.
From the respiratory system: respiratory disorders, increased cough.
Salbutamol may cause paradoxical bronchospasm, which is a life-threatening condition. If this occurs, the drug should be discontinued immediately and alternative treatment should be instituted.
Others: muscle cramps, feeling of pressure in the muscles, hyperthermia, chills, mydriasis, bladder atony, increased sweating, thrombocytopenia, metabolic changes such as hypokalemia.
Some patients may develop a transient increase in blood aminotransferase levels caused by bromhexine.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
After each use, the bottle must be tightly closed with a lid and stored in accordance with the storage conditions indicated on the packaging.
Packaging
100 or 200 ml in a polyethylene bottle. 1 bottle together with a measuring cup in a cardboard box.
Vacation category
According to the recipe.
Producer
Unique Pharmaceutical Laboratories (a division of J.B. Chemicals and Pharmaceuticals Ltd.).
Location
Plot No. 215-216 J. I. D. C., Industrial Area, Panoli – 394 116, Bharuch District, India.
