Bromhecomb (Tablets, Syrup) Instructions for Use

ATC Code

R05C (Expectorants, excluding combinations with antitussives)

Active Substances

Guaifenesin (Rec.INN registered by WHO)

Salbutamol (Rec.INN registered by WHO)

Bromhexine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with mucolytic, expectorant and bronchodilatory action

Pharmacotherapeutic Group

Drugs used for cough and colds; expectorants, excluding combinations with antitussives

Pharmacological Action

A combined drug that has bronchodilatory, expectorant, and mucolytic action.

Salbutamol is a bronchodilator that stimulates β₂-adrenergic receptors in the bronchi, blood vessels, and myometrium. It prevents or relieves bronchospasm, reduces resistance in the airways, and increases vital lung capacity. It causes dilation of the coronary arteries and does not lower blood pressure.

Bromhexine is a mucolytic agent that has expectorant and antitussive action. It increases the serous component of bronchial secretion; activates the cilia of the ciliated epithelium, reduces sputum viscosity, increases its volume, and improves discharge.

Guaifenesin is a mucolytic agent that reduces the surface tension of the structures of the bronchopulmonary apparatus; stimulates the secretory cells of the bronchial mucosa that produce neutral polysaccharides, depolymerizes acid mucopolysaccharides, reduces sputum viscosity, activates the ciliary apparatus of the bronchi, facilitates sputum removal, and promotes the transition of an unproductive cough to a productive one.

Indications

Acute bronchitis, including tracheobronchitis; acute bronchitis caused by respiratory viruses; chronic bronchitis not otherwise specified (NOS); COPD; asthmatic bronchitis; pneumonia.

ICD codes

Dosage Regimen

Administer orally. The single dose is age-dependent; administer three times daily.

Adhere to a maximum treatment duration of 4-5 days. Consult a physician if symptoms persist beyond this period.

For adults and children aged 14 years and older, the typical single dose is one tablet or 10 milliliters of syrup.

For children aged 6 to 13 years, the typical single dose is one-half tablet or 5 milliliters of syrup.

For children aged 2 to 5 years, the typical single dose is one-quarter tablet or 2.5 milliliters of syrup. Use in this age group requires strict medical supervision.

This medication is contraindicated in children under 2 years of age.

Accurately measure the syrup dose using the provided measuring device. Do not use household spoons.

Take the dose with a sufficient amount of water.

Do not increase the dose or frequency of administration without medical advice.

Discontinue use and seek immediate medical attention if you experience chest pain, irregular heartbeat, severe dizziness, or signs of a severe allergic reaction.

Monitor for hypokalemia, especially with concomitant use of diuretics or corticosteroids.

Avoid concurrent use with antitussive drugs, such as those containing codeine, as this may impede sputum clearance.

Be aware that guaifenesin may cause a harmless pink discoloration of urine.

Adverse Reactions

From the cardiovascular system: often – tachycardia; rarely – arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole, peripheral vasodilation; frequency unknown – myocardial ischemia.

From the nervous system very often – tremor; often – headache; very rarely – hyperactivity.

From the digestive system possible – exacerbation of gastric and duodenal ulcers, nausea, vomiting, diarrhea and pain in the upper abdomen.

From the skin and subcutaneous tissues severe skin adverse reactions are possible, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis.

From the immune system possible – angioedema, rash, urticaria, itching, hypersensitivity, anaphylactic reaction, anaphylactic shock.

From metabolism rarely – hypokalemia.

From the musculoskeletal system often – muscle cramps; very rarely – feeling of muscle tension.

From the respiratory system possible – bronchospasm.

From the kidneys and urinary system: possible – pink coloration of urine.

Contraindications

Hypersensitivity to bromhexine, guaifenesin, salbutamol; pregnancy, breastfeeding period; tachyarrhythmia, myocarditis; heart defects (including aortic stenosis); decompensated diabetes mellitus; thyrotoxicosis; glaucoma; hepatic and/or renal failure; gastric and duodenal ulcer in the acute phase; gastric bleeding; children under 2 years of age.

With caution

Diabetes mellitus; arterial hypertension; gastric and duodenal ulcer in remission phase; hyperthyroidism; angina pectoris; severe cardiovascular diseases; in bronchial diseases accompanied by excessive accumulation of secretions.

Should not be used in combination with beta-blockers.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated for use in hepatic failure.

Use in Renal Impairment

Contraindicated for use in renal failure.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Special Precautions

Bromhexine

Patients should be warned about a possible increase in mucus secretion.

If skin or mucous membrane lesions occur, seek medical attention immediately and as a precaution, discontinue bromhexine hydrochloride.

Guaifenesin

Do not use simultaneously with cough suppressants or combined cold medicines.

Guaifenesin colors urine pink.

Excessive use of Guaifenesin may cause kidney stone formation.

If urine is collected within 24 hours after taking guaifenesin, its metabolite may change the color of urine, and 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA) may be detected in the laboratory.

Salbutamol

Bronchodilators should not be used as the sole or main drug in the treatment of patients with severe or unstable asthma. In severe asthma, regular assessment of the condition is necessary, including lung function tests, as patients are at risk of severe attacks and even death. If treatment becomes ineffective, patients should seek medical attention.

The dose or frequency of use should be increased only on the recommendation of a doctor.

Salbutamol causes peripheral vasodilation, which may be accompanied by reflex tachycardia and increased cardiac output or thyrotoxicosis. Use with caution in patients suffering from angina pectoris, severe forms of tachycardia or thyrotoxicosis.

Like other beta-adrenergic receptor agonists, Salbutamol can cause reversible metabolic changes, such as increased blood glucose concentration. Patients with diabetes may be unable to compensate for the increase in blood glucose concentration, and ketoacidosis has been reported in such patients.

Effect on ability to drive vehicles and operate machinery

Given the side effect profile (dizziness, drowsiness and others), it is recommended to refrain from driving vehicles and operating machinery, and from engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions during treatment.

Drug Interactions

Theophylline and other xanthines, when used concomitantly, increase the likelihood of tachyarrhythmias.

The Salbutamol included in the combination is not recommended for patients who are taking MAO inhibitors and/or tricyclic antidepressants.

Use with caution concomitantly with anesthetic agents such as chloroform, cyclopropane, halothane and other halogen-containing drugs.

It is not recommended to use this combination simultaneously with non-selective beta-adrenergic receptor blockers, such as propranolol.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Concomitant administration with drugs containing codeine and other antitussives makes it difficult to discharge liquefied sputum.

The Bromhexine contained in the drug promotes the penetration of antibiotics into the lung tissue.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.