Sinotussin (Syrup) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

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)

Dosage Form

Sinotussin

Syrup: 50 ml, 90 ml, 100 ml, 125 ml, 150 ml, or 200 ml bottle

Dosage Form, Packaging, and Composition

Syrup is a transparent, viscous orange liquid with a characteristic odor; slight opalescence is allowed.

Excipients: sucrose, sorbitol 70% (non-crystallizing), glycerol, propylene glycol, sodium benzoate, citric acid monohydrate, sorbic acid, color sunset yellow (E110), levomenthol, blackcurrant flavor, pineapple flavor, purified water.

50 ml – bottles.
90 ml – bottles.
100 ml – bottles.
125 ml – bottles.
150 ml – bottles.
200 ml – bottles.

Clinical-Pharmacological Group

Drug with mucolytic, expectorant and bronchodilatory action

Pharmacotherapeutic Group

Combined expectorant

Pharmacological Action

A combined drug that has a bronchodilator, expectorant and mucolytic effect.

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

Bromhexine is a mucolytic agent that has an expectorant and antitussive effect. It increases the serous component of bronchial secretion; activates the cilia of the ciliated epithelium, reduces the viscosity of sputum, 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 the viscosity of sputum, activates the ciliary apparatus of the bronchi, facilitates the removal of sputum 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 three times daily.

Adhere strictly to the following single doses based on patient age.

For children aged 2 to 4 years, administer 2.5 ml per dose.

For children aged 5 to 12 years, administer 5 ml per dose.

For adolescents over 12 years and adults, administer 10 ml per dose.

Use a measuring cup or a dosing syringe for accurate measurement.

Do not use a household teaspoon for dosing.

The maximum duration of self-administered therapy is 4 to 5 days.

Discontinue use and consult a physician if symptoms persist beyond this period or worsen.

Do not exceed the recommended dosage or frequency of administration.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose.

Do not double the dose to catch up.

Shake the bottle well before each use.

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; tachyarrhythmia, myocarditis; heart defects (including aortic stenosis); decompensated diabetes mellitus; thyrotoxicosis; glaucoma; hepatic and/or renal failure; gastric and duodenal ulcers in the acute phase; gastric bleeding; children under 2 years of age.

With caution

Diabetes mellitus; arterial hypertension; gastric and duodenal ulcers in remission; 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, you should immediately seek medical help and, as a precaution, stop taking bromhexine hydrochloride.

Guaifenesin

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

Guaifenesin colors urine pink.

Excessive use of Guaifenesin may cause kidney stones.

If urine is collected within 24 hours after taking guaifenesin, its metabolite may change the color of the 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 only or main drug in the treatment of patients with severe or unstable asthma. In severe asthma, regular assessment of the condition is necessary, including determination of lung function, as patients are at risk of severe attacks and even death. If treatment becomes ineffective, patients should seek medical help.

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. It should be used 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 the ability to drive vehicles and machinery

Given the profile of side effects (dizziness, drowsiness and others), it is recommended to refrain from driving vehicles and 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 simultaneously, 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 together 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.

Simultaneous 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.