Tussin Plus (Syrup) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

ATC Code

R05DA20 (Opium alkaloids and their derivatives in combination)

Active Substances

Guaifenesin (Rec.INN registered by WHO)

Dextromethorphan (Rec.INN registered by WHO)

Dosage Form

Tussin Plus

Syrup 100 mg+10 mg/5 ml: bottle 118 ml with measuring cup

Dosage Form, Packaging, and Composition

Syrup of orange-red color with a slight cherry smell.

Excipients: citric acid, flavoring, glycerol, high fructose corn syrup, sodium saccharin, sodium benzoate, cherry flavor, FD&C Red No. 40 dye, water.

118 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Combined antitussive agent (antitussive+expectorant agent)

Pharmacological Action

Guaifenesin has an expectorant effect by increasing the secretion of the liquid components of bronchial mucus, depolymerizing acidic mucopolysaccharides, and increasing the activity of the ciliated epithelium.

Dextromethorphan suppresses excessively intense afferent impulses from the respiratory tract mucosa, increases the cough threshold, reducing the intensity of dry irritating cough. Dextromethorphan is the D-isomer of levorphanol, its potency is close to that of codeine, however, it does not have analgesic properties, does not depress the respiratory center and the activity of the ciliated epithelium. The duration of the antitussive action is 5-6 hours.

Pharmacokinetics

Guaifenesin is rapidly absorbed from the gastrointestinal tract (within 25-30 minutes after oral administration). T_1/2 is 1 hour. It penetrates into tissues containing acidic mucopolysaccharides. It is metabolized in the liver. It is excreted by the lungs (with sputum) and by the kidneys in the form of inactive metabolites.

Dextromethorphan is rapidly absorbed from the gastrointestinal tract and its action begins to manifest within 15-30 minutes. Dextromethorphan is metabolized primarily by liver enzymes, undergoing O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfates. In humans, (+)-3-hydroxy-N-methylmorphinan, (+)-3-hydroxymorphinan, and traces of the unmetabolized drug can be detected in the urine after oral administration.

Indications

• Relief of symptoms of colds, influenza, acute respiratory viral infections accompanied by cough.

ICD codes

Dosage Regimen

Administer orally after meals using the provided measuring cup or a standard teaspoon.

For adults and children over 12 years: administer 10 ml (2 teaspoons) every 4 hours.

For children 6 to 12 years: administer 5 ml (1 teaspoon) every 4 hours.

Do not exceed 6 doses within a 24-hour period.

The maximum daily dose for adults and children over 12 is 60 ml.

The maximum daily dose for children 6 to 12 years is 30 ml.

This medication is contraindicated for children under 6 years of age.

Use the supplied measuring cup for accurate dosing; 1 TSP marking equals 1 teaspoon (5 ml).

Maintain adequate fluid intake during therapy to aid in bronchial secretion clearance.

If symptoms persist beyond 7 days, discontinue use and consult a physician.

Adverse Reactions

Dyspepsia (nausea, vomiting), diarrhea, exacerbation of gastric and duodenal ulcers, dizziness, headache, drowsiness or insomnia, increased excitability (especially in children), allergic reactions (skin rash, urticaria, hyperthermia).

Contraindications

• Severe organic diseases of the central nervous system;
• Gastric and duodenal ulcer;
• Gastric bleeding (in history);
• Wet cough with copious sputum production;
• Concomitant use of drugs containing substances that are part of the drug Tussin Plus;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

Use with caution in patients with renal and hepatic insufficiency, bronchial asthma, during pregnancy and lactation.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in patients with hepatic insufficiency.

Use in Renal Impairment

Use with caution in patients with renal insufficiency.

Pediatric Use

Contraindicated in children under 6 years of age.

For children 6-12 years: 1 teaspoon every 4 hours.

Special Precautions

During treatment, it is recommended to take a sufficient amount of fluid.

Urine may turn pink.

Results of the determination of 5-hydroxyindoleacetic acid in urine (when using the nitrosynaphthol reagent) may be falsely elevated due to the effect of guaifenesin metabolites on color (guaifenesin intake should be discontinued 48 hours before urine collection for this test).

Guaifenesin and its metabolites may cause a color change in the determination of vanillylmandelic acid in urine and falsely elevate the results of the catecholamine test (guaifenesin intake should be discontinued 48 hours before urine collection for this test).

The drug Tussin Plus is supplied with a dosing cup with graduations of 1 TSP = 1 teaspoon = 5 ml.

Effect on ability to drive vehicles and mechanisms

During the treatment period, caution should be exercised when performing work requiring concentration, increased speed of motor and mental reactions, and alcohol consumption should be avoided.

Overdose

Symptoms particularly high doses of guaifenesin may cause nausea and vomiting.

Treatment: measures to replenish body fluids should be carried out, electrolyte levels should be monitored.

Symptoms due to dextromethorphan: agitation, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonia, ataxia.

Treatment gastric lavage, intake of activated charcoal, symptomatic therapy.

Drug Interactions

Tussin Plus is compatible with bronchodilators, antimicrobial agents, cardiac glycosides.

Tussin Plus is not prescribed simultaneously with antitussives (including those containing codeine) and mucolytic agents.

Incompatible with drugs that inhibit MAO (including furazolidone, procarbazine, selegiline), which, when used simultaneously, can cause an adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial bleeding, drowsiness, nausea, spasms, tremor.

Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, may increase the concentration of the drug in the blood.

Tobacco smoke may lead to increased secretion of glands against the background of cough reflex inhibition.

Storage Conditions

Store the drug at a temperature from 15°C (59°F) to 30°C (86°F). Do not store in the refrigerator. Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.