Stoptussin-teva

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STOPTUSSIN-TEVA (STOPTUSSIN-TEVA)

Composition:

Active substances: butamirate citrate, guaifenesin;

5 ml of syrup contain butamirate citrate 4 mg, guaifenesin 100 mg;

Excipients: maltitol liquid; sorbic acid; citric acid monohydrate; sodium citrate; propyl gallate; disodium edetate; potassium acesulfame; sodium cyclamate; hydroxyethylcellulose; caramel-iris flavoring; purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear, colorless or slightly yellowish solution with a mild aroma.

Pharmacotherapeutic group. Combined preparations containing antitussives and expectorants. ATC code R05FB02.

Pharmacological properties.

Pharmacodynamics.

A combined preparation exerting antitussive, mucolytic, and expectorant effects. Butamirate citrate belongs to non-opioid antitussive agents with peripheral action. It exerts a local anesthetic effect on nerve endings transmitting ascending irritation signals from the respiratory tract. In contrast to opioid antitussive agents, it does not exhibit central inhibitory effects, does not suppress the respiratory center, and does not cause dependence.

The antitussive effect of butamirate citrate is complemented by the expectorant action of guaifenesin. Guaifenesin has secretolytic properties (due to direct enhancement of bronchial gland secretion and stimulation of elimination of acidic glycoproteins from acinar cells) and secretomotor properties (reduces sputum viscosity and facilitates mucus evacuation and its expectoration).

Pharmacokinetics.

Butamirate citrate is rapidly and completely absorbed, with 98% bound to plasma proteins. It is metabolized to form two metabolites, which also exert antitussive effects. 90% of the metabolites are excreted by the kidneys, and only a small portion is eliminated in feces. The biological half-life is approximately 6 hours.

Guaifenesin is rapidly and easily absorbed from the gastrointestinal tract after oral administration. A negligible amount binds to plasma proteins. It is excreted by the kidneys, mainly in the form of metabolites, with a small portion excreted unchanged. The biological half-life is 1 hour.

Clinical characteristics.

Indications.

Dry, irritating, paroxysmal cough of various origins; the drug may be used to relieve cough during pre- and post-operative periods.

Contraindications.

Hypersensitivity to any component of the medicinal product, myasthenia gravis, first trimester of pregnancy (see section "Use during pregnancy or breastfeeding"). StopTussin-Teva should not be used in children under 6 months of age.

Interaction with other medicinal products and other forms of interaction.

Since butamirate suppresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to mucus stasis in the airways, increasing the risk of bronchospasm and respiratory tract infection.

Lithium and magnesium enhance the effect of guaifenesin.

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid, enhances the suppressive effect of alcohol, sedatives, hypnotics, and general anesthetics on the central nervous system, and also enhances the action of muscle relaxants.

The central nervous action of muscle relaxants may increase the adverse effects of guaifenesin, particularly muscle weakness.

Effect on laboratory test results

Guaifenesin may cause false-positive results in diagnostic tests for 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as reagent) and vanillylmandelic acid in urine. Therefore, treatment with StopTussin-Teva should be discontinued 48 hours before urine collection for these tests.

Special precautions for use.

This medicinal product contains liquid maltitol. Patients with rare hereditary fructose intolerance should not take this medicinal product.

During treatment, patients should abstain from consuming alcoholic beverages.

Stopussin-Teva should not be used in patients with productive cough and/or persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Use with caution in patients with tuberculosis or pneumoconiosis.

If cough persists or worsens, the treatment should be re-evaluated.

Use during pregnancy or breastfeeding.

Pregnancy

There have been reports of increased incidence of inguinal hernia in newborns following use of guaifenesin during the first trimester of pregnancy. Therefore, the medicinal product is contraindicated during the first trimester of pregnancy.

Use of the medicinal product during the second and third trimesters of pregnancy is possible only after careful consideration of the benefit-risk ratio.

Breastfeeding

It is unknown whether butamirate citrate or guaifenesin passes into breast milk. Experience with use in breastfeeding mothers is limited; therefore, the risk of adverse effects in infants cannot be excluded. It is recommended to discontinue breastfeeding during the period of treatment with this medicinal product.

Ability to influence reaction speed when driving or operating machinery.

This medicinal product may negatively affect activities requiring increased attention (e.g., driving a car, operating machinery, or working at heights) due to the possibility of somnolence and dizziness occurring.

Dosage and Administration.

This medicinal product is intended for use in children from 6 months of age and adults. The dosage should be adjusted according to the patient's body weight:

up to 12 kg – 1.25 ml 3–4 times daily;

12–20 kg – 2.5 ml 3 times daily;

20–40 kg – 2.5 ml 3–4 times daily;

40–70 kg – 5 ml 3 times daily;

70–90 kg – 5 ml 4 times daily;

90 kg and above – 7.5 ml 3–4 times daily.

The interval between doses should be 4–6 hours.

The dose should be measured using the graduated pipette provided.

The preparation should be taken after meals, with a sufficient amount of liquid (water, tea, fruit juice).

Do not use the preparation for more than 7 days without consulting a physician.

Children.

This medicinal product is indicated for use in children from 6 months of age, according to the indications (dosage and administration are given in the section "Dosage and Administration").

Overdose.

In case of overdose, symptoms of guaifenesin toxicity predominate: drowsiness, muscle weakness, nausea, vomiting, diarrhea, dizziness, arterial hypotension. Radiolucent urolithiasis is possible.

There is no specific antidote.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy aimed at supporting cardiovascular and respiratory function, renal function, and maintaining electrolyte balance.

Adverse Reactions.

The drug is well tolerated by patients when the recommended dosage is followed. Adverse effects usually resolve after dose reduction.

Metabolism and nutrition disorders: anorexia.

Nervous system disorders: headache, somnolence.

Respiratory system disorders: dyspnea.

Ear and labyrinth disorders: dizziness.

Gastrointestinal disorders: discomfort in the gastrointestinal tract, nausea, abdominal pain, vomiting, diarrhea. If unpleasant stomach sensations or other unusual effects occur, the use of the drug should be discontinued and medical advice should be sought.

Skin and subcutaneous tissue disorders: allergic reactions, including anaphylactic shock, angioneurotic edema, skin rashes, pruritus, urticaria, exanthema.

Urinary system disorders: urolithiasis.

Shelf life. 3 years.

After first opening – 4 weeks.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 100 ml in a bottle, 1 bottle with a measuring pipette in a box.

Availability category. Over-the-counter.

Manufacturer. Teva Czech Industries s.r.o.

Manufacturer's address and place of business.

Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic.