Stoptussin-teva

INSTRUCTIONS for medical use of the medicinal product Stoptussin-Teva (Stoptussin-Teva)

Composition:

Active substances: butamirate citrate, guaifenesin;

1 ml of solution contains butamirate citrate 0.004 g, guaifenesin 0.1 g;

Excipients: ethanol 96%, polysorbates, propylene glycol, liquid licorice extract, alpine flowers flavor, purified water.

1 ml contains 34 drops.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: clear viscous liquid, ranging from yellow to yellow-brown, sweetish and slightly bitter in taste.

Pharmacotherapeutic group. Combined preparations containing antitussives and expectorants.

ATC code R05FB02.

Pharmacological properties.

Pharmacodynamics.

A combination drug 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. Unlike opioid antitussive agents, it does not exhibit central inhibitory effects, does not suppress the respiratory center, and does not cause dependence.

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

Pharmacokinetics.

Butamirate citrate is rapidly and completely absorbed; 98% of it is bound to plasma proteins. It is metabolized to form two metabolites, both of which also exert antitussive effects. Approximately 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 readily absorbed from the gastrointestinal tract after oral administration. A negligible amount binds to plasma proteins. It is excreted primarily 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 can be used to relieve cough in the pre- and postoperative periods.

Contraindications.

Hypersensitivity to any component of the drug, 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 accumulation 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 central nervous system (CNS) depressant effects of alcohol, sedatives, hypnotics, and general anesthetics, and also enhances the action of muscle relaxants.

The central nervous effects 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 (using nitrosonaphthol as reagent in the photometric method) 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 38% v/v ethanol (alcohol), i.e. 350 mg/dose, equivalent to 8.9 ml of beer or 3.7 ml of wine per dose. The product is harmful for patients suffering from alcoholism. The alcohol content should be taken into account when administering to patients with liver disease, epilepsy, during pregnancy and breastfeeding, and in children.

During treatment, patients should abstain from consuming alcoholic beverages.

StopTussin-Teva should not be administered to 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 during the second and third trimesters of pregnancy is possible only after careful assessment of the benefit-risk ratio.

Breastfeeding

It is unknown whether butamirate citrate or guaifenesin is excreted in breast milk. Experience with use in breastfeeding mothers is limited; therefore, the risk of adverse effects in infants cannot be excluded. Breastfeeding should be discontinued during treatment with this medicinal product.

Ability to affect reaction speed when driving or operating machinery

The medicinal product may negatively affect activities requiring increased attention (such as driving, operating machinery, or working at heights) due to the possibility of causing somnolence or dizziness.

Administration and Dosage.

Adhere to dosing based on patient's body weight:

up to 7 kg – 8 drops every 6–8 hours (3–4 times daily);

7–12 kg – 9 drops every 6–8 hours (3–4 times daily);

12–20 kg – 14 drops every 8 hours (3 times daily);

20–30 kg – 14 drops every 6–8 hours (3–4 times daily);

30–40 kg – 16 drops every 6–8 hours (3–4 times daily);

40–50 kg – 25 drops every 8 hours (3 times daily);

50–70 kg – 30 drops every 8 hours (3 times daily);

70 kg and above – 40 drops every 8 hours (3 times daily).

The medication should be taken after meals. The required number of drops should be mixed with approximately 100 mL of liquid (water, tea, fruit juice). For children unable to drink 100 mL, the volume of liquid may be reduced to ensure intake of the necessary dose.

Maximum daily dose of guaifenesin: for children aged 6 months to 2 years – 300 mg/day (102 drops); for children aged 2 to 6 years – 600 mg/day (204 drops); for children aged 6 to 12 years – 1200 mg/day; for adults and children aged 12 years and older – 2400 mg/day.

Do not use the medication for longer than 7 days without consulting a physician.

Children.

The medication may be administered to children aged 6 months and older according to indications (dosage and administration instructions are provided in the section "Administration and Dosage").

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 functions, renal function, and maintaining electrolyte balance.

Side effects

The drug is generally well tolerated when administered at the recommended dosage. 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 gastric discomfort or other unusual effects occur, administration of the drug should be discontinued and medical advice 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.

Storage conditions: Store at a temperature not exceeding 25 °C in the original packaging, in a place inaccessible to children. Do not refrigerate or freeze!

Packaging: 10 ml or 25 ml of solution in a bottle with a dropper cap; 1 bottle per carton.

Availability: Over-the-counter (without prescription).

Manufacturer: Teva Czech Industries s.r.o.

Manufacturer's address and place of business:

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