Stoptussin-teva

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

Composition:

Active substances: butamirate citrate, guaifenesin;

One tablet contains: butamirate citrate 4 mg, guaifenesin 100 mg;

Excipients: silicon dioxide colloidal anhydrous, mannitol (E 421), microcrystalline cellulose, glyceryl dibehenate, magnesium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: round-shaped white tablets with a score line on one side.

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

Pharmacological properties.

Pharmacodynamics.

A combination medication 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 effect of butamirate citrate is complemented by the expectorant action of guaifenesin. Guaifenesin possesses 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 expectoration).

Pharmacokinetics.

Butamirate citrate is rapidly and completely absorbed, with 98% binding to plasma proteins. It is metabolized, forming two metabolites, both of which also exert antitussive effects. 90% of the metabolites are excreted via 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, primarily 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.

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 12 years 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 stagnation 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 adverse effects of guaifenesin, particularly muscle weakness.

Effect on laboratory test results

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

Instructions for Use

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.

The drug should be used with caution in patients with asthma, tuberculosis, or pneumoconiosis.

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

Use during pregnancy or breastfeeding.

Pregnancy

No controlled studies in pregnant women or animal studies have been conducted.

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

Use of the drug 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 are excreted in 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 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 a vehicle, operating machinery, or working at heights) due to the possibility of developing somnolence or dizziness.

Dosage and Administration.

Follow dosing according to the patient's body weight:

up to 50 kg − ½ tablet 4 times daily;

50–70 kg − 1 tablet 3 times daily;

70–90 kg − 1½ tablets 3 times daily;

90 kg and above − 2 tablets 3 times daily.

The interval between individual doses should be 4–6 hours. The tablet may be divided in half.

The medication is recommended to be taken after meals, with sufficient amount of liquid (water, tea, juice).

Children.

The medicinal product may be used in children aged 12 years and older, according to the indications (dosage and administration are specified 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 functions, kidney function, and maintaining electrolyte balance.

Side effects.

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

Metabolism and nutrition disorders: anorexia.

Nervous system disorders: headache, drowsiness.

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, the drug should be discontinued and a physician consulted.

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

Packaging. 10 tablets in a blister pack, 2 blisters per carton.

Availability. Over-the-counter.

Manufacturers. Teva Czech Industries s.r.o.

Teva Operations Poland Sp. z o.o.

Manufacturers' addresses.

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

Mogilska 80, 31-546 Kraków, Poland.