Instructions Tuspan syrup 1.5 mg/ml bottle 100 ml
Composition
active ingredient: butamirate citrate;
1 ml of syrup contains 1.5 mg of butamirate citrate;
Excipients: non-crystallizing liquid sorbitol (E 420); glycerin; sodium saccharin; benzoic acid (E 210); vanillin; rectified ethyl alcohol (96%); sodium hydroxide; purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent solution from colorless to brownish-yellowish color.
Pharmacotherapeutic group
Medicines used for coughs and colds. Cough suppressants. ATX code R05D B13.
Pharmacological properties
Pharmacodynamics
A centrally acting non-opiate antitussive. However, the exact mechanism of action remains unknown.
The active ingredient of the drug is butamirate citrate, which suppresses cough and differs in its structure and pharmacological action from opium alkaloids. It is believed that this substance acts on the central nervous system. Butamirate citrate causes a nonspecific anticholinergic and bronchospasmolytic effect, which improves respiratory function. Butamirate citrate does not cause habituation or dependence.
Butamirate citrate has a wide therapeutic range, so it is well tolerated in therapeutic doses and is well suited as a cough suppressant in children.
Pharmacokinetics
Butamirate is rapidly absorbed, distributed in the body and then mainly hydrolyzed to 2-phenylbutyric acid and diethylaminoethoxyethanol, which also have antitussive activity. 2-phenylbutyric acid is further partially metabolized by hydroxylation. Butamirate and 2-phenylbutyric acid in the body are highly bound to blood proteins.
The effect of food on bioavailability has not been confirmed. The metabolism of butamirate to 2-phenylbutyric acid and diethylaminoethoxyethanol is completely proportional in the dose range of 22.5–90 mg.
Measurable concentrations of butamirate are detected in the blood within 5–10 minutes after administration of 22.5 mg, 45 mg, 67.5 mg and 90 mg. Peak plasma concentrations are reached within 1 hour for all four doses with a mean peak plasma concentration of 16.1 ng/mL for the 90 mg dose.
The mean maximum plasma concentration of 2-phenylbutyric acid is reached within 1.5 hours with the highest exposure observed after 90 mg (3052 ng/mL).
The mean maximum plasma concentration of diethylaminoethoxyethanol is reached within 0.67 hours with the highest exposure observed after 90 mg (160 ng/mL).
Metabolites are excreted mainly by the kidneys. Butamirate is detected in the urine within 48 hours after administration. According to the results of measurements, the half-life for butamirate is 1.48–1.93 hours, for 2-phenylbutyric acid — 23.26–24.42 hours, for diethylaminoethoxyethanol — 2.72–2.90 hours.
There is no evidence of the influence of liver and kidney dysfunction on the pharmacokinetic parameters of butamirate.
Indication
Symptomatic treatment of cough (including dry) of various origins.
Contraindication
Hypersensitivity to the active or excipients of the drug.
Interaction with other medicinal products and other types of interactions
Concomitant use of expectorants should be avoided. The exact mechanism of interaction with other drugs is not known, but the central mechanism of action of the drug, which suppresses cough, may be enhanced by the action of strong depressants, including alcohol.
Application features
Given that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided, as this may lead to mucus stagnation in the respiratory tract, which increases the risk of bronchospasm and respiratory tract infection.
The syrup contains sweeteners - sodium saccharin and sorbitol, so it can be prescribed to patients with diabetes. Sorbitol is a source of fructose, so Tuspan® should not be used in patients with fructose intolerance.
If the patient has been diagnosed with an intolerance to some sugars, consult a doctor before taking this medicine.
Tuspan® contains a small amount of ethanol (alcohol), which is less than 100 mg/dose. The medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium-free.
If the cough persists for more than 7 days, you should consult a doctor.
Patients whose symptoms worsen or do not improve within 7 days and/or are accompanied by fever, rash, or persistent headache should have further investigations to identify the underlying cause of the condition.
Keep the medicine out of the reach and sight of children.
Use during pregnancy or breastfeeding
During pregnancy, Tuspan® can be used only as prescribed by a doctor if there are direct indications for such treatment. If the expected benefit to the pregnant woman outweighs the possible risk to the fetus, the lowest effective dose and the shortest duration of treatment should be prescribed.
It is not known whether the active substance or its metabolites pass into breast milk.
For safety reasons, the benefits and risks of using Tuspan® during breastfeeding should be carefully weighed. The use of the drug during lactation is possible only on the advice of a doctor, if, in his opinion, the expected positive effect for the mother outweighs the potential risk to the child. In such cases, the lowest effective dose and the shortest duration of treatment should be prescribed.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine may cause fatigue and affect your reaction when driving vehicles or using other mechanisms.
Method of administration and doses
For oral use only.
Children aged 3 to 6 years: 5 ml (7.5 mg) 3 times a day; maximum daily dose is 15 ml (22.5 mg).
Children aged 6 to 12 years: 10 ml (15 mg) 3 times a day; maximum daily dose is 30 ml (45 mg).
Adolescents aged 12 years and over: 15 ml (22.5 mg) 3 times a day; maximum daily dose is 45 ml (67.5 mg).
Adults: 15 ml (22.5 mg) 4 times a day; maximum daily dose is 60 ml (90 mg).
The measuring cup should be washed and dried after each use and after use by another person.
The maximum course of treatment without a doctor's prescription should not exceed 1 week.
It is advisable to take the medicine before meals.
The lowest dose necessary to achieve an effect should be used for the shortest possible treatment period.
Do not exceed the specified dose.
Children.
The drug in this dosage form is not used in children under 3 years of age.
Overdose
Overdose of Tuspan® may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness and hypotension.
Further treatment should be carried out according to clinical indications.
There is no specific treatment for butamirate overdose. If an overdose occurs, the patient should be treated symptomatically and vital signs monitored.
Adverse reactions
Nervous system disorders (uncommon: ≥ 1/10,000, 1/1000): dizziness, drowsiness.
Gastrointestinal disorders (uncommon: ≥ 1/10,000, 1/1000): nausea, diarrhea.
Immune system disorders (uncommon: ≥ 1/10,000, 1/1000): anaphylactic shock.
Skin and subcutaneous tissue disorders (uncommon: ≥ 1/10,000, 1/1000): angioedema, skin rash, urticaria, itching.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
The shelf life after opening the bottle is 1 month.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
100 ml or 200 ml of syrup in polymer bottles, sealed with polymer caps, 1 bottle with a measuring cup in a pack.
Vacation category
Without a prescription.
Producer
JSC "VITAMINS".
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Uspenska st., 31.
