Cough syrup pulmo

INSTRUCTIONS for medical use of the medicinal product COUGH SYRUP PULMO

Composition:

Active substance: butamirate;

1 ml of syrup contains 1.5 mg of citric acid butamirate;

Excipients: sorbitol (E 420), glycerol, sodium saccharin, benzoic acid (E 210), vanillin, ethanol 96%, sodium hydroxide, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: a clear, colorless solution with a specific odor.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Antitussives. ATC code R05D B13.

Pharmacological properties.

Pharmacodynamics.

A non-opioid antitussive agent with central action. However, the exact mechanism of action remains unknown.

The active ingredient of the medicinal product is butamirate citrate, which suppresses cough and differs in its structure and pharmacological action from opium alkaloids. The substance is considered to act on the central nervous system. Butamirate citrate produces a non-specific anticholinergic and bronchospasmolytic effect, which improves respiratory function. The drug does not cause habituation or dependence.

Butamirate citrate has a wide therapeutic range; therefore, the drug is well tolerated at therapeutic doses and is well suited as a cough-suppressant agent for children.

Pharmacokinetics.

Butamirate is rapidly absorbed, distributed throughout the body, and subsequently hydrolyzed predominantly to 2-phenylbutyric acid and diethylaminoethoxyethanol, both of which also possess antitussive activity. 2-Phenylbutyric acid is further partially metabolized via hydroxylation. Butamirate and 2-phenylbutyric acid are highly bound to plasma proteins.

The effect of food on bioavailability has not been confirmed. The metabolism of butamirate to 2-phenylbutyric acid and diethylaminoethoxyethanol is completely proportional within the dose range of 22.5 mg–90 mg.

Measurable concentrations of butamirate appear in the blood within 5–10 minutes after administration of 22.5 mg, 45 mg, 67.5 mg, and 90 mg doses. Maximum plasma concentrations are reached within 1 hour for all four doses, with a mean peak plasma concentration of 16.1 ng/mL observed after the 90 mg dose.

The mean peak plasma concentration of 2-phenylbutyric acid is reached within 1.5 hours, with the highest exposure observed after the 90 mg dose (3052 ng/mL).

The mean peak plasma concentration of diethylaminoethoxyethanol is reached within 0.67 hours, with the highest exposure observed after the 90 mg dose (160 ng/mL).

Metabolites are primarily excreted by the kidneys. Butamirate is detectable in urine for up to 48 hours after administration. According to measurements, the elimination half-life is 1.48–1.93 hours for butamirate, 23.26–24.42 hours for 2-phenylbutyric acid, and 2.72–2.90 hours for diethylaminoethoxyethanol.

There is no evidence of the influence of hepatic or renal impairment on the pharmacokinetic parameters of butamirate.

Clinical characteristics.

Indications.

Symptomatic treatment of cough (including dry cough) of various origins.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of expectorants should be avoided. The exact mechanism of interaction with other medicinal products has not been studied, but the central cough-suppressant mechanism of action of the medicinal product may be enhanced by strong depressants, including alcohol.

Special precautions for use.

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.

The syrup contains sweeteners – sodium saccharin and sorbitol, and can be prescribed to patients with diabetes mellitus. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Should not be used in patients with fructose intolerance.

If cough persists for more than 7 days, medical advice should be sought.

If the patient's condition worsens or does not improve within 7 days and/or is accompanied by fever, rash, or persistent headache, additional investigations should be performed to identify the underlying cause.

Keep out of reach and sight of children.

If a patient has known sugar intolerance, consult a physician before taking this medicinal product.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Use during pregnancy or breastfeeding.

The safety of using the drug during pregnancy or breastfeeding has not been evaluated in specific clinical studies. Animal studies have not indicated any direct or indirect adverse effects on pregnancy or fetal health.

During pregnancy, the drug should be used only as prescribed by a physician when there are clear clinical indications. If the expected benefit to the pregnant woman outweighs the potential risk to the fetus, the lowest effective dose and shortest duration of treatment should be prescribed.

It is unknown whether the active substance and/or its metabolites are excreted in breast milk.

For safety reasons, the benefits and risks of using the drug during breastfeeding should be carefully weighed. The use of this medicinal product during breastfeeding may be considered if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the infant. In such cases, the lowest effective dose and shortest duration of treatment should be prescribed.

Ability to influence reaction speed when driving or operating machinery.

May cause fatigue and affect reaction ability when driving or operating machinery.

Dosage and Administration

For oral use only.

Children aged 3 to 6 years: 5 mL (7.5 mg, or 1 measuring spoon) three times daily; maximum daily dose — 15 mL (22.5 mg, or 3 measuring spoons).

Children aged 6 to 12 years: 10 mL (15 mg, or 2 measuring spoons) three times daily; maximum daily dose — 30 mL (45 mg, or 6 measuring spoons).

Adolescents aged 12 years and older: 15 mL (22.5 mg, or 3 measuring spoons) three times daily; maximum daily dose — 45 mL (67.5 mg, or 9 measuring spoons).

Adults: 15 mL (22.5 mg, or 3 measuring spoons) four times daily; maximum daily dose — 60 mL (90 mg, or 12 measuring spoons).

The measuring spoon should be washed and dried after each use and after use by another person.

The duration of treatment without a doctor's prescription should not exceed 1 week.

The medicinal product should preferably be taken before meals.

The lowest effective dose required to achieve the desired effect should be used for the shortest possible treatment duration.

Do not exceed the stated dose.

Children.

Butamirate citrate in this pharmaceutical form is not administered to children under 3 years of age — another pharmaceutical form (oral drops, solution) may be used.

Overdose.

Overdose of the drug may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, and arterial hypotension.

Further treatment should be carried out according to clinical indications.

There is no specific antidote for butamirate overdose. In case of overdose, symptomatic treatment and monitoring of vital functions are required.

Side effects.

Central nervous system (rare: ≥ 1/10,000, < 1/1,000): dizziness, drowsiness.

Gastrointestinal tract (rare: ≥ 1/10,000, < 1/1,000): nausea, diarrhea.

Immune system (rare: ≥ 1/10,000, < 1/1,000): anaphylactic shock.

Skin and subcutaneous tissue (rare: ≥ 1/10,000, < 1/1,000): angioneurotic edema, skin rash, urticaria, pruritus.

Shelf life. 2 years from the date of manufacture when stored in bulk packaging.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 100 ml in a bottle with a measuring spoon in a box.

Availability category. Over-the-counter.

Manufacturer: Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address and location of business activity.

33, Astronomichna Street, lit. "V-1", Kharkiv, Kharkiv region, 61085, Ukraine.