Cough drops pulmo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PULMO COUGH DROPS

Composition:

Active substance: butamirate citrate;

1 ml (22 drops) of the preparation contains 5 mg of butamirate citrate;

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

Pharmaceutical form. Oral drops, solution.

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

Pharmacotherapeutic group. Agents used for cough and colds. ATC code R05DB13.

Pharmacological properties.

Pharmacodynamics.

A non-opioid antitussive agent with central action. The active ingredient of the drug is butamirate citrate, which suppresses cough and differs in structure and pharmacological action from opium alkaloids. The substance is believed to act on the central nervous system. Butamirate citrate exhibits a nonspecific anticholinergic and bronchospasmolytic effect, which improves respiratory function. PULMO Cough Drops do not cause habituation or dependence.

Butamirate citrate has a wide therapeutic range; therefore, PULMO Cough Drops are well tolerated even at high doses and are suitable for cough relief in 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 extensively protein-bound in the body.

The effect of food on bioavailability has not been confirmed. The metabolism of butamirate to 2-phenylbutyric acid and diethylaminoethoxyethanol is dose-proportional.

Metabolites are excreted mainly by the kidneys. Butamirate is detectable in urine up to 48 hours after administration. The elimination half-life of butamirate is 1.5–1.9 hours, of 2-phenylbutyric acid is 23.3–24.4 hours, and of diethylaminoethoxyethanol is 2.7–2.9 hours.

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 in children.

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.

Avoid concomitant use of expectorants.

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 product contains sorbitol. It should not be used in patients with fructose intolerance.

If cough persists for more than 7 days, a physician should be consulted.

Use during pregnancy or breastfeeding.

The safety of using the drug during pregnancy and breastfeeding has not been evaluated in specific studies.

Butamirate citrate should not be used during the first three months of pregnancy. During other periods of pregnancy, butamirate citrate may be used only on a physician's prescription and only when clearly indicated. Butamirate citrate may also be prescribed by a physician in another pharmaceutical form (syrup).

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 butamirate citrate during breastfeeding should be carefully weighed. Use of butamirate citrate during breastfeeding is possible if, in the physician’s opinion, the expected beneficial effect for the mother outweighs the potential risk to the infant.

Ability to affect reaction rate while driving or operating machinery.

PULMO Cough Drops may cause drowsiness. It should be borne in mind that the drug may affect psychomotor reactions.

Dosage and Administration.

The medication is intended for use in children.

The single dose depends on the child's age and is as follows:

• Children from 2 months to 1 year of age – 10 drops, 4 times daily;
• Children from 1 to 3 years of age – 15 drops, 4 times daily;
• Children from 3 years of age – 25 drops, 4 times daily.

To accurately measure the dose, the bottle should be held vertically with the dropper tip facing downward.

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

The medication should be taken 30 minutes before meals with a small amount of water.

Children.

There is no experience with use in infants under 2 months of age.

The medication may be administered to children under 2 years of age only under medical supervision.

Overdose.

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

Standard emergency measures should be applied: gastric lavage, activated charcoal administration, and monitoring of vital functions, if necessary.

There is no specific antidote.

Side effects.

From the nervous system: rare (>1/10,000, <1/1,000) – drowsiness.

From the gastrointestinal tract: rare – nausea, diarrhea.

Allergic reactions: rare – anaphylactic shock, angioneurotic edema, skin rash, urticaria, pruritus.

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

Storage conditions.

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

Keep out of reach of children.

Packaging. 20 ml in a bottle sealed with a dropper stopper and closed with a cap, in a box.

Dispensing category. Over-the-counter.

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

Manufacturer's location and address of business activity.

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