Gripocitron-broncho

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPOCYTRON-BRONHO (GRIPOCITRON-BRONHO)

Composition:

Active substance: butamirate;

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, 96% ethanol, sodium hydroxide, purified water.

Pharmaceutical form. Oral drops, solution.

Main physico-chemical characteristics: clear, colorless solution with a specific odor.

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

Pharmacological Properties.

Pharmacodynamics. 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 considered to act on the central nervous system. Butamirate citrate exhibits a nonspecific 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 even at high doses and is well suited as an antitussive agent for children.

Pharmacokinetics. Butamirate is rapidly absorbed, distributed in the body, and subsequently mainly hydrolyzed 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 proportional to the dose.

Metabolites are excreted mainly by the kidneys. Butamirate is detectable in urine up to 48 hours after administration. The elimination half-life is 1.48–1.93 hours for butamirate, 23.26–24.42 hours for 2-phenylbutyric acid, and 2.72–2.9 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 in children.

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

Interaction with other medicinal products and other forms of interactions. Concomitant use of expectorants should be avoided.

Special precautions for use

Since butamirate suppresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to mucus retention in the airways, increasing the risk of bronchospasm and respiratory tract infection.

If a patient has known intolerance to certain sugars, consult a physician before taking this medicinal product.

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

If cough persists for more than 7 days, consult a physician.

Use during pregnancy or breastfeeding. The drug is intended for use in children.

Safety of use during pregnancy or breastfeeding has not been evaluated in specific studies.

The drug should not be used during the first three months of pregnancy. During other periods of pregnancy, the drug may be used only on a physician's prescription and only if there are clear clinical indications for such treatment.

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. Use of the drug during breastfeeding is possible only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction speed when driving vehicles or operating machinery. The drug is intended for use in children. Rarely, the drug may cause drowsiness, which could have a slight effect on the ability to drive vehicles or operate machinery. Therefore, caution should be exercised when driving a vehicle or performing other tasks requiring alertness (e.g., operating mechanical devices).

Method of Administration and Dosage

The medication is intended for use in children.

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

• Children aged 2 months to 1 year: 10 drops, 4 times daily;
• Children aged 1 to 3 years: 15 drops, 4 times daily;
• Children aged 3 years and older: 25 drops, 4 times daily.

To accurately measure the dose, the bottle should be held vertically with the opening pointing downward.

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

Children. Not intended for children under 2 months of age.

For children under 2 years of age, use only as directed by a physician.

For children aged 3 years and older, another dosage form may be used, namely, Gripocitron-BRONCHO syrup.

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

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

There is no specific antidote.

Adverse reactions.

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

From the gastrointestinal tract: rare – nausea, diarrhea.

From the immune system: rare – anaphylactic shock.

From the skin and subcutaneous tissue: rare – angioneurotic edema, skin rashes, urticaria, pruritus.

Shelf life. 2 years.

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 closed with a dropper stopper, in a box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business. 22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.