Bromhexine oral solution 4mg/5ml, 60ml

Composition

>1 ml of the solution contains: Active ingredient: Bromhexinee hydrochloride. – 0,8 MGM Auxiliary substances:  levomentol 0.068 mg; hydrochloric acid 2 mol / l to pH 3.0; methyl parahydroxy benzoate 1.64 mg; ethanol 96% 30.0 mg; sorbitol 300.0 mg; purified water 762.0 mg

Pharmacological action

Pharmacotherapy group: expectorant mucolytic agent

ATX code: [R05CB02]

Pharmacological properties

Pharmacodynamics .

Bromhexinee Nicomed has mucolytic (secretolytic), expectorant and weak antitussive effect. The mucolytic effect is associated with depolymerization of mucoprotein and mucopolysaccharide fibers and an increase in the serous component of bronchial secretions.

Pharmacokinetics

When taken orally, Bromhexinee is almost completely (99%) absorbed in the gastrointestinal tract within 30 minutes. Bioavailability depends on the individual characteristics of the body, the activity of renal enzymes during the primary passage of the Active ingredient through the liver and is approximately 20%. Bromhexinee in plasma binds to proteins, penetrates through the blood-brain and placental barriers.

In the liver, Bromhexinee undergoes demethylation and oxidation, while some of the resulting metabolites (ambroxol) remain active. The maximum half-life is 15 hours due to slow reverse diffusion from tissues. The maximum concentration in the blood is reached approximately 1 hour after ingestion. It is excreted by the kidneys. In chronic renal failure, the release of Bromhexinee Metabolites is disrupted. With repeated use, Bromhexinee may accumulate.

Indications

Acute and chronic bronchopulmonary diseases accompanied by the formation of sputum of increased viscosity (bronchial asthma, pneumonia, tracheobronchitis, obstructive bronchitis, bronchiectasis, emphysema, cystic fibrosis, tuberculosis, pneumoconiosis). Rehabilitation of the bronchial tree in the preoperative period and during therapeutic and diagnostic intra-bronchial manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Contraindications

-hypersensitivity to the components of the drug;- pregnancy and lactation;- peptic ulcer disease (in the acute stage);- children under 3 years of age.

Use with caution in patients with a history of gastric bleeding, bronchial diseases accompanied by excessive accumulation of secretions, in the presence of a history of episodes of hemoptysis, renal and/or hepatic insufficiency.

The presence of alcohol in the preparation (3%) may have an adverse effect on children, pregnant women, people with brain diseases, traumatic brain injury, alcoholism.

Side effects

Nausea, vomiting, exacerbation of gastric ulcer and duodenal ulcer, allergic reactions, dizziness, headache, increased activity of “hepatic” transaminases in the blood serum are rarely possible with prolonged use of the drug.

Interaction

Bromhexinee Nicomed is not prescribed simultaneously with antitussive drugs (including those containing codeine), because they can make it difficult to cough up sputum diluted with Bromhexinee Nicomed. Bromhexinee Nicomed promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin), sulfonamide preparations into the bronchial secret. The drug is incompatible with alkaline solutions.

How to take, course of use and dosage

Inside. Adults and children over 10 years of age: 10-20 ml 3 times a day. Children from 6 to 10 years – 5-10 ml 3 times a day. Children from 3 to 6 years – 2.5-5 ml 3 times a day. For the convenience of dosing the drug, use the attached measuring beaker. During treatment, it is recommended to consume a sufficient amount of liquid, which supports the secretolytic effect of Bromhexinee.

Overdose

Life – threatening overdoses of Bromhexinee Nicomed in humans are not known. The following symptoms may occur: nausea, vomiting, diarrhea, and other gastrointestinal disorders. Treatment:  There is no specific antidote. In case of overdose, it is necessary to induce vomiting, and then give the patient a liquid (milk or water). Gastric lavage is recommended within 1-2 hours after taking the drug.

Special instructions

For patients with diabetes: 5 ml of the solution contains 1.5 g of sorbitol, which corresponds to 0.12 bread units. The composition of the drug includes alcohol in a concentration of 3%, which is 0.6 g per dose of the drug for adults (20 ml), respectively, for children (2.5 ml) – 0.075 g.

Impact on the ability to drive vehicles and equipment

Taking the recommended therapeutic doses (20 ml 3 times a day) does not affect the speed of psychomotor reactions of the patient.

Significantly exceeding the recommended dosage of a drug containing 3% alcohol can affect the speed of psychomotor reactions and pose a danger when driving a car or working with equipment.

Storage conditions

Store at a temperature of +15 to +25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Bromhexinee

Dosage form

oral solution