Star Broncho, 15 mg/5 ml 120 ml

Mucolytic and expectorant, is an active N-demethylated metabolite of bromhexine. It has secretomotor, secretolytic and expectorant action. It stimulates serous cells of bronchial mucosa, increases motor activity of atomizing epithelium by effect on type 2 pneumocytes in alveoli and Clara cells in bronchioles, increases formation of endogenous surfactant – surface-active substance, providing gliding of bronchial secretion in airway lumen.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and helping to reduce the viscosity and liquefy sputum; this improves mucociliary transport and facilitates removal of sputum from the bronchial tree.

When ambroxol is taken orally, the effect, on average, occurs within 30 minutes and lasts for 6-12 hours, depending on the single dose.

Pharmacokinetics

Ambroxol is quickly and almost completely absorbed after oral administration. T_max is 1-3 h. Binding to plasma proteins is approximately 85%. It penetrates the placental barrier and is excreted with breast milk. Metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys. Excreted mainly by the kidneys – 90% as metabolites, less than 10% unchanged. T_1/2 from plasma is 7-12 hours. T_1/2 of ambroxol and its metabolites is approximately 22 h.

Due to high binding to proteins and large V_d and slow reverse penetration from tissues into blood, no significant excretion of ambroxol occurs during dialysis or forced diuresis. Ambroxol clearance in patients with severe hepatic failure is reduced by 20-40%. In severe renal failure, the T_1/2 of ambroxol metabolites is increased.

Indications

Acute and chronic respiratory diseases accompanied by viscous sputum:

• acute and chronic bronchitis;
• pneumonia;
• chronic obstructive pulmonary disease;
• bronchial asthma with difficult expectoration;
• bronchiectatic disease.

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Active ingredient

Ambroxol

Composition

5 ml of solution for oral administration contains:

active substance:

Ambroxol hydrochloride 15.00 mg;

auxiliary substances:

citric acid monohydrate 1.00 mg,

sorbitol liquid 70% 2250.00 mg,

glycerol 860.00 mg,

methyl parahydroxybenzoate 6.00 mg,

Interaction

Ambroxol should not be taken simultaneously with cough suppressants because of possible suppression of the cough reflex and retention of secretion in the airways.

Ambroxol should not be taken simultaneously with agents that suppress bronchial secretion.

Ambroxol increases penetration of some antibiotics (e.g., amoxicillin, cefuroxime, erythromycin, doxycycline) into the lung tissue and, therefore, increases their concentration in the pulmonary parenchyma.

Directions for use

Orally, after meals.

Mucolytic effect of the drug is manifested by taking a large amount of fluid. Therefore, during the treatment it is recommended to drink plenty of fluids. The drug should not be taken immediately before going to bed.

A teaspoon is used for dosing.

Adults and children over 12 years

During the first 2-3 days 10 ml (30 mg) of the oral solution 3 times a day, then the dose should be reduced to 10 ml (30 mg) of the oral solution 2 times a day.

Children from 6 to 12 years

5 ml (15 mg) of the oral solution 2-3 times a day.

Children from 2 to 6 years

2.5 ml (7.5 mg) of the oral solution 3 times a day.

Children under 2 years

2.5 ml (7.5 mg) of oral solution 2 times a day.

Special Instructions

Ambroxol should not be taken simultaneously with anti-cough drugs that may inhibit the cough reflex, such as codeine, because this may impede removal of liquefied sputum from the bronchi.

Ambroxol should be used with caution in patients with impaired cough reflex or impaired mucociliary transport because of the possibility of sputum accumulation.

Patients taking ambroxol are not recommended to perform breathing exercises due to difficulty in sputum discharge. In patients who are in a serious condition, aspiration of liquefied sputum should be performed.

Ambroxol should not be taken immediately before going to bed.

In patients with bronchial asthma, ambroxol may increase coughing.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – a flu-like condition may be observed in the early phase: fever, body pain, rhinitis, cough, pharyngitis. In symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be prescribed incorrectly.

Contraindications

• high sensitivity to ambroxol, bromhexine or other drug components;
• Hereditary intolerance to fructose (due to the fact that the drug contains sorbitol);
• Pregnancy (1st trimester);

Breastfeeding period.

• Pregnancy (1st trimester);
• Breast-feeding period;
• children under 6 years of age (for the dose 30 mg/5 ml);
• In children under 2 years, the drug may be used only with the prescription.

Cautions

• pregnancy (II-III trimester);
• hepatic failure;
• renal failure;
• renal failure
• gastric and duodenal ulcer in acute stage;
• disorder of bronchial motor function and increased sputum formation (with immobile cilia syndrome).

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Side effects

Allergic reactions: rare – skin rash, urticaria, exanthema, facial edema, dyspnea, itching, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, allergic contact dermatitis.

The digestive system: frequently – nausea; infrequently – vomiting, diarrhea, dyspepsia, abdominal pain.

Nervous system disorders: often – dysgeusia.

Skin and subcutaneous tissue disorders: very rare – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown – acute generalized eczematous pustulosis.

Respiratory system: often – decreased sensitivity in the oral cavity or pharynx; rarely – dry mucous membrane of the airways, rhinorrhea; in single cases – dry mucous membrane of the throat.

Overdose

No specific symptoms of overdose in humans have been described. There are reports on accidental overdose, which resulted in observed symptoms of known ambroxol side effects: nausea, dyspepsia, diarrhea, vomiting, abdominal pain.

Treatment: artificial vomiting, gastric lavage during the first 1-2 hours after drug administration, symptomatic therapy. Due to the high degree of binding of ambroxol to blood plasma proteins and large volume of distribution, hemodialysis or forced diuresis is inexpedient.

Similarities

Ambrohexal, Lazolvan, Halixol, Ambroxol, Ambrobene, Orvis Broncho, ORVIS, Lazolvan Max, Zvezdochka, Zvezdochka for colds