The solution for oral administration of "Zvezdochka Broncho" contains Ambroxol hydrochloride and is a mucolytic. It is used for acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum.
Active ingredient: Ambroxol hydrochloride 15.00 mg; excipients: citric acid monohydrate 1.00 mg or 2.00 mg, liquid sorbitol 70% 2250.00 mg, glycerol 860.00 mg, methyl parahydroxybenzoate 6.00 mg, propyl parahydroxybenzoate 1.5 mg, propylene glycol 150.00 mg, strawberry flavor 2.50 mg, water purified to 5 ml.
Indications / Application Notes
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum: - acute and chronic bronchitis; - pneumonia; - chronic obstructive pulmonary disease; - bronchial asthma with difficulty in sputum discharge; - bronchiectatic disease;
Contraindications • hypersensitivity to ambroxol, bromexin or other components of the drug; • hereditary fructose intolerance (due to the fact that the drug contains sorbitol); • pregnancy (I trimester); • period of breastfeeding; • in children under 2 years of age, the drug can be used only as directed by a doctor. Carefully: • pregnancy (II-III trimester); • liver failure; • renal failure; • peptic ulcer of the stomach and duodenum in the acute stage; • violation of the motor function of the bronchi and increased sputum formation (with the syndrome of motionless cilia).
Mode of application
Adults and children over 12 years old. For the first 2-3 days, take 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. 6 Children from 6 to 12 years old. 5 ml (15 mg) of oral solution 2-3 times a day. Children from 2 to 6 years. 2.5 ml (7.5 mg) of oral solution 3 times a day. Children under 2 years of age. 2.5 ml (7.5 mg) of oral solution 2 times a day. The maximum daily dose for adults is 120 mg of ambroxol; the maximum daily dose for children from 6 to 12 years old is 45 mg of ambroxol; the maximum daily dose for children from 2 to 6 years is 22.5 mg of ambroxol; the maximum daily dose for children under 2 years is 15 mg of ambroxol. The duration of treatment is determined individually depending on course of the disease. It is not recommended to take Ambroxol for more than 4-5 days without consulting a doctor.
Side effects
The incidence of adverse reactions that develop when taken Ambroxol, classified according to WHO recommendations: very often - not less than 10%; often - at least 1% and less than 10%; infrequently - not less than 0.1% and less than 1%; rarely - not less than 0.01% and less than 0.1%; very rarely - less 0.01%, including isolated cases; frequency is unknown. Immune System Disorders Rarely: hypersensitivity reactions, skin rash, urticaria. Frequency unknown: anaphylactic reactions (including anaphylactic shock), angioedema, skin itching. Disorders of the nervous system Often: dysgeusia (violation of taste). Respiratory system disorders Infrequently: shortness of breath (as a sign of a hypersensitivity reaction). Frequency unknown: Decreased sore throat (numbness). Gastrointestinal Disorders Often: nausea, decreased sensitivity in the oral cavity (numbness). Infrequently: dyspepsia, vomiting, diarrhea, abdominal pain, dry mucous membrane shells of the oral cavity and pharynx. Very rarely: hypersalivation (excessive salivation). Disorders of the skin and subcutaneous tissue Frequency unknown: erythema multiforme exudative syndrome Stevens-Johnson, toxic epidermal necrolysis (syndrome Lyella), acute generalized exanthematous pustulosis. General disorders and disorders at the injection site Infrequently: fever.
Special instructions
In children and patients with a reduced cough reflex (elderly patients, patients in an unconscious state, or in a state immobilization) should ensure the evacuation of bronchial secretions. The decrease in viscosity of a large amount of secretion should be combined with its aspiration. At the beginning of ambroxol therapy, an increase in cough is possible in patients with bronchial asthma. For children over 2 years of age, Ambroxol should be used only as directed by a doctor. Patients taking Ambroxol are not recommended to perform respiratory gymnastics due to difficulty in sputum discharge. In severe diseases of the liver and kidneys, the drug Zvezdochka Broncho should be used with caution, decreasing the dose and increasing the intervals between doses of the drug. In such cases, it is recommended that treatment under the supervision of a doctor. When using Ambroxol preparations, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome (toxic epidermal necrolysis). Therefore, when any changes in the skin and mucous membranes urgently need to contact to the doctor and stop taking the drug. When using Ambroxol preparations in the form of a solution for oral administration it should be borne in mind that calorie content is 2.6 kcal / g sorbitol. The drug Zvezdochka Broncho can be prescribed to patients with sugar diabetes. 5 ml of oral solution contains 2.1 mg of sorbitol, which corresponds to 0.18 XE. Zvezdochka Broncho may cause an allergic reaction. (possibly delayed type) and bronchospasm, due to the presence in the composition methyl parahydroxybenzoate and propyl parahydroxybenzoate. Taking Zvezdochka Broncho may be minor laxative effect due to the presence of sorbitol. Mucolytic agents may be irritating to the mucous membrane of the gastrointestinal tract, therefore ambroxol should be used with caution in patients with peptic ulcer stomach and duodenum
Release form
Solution for oral administration 15 mg / 5 ml. 120 ml per bottle of polyethylene terephthalate. 1 bottle with instructions for use in a cardboard box
Storage conditions
In a dark place at a temperature of no higher than25 ºС. Keep out of the reach of children.
Shelf life
3 years