Ambrobene, syrup 15 mg/5 ml 100 ml

Indications

Cough, Bronchitis, Tracheitis, Lung inflammation (pneumonia), Bronchial asthma, Chronic obstructive pulmonary disease Acute and chronic respiratory diseases accompanied by impaired sputum formation and discharge.

Active ingredient

Ambroxol

Composition

Syrup contains 100 ml of the active substance: ambroxol hydrochloride 0.30 g, auxiliary substances: sorbitol liquid 70% 60.00 g, propylene glycol 5.00 g, raspberry flavoring 0.10 g, saccharin 0.01 g, purified water 49.44 g.

How to take, the dosage

The syrup should be taken after meals using the provided measuring cup.

Children under 2 years should take ½ cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day).

Children 2 to 6 years should take ½ cup measure (2.5 ml syrup) 3 times daily (22.5 mg ambroxol per day).

Children 6 to 12 years old should take 1 measuring cup (5 ml syrup) 2-3 times a day (30-45 mg ambroxol per day).

Adults and children over 12 years in the first 2-3 days of treatment should take 2 measuring cups (10 ml syrup) 3 times a day (90 mg ambroxol per day). If therapy is ineffective, adults may increase the dose to 4 measuring cups (20 ml syrup) 2 times a day (120 mg ambroxol per day). On subsequent days, take 2 measuring cups (10 ml syrup) 2 times a day (60 mg ambroxol per day).

The duration of treatment is chosen individually, depending on the course of the disease. It is not recommended to take Ambrobene without a doctor’s prescription for more than 4-5 days.

The 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.

Interaction

Concomitant use of ambroxol and cough suppressants may cause cough reflex stasis. Therefore, such combinations should be chosen with caution. When concomitant use of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, concentration of the latter in sputum and bronchial secretion increases.

Special Instructions

It should not be combined with anti-cough drugs that make it difficult to expectorate sputum. In children under 2 years of age the drug may be used only by prescription. Severe skin reactions, such as Stevens-Johnson syndrome and Lyell syndrome, have been extremely rarely observed when using ambroxol. In case of changes in the skin or mucous membranes it is necessary to consult a doctor urgently and discontinue the drug. The effect on the ability to drive vehicles and to operate machines and mechanisms is not known so far. The caloric value is 2.6 kcal/g sorbitol. Sorbitol may have a mild laxative effect. 1 measuring cup (5 ml syrup) contains 2.1 g sorbitol, which corresponds to 0.18 units.

Contraindications

– hypersensitivity to ambroxol or to one of the excipients;

– pregnancy (first trimester);

– sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution: impaired bronchial motor function and increased sputum formation (in fixed cilia syndrome), gastric and 12 duodenal ulcer during exacerbation, pregnancy (II-III trimester), lactation period.

Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing long intervals between doses or taking the drug in a smaller dose.

Side effects

General disorders:

Rarely (≥ 0.1% to < 1%): allergic reactions (urticaria, skin rash, angioedema of the face, shortness of breath, itching), fever, weakness, headache.

Very rare (< 0.01%): anaphylactic reactions, including anaphylactic shock.

Gastrointestinal tract:

Rarely (≥ 0.1% to < 1%): nausea, abdominal pain, vomiting, diarrhea, constipation.

Others:

Rarely (≥ 0.1% to < 1%): dry mucous membrane of the mouth and respiratory tract, exanthema, rhinorrhea, dysuria.

Overdose

Symptoms:

There are no signs of intoxication in ambroxol overdose. There have been reports of nervous agitation and diarrhea.

Ambroxol is well tolerated when taken orally in doses up to 25 mg/kg/day.

In severe overdose, increased salivation, nausea, vomiting, and decreased blood pressure are possible.

Treatment:

The methods of intensive therapy, such as inducing vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is indicated.

Pregnancy use

Pregnancy:

There are insufficient data regarding the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have shown no teratogenic effects.

The use of Ambrobene in pregnancy (II-III trimester) is possible only by prescription, after careful assessment of the risk/benefit ratio.

Breastfeeding period:

Animal studies have shown that ambroxol penetrates into breast milk. Because of the insufficient study of the drug use in women during breast-feeding period, the use of Ambrobene is possible only by prescription and after careful evaluation of the risk/benefit ratio.

Similarities

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