Ambrobene, syrup 15 mg/5 ml 100 ml

Name: Ambrobene, syrup 15 mg/5 ml 100 ml
SKU: 24493
Availability: InStock

€3.67

EAN: 4030096245128 SKU: 24493 Categories: Medicine, Respiratory system, Sputum liquefaction

Description

Pharmacological group: expectorant mucolytic.

ATX code: R05CB06

Pharmacological action

Pharmacodynamics:

Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has secretomotor and secretolytic and expectorant action.

After oral administration the action comes within 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates serous gland cells of the bronchial mucosa. By activating cells of the ciliated epithelium and reducing sputum viscosity, it improves mucociliary transport.

Ambroxol activates surfactant formation with a direct effect on alveolar type 2 pneumocytes and small airway Clara cells.

Studies on cell cultures and in vivo animal studies have shown that ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult.

An antioxidant effect of ambroxol has also been proven in preclinical studies. Ambroxol when used together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases their concentration in sputum and bronchial secretion.

Pharmacokinetics

Ambroxol is almost completely absorbed from the gastrointestinal tract when taken orally. The maximum concentration is reached 1-3 hours after oral administration. Due to presystemic metabolism the absolute bioavailability of ambroxol after oral administration is reduced by approximately ⅓. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Binding to plasma proteins is about 85% (80-90%). The plasma elimination half-life is 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

It is excreted mainly by the kidneys as metabolites – 90%, less than 10% is excreted unchanged.

Given its high plasma protein binding, large volume of distribution and slow redistribution from the tissues into the blood, there is no significant excretion of ambroxol with dialysis or forced diuresis.

In patients with severe liver disease ambroxol clearance is reduced by 20-40%. In patients with severe renal impairment the half-life of ambroxol metabolites is prolonged.

Ambroxol penetrates the cerebrospinal fluid and through the placental barrier, and is excreted in breast milk.

Indications

Active ingredient

Composition

How to take, the dosage

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

Children under 2 years should take Â½ cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day).

Children 2 to 6 years should take Â½ 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

Special Instructions

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

Others:

Rarely (â¥ 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

Additional information

Weight	0.225 kg
Shelf life	5 years.
Conditions of storage	Keep out of the reach of children at temperatures under 25°C.
Manufacturer	Merkle GmbH, Germany
Medication form	syrup
Brand	Merkle GmbH