Ambrobene, 15 mg/2 ml 2 ml 5 pcs

Name: Ambrobene, 15 mg/2 ml 2 ml 5 pcs
SKU: 24497
Availability: InStock

€5.03

EAN: 4030096254618 SKU: 24497 Categories: Medicine, Respiratory system, Sputum liquefaction

Description

Pharmacotherapeutic group: expectorant mucolytic.

ATC code: R05CB06

Pharmacological action:

Pharmacodynamics:

Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexin 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, secretolytic and expectorant action.

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 amoxicycycline, cefuroxime, erythromycin and doxycycline increases their concentration in sputum and bronchial secretion.

Pharmacokinetics:

In parenteral administration, ambroxol rapidly penetrates tissues. The highest concentration is found in the lungs. The maximum concentration is reached after 1-3 hours.

The 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 the high binding to plasma proteins, large volume of distribution and slow redistribution from tissues into 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%.

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

Indications

Acute and chronic respiratory tract diseases accompanied by impaired sputum formation and discharge.

Active ingredient

Ambroxol

Composition

1 ampoule (2 ml) contains: active substance ambroxol hydrochloride 15.0 mg; excipients: citric acid monohydrate 1.8 mg, sodium chloride 13.6 mg, sodium hydrophosphate heptahydrate 4.7 mg, hydrochloric acid 25% 0.02 mg, water for injection up to 2 ml.

How to take, the dosage

The drug Ambrobene is administered intravenously (slowly by trickle or drip). As the solvent used is 0.9% sodium chloride solution, 5% glucose solution, Ringer-Locke’s solution or other basic solution with pH no higher than 6.3.

The solution should be administered intravenously, slowly, for at least 5 minutes.

Adults usually prescribe one ampoule 2-3 times a day (30-45 mg/day), in severe cases the dose may be increased: 2 ampoules 2-3 times a day (60-90 mg/day).

Children The drug is prescribed in a daily dose at the rate of 1.2 to 1.6 mg per 1 kg of body weight. Usually, children under 2 years of age take 1 ml (1/2 ampoule) 2 times a day (15 mg/day); children from 2 to 5 years of age take 1 ml (1/2 ampoule) 3 times a day (22.5 mg/day);

Children over 5 years of age take 2 ml (1 ampoule) 2-3 times (30-45 mg/day).

The injections are stopped after the disappearance of acute manifestations of the disease and switch to oral administration of other dosage forms of the drug.

The duration of treatment is chosen individually depending on the course of the disease.

Interaction
Interaction
Concomitant use of ambroxol and cough suppressants may cause cough reflex stasis. Therefore, such combinations should be chosen with caution. When coadministration of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, concentration of the latter in sputum and bronchial secretion increases. The administration of ambroxol (pH 5.0) should not be combined with the administration of other solutions with pH more than 6.3, because the difference between the pH values of the solutions may lead to precipitation of ambroxol base.

Special Instructions
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 Ambrobene. In case of changes in the skin or mucous membranes it is necessary to consult a doctor urgently and stop taking the drug. Influence on driving ability and on operation of machines and mechanisms is not known up to date.

Contraindications
Contraindications
high sensitivity to ambroxol or to one of the excipients;
pregnancy (first trimester).
Cautions: In patients with impaired bronchial motor function and increased sputum production (in immobile cilia syndrome), Ambrobene should be used with caution because of the risk of sputum stasis.
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
Side effects
Unwanted effects are classified according to their frequency of occurrence: very frequently (≥ 1/10), frequently (≥ 1/100, < 1/10), infrequently (≥ 1/1000, < 1/100), rarely (≥ 1/10000, < 1/1000), very rarely (< 1/10000), unknown frequency – available data are not sufficient to estimate the frequency of side effects.
Injury to the immune system:
Infrequent: allergic reactions such as rash, facial edema, dyspnea, pruritus, fever. Very rare: anaphylactic reactions, including anaphylactic shock.
Unknown frequency: urticaria
Gastrointestinal tract:
Infrequent: nausea, abdominal pain, vomiting, diarrhea, dyspepsia.
Nervous system disorders:
Infrequent: dizziness.
In rare cases, severe headache, feeling of fatigue, heaviness in the legs, feeling of brokenness were observed when the drug was rapidly administered.

Overdose
Overdose
Symptoms: Signs of intoxication in ambroxol overdose have not been revealed. There are reports of nervous agitation and diarrhea. Ambroxol is well tolerated when parenteral administration at a dose of up to 15 mg/kg/day and when administered orally at a dose of up to 25 mg/kg/day. In severe overdose increased salivation, urge to vomit, vomiting, decreased blood pressure are possible. Treatment: Urgent measures such as inducing vomiting, gastric lavage should be used only in cases of severe overdose. Symptomatic treatment is indicated.

Pregnancy use
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 the drug 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 lactation it is possible to use Ambrobene only by prescription and after careful assessment of risk/benefit ratio.

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

Additional information
Weight 0.030 kg
Shelf life
5 years
Conditions of storage
At a temperature not exceeding 25 °C
Manufacturer
Merkle GmbH, Germany
Medication form
solution
Brand
Merkle GmbH