Ambrobene - instructions for use, doses, side effects, contraindications

auxiliary substances: citric acid monohydrate 1.8 mg, sodium chloride 13.6 mg, sodium hydrogen phosphate heptahydrate 4.7 mg, hydrochloric acid 25% 0.02 mg, water for injection 1979.9 mg.

Description:

Transparent from colorless to light yellow color solution.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is a benzylamine - a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and by the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. Has a secreto-motor, secretolitic and expectorant action.

Pre-clinical studies have shown that ambroxol stimulates serous cells of the glands of the bronchial mucosa. Activating cells of the ciliated epithelium and reducing the viscosity of sputum improves mucociliary transport.

Ambroxol activates the formation of a surfactant, having a direct effect on alveolar pneumocytes of type 2 and Clara cells of small airways.

Research on cell cultures and research in vivo on animals 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.

Also, in preclinical studies, the antioxidant effect of ambroxol was demonstrated.Ambroxol when combined with antibiotics amoxycycline, cefuroxime, erythromycin and doxycycline increases their concentration in sputum and bronchial secretion.

Pharmacokinetics:

With parenteral administration ambroxol quickly penetrates into the tissues. The highest concentration is found in the lungs. The maximum concentration is achieved in 1-3 hours. Binding to plasma proteins is about 85% (80-90%). The half-life of the plasma is from 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

It is excreted mainly by kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high connection with plasma proteins, a large volume of distribution and a slow redistribution from tissues to the blood, there is no significant removal of ambroxol in dialysis or forced diuresis.

In patients with severe liver disease, ambroxol clearance is reduced by 20-40%. Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and also excretes into breast milk.

Indications:

Acute and chronic diseases of the respiratory tract, accompanied by a violation of education and sputum discharge.

Contraindications:

- increased sensitivity to ambroxol or to one of the excipients;

- pregnancy (I trimester).

Carefully:

In patients with bronchial motor dysfunction and increased sputum production (with the syndrome of immobile cilia), Ambrobene should be used with caution in connection with the risk of sputum stagnation.

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

Pregnancy and lactation:

Pregnancy:

There is insufficient data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Studies conducted on animals did not reveal a teratogenic effect.

The use of Ambrobene during pregnancy (II-III trimester) is possible only according to the doctor's prescription, after a thorough assessment of the risk / benefit ratio.

Breastfeeding period:

Studies conducted on animals have shown that ambroxol penetrates into breast milk. Due to insufficient study of the use of the drug in women during lactation, the use of Ambrobene is possible only according to the doctor's prescription, after a thorough assessment of the risk / benefit ratio.

Dosing and Administration:

The drug Ambrobene is administered intravenously (slowly struino or drip). As a solvent, 0.9% sodium chloride solution, 5% glucose solution, Ringer-Locke solution or other basic solution with a pH not higher than 6.3 is used.

The daily dose is 30 mg per 1 kg of body weight, evenly distributed over four injections per day. The solution should be administered intravenously, slowly, for at least 5 minutes.

Injections stop after the disappearance of acute manifestations of the disease and go on to enter into other dosage forms of the drug.

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

Side effects:

Common violations:

Rare (from> 0.1% to <1%): allergic reactions (skin rash, face swelling, shortness of breath, itching), fever.

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

In rare cases with rapid administration of the drug, severe headaches, fatigue, weakness, venous edema were observed.

From the gastrointestinal tract:

Rarely (from> 0.1% to <1%); nausea, abdominal pain, vomiting.

Overdose:

Symptoms:

Signs of intoxication with an overdose of ambroxol have not been identified. There is information about nervous arousal and diarrhea.

Ambroxol is well tolerated when ingested at a dose of up to 25 mg / kg / day.

In the case of severe overdose, excessive salivation, nausea, vomiting, and lowering of blood pressure are possible.

Treatment:

Intensive therapies, such as 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.

Interaction:

With the simultaneous use of ambroxol and antitussives due to the suppression of the cough reflex, stasis may arise. Therefore, such combinations should be selected with caution.

With the joint administration of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretion increases. The introduction of ambroxol (pH 5.0) should not be combined with the introduction of other solutions with a pH of more than 6.3, since the difference between the pH values of the solutions may precipitate the base of ambroxol.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

In children under 2 years of age, the drug can be administered only as directed by a doctor. Very rarely, skin reactions in severe form, such as Stevens-Johnson syndrome and Lyell's syndrome, were observed with the use of Ambrobene. When changing skin or mucous membranes, you should urgently consult a doctor and stop taking the drug.

Effect on the ability to drive transp. cf. and fur:

The impact on the ability to drive vehicles and to control machines and mechanisms is not known to this day.

Form release / dosage:Solution for intravenous administration 15 mg / 2 ml.

Packaging:

2 ml of the drug in a dark glass ampoule (type 1) with a white point and two rings to indicate the location of the ampoule fracture.

5 ampoules per plastic tray. 1 pallet with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:5 years.
Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014731 / 03

Date of registration:11.01.2009

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Ambroben (Ambrobene)