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

1 tablet contains: active substance Ambroxol hydrochloride 30.00 mg; Excipients: lactose monohydrate 169.46 mg, corn starch 36.33 mg, magnesium stearate 2.41 mg, silicon dioxide colloidal anhydrous 1.80 mg.

Description:

Round biconvex tablets are white, with a dividing risk on one side, the other side is smooth.

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.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

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 (amoxicillin, cefuroxime, erythromycin and doxycycline) increases their concentration in sputum and bronchial secretion.

Pharmacokinetics:

Ingestion ambroxol almost completely absorbed from the gastrointestinal tract. The maximum concentration is achieved 1-3 hours after ingestion. Due to presystemic metabolism, the absolute bioavailability of ambroxol after oral administration decreases approximately 1/3. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. The protein binding of plasma 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%. In patients with severe impairment of renal function, the half-life of metabolites of ambroxol is increased.

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:

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

- use in children under 6 years;

- pregnancy (I trimester);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:

Disturbance of motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum during the exacerbation, pregnancy (II-III trimester), the period of lactation.

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

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 breastfeeding, Ambrobe can be used only by the doctor's prescription, after a thorough assessment of the risk / benefit ratio.

Dosing and Administration:

Tablets should be swallowed whole, without chewing, after eating, squeezed large amounts of liquid.

Children from 6 to 12 years old should be taken on 1/2 tablets 2-3 times a day (15 mg ambroksola 2-3 times a day).

Adults and children over 12 years of age in the first 2-3 days of treatment should take 1 tablet 3 times a day (30 mg ambroksola 3 times a day). If therapy is ineffective, adults can increase the dose to 2 tablets 2 times a day (120 mg ambroksola per day). In the following days should take 1 tablet 2 times a day (30 mg ambroksola 2 times a day).

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. The mucolytic effect of the drug manifests itself when a large amount of liquid is taken.Therefore, during treatment, a generous drink is recommended.

Side effects:

Common violations:

Rarely (from ≥ 0.1% to <1%): allergic reactions (urticaria, skin rash, angioedema, dyspnea, itching), fever, weakness, headache.

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

From the gastrointestinal tract:

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

Other:

Rarely (from ≥ 0.1% to <1%): dryness of the mucous membrane of the oral cavity and respiratory tract, exanthema, rhinorrhea, dysuria.

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.

Special instructions:

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

Very rarely, when Ambroben was used, severe skin reactions were observed, such as Stevens-Johnson syndrome and Lyell's syndrome. When changing skin or mucous membranes, it is necessary to 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:

Tablets 30 mg.

Packaging:

For 10 tablets per blister of PVC / A1-foil.

For 2 or 5 blisters with instructions for use are placed 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 / 01

Date of registration:15.01.2009 / 09.03.2017

Expiration Date:Unlimited

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: & nbsp31.07.2017

Illustrated instructions

Instructions

Ambroben (Ambrobene)