Ambroxol

General characteristics. Structure:

 

Dosage form	Quantity active ingredient	Trademarks
solution for intake and inhalations	7,5 mg/ml	common form
syrup	3 mg/ml, 6 mg/ml	common form
tablets	30 mg	common form
capsules of the prolonged action	75 mg	To Ambrobena, Ambrogeksal
solution for intravenous administration	7,5 mg/ml	To Ambrobena
tablets are sparkling	30 mg, 60 mg	"Ambroksol-Hemofarm"

Pharmacological properties:

Pharmacodynamics. Mucolytic means, stimulates prenatal development of lungs (increases synthesis, secretion of surfactant and blocks its disintegration). Possesses sekretomotorny, sekretolitichesky and expectorant action; stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the maintenance of a mucous secret and release of surfactant (surfactant) in alveoluses and bronchial tubes; normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from Clark's cells, reduces viscosity of a phlegm. Increases physical activity of a ciliary epithelium, increases mukotsiliarny transport.

After intake action comes in 30 min., at rectal administration - in 10-30 min. and continues within 6-12 hours. At parenteral administration action comes quickly and continues within 6-10 hours.

Pharmacokinetics. Absorption - high (at any ways of introduction), time of achievement of the maximum concentration (TCmax) - 2 h, communication with proteins of plasma - 80%. Gets through a blood-brain barrier, a placental barrier, it is allocated with breast milk. Metabolism - in a liver, forms dibromantranilovy acid and glucuronic conjugates. Elimination half-life of 7-12 hours. T1/2 increases at a heavy chronic renal failure, does not change at an abnormal liver function. It is removed by kidneys: 90% in the form of water-soluble metabolites, in not changed look - about 5%.

Indications to use:

The acute and chronic respiratory diseases which are followed by formation of a viscous phlegm: acute and chronic bronchitis of various etiology, pneumonia, HOBL, bronchial asthma with difficulty of an otkhozhdeniye of a phlegm, a bronchoectatic disease, a mucoviscidosis of lungs, tracheitis and laryngotracheitis. Inflammatory diseases of a nasopharynx and adnexal bosoms at which slime fluidifying is necessary. Sanitation of a bronchial tree in before - and the postoperative period. Stimulation of prenatal maturing of lungs, treatment and prevention (at threat of premature births and at the shown artificial premature births during the period between 28 and 34 weeks of pregnancy if the clinical picture allows to assume extension of duration of gestation for 3 days) respiratory a distress syndrome at premature children and newborns.

Route of administration and doses:

Tablets, syrup, solution for intake should be accepted inside during meal or after food, washing down with enough liquid.

It is possible to wash down drug both with water, and tea, milk, fruit juice.

Reception of liquid promotes effective fluidifying of slime at treatment by Ambroxol.

To adults and children 12 years are more senior appoint - tablets: on 30 mg 3 times a day in the first 2-3 days, then on 30 mg 2 times or 15 mg 3 times a day, or on 1 capsule ретард (75 mg) in the morning; children are 6-12 years old - 15 mg 2-3 times a day.

Solution for intake (7.5 mg/ml) by the adult during the first 2-3 days - on 4 ml, and then on 2 ml 3 times a day or on 4 ml 2 times a day; to children up to 2 years - 1 ml 2 times a day, 2-5 years - 1 ml 3 times a day, 5-12 years - 2 ml 2-3 times a day.

Syrup (3 mg/ml) the adult - in the first 2-3 days on 10 ml, and then on 5 ml 3 times a day or on 10 ml 2 times a day.

In hard cases of a disease the dose is not reduced during all course of treatment.

To children of 5-12 years appoint 15 mg 2-3 times a day, 2-5 years - 7.5 mg 3 times a day, up to 2 years - 7.5 mg 2 times a day.

In the form of inhalations appoint to adults and children 5 years on 15-22.5 mg, children up to 2 years - 7.5 mg, to children of 2-5 years - 15 mg 1-2 times a day are more senior. In case there is no opportunity to carry out more than one inhalation a day, in addition apply tablets, solution or syrup orally.

Parenterally enter intramusculary, intravenously (slowly, struyno or kapelno) or п / to: the adult - on 15 mg, in hard cases - 30 mg 2-3 times a day; to children - 1.2-1.6 mg/kg 3 times a day. Usually to children up to 2 years - 7.5 mg 2 times a day, from 2 to 5 years - 7.5 mg 3 times a day, of 5 years - 15 mg 2-3 times a day.

For treatment respiratory the distress syndrome at premature and newborn children is entered intravenously or intramusculary - 10 mg/kg/days, frequency rate of introduction - 3-4 times, if necessary the dose can be increased to 30 mg/kg/days.

For intravenously drop introduction of 50 ml part in 500 ml of infusion solution (as solvent apply 0.9% NaCl solution, 5% dextrose solution, Solution Ringer-Locke or other basic solution with pH not higher than 6.3), enter during 2 h with a speed of 84 of cap/min.

Repeated treatment according to the provided scheme can be carried out in 14 days (when saving indications).

Parenteral administration stops after disappearance of acute displays of a disease (pass to intake or rectal administration).

Rektalno, the adult and children 12 years - on 1 suppository (30 mg) 3 times a day 2-3 days, then on 60 mg 2 times a day, the maximum daily dose - 0.12 g are more senior; children are 6-12 years old - on 15 mg 2-3 times a day.

It is not recommended to apply without medical appointment more than within 4-5 days.

Features of use:

It is not necessary to combine with the antibechic medicines complicating removal of a phlegm.

Inhalation solution can be applied, using any modern equipment for inhalations (except steam inhalers).

Before inhalation drug mixes up from 0.9% NaCl solution (for optimum moistening of air it is possible to part in the ratio 1:1) and is warmed up to body temperature.

Inhalations should be carried out in the mode of usual breath (not to provoke tussive pushes).

The patients having bronchial asthma in order to avoid nonspecific irritation of respiratory tracts and their spasm before inhalation of Ambroxol need to apply bronchial spasmolytics.

The patients suffering from a diabetes mellitus can appoint in the form of syrup (5 ml of syrup contain sorbite and saccharin in the quantity corresponding of 0.18 HE).

Children up to 5 years are not recommended to apply suppositories of 15 mg, up to 12 years - 30 mg (apply suppositories of 15 mg to them).

Side effects:

Allergic reactions: Skin rash, a small tortoiseshell, a Quincke's disease, in some cases - allergic contact dermatitis, an acute anaphylaxis.

Seldom. Weakness, a headache, diarrhea, dryness in a mouth and airways, a dieback, a rhinorrhea, locks, a dysuria

Interaction with other medicines:

Combined use of Ambroxol and antibechic medicines because of suppression of cough leads to difficulty of an otkhozhdeniye of a phlegm. Therefore such combination is not shown.

Increases penetration into a bronchial secret of a number of antibiotics: amoxicillin, tsefuroksim, erythromycin and doxycycline.

Solution for injections cannot be used with the solutions having pH higher than 6.3.

Contraindications:

Hypersensitivity, pregnancy (the I trimester), fenilketonuriya (for the dosage forms containing aspartame).

Overdose:

At prolonged use in high doses. Gastralgia, nausea, vomiting.

At bystry intravenous administration. Feeling of catalepsy, adynamia, intensive headaches, lowering of arterial pressure, short wind, hyperthermia, fever.

Symptoms: Nausea, vomiting, diarrhea, dyspepsia.

Treatment. Artificial vomiting, a gastric lavage in the first 1-2 h after administration of drug; reception of fat-containing products.

Issue conditions:

According to the recipe