Ambroxol ретард
Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: R05CB06
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: 75 mg of Ambroxol of a hydrochloride in 1 capsule.
Excipients: gipromelloz (gidroksipropilmetiltsellyuloz), коллидон SR [polyvinyl acetate of 80%, povidone of 19%, sodium lauryl sulfate of 0,8%, silicon dioxide of 0,2%], gieteloza (hydroxyethylcellulose), magnesium stearate.
Gelatinous solid capsules (gelatin, titanium dioxide, dye blue patent, methylparahydroxybenzoate, пропилпарагидроксибензоат).
Mucolytic means for treatment of acute and chronic respiratory diseases at children and adults. Causes the expressed expectorant effect.
Pharmacological properties:
Pharmacodynamics. Mucolytic means. 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 cells Klara, reduces viscosity of a phlegm. Increases physical activity of a ciliary epithelium, increases mukotsiliarny transport.
After intake action comes in 30 minutes.
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.
It is metabolized in a liver by conjugation, forms pharmacological inactive metabolites: dibromantranilovy acid and glucuronic conjugates. The elimination half-life (T1/2) – 7-12 h, and total T1/2 in plasma (Ambroxol and its metabolites) reaches 22 h. It is removed by kidneys: 90% in the form of water-soluble metabolites, in not changed look – 5%.
The elimination half-life of Ambroxol and its metabolites increases at a heavy chronic renal failure; does not change at abnormal liver functions.
Indications to use:
- respiratory diseases with formation of a viscous phlegm:
- acute and chronic bronchitis;
- pneumonia;
- chronic obstructive pulmonary disease;
- bronchial asthma with difficulty of an otkhozhdeniye of a phlegm;
- bronchoectatic disease.
Route of administration and doses:
Inside, during meal, with a small amount of liquid. To adults and children 12 years are more senior appoint on 1 capsule 75 mg in the morning.
It is not recommended to apply without appointment of the doctor more than within 4-5 days.
Features of use:
It is not necessary to combine with the antibechic medicines complicating removal of a phlegm.
The patients accepting the drug Ambroxol ретард should not recommend performance of respiratory gymnastics.
At seriously ill patients of patients it is necessary to carry out aspiration of the liquefied phlegm.
It is not necessary to accept the drug Ambroxol ретард just before a dream.
Use at pregnancy and in the period of a lactation: Drug should not be used in the I trimester of pregnancy. Use of drug during breastfeeding is possible only if the expected effect of therapy exceeds potential risk for a fruit and the baby (there are no reliable data about negative influence of drug on a fruit and babies so far).
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, a lock, a dysuria.
At prolonged use in high doses - a gastralgia, nausea, vomiting.
Interaction with other medicines:
Combined use with antibechic medicines (for example, containing codeine) leads to difficulty of an otkhozhdeniye of a phlegm against the background of reduction of cough.
Increases penetration into a bronchial secret of amoxicillin, a tsefuroksim, erythromycin and doxycycline.
Contraindications:
- hypersensitivity to Ambroxol or any other component of drug;
- pregnancy (I trimester);
- a peptic ulcer of a stomach and a 12-perstny gut in an aggravation stage;
- epileptic syndrome;
- disturbance of motility of bronchial tubes, large volumes of the allocated secret (danger of emergence of stagnation of a secret in bronchial tubes);
- age up to 12 years.
With care: a liver failure, a renal failure, a peptic ulcer of a stomach and a 12-perstny gut (in the anamnesis), pregnancy (the II-III trimester), the lactation period, and also patients with the weakened tussive reflex or the broken mukotsiliarny transport because of a possibility of accumulation of a phlegm; patients with bronchial asthma (Ambroxol can strengthen cough).
Overdose:
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: artificial vomiting, a gastric lavage in the first 1-2 hours after administration of drug; reception of fat-containing products.
Storage conditions:
In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to use after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
Capsules of the prolonged action of 75 mg. On 10, 14, 15 or 20 capsules in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3 blister strip packagings together with the application instruction place in a pack from a cardboard.