Composition, form of production and packaging
? Tablets are white or almost white, flat, round, chamfered, with a risk on one side and engraved "E231" - on the other, without or almost no odor.
Ambroxol hydrochloride 30 mg
Excipients: lactose monohydrate - 84 mg, microcrystalline cellulose - 30 mg, sodium carboxymethyl starch (type A) - 10 mg, povidone K30 - 5 mg, magnesium stearate - 1 mg.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
Expectorant (mucolytic) drug. Ambroxol is an active metabolite of bromhexine, belongs to the benzylamine group of mucolytic substances.
It dilutes sputum by increasing the production and increasing activity of hydrolytic enzymes that break down the bonds between mucopolysaccharides of sputum.
Improves the rheological properties of sputum, reducing its viscosity and adhesive properties, by stimulating serous cells of the glands of the bronchial mucosa and normalizing the ratio of mucous and serous sputum components. Increases mucociliary transport, increasing the motor activity of the ciliated epithelium. Does not cause excessive secretion, reduces spastic hyperreactivity of the bronchi.
Contributes to the production of surfactant.
The effect develops 30 minutes after taking the drug.
After oral administration, it is almost completely absorbed from the digestive tract. Bioavailability after oral administration is approximately 60%. Time to reach C maxin blood plasma - 2 h.
Binding to plasma proteins is about 80%.
Penetrates through the placental barrier. Its concentration in the fetus is 2-4 times higher than that of the mother. It is found in breast milk and cerebrospinal fluid.
It is exposed to active metabolism at the "first passage" through the liver.
T 1/2 is about 7 hours.
About 90% of the dose taken is excreted in the urine in the form of glucuronide conjugate ambroxol or oxidized products of its metabolism.
Pharmacokinetics in special clinical cases
T 1/2 increases with severe renal failure, it does not change if liver function is impaired.
- acute and chronic diseases of the respiratory system, accompanied by the formation of viscous sputum: bronchitis, bronchial asthma, chronic obstructive pulmonary disease, pneumonia, bronchoectatic disease;
- inflammatory diseases of the ENT organs (sinusitis, otitis), which require liquefaction of mucus.
Adults and children over 12 years of age the drug is administered in the first 2-3 days of 1 tab. 3 times / day, and in the following days - 1 tab. 2 times / day or 1/2 tablet. 3 times / day. In severe cases, the dose is not reduced throughout the course of treatment.
Children aged 5-12 years, the drug is prescribed to 1/2 tab. 2-3 times / day. Children under the age of 5 years are not prescribed the drug Haliksol in the form of tablets.
The doctor decides individually whether to take Chaliixol for more than 4-5 days.
Tablets should be taken orally after eating and washed down with plenty of fluids. Abundant fluid intake contributes to liquefaction of mucus during treatment with Chaliixol.
From the side of the central nervous system: rarely - weakness, headache.
From the digestive system: rarely - diarrhea, constipation, dry mouth, gastralgia, nausea, vomiting.
On the part of the respiratory system: rarely - dry airways, rhinorrhea.
Allergic reactions: rarely - exanthema, urticaria; extremely rare - acute anaphylactic reactions, the causal relationship of which with the use of ambroxol is not established.
Halixol, as a rule, is well tolerated.
ulcerative gastrointestinal lesion;
- I trimester of pregnancy;
- lactation period (breastfeeding);
- hypersensitivity to ambroxol or bromhexine;
- The drug is not intended for use in children under 5 years of age.
With caution should be used in patients with severe renal failure.
PREGNANCY AND LACTATION
The drug is contraindicated in the first trimester of pregnancy.
Ambroxol is excreted in breast milk, so if you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should be used in patients with severe renal failure. In patients with severe renal insufficiency, the drug should be given at low doses or increased intervals between doses
APPLICATION FOR CHILDREN
In children, the drug is used according to the indications. The drug is not intended for use in children under 5 years of age
You should not prescribe concomitantly with antitussive drugs due to difficulty in sputum production.
The use of the drug in patients with impaired bronchial motor function or abundant sputum with low viscosity requires caution because of the danger of stagnation of bronchial secretions.
The drug does not contain alcohol.
Symptoms: nausea, vomiting, diarrhea, indigestion.
Treatment: induce vomiting, then prescribe a drink (milk or tea), intake of fat-containing foods. Gastric lavage is recommended for 1 -2 hours after taking the drug. It is necessary to constantly monitor the function of the cardiovascular system.
Antitussive medications (including codeine) can make it difficult to secrete sputum, liquefied with ambroxol.
Halixol В® promotes penetration of some antibiotics into the bronchial secret (including amoxicillin, cefuroxime, erythromycin, doxycycline).
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature not higher than 30 В° C in a place out of the reach of children. Shelf life - 5 years.