XALIKSOL
Active material: Amʙroksol
When ATH: R05CB06
CCF: Mucolytic and expectorant drugs
ICD-10 codes (testimony): H66, J01, J15, J20, J32, J42, J44, J45, J47
When CSF: 12.02.02
Manufacturer: EGG PHARMACEUTICALS Plc (Hungary)
Pharmaceutical form, composition and packaging
◊ Pills white or nearly white, flat, round, chamfered, with Valium on one party and chasing the Stylized “E” and “231” – on the other side, with little or no odor.
| 1 tab. | |
| ambroxol hydrochloride | 30 mg |
Excipients: lactose monohydrate, microcrystalline cellulose, polyvidone, sodium carboxymethyl, magnesium stearate.
10 PC. – blisters (2) – packs cardboard.
◊ Syrup a colorless or pale yellow, clear, no sediment, with a characteristic odor.
| 10 ml | |
| ambroxol hydrochloride | 30 mg |
Excipients: sorbitol, povidone K90, citric acid monohydrate, sodium cyclamate, Strawberry flavor 22754, Banana flavor 270650, Sodium benzoate, sodium citrate, Purified water.
100 ml – vials of dark glass (1) complete with a measured glass – packs cardboard.
Pharmacological action
Expectorant (mukoliticeskij) preparation. Ambroxol - the active metabolite of Bromhexine, It belongs to the group of the benzylamine mucolytic agents.
Phlegm by strengthening the development and enhance the activity of hydrolytic enzymes, break down the relationship between mucopolysaccharides sputum.
It improves the rheological properties of sputum, reducing its viscosity and adhesive properties, due to the stimulation of serous cells of glands of bronchial mucosa and the normalization of relations mucous and serous components of sputum. Increases mucociliary transport, increasing the motor activity of ciliated epithelium. It does not cause excessive secretion of Education, reduces spastic bronchial hyperreactivity.
It promotes the development of surfactant.
The effect is a 30 minutes after administration.
Pharmacokinetics
Absorption
Once inside almost completely absorbed from the gastrointestinal tract. Bioavailability after oral administration is about 60%. The time to reach Cmax plasma – 2 no.
Distribution
Plasma protein binding is about 80%.
It penetrates through the placental barrier. Its concentration in the body of the fetus in 2-4 times higher, than the mother. It is found in breast milk, and cerebrospinal fluid.
Metabolism
Treated with the active metabolism “first pass” through the liver.
Deduction
T1/2 is about 7 no.
About 90% the dose is excreted in the urine in the form of glucuronide conjugates of ambroxol or its oxidized products of metabolism.
Pharmacokinetics in special clinical situations
T1/2 increases in severe renal insufficiency, It does not change with abnormal liver function.
Testimony
- Acute and chronic respiratory diseases, accompanied by the formation of viscous mucus: bronchitis, bronchial asthma, chronic obstructive pulmonary disease, pneumonia, bronchiectasis;
- Inflammatory diseases of the upper respiratory tract (sinusitis, otitis), where necessary thinning mucus.
Dosage regimen
Adults and children over 12 years drug in tablet form prescribed in the first 2-3 the day on 1 tab. 3 times / day, and on subsequent days – by 1 tab. 2 times / day, or 1/2 tab. 3 times / day.
The drug is administered in the form of syrup in the first 2-3 the day on 10 ml 3 times / day, and on subsequent days - under 10 ml 2 times / day, or 5 ml 3 times / day.
In severe cases, the dose does not decrease during the course of treatment.
For children 5-12 years the drug in tablet form appoint 1/2 tab. 2-3 times / day. The drug is in the form of a syrup appoint 5 ml 2-3 times / day.
Children under 5 s recommended to use Haliksol® in the form of a syrup.
For children 2-5 years appoint 2.5 ml syrup 3 times / day.
Children under 2 years appoint 2.5 ml syrup 2 times / day.
At severe renal insufficiency the drug should be administered in lower doses or increase the interval between doses.
The need for acceptance Haliksola® more 4-5 days, the doctor decides individually.
The tablets or syrup, taken orally after a meal and drink plenty of fluids. Syrup can be taken using the measuring cup, located in the package. Abundant fluid intake contributes to liquefaction of the mucus in the treatment Haliksolom® .
Side effect
CNS: rarely – weakness, headache.
From the digestive system: rarely – diarrhea, constipation, dry mouth, gastralgia, nausea, vomiting.
The respiratory system: rarely - dry airways, rhinorrhea.
Allergic reactions: rarely – rash, hives; rarely – acute anaphylactic reactions, the causal relationship to the reception which ambroxol is not installed.
Other: dizurija.
Xaliksol, usually, well tolerated.
Contraindications
- Ulcerative lesions GIT;
- I trimester of pregnancy;
- Lactation (breast-feeding);
- Hypersensitivity to ambroxol or Bromhexine;
- The drug in tablet form is not intended for use in children under the age of 5 years.
FROM caution use in patients with severe renal insufficiency.
Pregnancy and lactation
The drug is contraindicated for use in the I trimester of pregnancy.
Ambroxol is excreted in breast milk, therefore, if necessary, use during lactation should decide the issue of termination of breastfeeding.
Cautions
It should not be administered concurrently with antitussive drugs because of the difficulty sputum.
Use of the drug in patients with impaired motor function of bronchi or copious sputum low viscosity requires caution because of the danger of stagnation of bronchial secretions.
Syrup soderzhit nespetsifichnыe podslastiteli, sorbitol, sodium cyclamate, so people with diabetes can use this drug, However, the content of sorbitol (1.2 d of 5 ml) It should be taken into consideration by patients, with diabetes.
The product does not contain alcohol.
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: induce vomiting, then assign drink (milk or tea), receiving fat-containing products. Gastric lavage is recommended for 1 -2 h after dosing. It should constantly monitor the function of the cardiovascular system.
Drug Interactions
Cold preparations (incl. codeine) may impede the sputum, liquefied ambroxol.
Xaliksol® It promotes penetration in bronchial secretion of certain antibiotics (incl. amoksiцillina, tsefuroksyma, Erythromycin, doxycycline).
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug is in the form of tablets should be stored at a temperature no higher than 30 ° C in the dark, reach of children. Shelf life - 5 years.
The drug is in the form of syrup should be kept at a temperature of 15 ° to 25 ° C out of reach of children. Shelf life - 5 years.
