Haliksol

General characteristics. Structure:

Tablets of 1 table.
Active agent: Ambroxol hydrochloride of 30 mg
excipients: lactoses monohydrate; MKTs; povidone; sodium carboxymethylstarch; magnesium stearate  
in the blister of 10 pieces; in a pack cardboard 2 blisters.

Syrup of 10 ml
Active agent: Ambroxol hydrochloride of 30 mg
excipients: sorbite; povidone (K-90); citric acid monohydrate; sodium cyclomate; fragrance strawberry 22754; fragrance banana 270650; Natrium benzoicum; sodium citrate; the water purified  
in bottles of dark glass on 100 ml, complete with a measured glass; in a pack a cardboard 1 set.

Description of a dosage form

Tablets: white or almost white flat round tablets with a facet, with risky on one party and an engraving on another, without or almost inodorous.
Syrup: colourless or pale yellow color, the transparent liquid without deposit possessing a characteristic smell.

Pharmacological properties:

Pharmacological action - expectorant, mucolytic, increasing production of surfactant.

Pharmacokinetics. Almost it is completely soaked up from a GIT. Linkng with blood proteins — about 80%. Is exposed to active metabolism at "the first passing" through a liver. Bioavailability after intake makes about 60%. Tmax is 2 h. About 90% are removed with urine in the form of a glyukuronidny conjugate of Ambroxol or the oxidized products of his metabolism. T1/2 is about 7 h, increases at a heavy renal failure, does not change at an abnormal liver function. Gets through a placental barrier, concentration in an organism of a fruit is 2-4 times higher, than at mother. It is found in breast milk and medullispinal liquid.

Pharmacodynamics. Liquefies a phlegm due to strengthening of development and increase in activity of the hydrolytic enzymes splitting bonds between phlegm mucopolysaccharides. Improves rheological properties of a phlegm, reducing its viscosity and adhesive properties, due to stimulation of serous cells of glands of a mucous membrane of bronchial tubes and normalization of a ratio of serous and mucous components of a phlegm. Increases mukotsiliarny transport, increasing physical activity of a ciliary epithelium. Does not cause excessive formation of a secret, reduces a spastic hyperactivity of bronchial tubes. Promotes production of surfactant.
The effect develops in 30 min. after administration of drug.

Indications to use:

The acute and chronic diseases of a respiratory organs which are followed by formation of a viscous phlegm: bronchitis, bronchial asthma, HOBL, pneumonia, bronchoectatic disease.
Inflammatory diseases of ENT organs (sinusitis, otitis) at which slime fluidifying is necessary.

Route of administration and doses:

Inside, after food, washing down with a large amount of liquid (plentiful reception of liquid promotes fluidifying of slime at treatment by Ambroxol). Syrup can be accepted by means of a measured cap.
Tablets: to adults and children 12 years — a usual daily dose in the first 2–3 days of treatment are more senior: according to 1 tab. 3 times a day, in the next days — according to 1 tab. 2 times or according to 1/2 tab. 3 times a day. In hard cases of a disease the dose is not reduced during all course of treatment.
To children under 5 years recommend to accept Haliksol syrup.
To children at the age of 5–12 years — on 1/2 tab. 2-3 of time a day.
Syrup: to adults and children 12 years — a usual daily dose in the first 2–3 days of treatment are more senior: on 10 ml 3 times a day, then — on 10 ml 2 times or on 5 ml 3 times a day. In hard cases of a disease the dose is not reduced during all course of treatment.
To children up to 2 years — on 2,5 ml 2 times a day, 2–5 years — on 2,5 ml 3 times a day, 5–12 years — on 5 ml 2–3 times a day.
At a heavy renal failure it is necessary to reduce a dosage or to increase intervals between receptions.
At Haliksol's reception over 4-5 days consultation of the doctor is recommended.

Features of use:

It is not necessary to appoint along with antibechic drugs because of difficulty of expectoration.
Use for patients with disturbance of motor function of bronchial tubes or plentiful expectoration with low viscosity demands care because of danger of stagnation of a bronchial secret.

Syrup contains nonspecific sweeteners (sorbite and cyclomate of sodium) therefore patients with a diabetes mellitus can use drug, however content of sorbite (1,2 g / 5 syrup ml) has to be taken into account.
Drug does not contain alcohol.

Side effects:

Haliksol, as a rule, is well had. Seldom — weakness, a headache, a diarrhea/lock, dryness in a mouth and airways, a rhinorrhea, a dysuria, a gastralgia, nausea, vomiting, a dieback, a small tortoiseshell.

Interaction with other medicines:

Antibechic drugs (including codeine) can complicate expectoration, liquefied by Ambroxol. Haliksol promotes penetration into a bronchial secret of some antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline, etc.).

Contraindications:

Hypersensitivity to Ambroxol or Bromhexine, a GIT canker, pregnancy (the I trimester), children's age up to 5 years (tablet).
With care: heavy renal failure.

Use at pregnancy and feeding by a breast

Contraindicated in the I trimester of pregnancy. Drug is emitted in breast milk therefore at inclusion in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Overdose:

Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: to cause vomiting then to appoint drink (milk or tea), reception of fat-containing products. The gastric lavage is recommended during 1–2 h after administration of drug. It is necessary to watch function of cardiovascular system constantly.

Storage conditions:

Period of validity of 5 years. At a temperature of 15-25 °C. The opened bottle — 4 weeks.

Issue conditions:

According to the recipe

Packaging:

Tablets, 30 mg. According to 10 tab. in the blister from PVC / aluminum foil or PVC/PVDH / aluminum foil; 2 blisters are packed into a cardboard pack.

Syrup, 30 mg / 10 ml. 100 ml of syrup in a bottle of brown glass with a white aluminum lid with control of the first opening. 1 фл. with a measured glass it is packed into a cardboard pack.