Ambroxol, syrup 15mg/5ml, 100ml

Composition

5 ml of syrup contains the Active ingredient: Ambroxol hydrochloride 15 mg; Excipients: Benzoic acid Glycerol 85% Sorbitol 70% Hyethylose (Hydroxyethylcellulose 6000 MPas) Raspberry flavor Purified water

Pharmacological action

Mucolytic agent that stimulates prenatal lung development (increases the synthesis and secretion of surfactant and blocks its breakdown). It has secretomotor, secretolytic and expectorant effects; it stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucosal secretions and the release of surfactant in the alveoli and bronchi; it normalizes the disturbed ratio of serous and mucosal components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Clark cells, it reduces the viscosity of sputum. Increases motor activity of the ciliated epithelium, increases mucociliary transport. After ingestion, the effect occurs in 30 minutes and lasts for 6-12 hours. Absorption is high (with all routes of use), the maximum concentration in blood plasma (Tcmax) — after 2 hours, plasma protein binding-80%. Penetrates the blood-brain barrier( BBB), placental barrier, is excreted in breast milk. Metabolism – in the liver, forms dibromanthranilic acid and glucuronic conjugates. The semi-elimination period (T 1/2) is 7-12 hours. Excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged-5%. The elimination half-life increases with severe chronic renal failure, but does not change with impaired liver function.

Indications

Diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

Use during pregnancy and lactation

Preclinical trials and extensive clinical experience have not revealed any undesirable consequences of treatment with the drug during pregnancy.

However, you should follow the general rules for prescribing medications, especially in the first trimester. Lasolvan® penetrates into breast milk, but in therapeutic doses does not have a negative effect on the child.

If necessary, use Lasolvan® in the second and third trimesters of pregnancy, the potential therapy for the mother and the possible risk to the fetus should be evaluated

Contraindications

Hypersensitivity to all components of the drug; rare hereditary diseases, such as: galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for effervescent tablets), pregnancy (I trimester), phenylketonuria (for effervescent tablets); children under 12 years of age (effervescent tablets).

Side effects

Allergic reactions: skin rash, urticaria, angioedema, in some cases — allergic contact dermatitis, anaphylactic shock. Rarely-weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses — gastralgia, nausea, vomiting.

Interaction

Compatible with drugs that inhibit labor.

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough.

Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretion.

How to take, course of use and dosage

Both effervescent tablets and syrup are taken orally after meals. Tablets are effervescent. 1 or 1/2 effervescent tablets are dissolved in a glass of water (200 ml). Tablets should not be swallowed, chewed or sucked in the mouth. Adults and children over 12 years of age: in the first 2-3 days,1/2 tablet of effervescent (30 mg) 3 times a day or 1 tablet of 60 mg in the morning and 1/2 tablet (30 mg) in the evening; in the following days,1/2 tablet of effervescent (30 mg) 2 times a day. If necessary, to enhance the therapeutic effect in the first 2-3 days, you can prescribe 60 mg (1 effervescent tablet) 2 times/day. It is not recommended to use the drug for more than 4-5 days without a doctor’s appointment. Syrup 15 mg / 5 ml (1 scoop — 5 ml)Adults and children over 12 years of age: in the first 2-3 days of the disease,10 ml (2 scoops) 3 times a day; then 10 ml (2 scoops) 2 times a day. In severe cases of the disease, the dose is not reduced during the entire course of treatment. Children: from 5 to 12 years – 5 ml (1 measuring spoon) 2-3 times/day; from 2 to 5 years-2.5 ml (1/2 measuring spoon) 3 times/day; up to 2 years-2.5 ml (1/2 measuring spoon) 2 times/day. Children under 1 year of age can be prescribed the drug only after consultation with a doctor. Ambroxol-Chemopharm in the form of syrup should be taken orally, washed down with liquid. Keep an open bottle for 4 weeks. Taking the drug for more than 4-5 days only under the supervision of a doctor.

Overdose

Symptoms:  possible — nausea, vomiting, diarrhea, dyspepsia, gastralgia.

Treatment:  induction of vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing products, symptomatic therapy.

Special instructions

It should not be combined with antitussive medications that make it difficult to remove sputum.

Form of production

Syrup 15 mg / 5 ml. 100 ml of syrup in a dark glass bottle of hydrolytic group III, capped with a screw-on plastic lid with control of the first opening, equipped with a protection system against accidental opening by children. The top side of the lid is marked with a diagram of opening the bottle. 1 bottle complete with a measuring spoon (5 ml volume, with a risk for 2.5 ml volume) and instructions for use in a cardboard pack.

Storage conditions

List B. Syrup-store in a dark place at a temperature of 15 to 25 °C. Keep out of reach of children!

Shelf

life is 5 years. Do not use after the expiration date indicated on the package.

Active ingredient

Ambroxol

Dosage form

oral solution