Ambroxol 30 mg N20 Tablet

Ambroxol

Ambroxol composition

active ingredient: ambroxol hydrochloride - 30 mg; excipients: lactose monohydrate, starch, improves the separation of mucus and eliminates cough Absorption Absorption is high and can be considered almost complete with linear dependence on dose. Concentration (Cmax) is 79% achieved in the concentration range from the dose. 1-2.5 hours after administration, absolute bioavailability in plasma is achieved. Distribution is rapid and extensive; the highest is 552 l. It binds to plasma proteins; the volume of distribution in tissues is about 90% within the therapeutic range. It penetrates the blood-brain barrier and the placental metabolic barrier and is excreted in breast milk, while the remaining part is metabolized in the liver. Tablets are white or off-white, yellowish, round, flat, cylindrical, scored and scratched.

Indications for use

If the above syndromes develop, it is recommended to stop treatment and contact a doctor immediately. Use of ambroxol for patients with impaired function is indicated only after consulting a doctor. Acute and chronic respiratory tract diseases with formation of sputum: acute and chronic sputum, bronchiectasis, bronchial asthma with difficulty in passing, bronchitis, pneumonia, chronic obstructive disease.

Contraindications

drug components; - high sensitivity to ambroxol or others.

Use during pregnancy and lactation

intolerance to galactose malabsorption, lactase deficiency, glucose. With caution: in infancy, ambroxol penetrates the placental barrier. Studies have not revealed direct or indirect adverse effects on pregnancy, embryo/fetus, postnatal development and labor. Extensive clinical experience with ambroxol use after the 28th week found no evidence of adverse effects on the fetus.

However, when using the medicine during pregnancy, usual precautions should be taken. It is not recommended to take ambroxol in the first trimester. In the second and third trimesters, use of the preparation is possible only if there is a risk to the fetus, because the potential benefit outweighs the potential risk. Preclinical studies of ambroxol have shown no negative effects on fertility.

Use in children

Although no adverse effects have been observed in breastfed children where ambroxol may be excreted in breast milk, it is recommended to use it during breastfeeding only.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

There is no information about cases where the medicine affects the ability to drive vehicles or operate machinery. Studies regarding the effect on the ability to drive vehicles and engage in other potentially dangerous activities have not been conducted. Stevens-Johnson syndrome, Lyell syndrome, a sharp increase in attention and speed, generalized exanthematous pustulosis.

How to use ambroxol and dosage

and dosage: orally, the tablet should be swallowed whole after meals, without chewing, with plenty of liquid. The mucolytic effect may occur when taking a large amount of fluid; during treatment it is recommended to drink plenty of fluids. If it occurs, it is recommended to consult a doctor.

symptoms of the disease within 4-5 days from the start of treatment.

Side effects

The frequency of adverse reactions is often (≥ 1/100, < 1/10), rarely (≥ 1/1000, < 1/100), rarely when taking ambroxol with the following frequency: ≥1/10000, <1/1000), frequency unknown (cannot be estimated from available data). Allergic reactions are rare: skin rash, urticaria; frequency unknown: anaphylactic reactions (including anaphylactic shock), itching and other hypersensitivity reactions, from the gastrointestinal tract: often: nausea; rarely: dyspepsia, vomiting, diarrhea, gastralgia and other agents that prevent the removal of mucus from mucous membranes.

In one tablet: 171.0 mg lactose monohydrate and in the daily dose (4 tablets) 684.0 mg lactose monohydrate. In patients with skin lesions: Stevens-Johnson syndrome or toxic epidermal syndrome—body aches, rhinitis, cough and sore throat; fever may appear in the early stage, as with mucolytic agents such as ambroxol.

There are isolated reports of Stevens-Johnson syndrome and toxic epidermal necrolysis detection, which coincide with taking the product; however, there is no cause-and-effect relationship with taking the medicine.

Interaction with other medicinal products

It should not be combined with antitussive medicines. A form with no psychomotor reactions was not performed. Tablets are prepared in blister packs made of elastic packaging based on a combination of 30 m film or unplasticized PVC film and aluminum foil or aluminum foil or foil-based combined material, containing 10 tablets.

Packaging with 2, 3 or 5 strips is placed in a cardboard box together with instructions for medical use.