Flavamed forte solution for oral administration 0.03/5ml 100ml

Active substance

Ambroxol

Composition

5 ml of solution contains:
Active ingredient: Ambroxol hydrochloride - 30.00 mg;

Excipients: benzoic acid (E 210), glycerin (85%), sorbitol solution, does not crystallize (E 420), hydroxyethyl cellulose, purified water, raspberry flavor No. 516028.

Mechanism of action

Ambroxol is an active N-demethylated metabolite of Bromhexine. Possesses sekretomotorny, sekretolitichesky and expectorant action. Stimulates the serous cells of the glands of the mucous membrane of the bronchi, increasing the content of mucous secretion and, thus, normalizes the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretion, the formation of a surfactant (surfactant) and its content in the alveoli and bronchi. Increases motor activity of the ciliated epithelium, increases mucociliary transport of sputum. On average, when taken orally, the effect occurs after 30 minutes, the duration of action is 6-12 hours, depending on the single dose.

Indications

Impaired secretion and transport of sputum in acute and chronic respiratory diseases:

• acute and chronic bronchitis;
• pneumonia;
• chronic obstructive pulmonary disease;
• bronchial asthma;
• bronchiectasis.

Contraindications

• Hypersensitivity to Ambroxol and other components of the drug (see the “Composition” section);
• hereditary intolerance to fructose;
• I trimester of pregnancy and breastfeeding period.

Carefully

• impaired motility of the bronchi and increased secretion of mucus (for example, in rare ciliary syndrome of primary dyskinesia);
• severe renal impairment (creatinine clearance less than 30 ml / min) and / or severe hepatic impairment;
• peptic ulcer and duodenal ulcer, including in history;
• II and III trimesters of pregnancy;
• children's age up to 2 years (applies only on prescription).

Side effects

• sometimes (≥0.1, <1%) - nausea, abdominal pain, vomiting, diarrhea, hypersensitivity reactions (skin rash, swelling of the face, shortness of breath, itching), fever;
• very rarely (<0.01%) - Anaphylactic reactions, severe manifestations of the skin, such as epidermal necrolysis and Stevens-Johnson syndrome.

Interaction

With the combined use of the drug Flavamed Forte and antitussives, which inhibit the cough reflex, a dangerous stagnation of the secret may occur, so it is necessary to carefully weigh the decision on the appropriateness of this combination. With simultaneous use of ambroxol with antibiotics (amoxicillin, cefuroxime, erythromycin), the concentration of the latter increases in the sputum.

How to take, the course of administration and dosage

Flavamed Forte is intended for oral administration. The drug is taken orally after a meal with a glass of water. For the dosing of the drug, use a measuring spoon in the package, which is labeled 1/4 and 1/2, respectively, the number of its filling, and contains 5 ml of solution, which corresponds to 30 mg of ambroxol hydrochloride.

The secretolytic action of ambroxol hydrochloride is maintained on condition that a sufficient amount of fluid is supplied to the body, therefore, the patient must consume a lot of fluid during treatment.

Children under the age of 2 years appoint 1/4 scoop 2 times a day; at the age of 2-5 years - 1/4 scoop 3 times a day; at the age of 6-12 years - 1/2 measuring spoons of the solution 2-3 times a day.

Adults and adolescents over the age of 12 years - 1 scoop of solution 3 times a day for the first 2-3 days, then - 1 scoop 2 times a day. If necessary, adults can take 2 scoops 2 times a day.

The duration of treatment is determined by the doctor depending on the course of the disease, but the drug should not be used for more than 4-5 days without the supervision of a doctor.

Overdosage

Serious manifestations of intoxication in case of ambroxol overdose were not noted.

Symptoms There were reports of brief anxiety and diarrhea. With a significant overdose, hypersalivation, nausea, vomiting, and a decrease in blood pressure may occur.

Treatment. Emergency measures, such as induction of vomiting and gastric lavage, are not shown, they are used only with a significant overdose. If necessary, recommend symptomatic therapy.

Special notes

In severe renal failure, the possibility of accumulation of ambroxolol metabolites formed in the liver should be considered.

To maintain the secretolytic action of Ambroxol during the period of taking the drug, it is necessary to ensure the intake of fluid in sufficient quantities.

When prescribing the drug to patients with diabetes mellitus, it should be borne in mind that 5 ml of the solution (1 scool) contains 1.75 g of sorbitol, which corresponds to 0.15 XE.

Influence on the ability to drive vehicles and other mechanisms that require high concentration of attention

Not established

Solution