Ambroxol oral and inhalation solution 7.5mg/ml, 100ml

Composition

>1 ml of the solution contains: Active ingredient: Ambroxol hydrochloride-7,500 mgsupportable substances: benzalkonium chloride – 0,225 mg, sodium chloride – 6,220 mg, citric acid 2,000 mg, sodium hydrogen phosphate dihydrate – 4,350 mg, water – 989,705 mg

Pharmacological action of

Ambroxol has sekretomotornym, secretolytic and expectorant action: stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and secretion of surfactant (surfactant) in the alveoli and bronchi;normalizes the disturbed ratio of serous and mucous components of sputum. Activating hydrolyzing enzymes and increasing the release of lysosomes from Klara cells reduces the viscosity of sputum. Increases motor activity of cilia of the ciliated epithelium. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the removal of sputum from the respiratory tract.

Indications

Diseases of the respiratory tract, accompanied by the release of viscous sputum and difficulty in sputum discharge: acute and chronic bronchitis; pneumonia; bronchial asthma; bronchiectatic disease; COPD.

Recommendations for use

Inside, the drug is used after a meal, adding to water, tea, milk or fruit juice. Adults and children over 12 years of age: for the first 2-3 days,4 ml 3 times a day (which corresponds to 90 mg of ambroxol per day), then 4 ml 2 times a day (which corresponds to 60 mg of ambroxol per day);Children from 6 to 12 years: 2 ml 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day);Children from 2 to 6 years: 1 ml 3 times a day (which corresponds to 22.5 mg of ambroxol per day);Children under 2 years: 1 ml 2 times a day (which corresponds to 15 mg of ambroxol per day). ambroxol per day). For children under 2 years of age, the drug is prescribed only under the supervision of a doctor. The maximum daily dose when taken orally: for adults-90 mg, for children 6-12 years-45 mg, for children 2-6 years-22.5 mg, for children under 2 years-15 mg.

Contraindications

Hypersensitivity to ambroxol or auxiliary components of drugs; I trimester of pregnancy; lactation (breastfeeding); congenital fructose intolerance (for dosage forms containing fructose); children under 6 years of age (for tablets); children under 12 years of age (for extended-acting capsules).

With caution:  impaired bronchial motility and increased mucus secretion (for example, with rare fixed cilia syndrome); renal failure and / or severe liver failure; peptic ulcer of the stomach and duodenum (including in the anamnesis); II and III trimesters of pregnancy; children under 2 years of age (oral solution; only as prescribed by a doctor).

Side effects

Allergic reactions:  rarely – skin rash, urticaria, exanthema, facial edema, shortness of breath, pruritus, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, pruritus, allergic contact dermatitis.

From the digestive system:  often – nausea; infrequently-vomiting, diarrhea, dyspepsia, abdominal pain.

Nervous system disorders:  often-dysgeusia.

Skin and subcutaneous tissue disorders:  very rarely – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown-acute generalized eczematous pustulosis.

Respiratory system disorders:  often-decreased sensitivity in the oral or pharyngeal cavity; rarely-dryness of the respiratory tract mucosa, rhinorrhea; in isolated cases-dryness of the pharyngeal mucosa.

Interaction

Antitussive medications (such as codeine) – due to the suppression of the cough reflex, sputum may accumulate in the lumen of the respiratory tract with difficulty in removing it (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin-increased penetration of antibiotics into the bronchial secret.

Overdose

Symptoms: heartburn, dyspepsia, diarrhea, nausea, vomiting, upper abdominal pain. There are reports of short-term anxiety. With a severe overdose, a significant decrease in blood pressure is possible. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing products, symptomatic therapy.

Special instructions

Ambroxol should not be taken concomitantly with antitussive medications that may inhibit the cough reflex, such as codeine, as this may make it difficult to remove diluted sputum from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking ambroxol are not recommended to perform breathing exercises due to difficulty in sputum discharge. In patients in serious condition, dilute sputum aspiration should be performed.

Do not take ambroxol immediately before bedtime.

In patients with asthma, ambroxol may worsen coughing.

Patients with severe skin lesions-Stevens-Johnson syndrome or toxic epidermal necrolysis-may experience a flu-like condition in the early phase: fever, body aches, rhinitis, cough, pharyngitis. With symptomatic therapy, it is possible to mistakenly prescribe mucolytic agents, such as ambroxol hydrochloride.

Storage conditions

In a place protected from light when the temperature is not higher than 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Ambroxol

Dosage form

solution for oral use and inhalation