Amnebsmart^® (Solution) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

ATC Code

R05CB06 (Ambroxol)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Dosage Form

Amnebsmart®

Oral and inhalation solution 7.5 mg/1 ml: bottle 100 ml with dropper cap and measuring cup

Dosage Form, Packaging, and Composition

Solution for oral administration and inhalation transparent, colorless or slightly brownish.

Excipients: citric acid monohydrate, sodium hydrogen phosphate dihydrate, sodium chloride, benzalkonium chloride 50% solution, purified water.

100 ml – dark glass bottles (1) complete with a dropper cap and a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Groups

• Mucolytic agent
• Drugs used for cough and colds; expectorants, excluding combinations with cough suppressants; mucolytic agents

Pharmacological Action

Mucolytic and expectorant agent.

Ambroxol is a benzylamine – a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has secretomotor, secretolytic, and expectorant action.

After oral administration, the effect occurs within 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that Ambroxol stimulates serous cells of the bronchial mucosal glands. By activating ciliated epithelial cells and reducing sputum viscosity, it improves mucociliary transport.

Ambroxol activates the formation of surfactant, exerting a direct effect on alveolar pneumocytes type 2 and Clara cells of the small airways.

Studies on cell cultures and in vivo studies on animals have shown that Ambroxol stimulates the formation and secretion of a substance (surfactant) that is active on the surface of the alveoli and bronchi of the embryo and adult.

Also, preclinical studies have proven the antioxidant effect of ambroxol.

Pharmacokinetics

For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose-dependence in the therapeutic concentration range is characteristic. C_max after oral administration is reached within 1-2.5 hours. V_d is 552 L. In the therapeutic concentration range, plasma protein binding is approximately 90%. The transition of ambroxol from blood to tissues upon oral administration occurs rapidly. The highest concentrations of ambroxol are observed in the lungs. Using the method of introducing a radioactive label, it was calculated that after taking a single dose of the drug, about 83% of the taken dose is excreted in the urine over the next 5 days.

Indications

Respiratory tract diseases with viscous sputum production and difficulty in sputum expectoration.

ICD codes

Dosage Regimen

Determine the dose individually based on the patient’s age and the route of administration.

For oral administration, use the provided measuring cup. Administer the solution after meals.

Adults and children over 12 years: take 4 ml (30 mg) three times daily.

Children 6 to 12 years: take 2 ml (15 mg) two to three times daily.

Children 2 to 5 years: take 1 ml (7.5 mg) three times daily.

Children under 2 years: take 0.5 ml (approx. 3.75 mg) twice daily. Use the dropper for accurate dosing in this age group.

For inhalation use, employ a suitable nebulizer. Do not ingest the solution after inhalation.

Adults and children over 12 years: use 2-4 ml (15-30 mg) one to two times daily.

Children 2 to 12 years: use 1-2 ml (7.5-15 mg) one to two times daily.

For inhalation, mix the solution with an equal volume of sterile 0.9% sodium chloride solution. Follow the nebulizer manufacturer’s instructions for the procedure.

Do not use for more than 4-5 days without medical consultation. If symptoms persist or worsen, seek medical advice.

Adverse Reactions

From the digestive system frequently (1-10%) – nausea, decreased sensitivity in the oral cavity or pharynx; infrequently (0.1-1%) – dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth; rarely (0.01-0.1%) – dry throat.

From the immune system: rarely (0.01-0.1%) – skin rash, urticaria; anaphylactic reactions (including anaphylactic shock), angioedema, itching, hypersensitivity.

Nervous system disorders: frequently (1-10%) – dysgeusia (taste perception disorder).

Contraindications

Hypersensitivity to ambroxol; peptic ulcer of the stomach and duodenum; convulsive syndrome of various etiologies; first trimester of pregnancy; lactation period (breastfeeding).

With caution: second and third trimesters of pregnancy; renal and/or hepatic insufficiency.

Use in Pregnancy and Lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary of use in the second and third trimesters, the potential benefit of therapy for the mother and the possible risk to the fetus should be assessed.

Ambroxol crosses the placental barrier. Preclinical studies have not revealed direct or indirect adverse effects on pregnancy, embryonic/fetal, postnatal development, and labor. Extensive clinical experience with the use of ambroxol after the 28th week of pregnancy has found no evidence of a negative effect of the drug on the fetus.

Ambroxol may be excreted in breast milk. Although no adverse effects have been observed in breastfed infants, the use of Ambroxol in the form of a solution for oral administration and inhalation is not recommended during lactation.

Preclinical studies of ambroxol have not revealed a negative effect on fertility.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

Use is possible according to the dosing regimen.

Special Precautions

Inhalations should be carried out using special preparations containing Ambroxol intended for this procedure.

Drug Interactions

Antitussives – stagnation of bronchial secretion is possible (combination is not recommended).

Ambroxol, when used concomitantly with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline), increases their concentration in sputum and bronchial secretion.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.