Ambroxol
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMBROXOL
Composition:
Active substance: 5 ml of syrup contains ambroxol hydrochloride 15 mg;
Excipients: propylene glycol, methylparaben (E 218), propylparaben (E 216), ethanol 96%, sorbitol (E 420), raspberry flavor, purified water.
Pharmaceutical form. Syrup.
Main physicochemical properties: clear, colorless or slightly yellowish syrupy liquid, sweet in taste, with a characteristic odor.
Pharmacotherapeutic group.
Medicinal products used for cough and colds.
ATC code R05C B06.
Pharmacological properties.
Pharmacodynamics. Ambroxol is a mucolytic agent. It stimulates serous cells of bronchial mucosa glands, increasing the content of serous secretion, and restores the impaired ratio between serous and mucous components of sputum. The drug activates hydrolyzing enzymes, enhances the release of lysosomes from Clara cells, resulting in reduced sputum viscosity. Ambroxol increases surfactant levels in the lungs and improves mucociliary sputum transport.
Pharmacokinetics. After oral administration, ambroxol is almost completely absorbed in the gastrointestinal tract and rapidly distributed into body tissues, with the highest concentration found in the lungs. Maximum plasma concentration is reached within 0.5–3 hours. It binds to plasma proteins by approximately 90%. It crosses the blood-brain barrier and placental barrier, and is excreted into breast milk. It does not accumulate.
Metabolized in the liver via conjugation, forming pharmacologically inactive metabolites. The elimination half-life is 7–12 hours.
Clinical characteristics.
Indications.
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and weakened mucus clearance.
Contraindications.
Hypersensitivity to the components of the medicinal product, peptic ulcer of the stomach and duodenum, seizure disorders, rare hereditary conditions leading to intolerance to the excipient of the drug (see section "Special precautions").
Interaction with other medicinal products and other forms of interaction.
Concomitant use of this drug with cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, such combination should be used only after careful assessment by a physician of the expected benefit versus possible risk.
Special precautions for use
There have been only a few reports of severe skin reactions: Stevens-Johnson syndrome and Lyell's syndrome, occurring in temporal association with the use of ambroxol hydrochloride. In most cases, these can be explained by the severity of the underlying disease and/or concomitant use of other medications. Also, at the initial stage of Stevens-Johnson syndrome or Lyell's syndrome, patients may experience nonspecific, flu-like symptoms such as fever, malaise, rhinitis, cough, and sore throat. Symptomatic treatment with cough and cold remedies may be mistakenly used in such cases. Therefore, if new skin lesions or mucosal involvement occur, immediate medical attention should be sought and treatment with ambroxol hydrochloride should be discontinued.
Ambroxol, syrup 15 mg/5 ml, should be used with caution in patients with impaired bronchial motility and increased mucus secretion (e.g., in rare conditions such as primary ciliary dyskinesia), as ambroxol hydrochloride may enhance mucus secretion.
Patients with renal function impairment or severe hepatic insufficiency should take Ambroxol, syrup 15 mg/5 ml, only after consultation with a physician. When ambroxol hydrochloride—like any active substance metabolized in the liver and subsequently excreted by the kidneys—is administered, metabolites formed in the liver may accumulate in patients with severe renal insufficiency.
Ambroxol, syrup 15 mg/5 ml, contains 2.0 g of sorbitol in 5 ml (equivalent to 9.8 g with the maximum recommended daily dose). It may also have a mild laxative effect. The energy value of 1 g of sorbitol is 2.6 kcal.
This medicinal product should not be used by patients with rare hereditary fructose intolerance.
Ambroxol, syrup 15 mg/5 ml, may be used in patients with diabetes mellitus.
This medicinal product contains not less than 2.1% ethanol (alcohol), i.e., 250 mg/dose (10 ml), equivalent to 6.33 ml of beer or 2.64 ml of wine per dose.
Harmful for patients with alcoholism. Caution is advised when used in pregnant women and breastfeeding women, children, patients with liver disease, and patients with epilepsy.
The presence of propylparaben (E 216) and methylparaben (E 218) in the formulation may cause allergic reactions (possibly delayed).
Shelf life after opening the bottle – 30 days.
Use during pregnancy or breastfeeding
Ambroxol hydrochloride crosses the placental barrier. Animal studies have not revealed any direct or indirect harmful effects of ambroxol hydrochloride on pregnancy, embryonal/fetal development, parturition, or postnatal development.
Clinical studies have shown no harmful effects on the fetus when the drug is used after the 28th week of pregnancy.
However, usual precautions regarding medication use during pregnancy should be observed. In particular, ambroxol is not recommended during the first trimester of pregnancy.
Ambroxol hydrochloride is excreted into breast milk. Ambroxol is not recommended during breastfeeding.
Effect on ability to drive vehicles or operate machinery
There are no data on the effect of ambroxol on the ability to drive vehicles or operate machinery. Studies on the influence on reaction speed during driving or operating machinery have not been conducted.
Dosage and Administration.
If not otherwise prescribed, the recommended dose of Ambroxol, syrup 15 mg/5 ml, is as follows:
Children under 2 years of age: 2.5 ml (1/2 teaspoon) twice daily (equivalent to 15 mg of ambroxol hydrochloride per day);
Children aged 2–6 years: 2.5 ml (1/2 teaspoon) three times daily (equivalent to 22.5 mg of ambroxol hydrochloride per day);
Children aged 6–12 years: 5 ml (1 teaspoon) 2–3 times daily (equivalent to 30–45 mg of ambroxol hydrochloride per day);
Adults and children aged 12 years and older: 10 ml (2 teaspoons) three times daily (equivalent to 90 mg of ambroxol hydrochloride per day) for the first 2–3 days, followed by 10 ml (2 teaspoons) twice daily (equivalent to 60 mg of ambroxol hydrochloride per day).
If necessary, the therapeutic effect in adults and children aged 12 years and older may be enhanced by increasing the dose to 20 ml twice daily (equivalent to 120 mg of ambroxol hydrochloride per day).
Ambroxol, syrup 15 mg/5 ml, can be administered regardless of food intake. The dose of Ambroxol syrup 15 mg/5 ml can be measured using the dosing spoon provided.
In general, there are no restrictions regarding duration of treatment; however, prolonged therapy should be conducted under medical supervision.
Ambroxol, syrup 15 mg/5 ml, should not be used for longer than 4–5 days without consulting a physician.
Ambroxol, syrup 15 mg/5 ml, may be used in patients with diabetes mellitus; 5 ml contains 2.0 g of carbohydrates.
Children.
The medicinal product can be used in pediatric practice. For children under 2 years of age, use only as directed by a physician.
Overdose.
There have been no reports of specific overdose symptoms. Symptoms described in isolated reports of overdose and/or accidental administration correspond to the known adverse effects of Ambroxol, syrup 15 mg/5 ml, at recommended doses and require symptomatic treatment.
Side effects.
The following classification was used to assess the frequency of adverse reactions:
| very common |
≥ 1/10; |
| common |
≥ 1/100 – < 1/10; |
| uncommon |
≥ 1/1000 – < 1/100; |
| rare |
≥ 1/10000 – < 1/1000; |
| very rare |
< 1/10000; |
| frequency not known |
cannot be estimated from the available data. |
Immune system side effects:
Rare – hypersensitivity reactions;
Frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, and pruritus.
Skin and subcutaneous tissue side effects:
Rare – rash, urticaria;
Frequency unknown – serious skin adverse reactions (including erythema multiforme, Stevens–Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
Nervous system side effects:
Common – dysgeusia (taste disturbance).
Gastrointestinal side effects:
Common – nausea, heartburn, feeling of stomach fullness, oral numbness;
Uncommon – vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth;
Rare – throat dryness;
Very rare – constipation, hypersalivation.
Respiratory, thoracic and mediastinal side effects:
Common – pharyngeal numbness;
Very rare – rhinorrhea;
Unknown frequency – dyspnea (as a symptom of hypersensitivity reaction).
Renal and urinary side effects:
Very rare – dysuria.
General disorders:
Uncommon – fever, mucosal reactions.
The medicinal product contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).
Shelf life.
3 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
100 ml in bottles or jars in a carton with a measuring spoon.
Prescription status.
Over-the-counter (without a prescription).
Manufacturer/Applicant.
LLC "Ternopharm".
Manufacturer's location and address of place of business / Applicant's location.
46010, Ternopil, Fabrychna St., 4, Ukraine.
Tel./fax: (0352) 521-444, www.ternopharm.com.ua