Main physico-chemical properties: clear syrup with colorless to slight yellow tinge.
Drugs used for cough and catarrhal diseases. Mucolytics.
ATC code R05C B06.
Active substance of Abrol® syrup – ambroxol hydrochloride – increases secretion of airway glands. Ambroxol increases the secretion of pulmonary surfactant by direct effect on type II pneumocytes in alveoli and Clara cells in bronchioles, and also stimulates a ciliary activity. This leads to increased mucus secretion and mucociliary clearance improvement.
Activation of fluid secretion and increased mucociliary clearance facilitate mucus excretion and reduce a cough.
Ambroxol hydrochloride is known to have local anaesthetic effect that may be explained by its ability to block sodium channels. Blockage of neuronal sodium channels was characterized by reversible and concentration-dependent binding.
Ambroxol hydrochloride has anti-inflammatory effect; it significantly reduces blood cytokine release and tissue binding of mononuclear and polymorphonuclear cells.
There is evidence that ambroxol hydrochloride leads to significant decrease of pain and throat redness in patients with pharyngitis. Besides, ambroxol hydrochloride is known to be effective in treatment of upper respiratory tract since it contributes to fast pain relief and alleviation of pain associated discomfort in nasal and ear cavities, and trachea during breathing.
After ambroxol hydrochloride administration, concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) become higher in bronchopulmonary secret and sputum.
Absorption. Absorption of ambroxol hydrochloride from the not sustained-release oral forms is quick and almost complete, with a linear dependence in therapeutic range. Maximum blood plasma levels are reached in 1–2.5 hours in oral administration of fast-release medicine forms and averagely in 6.5 hours when using a sustained-release form.
Distribution. In oral administration, the distribution of ambroxol hydrochloride from blood to tissues is quick and pronounced, with the highest concentration of active substance in lungs. Distribution volume in oral administration is about 552 l. Approximately 90% of drug binds with proteins in blood plasma in therapeutic range.
Metabolism and excretion. Approximately 30% of the dose after oral administration is eliminated by first-pass metabolism. Ambroxol hydrochloride is metabolized mostly in liver via glucuronization and decomposition to dibromanthranilic acid (approximately 10% of dose). It is known that CYP3A4 is responsible for ambroxol hydrochloride metabolism to dibromanthranilic acid in human liver microsomes.
For 3 days of oral administration, about 6% of dose is excreted in unchanged from, whereas about 26% of dose is excreted in conjugated form with the urine.
Blood plasma elimination half-life is about 10 hours. Total clearance is in the range of 660 ml/min with a renal clearance that is approximately 8% of total clearance.
Pharmacokinetics in special patient groups. In patients with liver dysfunction, the ambroxol hydrochloride excretion is reduced, that causes 1.3–2 times higher blood plasma level. Since therapeutic range of ambroxol hydrochloride is sufficiently wide, the dose adjustment is not required.
Age and gender have no clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, so no dose adjustment is required.
Food intake does not influence the bioavailability of ambroxol hydrochloride.
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and sputum expectoration.
Abrol®, syrup 30 mg/5 ml cannot be used in patients with known hypersensitivity to ambroxol hydrochloride or to other drug ingredients.
There were several reports about acute skin lesions, namely Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) related to use of expectorants, such as ambroxol hydrochloride. Most of them could be explained by severity of underlying disease in patients and/or simultaneous administration of other drugs. Also at initial stage of Stevens-Johnson syndrome or Lyell's syndrome, patients may experience non-specific flu-like symptoms, such as fever, aches, rhinitis, cough, and sore throat. Symptomatic therapy against cough and cold can be wrongly administered in such non-specific symptoms similar to early flu ones. Therefore, in case of new lesions of skin or mucous membranes, seek medical attention immediately and discontinue treatment with ambroxol hydrochloride.
In patients with impaired bronchial motility and increased mucus secretion (eg. in such a rare disease as primary ciliary dyskinesia), Abrol®, syrup 30 mg/5 ml should be cautiously used as ambroxol may increase a mucus secretion.
In patients with impaired renal function or severe liver failure, Abrol®, syrup 30 mg/5 ml should be administered only after consulting a doctor. When administering ambroxol or any other substance which is metabolized in the liver and then excreted by the kidneys, metabolites accumulate in the liver in patients with severe renal insufficiency.
Abrol®, syrup 30 mg/5 ml contains sorbitol 1.2 g in 5 ml (equivalent to 4.9 g when administering the maximum recommended dose). If there has been diagnosed intolerance of some sugars, patient shall contact doctor before taking this medicine.
Interaction with other medicinal products and other forms of interaction.
Concomitant use of Abrol®, syrup 30 mg/5 ml with drugs that suppress the cough can lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, this combination is possible only after careful doctor’s evaluation of the ratio of expected benefits and possible risks from use.
Administration during pregnancy and lactation.
Pregnancy. Ambroxol hydrochloride crosses the placental barrier.
There is no evidence of harmful effect on the fetus after 28th week of pregnancy at drug administration. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the first trimester, the use of Abrol® is not recommended.
Especially in I-trimester of pregnancy Abrol® administration is not recommended.
Lactation. Ambroxol hydrochloride is excreted in breast milk. Abrol®, syrup 30 mg/5 ml is not recommended for use during lactation.
Effects on ability to drive and use machines.
There is no evidence for an effect on the ability to drive and use machines.
Studies have not been performed.
Dosage and administration.
Unless otherwise prescribed, the recommended dose of Abrol®, syrup 30 mg/5 ml is as follows:
children under 2 years: 1.25 ml 2 times a day (equivalent to ambroxol hydrochloride 15 mg per day);
children aged 2–5 years: 1.25 ml 3 times a day (equivalent to ambroxol hydrochloride 22.5 mg per day);
children aged 6–12 years: 2.5 ml up to 3 times a day (equivalent to ambroxol hydrochloride 30–45 mg per day);
adults and children over 12 years: usual dose is 5 ml 3 times a day (equivalent to ambroxol hydrochloride 90 mg per day) during the first 2–3 days and then 5 ml 2 times a day (equivalent to ambroxol hydrochloride 60 mg per day).
If necessary, the therapeutic effect for adults and children over 12 years may be enhanced by increasing the dose up to 10 ml 2 times a day (equivalent to ambroxol hydrochloride 120 mg per day).
Abrol®, syrup 30 mg/5 ml can be used regardless of food intake.
Abrol®, syrup 30 mg/5 ml can be measured with the attached measuring cup.
It should be noted that measuring cup is not designed to measure doses of 1.25 ml of syrup (for children aged 2 to 5 years). For measuring the dose of 1.25 ml, plastic disposable syringe without needle with capacity of 2 ml can be used.
In general, there is no limit on the use duration, but long-term treatment should be maintained under medical control.
Abrol®, syrup 30 mg/5 ml should not be used longer than 4–5 days without consulting a doctor.
Abrol®, syrup 30 mg/5 ml may be used in patients with diabetes mellitus; 5 ml contain 1.225 g of carbohydrates.
Abrol®, syrup 30 mg/5 ml does not contain alcohol.
The drug can be used in pediatric patients. In children under 2 years, it should be used as prescribed.
No specific overdose symptoms have been reported to date. Based on accidental overdose and medication error reports the observed symptoms are consistent with the known side effects of Abrol®, syrup 30 mg/5 ml at recommended doses and may need symptomatic treatment.
Immune system, skin and subcutaneous tissue adverse reactions: skin rash, urticaria, angioedema, pruritus, anaphylactic reactions (including anaphylactic shock), other hypersensitivity reactions, erythema, severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Nervous system: dysgeusia (taste disorder).
Gastro-intestinal tract: nausea, decreased sensitivity in the mouth, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth, constipation, drooling, dry throat.
Respiratory system, chest and mediastinum: reduced sensitivity in the throat, rhinorrhea, dyspnoea (as a symptom of hypersensitivity reaction).
Urinary system: dysuria.
General disorders: fever, mucous membranes reactions.
Store in original package at a temperature below 25°С.
Keep out of reach of children.
Store not more than 4 weeks after first opening the bottle.
100 ml in a bottle. Each bottle is in a carton box with a measuring cup.
Conditions of supply.
Location of manufacturer and the address of his business activity.
«KUSUM PHARM» LLC.
54, Skryabina St., Sumy 40020, Ukraine.
Last revision date.
24.07.2015 No. 462.
secretory therapy in acute and chronic bronchopulmonary diseases associated with bronchial secretion disorders and weakening of mucus movement.
5 mL of syrup contains ambroxol hydrochloride 30 mg.