Duro-Tuss AX Chesty Cough Liquid

A clear, very light yellow to colorless syrup with orange butterscotch flavour.
Each 5 mL of DURO-TUSS AX CHESTY COUGH Liquid contains 30 mg of Ambroxol hydrochloride.
It also contains Methyl Paraben 0.12% w/v and Propyl Paraben 0.04% w/v as preservatives.

Pharmacology: Pharmacodynamics: Preclinically, ambroxol hydrochloride, has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Improvement of mucociliary clearance has been shown in clinical pharmacologic studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration and eases cough. Patients in the ambroxol hydrochloride treatment group lost significantly fewer days through illness and had fewer days when they needed antibiotic therapy. Treatment with ambroxol hydrochloride also induced a statistically significant improvement of symptoms (difficulty of expectoration, cough, dyspnea, auscultatory signs) compared with placebo. A local anaesthetic effect of ambroxol hydrochloride has been observed in the rabbit eye model which may be explained by the sodium channel blocking properties. It was shown in vitro that ambroxol hydrochloride blocks cloned neuronal sodium channels; binding was reversible and concentration-dependent. Cytokine release from blood but also tissue-bound mononuclear and polymorphonuclear cells was found to be significantly reduced by ambroxol hydrochloride in vitro. In clinical studies in patients with sore throat, pharyngeal pain and redness was significantly reduced. Following the administration of ambroxol, antibiotic concentrations (amoxicilline, cefuroxime, erythromycin) in bronchopulmonary secretions and in the sputum are increased. Antiviral properties in in vitro studies and in animal models: In in vitro studies in human tracheal epithelial cells a reduction of rhinovirus (RV14) replication has been observed. In a mouse airway model, a reduction of Influenza A virus replication was observed with ambroxol pretreatment.
Pharmacokinetics: Absorption: Absorption of immediate release oral dosage forms of ambroxol hydrochloride is fast and complete, with dose linearity in the therapeutic range. Maximum plasma levels are reached within 1 to 2.5 hours after administration of the immediate-release formulation and after a median of 6.5 hours after administration of the slow-release formulation. Food was not found to have any effect on the bioavailability of ambroxol hydrochloride.
Distribution: Distribution of ambroxol hydrochloride from blood to tissue is rapid and pronounced, with the highest concentration of the active substance found in the lungs. The estimated volume of distribution after oral administration is 552 litres. In the therapeutic range, plasma protein binding is found to be approximately 90%.
Metabolism: About 30% of the orally administered dose is eliminated via first-pass metabolism.
Ambroxol hydrochloride is primarily metabolized in the liver through glucuronidation and cleavage to dibromanthranilic acid (approx. 10% of the dose). Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromoanthranilic acid.
Elimination: After 3 days of oral administration, ambroxol hydrochloride is eliminated renally, approx. 6% unchanged and approx. 26% in the form of its conjugates. The terminal elimination half-life of ambroxol hydrochloride is about 10 hours. Total clearance is in the range of 660 mL/min, with renal clearance accounting for approx. 8% of the total clearance. After 5 days an estimated 83% of total dose (radioactively marked) is eliminated with the urine.
Special patient groups: The elimination of ambroxol hydrochloride is reduced in patients with impaired liver function, resulting in plasma levels approx. 1.3 to 2 times higher. Due to the high therapeutic range of active substance, a dose adjustment is not necessary. Age and gender were not found to affect the pharmacokinetics of ambroxol hydrochloride to a clinically relevant degree. Therefore, deviating from the recommended dose is not necessary.

Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.

Adults and children over 12 years old: 10 mL 2 times a day.
This regimen is suitable for the therapy of acute respiratory tract disorders and for the initial treatment of chronic conditions up to 14 days.
Children 6-12 years old: 5 mL 2 to 3 times a day.
Children 2-5 years old: 2.5 mL 3 times a day.
Children 1-2 years old: 2.5 mL 2 times a day.
This dosage regimen is for initial treatment; the dosage may be halved after 14 days. In acute respiratory indications, medical advice should be sought if symptoms do not improve or worsen in the course of therapy.
DURO-TUSS AX CHESTY COUGH Liquid can be taken with or without food.
Route of Administration: Oral.

No specific symptoms of overdose have been reported to date. The symptoms observed in cases of accidental overdose or medication error are consistent with the known side effects at the recommended dose and may require symptomatic treatment.

Hypersensitivity to the active substance (ambroxol hydrochloride) or any of the other excipients listed.
DURO-TUSS AX CHESTY COUGH Liquid must not be used in children under 2 years of age except on medical advice.

Very rare cases of chronically associated severe skin impairments such as Stevens Johnson Syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported. In most cases, these could be explained by the severity of the underlying disease or concomitant administration of another drug. In the early stages of such severe skin reactions, initially only nonspecific flu-like symptoms appear, e.g. fever, arthralgia, runny nose, cough, and sore throat. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
In patients with impaired bronchial motility and copious secretions (as seen, for instance, in the rare and malignant primary ciliary dyskinesia), DURO-TUSS AX CHESTY COUGH Liquid must be used with caution because of the risk that secretions may accumulate.
In patients with impaired kidney function or severe liver disease, DURO-TUSS AX CHESTY COUGH Liquid should not be used except on medical advice. With ambroxol, as with any medicine that is metabolized hepatically and excreted renally, accumulation of the metabolites of ambroxol which are formed in the liver can be expected to occur in patients with severe renal failure.
Effects on Ability to Drive and Use Machine: There is no evidence from postmarketing data for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.

Pregnancy: Ambroxol hydrochloride crosses the placental barrier. Non-clinical studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, labour and delivery or postnatal development. Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus. However, the usual precautions concerning the administration of any medicine during pregnancy should be observed. The use of DURO-TUSS AX CHESTY COUGH Liquid is not recommended during the first trimester of pregnancy in particular.
Breast-feeding: Ambroxol has been shown to pass into breast milk in animal studies. Use while breast-feeding is not recommended.
Fertility: Non-clinical studies do not indicate direct or indirect harmful effects with respect to fertility.

The following categories are normally used when reporting the frequencies of side effects: See table.

Click on icon to see table/diagram/image

Immune system disorders: Rare: Hypersensitivity reactions.
Not known: Anaphylactic reactions including anaphylactic shock, angioedema and pruritus.
Skin and subcutaneous tissue disorders: Rare: Rash, urticaria.
Not known: Severe skin reactions (including Stevens Johnson syndrome, Toxic epidermal necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP).
Nervous system disorders: Common: Dysgeusia (e.g. changed taste).
Gastrointestinal disorders: Common: Nausea, oral hypoaesthesia.
Uncommon: Vomiting, diarrhoea, dyspepsia, abdominal pain, dry mouth.
Rare: Dry throat.
Very rare: Sialorrhoea Respiratory, thoracic and mediastinal disorders.
Common: Pharyngeal hypoaesthesia.
Not known: Dyspnoea (as a symptom of a hypersensitivity reaction).
General disorders and administration site conditions: Uncommon: Fever, mucous membrane reactions.

If DURO-TUSS AX CHESTY COUGH Liquid is used in combination with antitussives in patients with pre-existing respiratory diseases such as cystic fibrosis or bronchiectasis who are affected by mucus hypersecretion, a reduced cough reflex may lead to (serious) accumulation of mucus.

Store below 30°C.

Cough & Cold Preparations

R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

NP