Duro-Tuss Ax

Sustained-release capsule: DURO-TUSS AX is a combination of off-white to slightly yellowish pellets and blue to dark blue pellets encapsulated in empty gelatin capsule size #1 with transparent cap and transparent body.
Each sustained-release capsule contains: Ambroxol Hydrochloride 75 mg.
Syrup: Ambroxol hydrochloride (DURO-TUSS AX) is a clear light yellow to yellowish syrup, pineapple and orange flavor, sweet fruit taste.
Each 5 mL (1 teaspoonful) contains: Ambroxol hydrochloride 30 mg.

Mucolytic.
Pharmacology: Sustained-release capsule: This medicine contains ambroxol hydrochloride, which is a derivative of the mucolytic, bromhexine, which has been found to possess secretolytic and mucokinetic properties. Ambroxol hydrochloride accelerates mucus transport, promoting expulsion of thick, tenacious secretions from the respiratory tract.
Pharmacodynamics: Syrup: Mechanism of Action and Pharmacodynamic effects: Ambroxol is the active metabolite of bromhexine. Ambroxol causes an increase in secretion in the respiratory tract. It promotes surfactant production and stimulates ciliary activity. These effects assist the flow of mucus and its removal (mucociliary clearance).
An improvement in mucociliary clearance was demonstrated in clinical pharmacological studies. The increase in secretion and mucociliary clearance facilitates expectoration and reduces the cough.
Pharmacokinetics: Syrup: Absorption: Ambroxol normal release formulations are absorbed swiftly and almost completely after oral administration. Oral bioavailability is approx. 60% owing to the first-pass effect.
Plasma concentrations are in a linear relationship to the dose. Peak plasma levels are attained after 0.5 to 3 hours.
Distribution: Bioavailability of ambroxol hydrochloride is not affected by food. Plasma protein binding is around 90% in the therapeutic range. After oral intravenous and intramuscular administration ambroxol is distributed swiftly and extensively from the blood into the tissues. The highest active ingredient concentrations are measured in the lung.
Metabolism: Studies in human liver microsomes showed that CYP3A4 is the predominant isoform for ambroxol metabolism. Otherwise ambroxol is metabolized in the liver mainly by conjugation.
Elimination: Around 30% of an oral dose is eliminated via the first-pass effect. The terminal half-life is about 10 hours. Total clearance is the region of 660 mL/min, and renal clearance is 8% total clearance.
Children, Elderly, Gender: Age and gender do not affect the pharmacokinetics of ambroxol to any clinically relevant extent; therefore adjustment of the dose in unnecessary.
Renal Impairment: An accumulation of metabolites (predominantly conjugates of the parent substance) cannot be ruled out in severe renal impairment.

Sustained-release capsule: This is used for the treatment of acute respiratory tract diseases with impaired formation of secretions, particularly in acute exacerbations of chronic and asthmatic bronchitis, bronchial asthma and bronchiectasis. Treatment of respiratory disorders associated with viscid mucus eg, pneumonia, otitis media, sinusitis, nasopharyngitis. As secretolytic therapy for relieving cough in acute and chronic disorders of the respiratory tract associated with pathologically thickened mucus and impaired mucus transport.
Syrup: For the treatment of respiratory disorders associated with viscid or excessive mucus.

Sustained-release capsule: 1 capsule daily. The capsule should be swallowed whole without chewing after a meal with adequate fluid, or as prescribed by the physician.
Syrup: Adults and Children over 12 years: 10 mL (2 teaspoonfuls) 2 times daily.
Children 7-12 years: 5 mL (1 teaspoonful) 2 times daily.
Children 2-6 years: 2.5 mL (½ teaspoonful) 3 times daily.
Children 1-2 years: 2.5 mL (½ teaspoonful) 2 times daily.
Or as prescribed by the physician.
What Should the Patient Do If They Miss a Dose: Sustained-release capsule: The missed dose should be taken as soon as remembered if still needed for the condition being treated, and the subsequent doses should be taken at the recommended time or schedule (i.e., after 24 hours).
Do not double dose.

Sustained-release capsule: Symptoms of ambroxol overdose include extensions of the common undesirable effects (e.g., diarrhea, dyspepsia, pyrosis, nausea, vomiting, and skin rashes).
Syrup: In reports of unintentional overdosing and/or medication errors, the symptoms have largely corresponded with the known adverse effects. If manifestations of poisoning do occur symptomatic treatment is recommended.
What to Do When The Patient Has Taken More Than the Recommended Dosage: Sustained-release capsule: If a daily dose of 2 or more sustained-release capsules has been taken, a doctor should be consulted.

When Should the Patient Not Take This Medicine: If the patient is allergic to ambroxol hydrochloride or any of the excipients of the product.

Sustained-release capsule: Severe skin lesions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported rarely with the administration of mucolytics such as ambroxol. These may be due to the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, discontinue ambroxol and consult a physician immediately. The medicine should not be taken if the patient is pregnant or breastfeeding unless advised by a doctor.
Syrup: Should be used with care in patients with a history of peptic ulceration.

Pregnancy: Sustained-release capsule: Do not take if pregnant unless recommended by physician.
Syrup: Caution is advised when ambroxol is used during pregnancy. Use during the first trimester of pregnancy is not recommended. Ambroxol crosses placenta. Animal studies do not show either a direct or indirect harmful effect on pregnancy, embryofoetal development, parturition or postnatal development. Comprehensive controlled studies in pregnant women after the 28th week have not shown any harmful effects on the foetus.
Lactation: Sustained-release capsule: Do not take if breastfeeding unless recommended by physician.
Syrup: Ambroxol is excreted in breast milk and should not be taken during lactation. However, no adverse effects on the breastfed infants are expected.

Sustained-release capsule: Ambroxol hydrochloride is generally well tolerated. Mild stomach disturbance such as pyrosis (heartburn), dyspepsia, diarrhea, nausea, and vomiting may occur. Rash/urticaria, angioedema (rapid swelling of the skin), anaphylactic reactions (rare, life-threatening allergic reaction) and other allergic reactions have been reported.
Syrup: Ambroxol hydrochloride is generally well tolerated. Occasional incidence of headache, polyuria, and fatigue has been reported. Also mild gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur.
When Should the Patient Consult a Doctor: Sustained-release capsule: If the symptoms do not improve or new symptoms appear. If undesirable effect develops.

Sustained-release capsule: There are no reports of adverse drug interactions with other medications. Administration of ambroxol with antibiotics (e.g., amoxicillin, cefuroxime, erythromycin) leads to higher antibiotic concentration in bronchopulmonary secretions and in sputum. The patient should inform their doctor about any other medicines they are taking, especially other medicines for cough, cold and allergy.
Syrup: No report of drug interaction. Ambroxol hydrochloride can be administered with other drugs, particularly the standard medication for bronchitis syndrome such as corticosteroids, bronchospasmolytics, diuretics and antibiotics.

Store at temperatures not exceeding 30ºC.

Cough & Cold Preparations

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

Non-Rx