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.
Dosage / Direction For Use
Adult: Tablet: 1 tablet 3 times daily. The tablet should be taken after a meal with adequate fluid.Syrup: 5 mL of 30 mg/5 mL syrup 3 times daily. The syrup should be taken with food.Pediatric Syrup: 10 mL of 15 mg/5 mL syrup 2-3 times daily. In severe cases, the dose may be increased up to 20 mL 2 times daily.Children: Recommended Daily Dose: 1.2-1.6 mg/kg body weight; 6-11 years: Tablet: ½ tablet 3 times daily. Pediatric Syrup: 5 mL 3 times daily; 2-5 years: Pediatric Syrup: 2.5 mL 3 times daily. Oral Drops: 10-20 drops 3 times daily; <2 years (only when prescribed by a doctor): Pediatric Syrup: 2.5 mL 2 times daily. Oral Drops: 5-10 drops 3 times daily.Double strength syrup is for initial treatment; the dosage may be halved after 14 days.Initial Treatment: Syrup: Adult and Children >12 years: 5 mL 3 times daily. Children 6-12 years: 5 mL 2-3 times daily; 2-6 years: 2.5 mL 3 times daily; 1-2 years: 2.5 mL 2 times daily.Treatment Continuation: Pediatric Syrup: Children 6-12 years: 5 mL 2-3 times daily; 2-6 years: 2.5 mL 3 times daily; 1-2 years: 2.5 mL 2 times daily.Elderly: There are no relevant data available.Renal Impairment: In severe renal impairment, ambroxol must only be used under medical supervision; maintenance therapy should be reduced or the dosing interval extended (see Precautions). The secretolytic effect of ambroxol is supported by adequate fluid intake.Hepatic Impairment: In severe hepatic impairment, ambroxol must only be used under medical supervision.
Symptoms: In reports of unintentional overdosing and/or medication errors, the symptoms have largely corresponded with the known adverse effects.Treatment: If manifestations of poisoning do occur, symptomatic treatment is recommended.
Should be taken with food: Take immediately after meals.
Hypersensitivity to ambroxol or any of the excipients of Ambrolex.
General Warning: Physician should be consulted if cough persists for ≥14 days.Renal Impairment: In renal insufficiency, physician should be consulted before taking ambroxol hydrochloride. In severe renal impairment, accumulation of metabolites formed in the liver must be expected and consequently, the maintenance dose must be reduced or the dosing interval extended.Secretion Impairment: In patients with symptoms of chronic impairment of secretion production or clearance, ambroxol should be used only when prescribed by a physician.Peptic Ulcer: The use of ambroxol should be carefully considered in patients predisposed to peptic ulcers.Ciliary Dyskinesia: In patients with ciliary dyskinesia, the benefit of liquefaction of secretions should be carefully weighed against the risk of congestion of secretions.Antitussives: Concomitant administration of antitussives should be avoided due to the risk of congestion of secretions (see Interactions).Skin Damage: Very rare cases of severe skin damage eg, Stevens-Johnson syndrome and Lyell’s syndrome (toxic epidermal necrolysis) have been reported in a temporal relationship with the administration of mucolytic substances including ambroxol. In most cases, they could be explained by the severity of the underlying disease or concomitant administration of another medicine. In the early stage of such severe skin reactions, only non-specific flu-like symptoms may arise, eg, fever, pain in the limbs, cold, coughing and sore throat. (See Adverse Reactions.)If there is a new occurrence of damage to the skin or mucosa, medical advice should be obtained immediately and the treatment with ambroxol should be discontinued.Excipients: Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Ambrolex.Syrup contains sucrose and sorbitol, oral drops contain sorbitol and modified-release capsules contain sucrose. Patients with fructose intolerance should not take Ambrolex syrup, oral drops or modified-release capsules. A mild laxative effect may occur.Syrup contains methyl and propyl hydroxybenzoate (parabens) which may cause allergic reactions (possibly delayed).Syrup and oral drops contain ponceu 4R (E124) which may cause allergic reactions.Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed. An effect on the ability to drive and operate machinery is unknown.Impairment of Fertility: There are no relevant data available.Use in pregnancy: Caution is advised when ambroxol is used during pregnancy. Use during the 1st trimester of pregnancy is not recommended. Ambroxol crosses the placenta. Animal studies do not show either a direct or indirect harmful effect on pregnancy, embryofetal development, parturition or postnatal development. Comprehensive controlled studies in pregnant women after the 28th week have not shown any harmful effects on the fetus.Use in lactation: Ambroxol is excreted in breast milk and should not be taken during lactation. However, no adverse effects on the breastfed infant are expected.
Clinical Trial Data: Not relevant for Ambrolex.Post-Marketing Data: Adverse reactions are ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).Immune System Disorders (see Skin and Subcutaneous Tissue Disorder as follows): Not Known: Allergic reactions, anaphylactic reactions including anaphylactic shock.Nervous System Disorders: Common: Dysgeusia* (eg, altered flavors).Gastrointestinal Disorders: Common: Nausea, oral and pharyngeal hypoesthesia*. Uncommon: Diarrhea, vomiting, dyspepsia, abdominal pain, dry mouth*. Not Known: Dry throat*.Skin and Subcutaneous Tissue Disorders: Rare: Rash, urticaria. Now Known: Pruritus, angioedema.
Antitussives: Concomitant administration of antitussives may impair the expectoration of liquefied bronchial mucus due to inhibition of cough reflex and cause congestion of secretions (see Precautions).Antibiotics: After using ambroxol, the concentrations of the antibiotics amoxicillin, cefuroxime and erythromycin in bronchial secretions and sputum are increased.
Store at temperatures not exceeding 30°C. Protect from light.
Each tablet also contains maize starch, dibasic calcium phosphate, anhydrous microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide as excipients.Each 5 mL of syrup also contains granulated sucrose, sorbitol 70%, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium benzoate, citric acid monohydrate, propylene glycol, disodium edentate, thiourea, menthol, blackcurrant flavor, soluble ponceu 4R, purified water (15 mg/5 mL pediatric syrup) or deionized water (30 mg/5 mL syrup) as excipients.Each mL of oral drops also contains granulated sucrose, sorbitol 70%, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium benzoate, citric acid monohydrate, propylene glycol, disodium edentate, thiourea, menthol, blackcurrant flavor, soluble ponceu 4R, purified water as excipients.
Pharmacotherapeutic Group: Expectorants, excluding combinations with cough suppressants, mucolytics.Pharmacology: Pharmacodynamics: Mechanism of Action: 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 facilitate expectoration and reduce the cough.In in vitro studies, ambroxol showed a significant reduction in cytokine release, both in the blood and in mononuclear and polynuclear cells. The clinical relevance of these findings is unclear.Clinical Studies: Not relevant for Ambrolex.Pharmacokinetics: Absorption: Ambroxol formulations which are not sustained-release are absorbed rapidly and almost completely after oral administration. Oral bioavailability is approximately 60% owing to the first-pass effect. Plasma concentrations are in a linear relationship to the dose. Peak plasma levels are attained after 0.5-3 hrs. Ambroxol modified-release capsules, on the other hand, has delayed absorption [time to reach the peak plasma concentration (Tmax) 6.5±2.2 hrs] and a relative bioavailability of 95% compared with the tablets.Distribution: Plasma protein-binding is around 90% in the therapeutic range. After oral, IV and IM administration, ambroxol is distributed rapidly 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 (t½) is 10 hrs. Total clearance is in the region of 660 mL/min and renal clearance is 8% of total clearance.Special Patient Populations: Children, Elderly, Gender: Age and gender do not affect the pharmacokinetics of ambroxol to any clinically relevant extent; therefore, adjustment of the dose is unnecessary.Renal Impairment: An accumulation of metabolites (predominantly conjugates of the parent substance) cannot be ruled out in severe renal impairment.Toxicology: Nonclinical Information: No mutagenic, carcinogenic, teratogenic or embryotoxic effects were observed in the usual tests for genotoxicity, carcinogenicity and reproductive toxicity.