Swiss Pharma


Pharma Dynamic
Full Prescribing Info
Ambroxol hydrochloride.
Tablet: Each tablet contains: Ambroxol Hydrochloride 30 mg.
Syrup: Each 5 mL contains: Ambroxol Hydrochloride 15 mg.
Oral Drops: Each 1 mL contains: Ambroxol Hydrochloride 6 mg.
Pharmacology: Ambroxol hydrochloride possesses mucokinetic and secretolytic properties. It promotes the removal of tenacious secretions in the respiratory tract and reduces mucus statis. Expectoration of mucus is facilitated and breathing is ease considerably. Mucus secretion is normalized during Ambroxol treatment. Cough and sputum volume are often significantly reduced. The film-like secretion on the surface of the respiratory mucosa can thus perform its normal protective function.
Pharmacokinetics: Ambroxol hydrochloride is completely absorbed after oral administration (bioavailability approximately 60% as 1/3 of the dose is metabolized by the liver in the first pass effect). Taken by the fasting patient, it reaches maximum plasma concentration after approximately 2-½ hours. The average half-life is approximately 9-10 hours. The therapeutically effective plasma levels are slightly higher than 30 ng/mL and can be achieved with certainty by 230 mg/day orally (minimum steady state concentration approximately 50 ng/mL).
Measurement of the level after repeated administration did not produce any indication of cumulation at therapeutic dosage. Ambroxol HCl is changed into various inactive metabolites, which are mainly eliminated as water-soluble conjugates, eg glucoronides. After intravenous administration, 95% of the active substance is eliminated in the form of unchanged Ambroxol hydrochloride.
Acute and chronic disorders of the respiratory tract associated with abnormal bronchial secretions, particularly in exacerbations of chronic bronchitis, asthmatic bronchitis and bronchial asthma. In pre and post operative treatment.
Dosage/Direction for Use
Tablet: The recommendations for children are based on a total daily dose of 1.2 to 1.6 mg/kg body weight.
Adults and children over 10 years: 1 tablet 3 times a day.
Children from 5-10 years: ½ tablet 3 times a day. In long term therapy, the dose may be reduced to twice daily. The tablet should be taken after meals with liquid or as prescribed by the physician.
Syrup: The recommended for children are based on a total daily dose of 1.2 to 1.6 mg/kg body weight.
Adults and children over 10 years: 2 teaspoonfuls (10 mL) 3 times a day for the first 2-3 days; later 1 teaspoonful (5 mL) 3 times a day.
Children 6-10 years: 1 teaspoonful (5 mL) 2-3 times a day.
Children 2-5 years: ½ teaspoon (2.5 mL) twice daily or as prescribed by the physician.
Oral Drops: Less than 6 months: 0.5 mL twice a day or 6 mg a day.
7-12 months: 1 mL twice a day or 12 mg a day.
13-24 months: 1.25 mL twice a day or 15 mg a day.
No symptoms of overdosage have been reported in man to date. If they occur, symptomatic treatment should be provided.
There are no known contraindications.
Special Precautions
Tablet: Ambroxol hydrochloride contains preservative benzalkonium chloride. It has been reported that this preservative may cause bronchoconstriction in some patients with hyperactive airways.
Use In Pregnancy & Lactation
Preclinical studies have shown no hazard, but safety during human pregnancy has not yet been established. The usual precautions regarding use of drugs at this time, especially during the first trimester should be observed. Safety during lactation has not yet been established.
Side Effects
Ambroxol hydrochloride is generally well tolerated. Mild gastrointestinal side effects have occasionally been reported. Allergic reactions have occurred rarely, some of the affected patients also showed allergic reactions to other substances.
Drug Interactions
The combination of Ambroxol hydrochloride with other drug is possible. This refers particularly to preparations used as standard medications for bronchitic syndrome (cardiac glycosides, corticosteroids, bronchospasmolytics, diuretics and antibiotics).
Store at temperatures not exceeding 30°C.
ATC Classification
R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Tab & syr: Rx; oral drops: Non-Rx
Tab 30 mg x 100's. Syr 15 mg/5 mL x 60 mL. Oral drops 6 mg/mL x 10 mL.
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