Amxol

Ambroxol hydrochloride.

AMXOL TABLETS: Each tablet contains: Ambroxol HCl 30 mg.
AMXOL SYRUP: Each 5 ml contains: Ambroxol HCl 30 mg.

AMXOL (Ambroxol Hydrochloride) is a metabolite of bromhexine, which liquefies and changes the structure of bronchial secretions. By this way it promotes the expectoration of blocked-up secretions and also eases cough.

Acute and chronic diseases of the respiratory tract, especially in chronic bronchitis, asthmatoid bronchitis, bronchial asthma, bronchiectasis, laryngitis, sinusitis. Ambroxol hydrochloride reduces the viscosity of the sputum.

AMXOL TABLETS: Adult: 1 tablet 3 times daily.
The therapeutic effect may be enhanced by administering 2 tablets 2 times daily. The tablets should be taken with liquid.
AMXOL SYRUP: Adults and children over 12 years: 10 ml 2 times daily.
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: 5 ml 2 - 3 times daily.
Children 2 - 5 years: 2.5 ml 3 times daily.
Children 1 - 2 years: 2.5 ml 2 times daily.
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.
AMXOL TABLETS and AMXOL SYRUP can be taken with or without food.

No symptoms of overdosage have been reported. Should they occur, symptomatic treatment should be provided.

AMXOL is recommended not to prescribe during the first trimester of pregnancy.

Patient being treated with AMXOL should be warned to expect an increase in the flow secretions.
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 skin or mucous membrane damage occurs, seek medical advice immediately and discontinue treatment as a precaution.
Warning for Metabisulfite: Following oral ingestion, sodium metabisulfite is oxidized to sulfate and is excreted in the urine. Ingestion may result in gastric irritation due to liberation of sulfurous acid, while ingestion of large amounts of sodium metabisulfite can cause gastro-intestinal upsets, circulatory failure and central nervous system disturbances.

AMXOL is recommended not to prescribe during the first trimester of pregnancy.

Gastrointestinal Disorders: Frequency 1-10%: Dysgeusia, hypoesthesia, nausea.
Immune System Disorders: Frequency not known: Anaphylactic reactions including anaphylactic shock.
Skin and Subcutaneous Skin Disorders: Frequency not known: Severe skin reactions (including Stevens Johnson Syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP).

Store in a cool dry place at temperature not exceeding 30°C.
AMXOL TABLETS: Protect from light and moisture.
AMXOL SYRUP: Protect from light and excessive heat.
Shelf-Life: AMXOL TABLETS: The shelf-life period is 5 years.
AMXOL SYRUP: The shelf-life period is 3 years.

Cough & Cold Preparations

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

NP