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Amxolstad 60 mg/10 ml
OTC

Ambroxol hydrochloride has mucokinetic and expectorant properties. It stimulates, through its action on secreting cells, bronchial secretion and promotes the production of more mobilizable mucus. It increases ciliary activity.

Pack size Box of 10 ampoules x 10 ml. Box of 1 bottle x 60 ml, 100 ml.
Shelf-life 24 months
Composition Ambroxol hydrochloride.
Dosage forms and strengths Syrup
Each 10 ml syrup contains 60 mg ambroxol hydrochloride
Each 60 ml syrup contains 360 mg ambroxol hydrochloride
Each 100 ml syrup contains 600 mg ambroxol hydrochloride
Product code :

PRESCRIBING INFORMATION

Indications

Secretolytic therapy in acute and chronic diseases of the respiratory tract accompanied by abnormal bronchial secretions, particularly in exacerbation of chronic bronchitis, asthmatic bronchitis.

Dosage

  • Children up to 2 years: Take 1.25 ml twice a day.
  • Children from 2 to 5 years: Take 1.25 ml three times daily.
  • Children from 6 to 12 years: Take 2.5 ml two to three times daily.
  • Adults and adolescents from 12 years: Take 5 ml three times daily for the first 2 – 3 days and 5 ml twice a day thereafter. Therapeutic effect may be enhanced by increasing the dosage to 10 ml twice a day.
    In principle, the duration of use is not limited on medical advice. Nevertheless, Amxolstad 60 mg/10 ml should not be taken for longer 4 – 5 days without the advice of a doctor.

Usage

Amxolstad 60 mg/10 ml is administered orally, with or without food.

  • Hypersensitivity to ambroxol or to any ingredient in the formulation.
  • Active peptic ulcer.
  • Common
    Nausea and oral hypoaesthesia, dysgeusia (e.g. change taste), pharyngeal hypoaesthesia.
  • Uncommon
    Vomiting, dyspepsia, diarrhea, abdominal pain and dry mouth.
  • Patients with peptic ulcers and those with hemoptysis because ambroxol can lyse fibrin coagulates and therefore new bleeding.
  • There have been reports of severe cutaneous adverse reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthemous pustulosis (AGEP) associated with the use of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
  • Because of a possible build-up of secretion, Amxolstad 60 mg/10 ml should be used with caution in disturbed bronchomotor function and large quantities of secretion (e.g. in the rare primary ciliary dyskinesia).
  • In the event of renal insufficiency or severe hepatopathy, ambroxol hydrochcloride may only be used after consultation with a doctor. As with any medicinal product exhibiting hepatic metabolism followed by renal elimination, an accumulation of hepatic ambroxol metabolites is to be expected in severe renal impairment.
  • Amxolstad 60 mg/10 ml contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
  • Amxolstad 60 mg/10 ml contains sodium benzoate which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
  • Amxolstad 60 mg/10 ml is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
  • Pregnancy: The use of ambroxol hydrochloride is not recommended in the first trimester of pregnancy.
  • Ambroxol hydrochloride is not recommended for use in nursing mothers.
  • The effects on the ability to drive and use machines have not been studied.Patients should be aware of how they react to drug before driving or operating machinery.