NACSYS Effervescent tablet Ref.[49981] Active ingredients: Acetylcysteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: ALTURiX Ltd, 287 Upper Fourth Street, Milton Keynes, MK9 1EH UK

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Mucolytics
ATC-code: R05CB01

Mechanism of action / Pharmacodynamic effects

Acetylcysteine is a mucolytic.

The mucolytic action is mediated by a reduction in the viscosity of bronchial mucus. This is explained by the depolymerisation with the disulfide bridges between the macromolecules in the mucus being opened.

In addition, acetylcysteine is a precursor of glutathione. Acetylcysteine is a derivative of the natural amino acid cysteine, which serves as a substrate for the synthesis of glutathione in the body.

Apart from the fact that acetylcysteine is able to normalise a state of glutathione depletion, it is able to conjugate with various toxic compounds.

5.2. Pharmacokinetic properties

Absorption / Distribution

Acetylcysteine is rapidly absorbed after oral administration and distributed throughout the organism. The highest tissue concentrations are reached in the liver, kidneys and lungs.

Biotransformation / Elimination

Acetylcysteine is mainly deacetylated to cysteine in the liver. Most of this is processed in the amino acid metabolism. Moreover, it forms reversible disulfide compounds with amino acids and proteins with free sulfydryl groups. Finally, high doses are largely converted into inorganic sulfate, which undergoes renal excretion.

5.3. Preclinical safety data

Preclinical data of acetylcysteine based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction do not indicate a risk to humans.

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