Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Pharmacotherapeutic group: Other drugs for functional gastrointestinal disorders
ATC code: A03AX08
Alverine citrate is an antispasmodic with a direct action on smooth muscle.
Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.
After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing.
The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.
Although preclinical data are limited, those available indicate that alverine citrate has no significant potential for toxicity at the proposed dose level.
Alverine citrate acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.
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