ELITAN Tablet Ref.[50390] Active ingredients: Metoclopramide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Propulsives
ATC code: A03FA01

Action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract, where it encourages normal peristaltic action. This gives a fundamental approach to control of conditions where disturbed gastro-intestinal motility is the common underlying factor. The anti-emetic action is by three routes. It promotes normal gastric emptying and may abolish gastric stasis which is part of the vomiting reflex. Central dopamine receptors are inhibited, thus raising the threshold of the chemoreceptor trigger zone and reducing the reaction of the adjacent vomiting centre to centrally acting emetics. The sensitivity of visceral afferent nerves to the vomiting centre is reduced which reduces the effect of locally acting emetics and irritants.

5.2. Pharmacokinetic properties

Metoclopramide is metabolised in the liver. Metoclopramide and its metabolites are primarily eliminated by the kidney.

Renal impairment

The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).

Hepatic impairment

In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.

5.3. Preclinical safety data

No further relevant data.

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