ULCEDINE Film coated table Ref.[28024] Active ingredients: Famotidine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Codal-Synto Ltd., 21 Constantinoupoleos St., 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: H2-receptor antagonists, Drugs for acid related disorders
ATC code: A02BA03

Ulcedine is a highly specific and potent competitive H2-receptors antagonist which is a reversible competitive blocker of histamine at H2-receptors, particularly those in the gastric parietal cells. The H2 antagonists are not anticholinergic agents and do not affect the H1 receptors. H2 antagonists inhibit all phases of gastric secretion cause by histamine, muscarinic agonists and gastrin.

5.2. Pharmacokinetic properties

Ulcedine is orally administered. Famotidine preparations reach the peak plasma concentration within 1 to 3 hours after administration and the peak plasma concentration of a 40 mg dose is 0.076 to 0.1 mcg/ml.

Plasma levels after multiple doses of famotidine are similar to those after single doses. Famotidine is eliminated by renal (65% to 70%) and metabolic (30% to 35%) routes. The only metabolite identified is the S-oxide.

5.3. Preclinical safety data

No further relevant data.

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