ULCERAN Film-coated tablet Ref.[28255] Active ingredients: Famotidine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), H2-receptor antagonists
ATC code: A02BA03

Ulceran 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

Ulceran 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 protein binding is low (15-20% and plasma half-life after a single dose or multiple repeated doses (for 5 days) was approximately 3 hours.

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. Approximately 25-60% of the oral dosage is excreted in the urine mainly as unchanged drug. A small amount maybe excreted as a sulfoxide.

5.3. Preclinical safety data

No further relevant data.

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