देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PANTOPRAZOLE SODIUM SESQUIHYDRATE
TAKEDA INDONESIA - Indonesia
PANTOPRAZOLE SODIUM SESQUIHYDRATE
20 MG
TABLET SALUT ENTERIK
DUS, 1 BLISTER @ 7 TABLET SALUT ENTERIK
TAKEDA Gmbh - Germany
2016-01-20
1 Instructions for Use Pantozol ® 20 mg Active ingredient: Pantoprazole sodium sesquihydrate COMPOSITION Each one gastro-resistant tablet/enteric coated contains 22.6 mg Pantoprazole sodium sesquihydrate (equivalent to pantoprazole 20 mg) MECHANISM OF ACTION Pharmacodynamic properties : Proton pump inhibitors : ATC code : A02BC02 Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H + , K + -ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. As with other proton pump inhibitors and H 2 receptor inhibitors, treatment with pantoprazole causes a reduced acidity in the stomach and thereby an increase in gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, the substance can affect hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously. PHARMACOKINETIC PROPERTIES : - GENERAL PHARMACOKINETICS : Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 20 mg oral dose. On average at about 2.5 p.a. the maximum serum concentrations of about 1 – 1.5 µg/ml are achieved, and these values remain constant after multiple administration. Volume of distribution is about 0.15 l/kg and clearance is about 0.1 l/h/kg. Terminal half-life is about 1 h. There were a few cases of subjects with delayed elimination. Because of the specific activation of pantoprazole in the parietal cell the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secret पूरा दस्तावेज़ पढ़ें