País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
PANTOPRAZOLE
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
A02BC02
40 mg
ENTERIC COATED TABLET
PANTOPRAZOLE 40 mg
ORAL
Prescription Only
Takeda GmbH
ACTIVE
1996-08-14
INSTRUCTIONS FOR USE CONTROLOC® 40 MG Active ingredient: Pantoprazole sodium sesquihydrate Description Controloc: contains Pantoprazole, a proton pump inhibitors which inhibits the gastric H + K + ATPase which is responsible for acid secretion in the parietal cells of the stomach. Pantoprazole is white to off‐white powder with a molecular weight of 432.4. Pantoprazole is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n‐hexane. Pantoprazole is a racemic mixture with a melting point of 138° C. The chemical name for Pantoprazole is sodium‐5‐(difluoromethoxy)‐2‐[[(3,4‐dimethoxy‐2‐ pyridinyl)methyl] sulfinyl]‐1 H‐benzimidazole sesquihydrate and is represented by the following chemical structure : Empirical chemical structure : C 16 H 14 F 2 N 3 NaO 4 Sx1.5H 2 O NAME AND STRENGTH OF ACTIVE INGREDIENT Active ingredient 40mg pantoprazole (as pantoprazole sodium sesquihydrate 45.1 mg) Excipients Sodium carbonate; D‐mannitol (corresponding to 0.0036 BU); crospovidone; povidone K 90; povidone K 25; calcium stearate; propylene glycol; methylhydroxypropylcellulose; poly(ethyl acrylate‐co‐methacrylic acid) 1:1; polysorbate 80; sodium dodecyl sulfate; triethyl citrate; colours (E 171, E 172);printing ink. PHARMACOTHERAPEUTIC / INDICATION GROUP / ACTION MECHANISM Selective proton pump inhibitor, substituted benzimidazole PHARMACODYNAMIC PROPERTIES 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 canaliculi of the parietal cells Leer el documento completo
INSTRUCTIONS FOR USE 1. NAME OF THE MEDICINAL PRODUCT CONTROLOC® 20 MG CONTROLOC® 40 MG CONTROLOC® I.V 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _CONTROLOC® 20 MG_ 1 gastro-resistant (enteric coated) tablet contains 20 mg pantoprazole (as pantoprazole sodium) for oral use. Active ingredient: 20mg pantoprazole (as pantoprazole sodium sesquihydrate 22.6 mg) _CONTROLOC® 40 MG_ 1 gastro-resistant (enteric coated) tablet contains 40 mg pantoprazole (as pantoprazole sodium) for oral use. Active ingredient: 40mg pantoprazole (as pantoprazole sodium sesquihydrate 45.1 mg) _CONTROLOC® I.V_ 1 vial contains 40 mg pantoprazole (as pantoprazole sodium) as powder for solution for injection. Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per vial. Active ingredient: 40mg pantoprazole (as pantoprazole sodium 42.3 mg) 3. PHARMACEUTICAL FORM _CONTROLOC® 20 MG_ Gastro-resistant tablets, yellow, oval, biconvex, “P20” in brown printing ink Packs with 7 and 14 gastro-resistant tablets _CONTROLOC® 40 MG_ Gastro-resistant tablets, yellow, oval, biconvex, “P40” in brown printing ink Packs with 7and 14 gastro-resistant tablets _CONTROLOC® I.V_ Powder for solution for injection Packs of 1 vial with 42.3mg white to off-white powder 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS _CONTROLOC® 20 MG_ • Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). • Long-term management and prevention of relapse in reflux oesophagitis. • Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti- inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. _CONTROLOC® 40 MG _ • In combination with two appropriate antibiotics (see Dosage) for the eradication of H.pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. • Duodenal ulcer • Gastric ulcer • Moderate and severe reflux oesophagitis _CONTROLOC® Leer el documento completo