Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
PANTOPRAZOLE SODIUM SESQUIHYDRATE
10 Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
PANTOR TABLET _ _ Pantoprazole sodium sesquihydrate (20 mg, 40 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Pantor used for 2. How Pantor works 3. Before you use Pantor 4. How to use Pantor 5. While you are using it 6. Side effects 7. Storage and Disposal of Pantor 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT PANTOR IS USED FOR Pantor 40 is indicated for the short term treatment of duodenal ulcer, gastric ulcers and reflux esophagitis (inflammation of the oesophagus (a tube that runs from the throat to the stomach) accompanied by the regurgitation of stomach acid). If the duodenal ulcer has been demonstrated to be associated with _Helicobacter _ _pylori_ (bacteria) infection, Pantor 40 used in combination with appropriate antibiotics may be useful. Pantor 20 is indicated for symptomatic treatment improvement (e.g. heartburn, acid regurgitation, pain on swallowing) and healing of mild gastro- esophageal reflux disease (GERD) caused by reflux of acid from the stomach. Pantor 20 is indicated for long term management and prevention of relapse in Gastro Esophageal Reflux Disease (GERD). HOW PANTOR WORKS Pantoprazole is a selective “proton pump inhibitor”. Pantoprazole belongs to a group known as substituted benzimidazole which stop the secretion of gastric acid in the stomach by specific blockade of the proton pumps of the parietal cells. BEFORE YOU USE PANTOR - _When you must not use it _ Do not take Pantor: • If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredient of Pantor. • If you have severe liver disease. Your doctor will check your liver enzymes more frequently, especially when you are taking Pantor as a long term treatment. Prior to treatment, the possibility of a life-threatening gastric ulcer or a life-threatening oesophagus disease should be excluded. Diagnosis of reflux oesophagitis will be confirmed by endoscopy (used for examination of digest Leggi il documento completo
xxxxxxxx-5253 COMPOSITION: PANTOR 20 Each enteric-coated tablet contains: Pantoprazole sodium sesquihydrate equivalent to Pantoprazole 20 mg Colours: Yellow Oxide of Iron & Titanium Dioxide PANTOR 40 Each enteric-coated tablet contains: Pantoprazole sodium sesquihydrate equivalent to Pantoprazole 40 mg Colours: Yellow Oxide of Iron & Titanium Dioxide PHARMACOLOGICAL ACTION: SITE AND MECHANISM OF ACTION/ PHARMACODYNAMIC Pantoprazole is a proton pump inhibitor, i.e., it inhibits specifically and dose proportionally H+,K+-ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. Pantoprazole is a substituted benzimidazole which accumulates in the acidic compartment of the parietal cells after absorption. In the parietal cell it is protonated and chemically re-arranged to the active inhibitor, a cyclic sulphenamide, which binds to the H+,K+-ATPase, thus inhibiting the proton pump and causing suppression of stimulated and basal gastric acid secretion after single and multiple intravenous and oral pantoprazole dosing. Because pantoprazole acts distal to the receptor level, it can influence gastric acid secretion irrespective of the nature of the stimulus. Pantoprazole exerts its full effect in a strongly acidic environment (pH<3) and remains mostly inactive at higher pH values, which explains its selectivity for the acid secreting parietal cells of the stomach. Therefore, the complete pharmacological and therapeutic effect for pantoprazole can only be achieved in the acid-secreting parietal cells. By means of a feedback mechanism this effect is diminished at the same rate as acid secretion is inhibited. EFFECT ON GASTRIC ACID SECRETION The mean inhibition of pentagastrin stimulated acid output after 40 mg/day is 85% after seven days, 2½ to 3½ hours after dosing. After stopping the intake of pantoprazole, there is no evidence of rebound hypersecretion and 7 days after taking the last dose, the acid output is normal. Pantoprazole maintains the physiological pH-rhythm. The Leggi il documento completo