Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate
Torrent Australasia Pty Ltd
Pantoprazole sodium sesquihydrate
Registered
Pantoprazole GH CMI v1.0 December 2014 Page 1 of 5 CONSUMER MEDICINE INFORMATION PANTOPRAZOLE GH _PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE) 20 & 40MG ENTERIC-COATED TABLETS _ _WHAT IS IN THIS LEAFLET _ This leaflet answers some common questions about pantoprazole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking pantoprazole against the benefits this medicine is expected to have for you. Use pantoprazole as directed and follow the advice given in the leaflet. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. _WHAT PANTOPRAZOLE GH IS USED _ _FOR _ The name of your medicine is PANTOPRAZOLE GH pantoprazole (as sodium sesquihydrate) enteric-coated tablets. It contains the active ingredient called pantoprazole 20mg or 40mg. ULCERS Pantoprazole is used to treat and help heal duodenal and gastric ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These can be caused in part by too much acid being made in the stomach. Pantoprazole may also be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (inflammation of the joints). REFLUX DISEASE Pantoprazole is also used to treat reflux oesophagitis or reflux disease. This can be caused by washing back (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Pantoprazole is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME Pantoprazole is used to tr Read the complete document
1 PRODUCT INFORMATION PANTOPRAZOLE GH PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE) 20 MG AND 40 MG ENTERIC COATED TABLETS NAME OF THE MEDICINE Pantoprazole (as sodium sesquihydrate) .1.5H 2 O Chemical name : Sodium 5-(difluoromethoxy)-2-[(_RS_)-[3,4-dimethoxypyridin-2- yl)methyl]sulfinyl]-1_H_-benzimidazol-1-ide sesquihydrate. Molecular Formula: C 16 H 14 F 2 N 3 NaO 4 S . 1.5 H 2 O CAS number (pantoprazole sodium sesquihydrate): 164579-32-2 DESCRIPTION Pantoprazole is a substituted benzimidazole which inhibits basal and stimulated gastric secretion. It is a white to off white crystalline hygroscopic powder. Solubility is low at neutral pH and increases with increasing pH. Each tablet core contains the active ingredient, pantoprazole (as sodium sesquihydrate) 20 mg or 40 mg, mannitol, crospovidone, sodium carbonate anhydrous, hydroxypropylcellulose, calcium stearate. Tablet film coating contains hypromellose, iron oxide yellow, titanium dioxide, propylene glycol, Eudragit L30 D-55, triethyl citrate and purified talc 2 PHARMACOLOGY PHARMACODYNAMICS Pantoprazole inhibits specifically and dose proportionately H + /K + -ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. Following oral administration, pantoprazole accumulates in the acidic environment of the parietal cells where it is converted into the active form, a cyclic sulfenamide which binds to the H + /K + -ATPase thus inhibiting the proton pump. This causes potent and long-lasting suppression of basal and stimulated gastric acid secretion. As it acts distal to the receptor level it can influence gastric acid secretion irrespective of the nature of the stimulus (acetylcholine, histamine, gastrin). Since pantoprazole' only exerts its full effect in a highly acidic environment (pH < 3), remaining mostly inactive at higher pH values, it is considered a selective inhibitor in the acid secretory parietal cells. This effect is diminished at the same rate as acid secretion is inhibited by means of a feedback mechanism. Read the complete document