Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 45.1 mg (Equivalent: pantoprazole, Qty 40 mg)
Strides Pharma Science Pty Ltd
Pantoprazole sodium sesquihydrate
Tablet, enteric coated
Excipient Ingredients: triethyl citrate; sodium carbonate; hyprolose; iron oxide yellow; calcium stearate; crospovidone; hypromellose; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1)
Oral
100, 30
(S4) Prescription Only Medicine
1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:- i) duodenal ulcer, ii) gastric ulcer, iii) gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux oesophagitis iv) gastrointestinal lesions refractory H2 blockers v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics; i) Clarithromycin and amoxicillin, or ii) Clarithromycin and metronidazole, or iii) Amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. 4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.
Visual Identification: Yellow colored, enteric coated, oval biconvex tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-12-14
TOPRA™ 40 CONSUMER MEDICINE INFORMATION Pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TOPRA. 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 TOPRA against the benefits this medicine is expected to have for you. 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 TOPRA IS USED FOR The name of your medicine is TOPRA. It contains the active ingredient called pantoprazole. ULCERS TOPRA 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. Most people who have a peptic ulcer also have bacteria called _Helicobacter pylori _in their stomach. When TOPRA is taken with antibiotics the combination therapy will kill the _Helicobacter pylori _and let your ulcer heal. TOPRA 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 TOPRA 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. TOPRA is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME TOPRA is used to treat a rare condition called Zollinger-Ellison syndrome, w Прочетете целия документ
Page 1 of 20 PRODUCT INFORMATION TOPRA™ 40 ENTERIC-COATED DELAYED RELEASE TABLETS NAME OF THE MEDICINE Active ingredient: Pantoprazole (as sodium sesquihydrate) Chemical name: Sodium 5-(difluoromethoxy)-2-[(_RS_)-[(3,4-dimethoxypyridin-2- yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate CAS number: 164579-32-2 Molecular weight: 432.4 Molecular formula: C 16 H 14 F 2 N 3 NaO 4 S, 1½ H 2 O Chemical structure: DESCRIPTION Pantoprazole is a substituted benzimidazole which inhibits basal and stimulated gastric secretion. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder. It is freely soluble in water, soluble in methanol and practically insoluble in methylene chloride. TOPRA 40 is available as enteric coated-tablets containing 40 mg pantoprazole (as sodium sesquihydrate). TOPRA enteric-coated tablets contain the following inactive ingredients: sodium carbonate anhydrous, mannitol, crospovidone, calcium stearate, hypromellose, iron oxide yellow, hydroxypropylcellulose, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate. PHARMACOLOGY PHARMACODYNAMICS Pantoprazole is a proton pump inhibitor (PPI). It inhibits specifically and dose- proportionately H + /K + -ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. The substance is a substituted benzimidazole which accumulates in the acidic environment of the parietal cells after absorption. There, it is converted into the active form, a cyclic sulphenamide which binds to the H + /K + -ATPase, thus inhibiting the proton Page 2 of 20 pump and causing potent and long-lasting suppression of basal and stimulated gastric acid secretion. As pantoprazole acts distal to the receptor level, it can influence gastric acid secretion irrespective of the nature of the stimulus (acetylcholine, histamine, gastrin). Pantoprazole's selectivity is due to the fact that it only exerts its full effect in a strongly acidic environment (pH < 3), remaining mostly inactive at higher pH values. As a re Прочетете целия документ