Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium dihydrate
Arrow Pharma Pty Ltd
esomeprazole magnesium dihydrate
Registered
Medis Pharma Pty Ltd Version 01 1 NEXOLE_ _ ESOMEPRAZOLE MAGNESIUM DIHYDRATE enteric coated tablets _ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about NEXOLE. It does not contain all the information that is known about NEXOLE. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking NEXOLE against the benefits they expect it will 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 NEXOLE IS USED FOR _REFLUX OESOPHAGITIS _ _ _ NEXOLE is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. NEXOLE is also taken to help stop reflux oesophagitis coming back or relapsing. _ _ _ _ _UPPER GASTROINTESTINAL SYMPTOMS _ _ASSOCIATED WITH NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS (NSAIDS) _ _THERAPY _ _ _ NEXOLE is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. NEXOLE is also taken to help heal and prevent ulcers caused by NSAIDs. _PEPTIC ULCERS ASSOCIATED _ _WITH HELICOBACTER PYLORI _ _INFECTION _ _ _ Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called _Helicobacter _ _pylori_ in their stomach. 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 from the stomach. If you have a peptic ulcer, your doctor will prescribe NEXOLE with antibiotics. When NEXOLE and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibio Prečítajte si celý dokument
Page 1 of 23 PRODUCT INFORMATION NEXOLE 20MG AND 40MG ENTERIC-COATED TABLET NAME OF THE MEDICINE NEXOLE is a proton pump inhibitor. The active ingredient in NEXOLE is esomeprazole magnesium dihydrate, a substituted benzimidazole. Esomeprazole is the S-isomer of omeprazole. It is optically stable _in vivo_ , with negligible conversion to the R-isomer. The chemical name is di- [(S)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1 _H_ - benzimidazole]magnesium salt dihydrate. The chemical structure of esomeprazole magnesium dihydrate is: 2 Mg 2+ . 2H 2 O CAS number: 217087-10-0 Molecular formula: C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O Molecular weight: 749.2 (dihydrate) DESCRIPTION The NEXOLE 20 mg and 40 mg tablet are enteric coated and contain esomeprazole (as magnesium dihydrate). The tablets contain the following inactive ingredients: methacrylic acid polymer, purified talc, triethyl citrate, hypromellose, sucrose, maize starch, magnesium stearate, hydroxypropyl cellulose, glyceryl monostearate, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearylfumarate, titanium dioxide, macrogol 400, iron oxide red and iron oxide yellow. _ _ PHARMACOLOGY Esomeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H + , K + -ATPase proton pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. In humans, acid control with esomeprazole is dose dependent and is significantly greater, more sustained and less variable compared to that obtained with equal doses of omeprazole. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H + , K + -ATPase (the acid pump) and inhibits both basal and stimulated acid secretion. Page 2 of 23 EFFECT ON GASTRIC ACID SECRETION After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one h Prečítajte si celý dokument