País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
misoprostol, Quantity: 200 microgram
Pfizer Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: sodium starch glycollate; hydrogenated castor oil; microcrystalline cellulose; hypromellose
Oral
120 tablets, 20 tablets
(S4) Prescription Only Medicine
Cytotec is indicated in the treatment of acute duodenal and gastric ulcers. Cytotec is indicated for the prevention of stress-induced upper gastrointestinal mucosal bleeding and lesions in post-surgical patients in intensive care units. Cytotec is indicated for the prevention of gastric ulceration in patients in whom NSAID therapy is essential and who have been assessed at high risk of gastric ulceration, or the complications of gastric ulceration.
Visual Identification: White, hexagonal tablet, scored, marked "SEARLE/1461" on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1998-06-23
CYTOTEC ® _misoprostol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYTOTEC. It does not contain all of 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 CYTOTEC 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 CYTOTEC IS USED FOR • TO TREAT ACUTE ULCERS IN THE STOMACH (GASTRIC ULCERS), OR IN THE FIRST PART OF THE SMALL INTESTINE (DUODENAL ULCERS). • TO PREVENT DEVELOPMENT OF STOMACH ULCERS, WHICH MAY SOMETIMES BE CAUSED BY ARTHRITIS MEDICINES THAT ARE CALLED NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS). • TO PREVENT BLEEDING IN THE STOMACH OR UPPER INTESTINE IN HOSPITAL PATIENTS AFTER SURGERY. CYTOTEC makes your stomach produce less acid, and it helps your stomach protect itself against damage from acid and certain other substances, such as NSAIDs. The active ingredient in CYTOTEC is called misoprostol. Misoprostol is very similar to a group of substances called prostaglandins, which occur naturally in the stomach and other parts of the body. When the amount of these natural prostaglandins is lower than normal, there is a risk that ulcers may occur in the stomach or duodenum. This reduction in prostaglandins is often a side effect of NSAIDs. CYTOTEC can replace prostaglandins and help to prevent ulcers, or help heal the ulcer if you already have one. If you are taking an NSAID, CYTOTEC helps protect your stomach while you continue to receive the benefit of pain relief and reduction in joint swelling from your arthritis medicine. Your doctor, however, may prescribe CYTOTEC for another purpose. Ask your doctor if you have any questions about why CYTOTEC has been prescribed for you. There is no evidence that CYTOTEC is addictive. BEFORE YOU TAKE CYTOTEC _WHE Leer el documento completo
Version: pfpcytot11119 Supersedes: pfpcytot10609 Commercial/Non Commercial Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION – CYTOTEC ® (MISOPROSTOL) 1. NAME OF THE MEDICINE Misoprostol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CYTOTEC tablets contain 200 micrograms of misoprostol 3. PHARMACEUTICAL FORM Tablets 200 micrograms: Scored, white, hexagonal tablets, debossed on one side with SEARLE/1461. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CYTOTEC is indicated in the treatment of acute duodenal and gastric ulcers. CYTOTEC is indicated in the prevention of stress-induced upper gastrointestinal mucosal bleeding and lesions in post-surgical patients in intensive care units. CYTOTEC is indicated for the prevention of gastric ulceration in patients in whom NSAID therapy is essential and who have been assessed at high risk of gastric ulceration, or the complications of gastric ulceration. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE TREATMENT OF DUODENAL ULCERS: 800 micrograms per day in four divided doses with meals for four to eight weeks. The last dose should be taken at bedtime. TREATMENT OF GASTRIC ULCERS: 800 micrograms per day in four divided doses with meals for four to eight weeks. The last dose should be taken at bedtime. PREVENTION OF STRESS-INDUCED MUCOSAL BLEEDING AND LESIONS IN POST-SURGICAL ICU PATIENTS: 200 micrograms every four hours for up to 14 days. Version: pfpcytot11119 Supersedes: pfpcytot10609 Commercial/Non Commercial Page 2 of 9 PREVENTION OF NSAID-INDUCED GASTRIC ULCERATION: 400 to 800 micrograms per day in divided doses with meals and at bedtime, taken simultaneously with the NSAID as appropriate. The NSAID should be taken according to the schedule prescribed by the physician. Cytotec may be administered for the duration of NSAID therapy. There are no data beyond 12 months to support the long-term efficacy for misoprostol for this indication. Concomitant aluminium-containing antacids may be given as needed for relief of pain. DOSAGE ADJUSTMENT ELDERLY No dosage adjustment is recomme Leer el documento completo