국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
Diclofenac sodium,Misoprostol
Pfizer Australia Pty Ltd
Diclofenac sodium,Misoprostol
ARTHROTEC ® 50 (ARTH-ROW-TECH) _Diclofenac Sodium/Misoprostol (dic-low-fen-ack me-so-pros-tal)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Arthrotec 50. 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 Arthrotec 50 against the benefits it 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 ARTHROTEC 50 IS USED FOR _WHAT ARTHROTEC 50 DOES_ This medicine is used to relieve joint pain, tenderness, swelling and stiffness that may occur in osteoarthritis and rheumatoid arthritis, whilst protecting your stomach. Although this medicine can relieve the symptoms of pain and inflammation, it will not cure your condition. _HOW ARTHROTEC 50 WORKS_ This medicine contains two active ingredients: diclofenac sodium and misoprostol. Diclofenac sodium belongs to a family of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). These medicines work by relieving pain and inflammation. However, this kind of arthritis medicine can sometimes irritate the stomach or cause ulcers because it reduces the amount of natural protective substances (called prostaglandins) in the stomach lining. Misoprostol is very similar to these natural prostaglandins and can help protect the stomach. Arthrotec 50 therefore helps protect your stomach while you continue to receive the benefit from the anti-arthritis medicine. _TAKING ARTHROTEC 50_ ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine in children under the age of 18 years. BEFORE YOU TAKE ARTHROT 전체 문서 읽기
Version: pfpartht10617 Supersedes: pfpartht10217 Page 1 of 15 PRODUCT INFORMATION ARTHROTEC ® 50 (DICLOFENAC SODIUM/MISOPROSTOL) NAME OF THE MEDICINE ARTHROTEC 50 Diclofenac sodium 50 mg/Misoprostol 200 µg tablets. DICLOFENAC SODIUM The structural formula of diclofenac sodium is shown below: Chemical name: sodium [0-(2,6-dicloroanilino)phenyl] acetate Molecular formula: C 14 H 10 CI 2 NO 2 Na Molecular weight: 318.1 CAS registry number: 15307-86-5. MISOPROSTOL The structural formulae of the two diastereomers of misoprostol are shown below: Chemical name: (±)-methyl(13E)-11,16-dihydroxy-16-methyl-9-oxoprost-13-enoate Molecular formula: C 22 H 38 O 5 Molecular weight: 382.5 CAS registry number: 59122-46-2. DESCRIPTION Diclofenac sodium is a white to off-white, virtually odourless, crystalline powder. Version: pfpartht10617 Supersedes: pfpartht10217 Page 2 of 15 Misoprostol is a water-soluble, viscous liquid and is a racemic compound containing approximately equal amounts of the two diastereomers. ARTHROTEC 50 tablets consist of a diclofenac sodium core and a misoprostol mantle. The tablets also contain castor oil-hydrogenated, starch-maize, cellulose-microcrystalline, crospovidone, talc-purified, hypromellose lactose, magnesium stearate, povidone, silica-colloidal anhydrous, methacrylic acid copolymer, sodium hydroxide and triethyl citrate. PHARMACOLOGY PHARMACODYNAMICS ARTHROTEC 50 is effective in treating the signs and symptoms of rheumatoid arthritis and osteoarthritis. This activity is due to the presence of diclofenac which has been shown to have anti-inflammatory and analgesic properties. As with other non-steroidal anti-inflammatory drugs (NSAIDs), the exact mechanism of action of diclofenac is not known. However, it may be related to the ability of diclofenac to inhibit prostaglandin synthetase. _ANTIARTHRITIC EFFECTS _ Diclofenac sodium (75-150 mg daily) has equivalent or superior efficacy to aspirin (3-5 g daily), and indomethacin (75-100 mg daily), and a variety of other NSAIDs in treating rheumatoid 전체 문서 읽기