Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Celecoxib
Pfizer Australia Pty Ltd
Medicine Registered
CELEBREX ® _celecoxib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CELEBREX. 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 CELEBREX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START CELEBREX AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT CELEBREX IS USED FOR CELEBREX is used to relieve the symptoms of joint pain, tenderness, swelling and stiffness in: • osteoarthritis, • rheumatoid arthritis and • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. CELEBREX also provides short- term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. CELEBREX belongs to a group of medicines called Coxibs which are used to relieve pain and inflammation in a number of conditions. Although CELEBREX can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor, however, may have prescribed CELEBREX for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELEBREX HAS BEEN PRESCRIBED FOR YOU. CELEBREX is not recommended for use in children or adolescents under 18 years of age. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE CELEBREX _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CELEBREX IF: • YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE SEVERE HEART OR BLOOD VESSEL DISEASE AFFECTING THE CIRCULATION IN YOUR BRAIN OR LIMBS • YOU HAVE SEVERE LIVER PROBLEMS Your doctor will decide if your condition is too severe to take this medicine. • YOU HAVE PROBLEMS WITH YOUR KIDNEY FUNCTION • YOU HAVE HAD AN ATTACK OF ASTHMA, HIVES, ITCHING, SKIN RA Olvassa el a teljes dokumentumot
Version: pfpcelec10413 Supersedes: pfpcelec10912 Page 1 of 34 PRODUCT INFORMATION CELEBREX ® (CELECOXIB) NAME OF THE MEDICINE CELEBREX (celecoxib) 100 mg, 200 mg and 400 mg capsules. Celecoxib is a diaryl substituted pyrazole and has the following chemical structure and formula: CH 3 N N CF 3 S NH 2 O O Chemical name 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Molecular formula: C 17 H 14 F 3 N 3 O 2 S Molecular weight 381.38 CAS Registry Number: 169590-42-5. DESCRIPTION Celecoxib is weakly acidic with a pKa in water of 11.1 and is practically insoluble in water. Celecoxib is chemically unrelated to anti-inflammatory agents of steroidal or non-steroidal nature. Celecoxib does not contain a chiral centre. CELEBREX 100 mg, 200 mg and 400 mg capsules contain lactose, sodium lauryl sulfate, povidone, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide and the inks contain: iron oxide yellow CI 77492 (200 mg and 400 mg capsule); indigo carmine CI 73015 (100 mg capsule); brilliant blue FCF CI 42090 aluminium lake (400 mg capsule). Version: pfpcelec10413 Supersedes: pfpcelec10912 Page 2 of 34 PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: M01AH Coxibs. Celecoxib is a cyclooxygenase-2 (COX-2) specific inhibitor, a member of a larger class of non-steroidal anti-inflammatory drugs (NSAIDs) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of celecoxib is believed to be due to inhibition of _ _ prostaglandin synthesis, primaril Olvassa el a teljes dokumentumot