0 évaluation0% ont trouvé ce document utile (0 vote)
23 vues7 pages
ELECOXIB is approved by the FDA in the following formulation(s):. Used to treat or reduces the symptoms and signs of osteoarthritis, Rheumatic arthritis, menstrual cramps, and colonic polyps.
ELECOXIB is approved by the FDA in the following formulation(s):. Used to treat or reduces the symptoms and signs of osteoarthritis, Rheumatic arthritis, menstrual cramps, and colonic polyps.
ELECOXIB is approved by the FDA in the following formulation(s):. Used to treat or reduces the symptoms and signs of osteoarthritis, Rheumatic arthritis, menstrual cramps, and colonic polyps.
Trade name: Celecoxib Product Number: C-1502 Manufacturer/Supplier: LC Laboratories 165 New Boston Street Woburn, MA 01801 USA COMPOSITION/DATA ON COMPONENTS:
Chemical Name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl] benzenesulfonamide Synonyms: Celebrex, Celebra, Celecox, Onsenal, Solexa, SC-58635, YM-177 CAS Registry Number: 169590-42-5 Molecular Weight: 381.37 Molecular Formula: C 17 H 14 F 3 N 3 O 2 S
STRUCTURAL FORMULA:
PHYSICAL AND CHEMICAL PROPERTIES: Form: solid powder Color: white Odor: none
Melting point/Melting range: 160-162 C Danger of explosion: none
Solubility in / Miscibility with water: very poorly soluble in water; maximum solubility in plain water is estimated to be about 10-50 M; buffers, serum, or other additives may increase or decrease the aqueous solubility Solvent content: none Organic solvents: Soluble in ethanol at 100 mg/Ml CELECOXIB is approved by the FDA in the following formulation(s): Manufacturer: GD SEARLE Approval date: December 31, 1998 Strength(s): 100MG, 200MG
Manufacturer: GD SEARLE Approval date: August 29, 2002 Strength(s): 400MG
Manufacturer: GD SEARLE Approval date: December 15, 2006 Strength(s): 50MG USES ADVANTAGES Relieves pain and swelling (inflammation) Used to treat or reduces the symptoms and signs of Osteoarthritis, Rheumatic arthritis, Menstrual Cramps, and Colonic Polyps. Blocks the enzyme that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of Prostaglandins. * PROSTAGLANDINS are chemicals that are important contributors to the inflammation of arthritis that causes pain, fever, swelling and tenderness. Differs from other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term use) and does not interfere with the clotting of blood. Celecoxib is approved as an adjunctive (secondary) treatment among patients with FAP. * In FAP (Familial Adenomatous Polyposis), patients develop large numbers of polyps in their colons, and the polyps invariably become malignant. The only cure of FAP is removal of the entire colon.
DISADVANTAGES If too much, can cause common adverse effects like, headache, abdominal pain, dyspepsia, diarrhea, nausea, flatulence, and insomnia.
Other side effects include fainting, kidney failure, heart failure, aggravation of hypertension, chest pain, ringing in the ears, deafness, stomach and intestinal ulcers, bleeding, blurred vision, anxiety, photosensitivity, weight gain, water retention, flu-like symptoms, drowsiness and weakness.
Should not be used if youre pregnant or having breastfeeding. HOW CELEBREX WORKS The human body contains many enzymes that facilitate chemical reactions in the body. One of these enzymes is Cyclooxygenase-2 (COX-2), which is involved in causing inflammation and pain in parts of the body where there is arthritis or injury.
CELEBREX at recommended doses selectively inhibits COX-2, which helps relieve arthritis pain and inflammation as well as acute pain in adults.
HISTORY Honorees Peter Isakson, Ph.D., Jamie Masferrer, Ph.D., Karen Seibert, Ph.D., and John Talley, Ph.D. of Pharmacia created the molecule Celecoxib, the basis for the medicine Celebrex, which blocks the inflammation-triggering action of the COX-2 enzyme, bringing relief to millions of people around the world who suffer from osteoarthritis, rheumatoid arthritis, and pain. Dr. John Talley and his team of medicinal chemists manipulated molecules and made thousands of different analogs. They finally found a compound that was a strong selective inhibitor of COX-2, but it had a long half-life - it lingered in the body too long. The molecule was sent back to the laboratory and modified, and the scientists synthesized the compound that eventually became Celebrex. Clinical trials of Celebrex began in 1995. In all, some 13,000 volunteers in countries all over the world took part in the trials. In June 1998, the company submitted an application to the Food and Drug Administration (FDA) to market the drug. The FDA gave the application an accelerated review, and on December 30, 1998, Celebrex (100mg and 200mg) was approved for the treatment of osteoarthritis and rheumatoid arthritis. August 29, 2002 for 400mg Celebrex and December 15, 2006 for 50mg. It has also been approved for familial adenomatous polyposis, a rare and devastating disease that often leads to colon cancer.
INDICATIONS AND USAGE
CELEBREX is indicated:
1) For relief of the signs and symptoms of osteoarthritis. 2) For relief of the signs and symptoms of rheumatoid arthritis in adults. 3) For the management of acute pain in adults . 4) For the treatment of primary dysmenorrhea. 5) To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). The efficacy and safety of CELEBREX treatment in patients with FAP beyond six months have not been studied.
CONTRAINDICATIONS
1) CELEBREX is contraindicated in patients with known hypersensitivity to celecoxib. 2) CELEBREX should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. 3) CELEBREX should not be given to patients who have experienced asthma, urticaria, or allergic- type reactions after taking aspirin or other NSAIDs.