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Show brand of nabumetone Only an arthritis sufferer can understand. The things arthritis or pain medication should not use Relafen® you used to do without think- ing twice about them now can't Medications work differently for each indi- be done withouta lot of pain. vidual; your doctor knows your medical history best. And while most peopie Relafen® (nabumetone) may help. Avail- tolerate Relafen® well, some able by prescription only, Relafen® (rel’-ah- may experience side effects fen) is one of a number of medications that such as diarrhea, heartburn relieves the pain of osteoarthritis and rheu- and abdominalpain.In rare matoid arthritis. While it isn't a cure, Relafen® cases there could be more can significantly reduce pain and inflam- serious side effects such as stomach ulcers mation when used along with a program of and intestinal bleeding. Relafen? however, has regular exercise, joint protection and rest been found to have a low potential for such recommended by your doctor. ulcers. If you have any stomach or intestinal Brief Summary: Consult ful! prescribing intormation betore using PHARMACOLOGY:Relafen is8 nonmeroida!ant-mfiammatwry(NSAID) that exhibits ant-infismmatory, anatpesic anc antipyretic properties in pharmacotogic studies. As with other nonsteroidis! ant/~infiammatory agents, its mode of action is not known. However, the aby 2 adhe qeuuegientin apennic ony i taucend in tin anti-infiammatory effect The parem compound ts @ prodrup. which undergoes hepatic biotranstormation to the active componem,, §-methoxy-2-napnthylacetic acid (SMNA) & potent mhibito: of prostaplandin synthesis, INDICATIONS AND USAGE: Acute anc chronic weatment of signs anc symptoms of ostenarthrits anc Theumatwiti arthritis CORTRAINDICATIONS: Patents (1) wtp have previously exhibited hypersensitivity t it (2)inwhom Reteten, aspirin: otherNSAIDs induceasthma,utticarie crother allergic type reactions WARNINGS: Remain aien tor viceration anc biesding in panents Teated chronically even in the absence of previous & |. tract symptoms incontrolled clinical triats mvotving 1.577 patents tremed with Aeiefen(| 40 toliower ‘tor one yest end 527 tor wo years), the cumpiative incidence of peptic uicers was D.7% (85% Ct 0%, 0.8%)at three to six months, 0.5% (95% Ci: 0.7%, 0.2%) atone year anc D.B% (S% Ci 0.3%, 1.3%) at wo years. intorm patients of the signs ant symptoms of serous G.|, toxicity and what steps to take if they occur. Inpatients with active peptic utcer, weigh the benstits of Aelafen therapy against possibie hazards, institute an appropriate ulcer treatment regimen anc monitor the patients’ progress carefully tn conswering the use of reiatively large doses {within the recommended dosage Tange) anticipate benetit sufficeem to ‘the potential mcreaset risk of S.!. woxicity eareR pe EI undergoes extenswe hepatic metabolism, nm ‘However, aswithall NSAIDS1monito-paents with impaired renal function more close than patients with normal tena) tunction Evaluate patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, for evidence of the development of & more severe hepatic reaction white ‘on Relafen therapy. tf abnorma| liver tests persist or worsen, if clinical signs snc symptoms consisten with lwer disease develop o: if manifestations occu’ (e.p., eosmaphilig, rash, etc,), discontinue Relofen Use Relaten cautiously inpatients with severe hepatic impairment As with other NSAIDs, use Relafen cautiously in patients with 8 hustoryof conpestve heart failure, hypertension o7 other conditions predisposing to fividi retention. Based on UV. light photnsensitivity testing. Relafen may be associated with more reactions to sun exposure than might be exnectet hased on skin tanning types eS the potertun! risks (see WARNINGS, ant ADVERSE ) anc likely benefits of NSAID treatment particularywhenthe drupsareusecfor tesssenousconditionswhere Treatmentwithou! NSAIDs may represent an acceptable atternetwe to both the peter enc the mhwsicuan nenedministariny Relaten wi heer seen with other NSAIDs tn Two-year Studies CONMUCTed Mm MIC BNC Tat. nabumetone hat no stststicalty _ Rabymetone‘Tested lymphocytes in culture showed Chromosoma! aberrations Bt 8D meg/m. enc tugher concentrations (sous! to the average human exposure to Relafenatthe maximum recommenties dose) Nabumetone dic no: impair fertility of mate ov temate rats Treated orally a! toses 0! 320 mg/kg/day betore mating C Nabumetone dic notcause any teratogenc eftect mrats gwen up andinrabbitsuptomyAqyorally. However. mcreasedipos!-imptantation toss was Observed mn rats at 100 mg/ep orslly anc at higher doses (enua! to the average hwman exposure to BMINA at the maximum recommended human dose). There are np adequate, well-controited studies m pregnant women Use the drup during pregnancy only itclearyneeded. Because knowneffect of drugs ‘on the human feta! cartiovascula’ system (closure 0! Cuctus artenosus) use 0! Relaten durmg the third trimester of pregnancy ts not recommended, Thesftectsn! Retafenon laborantdelivery inwomenarenotknown As with otherdrugs known to prastaptandinsynthesis. an mereased mciienceotOystociaano teaver Occurred mn Tats treated throughout! pregnancy problems,be sure to tell your doctor. Also,tell Relaten® helps relieve the pain in your joints: hands,feet, your doctorif you have or have had high blood pressure, heart, liver or kidney problems. {has not known whether nahumetone or its metabolites are excreted in human milk. howeve:, SMN4 teexcreted mthe milk of tactatmp Tats. Becauseof the possible soverse eftacts of prostaplandin-synthesisinhibiting drugs on neonates. Relafen is not recom mended tor use in nursing mothers Satery anc efficacy in chitdran have not been establisnec! Ofthe 1,677 patients in U.S. clinica! studteswhoweretreatedwith Redster, £1) (24%) were 85 years of age or older: 2 patent) were 7 0 age:NC Nc overaldifterences metficacyor satety r ones. Similar resutts were observed ine one-year, non-US nahin surveillance study of 10,800 Relater patients. of whom 4,577 patients (42%) were Bf Reiaet—Diarmes hips and knees~wherever you need it. In clinical trials, it Relafen® could take the pain out of the reduced pain and inflammation things you used to take for granted. So ask for thousands of arthritis suf- your doctor if Relaien® is right for you. ferers around the world. <4 Saeed Relaten® is not recommended for women who are pregnant or nursing. People who For a free booklet about arthritis and Relatjen* have had an allergic reaction to any other call 1-800-734-1543. anowas andomme!pertoltowmnpmgestion0!31) Reketer tablets [15grems tote)) Stools were negatwe to: occutt binoc enc there was no tall i Serumhemagtobin concentration The pater: hac no othersymptoms. wes pwen ar +feceptn antagons: anc discharpec trom the Ragpita’ withou! sequelne DOSAGEAND ADMINISTRATION:Recommenderstsrimp tose 1000me ter m1 Please see important additional information in right-hand column. O©SmithKline Bescham 1004 t withwithouttnod Somepatentsabtamnsymptomatic:ralte*tron ——— Dosages ove: 2000 mp daity have not heen stuteet! Use the dose HOW SUPPLIED Venten the produc: name RELAFEN anc SOO in bottles of 100 anc Paciapes 0! 100tintencted! tor institutions) use onty) 75D product nameRELAFEN enc 750 im hotties of 100 anc! SOO. ane ir imprinter witt anc in Singte Unir imprinter with the Unity Pactanges 0! 100 (render! tor mstiuinona’ use oniy, ‘Store atcontrotied room temperature (52° twBES) in well-ctosen conteme: degpener (7 hgnt-rasistan conte: SOD mp (00's NDC 0029-485) .20 S00 mp S00's NDC 0028-485) .25 SBO mp SUP 100's NDC 0028-485) -?) BRS-ALLE 7S mp 1080's NDC B028-4862 21 75D mp SO0's NOC O028-4B52-25, ‘7SD mp SUP 100's NDC 0028-48577 me Beechar Pharmaceuticals Phitaietphs PA 1910 OQdSmithKime Bachan 19H. |