ASLT ALT scnridctdi ainswt known with patients in contraindicated is TABLETS SALSALATE related and osteoarthritis arthritis, rheumatoid of symptoms aiyi cd t tutrlfruai hw below. shown is formula structural its acid; salicylic indomethacin xOnly Rx TABLETS SALSALATE rdc fslaae nteteteto rhii iodr has disorders arthritic of treatment the in salsalate, of product niifamtr ciiyeuvln oaspirin to equivalent activity anti-inflammatory NIAIN N USAGE AND INDICATIONS C DESCRIPTION w ASLT ALT.Uetelws fetv oefrthe for dose effective lowest the Use TABLETS. SALSALATE I -yrx-ezi cd -abxpey se)i ie of dimer a is ester) 2-carboxyphenyl acid, 2-hydroxy-benzoic a Salsalate, ingredient active the contain TABLETS SALSALATE grgto4 h sfleso aiyi cd h ciei vivo in active the acid, salicylic of usefulness The aggregation4. rae ea atonetnlbodls hnplacebo than loss blood gastrointestinal fecal greater aeul osdrteptnilbnft n ik fSALSALATE of risks and benefits potential the consider Carefully hretdrto ossetwt niiulptettetetgoals treatment patient individual with use consistent duration to shortest deciding before options treatment other and TABLETS enestablished been oytyeeGyo,Plsrae8,Ttnu Dioxide) Titanium 80, Polysorbate Glycol, Polyethylene oimSac lclt,SercAi,Tl,adCaig(Hypromellose, Coating and Talc, Acid, Stearic Glycolate, Starch Sodium LNCLPHARMACOLOGY CLINICAL seWRIG) aslt sidctdfrrle ftesgsand signs disorder. the rheumatic of relief for indicated is Salsalate WARNINGS). (see otnefru o1 or fe h atds.Teparent The dose. last the after hours 16 to up for continue two the when aspirin, from than less 15% about is salsalate from c Thus, hours. more or 16 to 3.5 from acid salicylic of half-life S u edl oul ntesalitsieweei spartially is it where intestine small the in soluble readily but d 36gslaae5gaprn.Slclcai itasomto is biotransformation acid basis Salicylic equivalent aspirin). molar g acid salsalate/5 salicylic g a (3.6 on administered are drugs acid salicylic as remainder the compound, parent the of conjugate s osi cuuaei h lsao utpedsn.Fo slows Food dosing. multiple on plasma the in accumulate it does mL) mg/100 30 to (10 range therapeutic desired the within levels hogotte1-oritras hrpui lo levels blood Therapeutic intervals. 12-hour the throughout glucuronide a as kidneys the through excreted is 13% About hour. oseodlat-nlmaoydusi o ul eie.Although defined. fully not is drugs anti-inflammatory nonsteroidal salsalate. including salicylates all of absorption the aaiylmtdbornfrainrslsi nices nthe in increase an in results biotransformation capacity-limited a r yrlzdt w oeue fslclcai.Asgiiatportion significant A acid. salicylic of molecules two to hydrolyzed eetvl nii rsalni ytei nvivo in synthesis prostaglandin inhibit selectively other and salsalate of action anti-inflammatory of mode The niio fpotgadnsnhssi ir,slaaeapasto appears salsalate weak vitro, a in is synthesis salsalate) prostaglandin of of metabolite inhibitor primary (the acid salicylic o CONTRAINDICATIONS o,ifuna rfusmtm.Sm tde ugs possible a suggest studies Some symptoms. flu or influenza, pox, otisaslclt n hrfr sntrcmeddfruein use for recommended not is therefore and salicylate a contains soito ewe h eeomn fRy’ ydoeadthe and Syndrome Reye’s of development the between association yesniiiyt aslt.SLAAETBESsol o be not should TABLETS SALSALATE salsalate. to hypersensitivity eioeaiepi ntestigo ooayatr yasgraft bypass artery coronary of setting the in pain peri-operative ie optet h aeeprecdatm,utcra or urticaria, asthma, experienced have who patients to given ainswt hce o,ifuna rfusymptoms. flu or influenza, pox, chicken with patients of treatment the for contraindicated is TABLETS SALSALATE and Reactions, enrpre nsc ains(see patients such in reported been s fmdcnscnann aiyaeo sii.Salsalate aspirin. or salicylate containing medicines of use chicken have who individuals in develop may Syndrome Reye’s CB)srey(see surgery (CABG) WARNINGS legctp ecin fe aigaprno te NSAIDs. other or aspirin taking after reactions allergic-type eee aeyftl npyatclk ecin oNAD have NSAIDs to reactions anaphylactic-like fatal, rarely Severe, atv Ingredients: nactive pdetrs yrlssi h oy t aflf saotone about is half-life its body: the in hydrolysis esterase apid mon osntso aaiylmtdbornfrain nor biotransformation, capacity-limited show not does ompound dismtblts hs h muto aiyi cdavailable acid salicylic of amount the Thus, metabolites. its nd hobtceet,moada nacin n toe hc can which stroke, and infarction, myocardial events, thrombotic eftl hsrs a nraewt uaino s.Patients use. of duration with increase may risk This fatal. be Risk Cardiovascular SIsmycuea nrae iko eiu cardiovascular serious of risk increased an cause may NSAIDs • w ies a ea rae ik (See risk. greater at be may disease p TRIALS CB)srey(see surgery (CABG) • SIscuea nrae iko eiu gastrointestinal serious of risk increased an cause NSAIDs • o a a cu taytm uigueadwtotwarning without and use during time any at occur can g ypos lel ainsaea rae ikfrserious for risk greater at are patients Elderly symptoms. mnsrto.Ceial,slaae(aiyslclcai or acid (salicylsalicylic salsalate Chemically, dministration. sn ihslaaetieadywl aifcoiymiti blood maintain satisfactorily will day a twice salsalate with osing h aetcmon sasre nhne n undergoes and unchanged absorbed is compound parent the f trtda niifamtr oe fslaae Such salsalate. of doses anti-inflammatory at aturated eia Structure: hemical laaei noul nai ati lis(01m/La H1.0), pH at mg/mL (<0.1 fluids gastric acid in insoluble is alsalate ihi oseodlat-nlmaoyaetfroral for agent anti-inflammatory nonsteroidal a is hich vreeet nldn leig leain n perforation and ulceration, bleeding, including events dverse roeaiepi ntestigo ooayatr yasgraft bypass artery coronary of setting the in pain erioperative h tmc ritsie,wihcnb aa.Teeevents These fatal. be can which intestines, or stomach the f sritsia vns (See events. astrointestinal t adoaclrdsaeo ikfcosfrcardiovascular for factors risk or disease cardiovascular ith ASLT ALT scnridctdfrtetetetof treatment the for contraindicated is TABLETS SALSALATE ). 3 nieaprn aslt osntihbtplatelet inhibit not does salsalate aspirin, Unlike . PRECAUTIONS 5,6 O ncnrs oaprn aslt assno causes salsalate aspirin, to contrast In . WARNINGS ANNSGsritsia Risk Gastrointestinal WARNINGS ircytlieCluoe iio Dioxide, Silicon Cellulose, Microcrystalline OH ​ Mission WARNINGS O MISS-NP_40398 - reitn Asthma Preexisting ). O Type

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7 ). . 1 providing , CLINICAL ) 2 and ADOACLREFFECTS CARDIOVASCULAR C adoaclrTrmoi Events Thrombotic Cardiovascular i fu otreyasdrto aesona nrae ikof risk increased an shown have duration years three to up of eetv n oslcie a aeasmlrrs.Ptet with Patients risk. similar a have may nonselective, and selective eiu adoaclr(V hobtceet,myocardial events, thrombotic (CV) cardiovascular serious nw Vdsaeo ikfcosfrC ies a ea greater at be may disease CV for factors risk or disease CV known r ainstetdwt nNAD h oetefcieds hudbe should dose effective lowest the NSAID, an with treated patients nomdaottesgsado yposo eiu Vevents CV serious of symptoms and/or signs the about informed n h tp otk fte cu.Teei ocnitn evidence consistent no is There occur. they if take to steps the and patients and Physicians possible. duration shortest the for used t t s s ocretueo sii n nNADde nraeters of risk the increase does NSAID an and aspirin of use concurrent W h ramn fpi ntefrt1-4dy olwn CABG following days 10-14 first the in pain of treatment the T eiu atonetnl(I vns(see events (GI) Gastrointestinal serious ugr on nicesdicdneo ycrilifrto and infarction myocardial of incidence increased an found surgery s SIs nldn ASLT ALT,cnla oosto new of onset to lead can TABLETS, SALSALATE including NSAIDs, H epnet hs hrpe hntkn SIs NSAIDs, NSAIDs. taking when therapies these to response yetnino osnn fpeeitn yetnin ihrof either hypertension, pre-existing of worsening or hypertension nldn ASLT ALT,sol eue ihcuinin caution with used be should TABLETS, SALSALATE including w p oioe lsl uigteiiito fNADtetetand treatment NSAID of initiation the during closely monitored P hogottecus ftherapy. of course the throughout t F Edema and Failure Heart Congestive nptet ihfudrtnino er failure. heart or retention fluid with patients in atonetnl(I des vnsicuiginflammation, including events adverse (GI) gastrointestinal atonetnlEfcsRs fUcrto,Bedn,and Bleeding, Ulceration, of Effects-Risk Gastrointestinal N Perforation leig leain n efrto ftesoah small stomach, the of perforation and ulceration, bleeding, u itr fucrdsaeo atonetnlbedn.Ptet with Patients bleeding. gastrointestinal or disease ulcer NSAIDs of risk. history without not is therapy short-term even However, therapy. of course the during time some rae o n er hs rnscniu ihlne uainof duration longer with continue trends These year. one for treated hudb rsrbdwt xrm ato ntoewt prior a with those a in caution extreme with prescribed be should ains h eeo eiu pe Iavreeeto NSAID on event adverse GI upper serious a develop who patients, i efrto asdb SIsocri prxmtl %of 1% approximately in occur NSAIDs by caused perforation ypos nptet rae ihNAD.Ol n nfive in one Only NSAIDs. with treated patients in symptoms, leigwoueNAD aeagetrta 0fl increased 10-fold than greater a have NSAIDs use who bleeding patients of 2-4% about in and months, 3-6 for treated patients t des vnscnocra n ie iho ihu warning without or with time, any at occur can events adverse ikfrdvlpn Ibedcmae optet ihnihrof neither with patients to compared bleed GI a developing for risk hs ikfcos te atr htices h ikfrGI for risk the increase that factors Other factors. risk these foa otcseod ratcauat,lne uaino NSAID of duration use longer concomitant anticoagulants, or include corticosteroids NSAIDs oral with of treated patients in bleeding hrp,soig s fachl le g,adpo general poor and age, older alcohol, of use smoking, therapy, elhsau.Ms pnaeu eot fftlG vnsaein are events GI fatal of reports spontaneous Most status. health lel rdblttdptet n hrfr,seilcr hudbe should care special therefore, and patients debilitated or elderly ae ntetn hspplto.T iiieteptnilrs for risk potential the minimize To population. this treating in taken navreG vn nptet rae iha SI,telowest the NSAID, an with treated patients in event GI adverse an ikptet,atraeteaista ontivleNAD should NSAIDs involve not do that therapies alternate patients, risk fetv oesol eue o h hretpsil duration. possible shortest the for used be should dose effective yposo Iucrto n leigdrn SI hrp and therapy NSAID during bleeding and ulceration GI of symptoms ainsadpyiin hudrmi lr o in and signs for alert remain should physicians and Patients rmtyiiit diinleauto n ramn fasrosGI serious a if treatment and evaluation additional initiate promptly des vn sssetd hssol nld icniuto of discontinuation include should This suspected. is event adverse h SI ni eiu Iavreeeti ue u.Frhigh For out. ruled is event adverse GI serious a until NSAID the econsidered. be erssadohrrnlijr.Rnltxct a lobe seen been also has toxicity Renal injury. renal other and necrosis ogtr diitaino SIshsrsle nrnlpapillary renal in resulted has NSAIDs of administration Long-term ea Effects Renal oei h aneac frnlpruin nteepatients, these In perfusion. renal compensatory of a maintenance have the prostaglandins in renal role whom in patients in diitaino oseodlat-nlmaoydu a cause may drug anti-inflammatory nonsteroidal a of administration ALT sntrcmeddi hs ainswt advanced with patients these in recommended not is TABLETS eodrl,i ea lo lw hc a rcptt vr renal overt precipitate may which flow, and, blood formation renal prostaglandin in secondarily, in reduction dose-dependent a dacdrnldsae hrfr,tetetwt SALSALATE with treatment Therefore, disease. renal advanced eadn h s fSLAAETBESi ainswith patients in TABLETS SALSALATE of use the regarding icniuto fNADteayi sal olwdb recovery by followed usually is therapy NSAID of Discontinuation oteperamn state. pretreatment the to those are reaction this of risk greatest at Patients decompensation. oifraini vial rmcnrle lnclstudies clinical controlled from available is information No Disease Renal Advanced aigdueisadAEihbtr,adteelderly. the and inhibitors, ACE and diuretics taking ihipie ea ucin er alr,lvrdsucin those dysfunction, liver failure, heart function, renal impaired with frto,adsrk,wihcnb aa.AlNAD,bt COX-2 both NSAIDs, All fatal. be can which stroke, and nfarction, tsie rlreitsie hc a eftl hs serious These fatal. be can which intestine, large or ntestine, kn SIs ASLT ALT hudb sdwt caution with used be should TABLETS SALSALATE NSAIDs. aking a ocretueo sii iiae h nrae ikof risk increased the mitigates aspirin of use concurrent hat eay ssmtmtc pe Iucr,gosbedn,or bleeding, gross ulcers, GI Upper symptomatic. is herapy, easneo rvosC ypos ainssol be should Patients symptoms. CV previous of absence he s.T iiieteptnilrs o navreC vn in event CV adverse an for risk potential the minimize To isk. olre otold lncltil faCX2slcieNADfor NSAID selective COX-2 a of trials clinical controlled, large, wo rk (see troke ol eanaetfrtedvlpeto uheet,ee in even events, such of development the for alert remain hould udrtninadeeahv enosre nsm patients some in observed been have edema and retention luid rosC hobtceet soitdwt SI s.The use. NSAID with associated events thrombotic CV erious e nraigtelklho fdvlpn eiu Ieetat event GI serious a developing of likelihood the increasing se, tet ihhpreso.Bodpesr B)sol be should (BP) pressure Blood hypertension. with atients iia raso eea O- eetv n oslcieNSAIDs nonselective and selective COX-2 several of trials linical tet aigtizdso opdueismyhv impaired have may diuretics loop or thiazides taking atients ypertension AD,icuigSLAAETBES a as serious cause can TABLETS, SALSALATE including SAIDs, ihmycnrbt oteicesdicdneo Vevents. CV of incidence increased the to contribute may hich ARNINGS ro itr fppi le ies n/rgastrointestinal and/or disease ulcer peptic of history prior Ace CONTRAINDICATIONS ). 6.75 ll a

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(Ace feto ltltfnto sqatttvl es fsotrduration, shorter of less, quantitatively is function platelet on effect nma SIsihbtpaee grgto n aebe shown been of have symptoms and or aggregation signs platelet any inhibit exhibit NSAIDs anemia. they if checked hematocrit nldn ASLT ALT,sol aeterhmgoi or hemoglobin their have should TABLETS, SALSALATE including opiain fpeue oifciu,piflconditions. painful noninfectious, presumed of complications n eesbe ainsrciigSLAAETBES h may who TABLETS, SALSALATE their receiving aspirin, Patients reversible. Unlike and patients. some in time bleeding prolong to to up in occur may tests liver more or one of elevations Borderline Effects Hepatic h nmai oeie eni ainsrciigNAD,including NSAIDs, receiving patients in seen sometimes is Anemia Effects Hematological ri hma bomllvrts a curd hudbe should occurred, has test liver abnormal an whom in or reported. been have outcomes 1 ASLT ALT antb xetdt usiuefor substitute to expected be cannot TABLETS SALSALATE rtrpiss ainso ogtr ramn ihNSAIDs, with treatment long-term on Patients or erythropoiesis. occult retention, fluid to due be may This TABLETS. SALSALATE Notable therapy. continuing with transient be may or unchanged, eavreyafce yatrtosi ltltfnto,sc as such function, platelet in alterations by affected adversely be dysfunction, liver suggesting signs and/or symptoms with patient A sii ra.Ti ypo ope yial cusi asthmatic in occurs typically complex symptom This triad. aspirin initiated, be must therapy TABLETS SALSALATE If disease. renal icniuto fcriotrismyla odisease to lead may corticosteroids of discontinuation (see NSAIDs other or aspirin advisable. is function renal patient’s the of monitoring close ASLT ALT hudb discontinued. be should TABLETS SALSALATE severe more a of development the of evidence for evaluated rs Ibodls,o nicmltl ecie fetupon effect described incompletely an or loss, blood GI gross detecting in signs diagnostic these of utility the diminish of activity S pharmacological The corticosteroids. discontinue e ainswtotkonpirepsr oSLAAETABLETS. SALSALATE to exposure prior known without patients sii oidc shai uhpatients such in asthma induce to aspirin eeehptcratos nldn anieadftlfulminant fatal and jaundice including reactions, hepatic severe PRECAUTIONS hs ihcauaindsreso ainsreceiving patients or disorders coagulation with those e ainswoeprec hntswt rwtotnslplp,or polyps, nasal without or with rhinitis experience who patients A s hs aoaoyanraiismypors,myremain may progress, may abnormalities laboratory These to made is decision a if slowly tapered therapy their have swt te SIs npyati ecin a cu in occur may reactions anaphylactoid NSAIDs, other with As otcseod rt ra otcseodisfiiny Abrupt insufficiency. corticosteroid treat to or corticosteroids eai ecinwieo hrp ihSLAAETBES If TABLETS. SALSALATE with therapy on while reaction hepatic lnclsgsadsmtm ossetwt ie ies develop, disease liver with consistent symptoms and signs clinical S w ri ytmcmnfsain cu eg,esnpii,rs,etc.), rash, eosinophilia, (e.g., occur manifestations systemic if or des vnssc seflaiedraii,Stevens-Johnson dermatitis, exfoliative as such events adverse ainsi lncltil ihNAD.I diin aecssof cases rare addition, In NSAIDs. of 1% with approximately trials in clinical reported in been have patients normal) of limit upper nioglns hudb aeul monitored. carefully be should anticoagulants, S N reitn Asthma Preexisting ainswt shamyhv sii-estv sha h use The asthma. aspirin-sensitive have may asthma with Patients uhaprnsniieptet,SLAAETBESsol not should TABLETS SALSALATE patients, aspirin-sensitive such ydoe(J) n oi pdra erlss(E) hc can which (TEN), necrolysis epidermal toxic and (SJS), Syndrome ntaigteaywt nNADadproial uigtecourse the during periodically and NSAID an with therapy initiating soitdwt eeebocops hc a eftl Since fatal. be can which bronchospasm severe with associated fogigteay ainssol lob norgdt edthe read to encouraged be also should Patients therapy. ongoing of b faprni ainswt sii-estv shahsbeen has asthma aspirin-sensitive with patients in aspirin of te oseodlat-nlmaoydushsbe eotdin reported been has drugs and anti-inflammatory aspirin nonsteroidal between other bronchospasm, including reactivity, cross hudb nomdaottesgsadsmtm fsrosskin serious of symptoms and signs the about informed be should eamnsee optet ihti omo sii estvt and sensitivity aspirin of form this with patients to administered be ainssol eifre ftefloigifrainbefore information following the of informed be should Patients asthma. preexisting with patients in caution with used be should NOMTO O PATIENTS FOR INFORMATION aiettosadueo h rgsol edsotne tthe at discontinued be should drug the of use and manifestations hudb vie eas tmycuepeauecoueo the of closure premature cause may it because avoided be should f ainso ramn ihslaaesol ewre o otake to not warned be should salsalate with treatment on Patients d ra aesol eeecsdwe aslt specie nthe in prescribed is salsalate when exercised be should care Great General P nlt rgac,a ihohrNAD,SLAAETABLETS SALSALATE NSAIDs, other with as pregnancy, late In P rsneo hoi ea nufcec rppi le disease. ulcer peptic or insufficiency renal chronic of presence o s s nutritional by influenced be can acid salicylic of binding Protein eu rtiscue ydsae(huaodatrts etc.). arthritis, (rheumatoid disease by caused proteins serum lhuhcosratvt,icuigbocops,hsbeen has bronchospasm, r including reactivity, cross Although rtapaac fsi aho n te ino hypersensitivity. of sign other any or rash skin of appearance irst pre cainlywt o-ctltdslclts including salicylates, non-acetylated with occasionally eported aebto.Ptet npoogdcriotri hrp should therapy corticosteroid prolonged on Patients xacerbation. eain fATo S apoiaeytreo oetmsthe times more or three (approximately AST or ALT of levations uh ncssweea npyati ecinoccurs. reaction anaphylactoid an where cases in ought laae naprnsniiepatients aspirin-sensitive in alsalate, au,cmeiiebnigo te rg,adfutain in fluctuations and drugs, other of binding competitive tatus, ptts ie erssadhptcfiue oeo hmwt fatal with them of some failure, hepatic and necrosis liver epatitis, aa.Teesroseet a cu ihu ann.Patients warning. without occur may events serious These fatal. e cu arteriosus. uctus %o ainstkn SIsicuigSLAAETABLETS. SALSALATE including NSAIDs taking patients of 5% hrslcltss st vi oetal oi concentrations. toxic potentially avoid to as so salicylates ther ahlcodReactions naphylactoid i Reactions kin RECAUTIONS regnancy LAAETBESi euig[ee n]ifamto may inflammation and] [fever reducing in TABLETS ALSALATE LAAETBESsol o egvnt ainswt the with patients to given be not should TABLETS ALSALATE AD,icuigSLAAETBES a as eiu skin serious cause can TABLETS, SALSALATE including SAIDs, oehbtsvr,ptnilyftlbocops fe taking after bronchospasm fatal potentially severe, exhibit ho ll a) ​ j ean b​ reitn sha.Eegnyhl hudbe should help Emergency Asthma). Preexisting - 08/20/2018

09:31

M/N Item NP / AM CONTRAINDICATIONS 8,9 s 10 laaei eslkl than likely less is alsalate . # MS-P438/pa / MISS-NP_40398 and g o 1 e f 2 NSAID Medication Guide that accompanies each prescription effect-of furosemide and thiazides in some patients. This response OVERDOSAGE dispensed. has been attributed to inhibition of renal prostaglandin synthesis. Death has followed ingestion of 10 to 30 g of salicylates in adults, 1. SALSALATE TABLETS, like other NSAIDs, may cause serious CV During concomitant therapy with NSAIDs, the patient should be but much larger amounts have been ingested without fatal side effects, such as MI or stroke, which may result in observed closely for signs of renal failure (see PRECAUTIONS, outcome. hospitalization and even death. Although serious CV events can Renal Effects), as well as to assure diuretic efficacy. Symptoms: The usual symptoms of salicylism - tinnitus, vertigo, occur without warning symptoms, patients should be alert for the Lithium headache, confusion, drowsiness, sweating, hyperventilation, signs and symptoms of chest pain, shortness of breath, weakness, NSAIDs have produced an elevation of plasma lithium levels and a vomiting and diarrhea - will occur. More severe intoxication will slurring of speech, and should ask for medical advice when reduction in renal lithium clearance. The mean minimum lithium lead to disruption of electrolyte balance and blood pH, and observing any indicative sign or symptoms. Patients should be concentration increased 15% and the renal clearance was hyperthermia and dehydration. apprised of the importance of this follow-up (see WARNINGS, decreased by approximately 20%. These effects have been Cardiovascular Effects). Treatment: Further absorption of salsalate from the G.I. tract attributed to inhibition of renal prostaglandin synthesis by the 2. SALSALATE TABLETS, like other NSAIDs, can cause GI should be prevented by emesis (syrup of ipecac), and, if NSAID. Thus, when NSAIDs and lithium are administered discomfort and, rarely, serious GI side effects, such as ulcers and necessary, by gastric lavage. concurrently, subjects should be observed carefully for signs of bleeding, which may result in hospitalization and even death. lithium toxicity. Fluid and electrolyte imbalance should be corrected by the Although serious GI tract ulcerations and bleeding can occur administration of appropriate I.V. therapy. Adequate renal function Methotrexate without warning symptoms, patients should be alert for the signs should be maintained. Hemodialysis or peritoneal dialysis may be NSAIDs have been reported to competitively inhibit methotrexate and symptoms of ulcerations and bleeding, and should ask for required in extreme cases. medical advice when observing any indicative sign or symptoms accumulation in rabbit kidney slices. This may indicate that they including epigastric pain, dyspepsia, melena, and hematemesis. could enhance the toxicity of methotrexate. Caution should be DOSAGE AND ADMINISTRATION Patients should be apprised of the importance of this follow-up used when NSAIDs are administered concomitantly with Carefully consider the potential benefits and risks of SALSALATE (see WARNINGS, Gastrointestinal Effects: Risk of Ulceration, methotrexate. TABLETS and other treatment options before deciding to use SALSALATE TABLETS. Use the lowest effective dose for the Bleeding, and Perforation). Warfarin shortest duration consistent with individual patient treatment goals 3. SALSALATE TABLETS, like other NSAIDs, can cause serious The effects of warfarin and NSAIDs on GI bleeding are synergistic, (see WARNINGS). skin side effects such as exfoliative dermatitis, SJS, and TEN, such that users of both drugs together have a risk of serious GI which may result in hospitalizations and even death. Although bleeding higher than users of either drug alone. After observing the response to initial therapy with SALSALATE serious skin reactions may occur without warning, patients should TABLETS, the dose and frequency should be adjusted to suit an Drug/Laboratory Test Interactions: Salicylate competes with be alert for the signs and symptoms of skin rash and blisters, individual patient’s needs. Salsalate is indicated for relief of the thyroid hormone for binding to plasma proteins, which may be fever, or other signs of hypersensitivity such as itching, and should signs and symptoms of rheumatoid arthritis, osteoarthritis and reflected in a depressed plasma T4 value in some patients; thyroid ask for medical advice when observing any indicative signs or related rheumatic disorder. symptoms. Patients should be advised to stop the drug function and basal metabolism are unaffected. Adults: The usual dosage is 3000 mg daily, given in divided doses immediately if they develop any type of rash and contact their Carcinogenesis as follows: physicians as soon as possible. No long-term animal studies have been performed with salsalate to 4. Patients should promptly report signs or symptoms of evaluate its carcinogenic potential. 1) two doses of two 750 mg tablets; 2) two doses of three 500 mg unexplained weight gain or edema to their physicians. tablets; or 3) three doses of two 500 mg tablets. Some patients, Pregnancy Category C 5. Patients should be informed of the warning signs and e.g., the elderly, may require a lower dosage to achieve therapeutic symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, Teratogenic Effects blood concentrations and to avoid the more common side effects pruritus, jaundice, right upper quadrant tenderness, and “flu-like” Reproductive studies conducted in rats and rabbits have not such as auditory. symptoms). If these occur, patients should be instructed to stop demonstrated evidence of developmental abnormalities. However, Alleviation of symptoms is gradual, and full benefit may not be therapy and seek immediate medical therapy. animal reproduction studies are not always predictive of human evident for 3 to 4 days, when plasma salicylate levels have 6. Patients should be informed of the signs of an anaphylactoid response. There are no adequate and well-controlled studies in achieved steady state. There is no evidence for development of reaction (e.g. difficulty breathing, swelling of the face or throat). If pregnant women. these occur, patients should be instructed to seek immediate tissue tolerance (tachyphylaxis), but salicylate therapy may induce emergency help (see WARNINGS). Nonteratogenic Effects increased activity of metabolizing liver enzymes, causing a greater 7. In late pregnancy, as with other NSAIDs, SALSALATE TABLETS Because of the known effects of nonsteroidal anti-inflammatory rate of salicyluric acid production and excretion, with a resultant should be avoided because it will cause premature closure of the drugs on the fetal cardiovascular system (closure of ductus increase in dosage requirement for maintenance of therapeutic ductus arteriosus. arteriosus), use during pregnancy (particularly late pregnancy) serum salicylate levels. should be avoided. LABORATORY TESTS Children: Dosage recommendations and indications for salsalate Plasma salicylic acid concentrations should be periodically Labor and Delivery use in children have not been established. There exist no adequate and well-controlled studies in pregnant monitored during long-term treatment with salsalate to aid HOW SUPPLIED women. Although adverse effects on mother or infant have not maintenance of therapeutically effective levels: 10 to 30 mg/100 500 mg Tablets: Supplied in bottles of 100 count (NDC been reported with salsalate use during labor, caution is advised mL. Toxic manifestations are not usually seen until plasma 42192-365-10); white, round-shaped tablets debossed with “112” when anti-inflammatory dosage is involved. However, other concentrations exceed 30 mg/100 mL (see OVERDOSAGE). on one side. Urinary pH should also be regularly monitored: sudden salicylates have been associated with prolonged gestation and acidification, as from pH 6.5 to 5.5, can double the plasma level, labor, maternal and neonatal bleeding sequelae, potentiation of 750 mg Tablets: Supplied in bottles of 100 count (NDC resulting in toxicity. narcotic and barbiturate effects (respiratory or cardiac arrest in the 42192-366-10); white, capsule-shaped tablets, debossed with mother), delivery problems and stillbirth. In rat studies with “D-1200” on one side. Because serious GI tract ulcerations and bleeding can occur NSAIDs, as with other drugs known to inhibit prostaglandin without warning symptoms, physicians should monitor for signs Dispense contents with a child-resistant closure (as required) and synthesis, an increased incidence of dystocia, delayed parturition, in a tight container as defined in the USP. or symptoms of GI bleeding. Patients on long-term treatment with and decreased pup survival occurred. The effects of SALSALATE NSAIDs, should have their CBC and a chemistry profile checked TABLETS on labor and delivery in pregnant women are unknown. Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - periodically. If clinical signs and symptoms consistent with liver or 30°C (59°F - 86°F). [See USP Controlled Room Temperature]. renal disease develop, systemic manifestations occur (e.g., Nursing Mothers eosinophilia, rash, etc.) or if abnormal liver tests persist or It is not known whether salsalate as such is excreted in human Rx only worsen, SALSALATE TABLETS should be discontinued. milk; salicylic acid, the primary metabolite of salsalate, has been REFERENCES shown to appear in human milk in concentrations approximating 1. Morris HG, Sherman NA, McQuain C, et al: Effects of Salsalate DRUG INTERACTIONS the maternal blood level. Thus, the infant of a mother on salsalate ACE-inhibitors (Non- Acetylated Salicylate) and Aspirin (ASA) on Serum therapy might ingest in mother’s milk 30 to 80% as much Prostaglandins in Humans. Ther. Drug Monit. 7:435-438, 1985. Reports suggest that NSAIDs may diminish the antihypertensive salicylate per kg body weight as the mother is taking. Accordingly, effect of ACE-inhibitors. This interaction should be given 2. April PA, Curran NJ, Ekohlm BP, et al: Multicenter Comparative caution should be exercised when salsalate is administered to a Study of Salsalate (SSA) vs Aspirin (ASA) in Rheumatoid Arthritis consideration in patients taking NSAIDs concomitantly with nursing woman. ACE-inhibitors. (RA), Arthritis Rheumatism 30 (4 supplement):S93, 1987. Pediatric Use 3. Deodhar SD, McLeod MM, Dick WC, et al: A Short-Term Aspirin Safety and effectiveness of salsalate use in children have not been Comparative Trial of Salsalate and Indomethacin in Rheumatoid Salicylates antagonize the uricosuric action of drugs used to treat established. Arthritis. Curr. Med. Res. Opin., 5:185-188,1977. gout. ASPIRIN AND OTHER SALICYLATE DRUGS WILL BE 4. Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin ADDITIVE TO SALSALATE AND MAY INCREASE PLASMA (See WARNINGS section.) Analog, Salsalate, Arthritis and Rheumatism, 23:1303-1307, 1980. CONCENTRATIONS OF SALICYLIC ACID TO TOXIC LEVELS. Drugs Geriatric Use 5. Dick C, Dick PH, Nuki G, et al: Effect of Anti-inflammatory Drug and foods that raise urine pH will increase renal clearance and As with any NSAIDs, caution should be exercised in treating the Therapy on Clearance of 133Xe from Knee Joints of Patients with urinary excretion of salicylic acid, thus lowering plasma levels: elderly (65 years and older). Rheumatoid Arthritis. British Med. J. 3:278-280, 1969. acidifying drugs or foods will decrease urinary excretion and 6. Dick WC, Grayson MF, Woodburn A, et al: Indices of ADVERSE REACTIONS increase plasma levels. Salicylates given concomitantly with Inflammatory Activity. Ann. of the Rheum. Dis. 29:643-648, 1970. In two well-controlled clinical trials, the following reversible anticoagulant drugs may predispose to systemic bleeding. 7. Cohen A: Fecal Blood Loss and Plasma Salicylate Study of adverse experiences characteristic of salicylates were most Salicylates may enhance the hypoglycemic effect of oral Salicylsalicylic Acid and Aspirin. J. Clin. Pharmacol. 19:242-247, commonly reported with salsalate (n-280 pts; listed in descending antidiabetic drugs of the sulfonylurea class. Salicylate competes 1979. order of frequency): tinnitus, nausea, hearing impairment, rash, with a number of drugs for protein binding sites, notably penicillin, 8. Chudwin DS, Strub M. Golden HE, et al: Sensitivity to and vertigo. These common symptoms of salicylates, i.e., tinnitus thiopental, thyroxine, triiodothyronine, phenytoin, sulfinpyrazone, Non-Acetylated Salicylates in a Patient with Asthma, Nasal Polyps, or reversible hearing impairment, are often used as a guide to naproxen, warfarin, methotrexate, and possibly corticosteroids. and Rheumatoid Arthritis. Annals of Allergy 57:133-134, 1986. therapy. [When SALSALATE TABLETS is administered with aspirin, its 9. Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant protein binding is reduced, although the clearance of free Although cause-and-effect relationships have not been established, Idiosyncrasies in Adult Asthmatic Patients. J. Allergy Clin. SALSALATE TABLETS is not altered. The clinical significance of spontaneous reports over a ten-year period have included the Immunol 64:500-506, 1979. this interaction is not known; however,] as with other NSAIDs, following additional medically significant adverse experiences: 10. Stevenson DD, Schrank PJ, Hougham AJ, et al: Salsalate Cross concomitant administration of salsalate and aspirin is not generally abdominal pain, abnormal hepatic function, anaphylactic shock, Sensitivity in Aspirin-Sensitive Asthmatics. J. Allergy Clin. recommended because of the potential of increased adverse angioedema, bronchospasm, decreased creatinine clearance, Immunol 81:181, 1988. effects. diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and Manufactured for: urticaria. Furosemide Acella Pharmaceuticals, LLC, Clinical studies, as well as post marketing observations, have DRUG ABUSE AND DEPENDENCE Alpharetta, GA 30005 shown that SALSALATE TABLETS can reduce the natriuretic Drug abuse and dependence have not been reported with salsalate. 1-800-541-4802 Rev 0818-01

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