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Title: 8A Arthritis/rheumatic disorders


Source: MPR Pharmacists' Edition. 9.3 (Fall 2015): p118. From Gale Health and Medical Collection.
Document Type: Article
Copyright: COPYRIGHT 2015 Haymarket Media, Inc.
http://www.haymarket.com/monthly_prescribing_reference/multi/pharmacists_edition_usa_magazine/default.aspx
Full Text:
ADVIL Pfizer Cons. OTC
NSAID (propionic acid deriv.). Ibuprofen 200mg; gel caplets; caplets; tabs; liqui-gels. Indications: Minor arthritic pain.
Adults: 200-400mg eveiy 4-6 hours; max 1.2g/day.
Children: Use Children's form.
Contraindications: Aspirin allergy. Immediately before or after cardiac surgery.
Warnings/Precautions: Increased risk of severe stomach bleeding. History of GI disorders (eg, heartburn, bleeding ulcers). Hypertension. Heart disease. Liver cirrhosis. Renal disease. Asthma.
Reevaluate if pain persists or worsens after [greater than or equal to] 10 days or fever lasts [greater than or equal to] 3 days. Elderly. Pregnancy (avoid during 3rd trimester). Nursing mothers.
Interactions: Avoid aspirin or other pain relievers. Increased risk of GI bleed with anticoagulants, corticosteroids, other OTC or Rx NSAID-containing products (eg, ibuprofen, naproxen, others),
[greater than or equal to] 3 alcoholic drinks/day, or prolonged use. Caution with diuretics.
Adverse reactions: GI upset/bleed (discontinue if occurs), redness, swelling. See literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: Gel caplets--8, 24, 50, 100, 200; Caplets--24, 50, 72, 100, 150, 200; Tabs--8, 24, 50, 72, 100, 150, 200; Liquigels--20, 40, 80, 120, 160
ALEVE Bayer Consumer OTC :
NSAID (arylacetic acid deriv.). Naproxen sodium 220mg tabs, caplets, gelcaps, liquid gels.
Indications: Minor arthritic pain.
Adults: Take with fluids. 220mg every 8-12 hrs for up to 10 days. With experience, may give 440mg as 1st dose.
Children: Not recommended.
Elderly: Max 220mg every 12 hrs for up to 10 days.
Contraindications: Aspirin allergy. 3rd trimester of pregnancy. Coronary artery bypass graft surges
Warnings/Precautions: GI, hepatic, renal disease. Dehydration. Pregnancy. Nursing mothers: not recommended.
Interactions: Avoid aspirin, other pain relievers. Increased risk of GI bleed with alcohol.
Adverse reactions: GI upset, GI bleed, rash (discontinue if occurs). See literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: Tabs, caplets--24, 50, 100
Gelcaps, liquid gels--20, 40, 80
ANAPROX Roche Rx
NSAID (arylacetic acid deriv.). Naproxen sodium 275mg; tabs.
Also: ANAPROX DS Rx
Naproxen sodium 550mg; tabs.
Indications: Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Juvenile rheumatoid arthritis (JRA). Tendinitis. Bursitis. Acute gout.
Adults: Arthritis, spondylitis: 275mg or 550mg twice daily. Tendinitis, bursitis: Initially 550mg, then 550mg every 12 hrs or 275mg every 6-8 hrs; max 1.375g (first day), then max 1.1g/day. Acute
gout: 825mg once then 275mg every 8 hrs.
Children: <2yrs: not recommended. >2yrs: use susp form of naproxen.
Contraindications: Aspirin allergy. Coronary artery bypass graft surgery.
Warnings/Precautions: Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI adverse events (eg, bleeding, ulceration, perforation). Advanced renal disease:
not recommended. Active peptic ulcer. History of GI or inflammatory bowel disease. Impaired renal or hepatic function. Hypovolemia. Heart failure. Salt depletion. Edema. Hypertension.
Preexisting asthma. Bleeding disorders. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C); avoid in late pregnancy.
Nursing mothers: not recommended.
Interactions: Avoid concomitant aspirin. May potentiate protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Monitor oral anticoagulants. Increased risk of GI bleeding with oral
corticosteroids, SSRIs, smoking, alcohol. May antagonize diuretics, [beta]-blockers, ACEIs, ARBs, or other antihypertensives. Increased renal toxicity with ACEIs or ARBs. Methotrexate
excretion reduced. Increases serum lithium levels. Probenecid increases plasma levels and delays elimination. Concomitant H2 blockers, sucralfate, intensive antacid therapy: use immediaterelease forms of naproxen. Cholestyramine may delay absorption.
Adverse reactions: GI bleeding, peptic ulcer, constipation, heartburn, abdominal pain, nausea, headache, dizziness, drowsiness, pruritus, rash (discontinue if occurs), tinnitus, edema, nephritis,

nephrotic syndrome, jaundice, hepatitis. See full labeling re: risk of cardiovascular or GI events.
Generic availability: YES
How supplied: Tabs 275mg--100; 550mg--100
ANSAID Pfizer Rx
NSAID (phenylalkanoic acid deriv.). Flurbiprofen 50mg, 100mg; tabs.
Indications: Rheumatoid arthritis. Osteoarthritis.
Adults: 200-300mg/day in 2-4 divided doses; max single dose 100mg. Reduce dosage for renal impairment.
Children: Not recommended.
Contraindications: Aspirin allergy. Late pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Upper GI disease. Renal or hepatic dysfunction. Hypertension. Cardiac failure. Bleeding disorders. Hemoglobin <10g/dL.
Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Reduced diuresis and renal failure with diuretics. Attenuated antihypertensive effect of [beta]-blockers (except atenolol). Monitor oral anticoagulants. Avoid aspirin. May potentiate
lithium (monitor for toxicity), methotrexate.
Adverse reactions: Peptic ulcers, GI bleeding, renal failure, anemia, ocular changes, edema, elevated SGOT or SGPT level, hepatitis, nausea, vomiting, diarrhea, constipation, headache, CNS
stimulation or depression, rhinitis, rash (discontinue if occurs), dizziness, tinnitus, UTI-like signs and symptoms. See literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: Tabs 50mg--2000; 100mg--100, 2000
ARAVA Sanofi Aventis Rx
DMARD (pyrimidine synthesis inhibitor). Leflunomide 10mg, 20mg, 100mg; tabs. Indications: Active rheumatoid arthritis to reduce signs/symptoms, inhibit structural damage, and improve
physical function. May be used with aspirin, NSAIDs, and/or lowdose corticosteroids.
Adults: [greater than or equal to] 18yrs: Loading dose: 100mg daily for three days; maintenance 20mg daily. If not well tolerated, may reduce to 10mg daily; monitor closely. If ALT elevations >3
x ULN, discontinue and determine if leflunomide-induced; if positive, give cholestyramine and activated charcoal as needed. Max 20mg/day.
Children: <18yrs: not recommended.
Contraindications: Women of childbearing potential who are not using reliable contraception. Pregnancy (Cat.X).
Warnings/Precautions: Pre-existing hepatic disease or ALT>2xULN: not recommended. Monitor liver function (esp. ALT) and blood (WBCs, platelets, hemoglobin, HCT) at baseline, then
monthly for 1st six months; then every 6-8 weeks. Obtain (-) pregnancy test before starting therapy; use reliable contraception. All women of childbearing potential and men wishing to father a
child should use cholestyramine or activated charcoal to eliminate drug after therapy (see protocol in labeling). Test and treat, if positive for latent TB infection prior to starting therapy. Renal
impairment. Monitor BP Severe immunodeficiency, bone marrow dysplasia, severe uncontrolled infections, nursing mothers: not recommended.
Interactions: Concomitant methotrexate, other immunosuppressants: monitor for hepatic or hematologic toxicity monthly. May increase levels of diclofenac, ibuprofen, tolbutamide. Caution with
rifampin, and with other hepatotoxic drugs. Concomitant teriflunomide, live vaccines: not recommended; consider leflunomide long half-life before giving live vaccines after stopping therapy.
Monitor warfarin.
Adverse reactions: Diarrhea, elevated liver enzymes, alopecia, rash, respiratory infections, hypertension, headache, GI upset; rare: hepatotoxicity (may be fatal), interstitial lung disease,
immunosuppression (possible sepsis), bone marrow suppression, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, peripheral neuropathy: stop therapy and perform drug elimination
procedure.
Generic availability: 10mg, 20mg (YES); 100mg (NO)
How supplied: Tabs 10mg, 20mg--30; 100mg--blister pack (1 x 3)
ARTHROTEC 50 Pfizer Rx
NSAID + prostaglandin [E.sub.1], analogue. Diclofenac sodium 50mg (e-c), misoprostol 200mcg; tabs.
Also: ARTHROTEC 75 Rx
Diclofenac sodium 75mg (e-c), misoprostol 200mcg; tabs.
Indications: Osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk for developing NSAID-induced gastric or duodenal ulcers.
Adults: Swallow whole; food may reduce diarrhea. [greater than or equal to] 18yrs: OA: one Arthrotec 50 tab 3 times daily. RA: one Arthrotec 50 tab 3-4 times daily. Both: if not tolerated, may
reduce to one Arthrotec 50 or one Arthrotec 75 tablet twice daily (this may be less effective in preventing ulcers). Concomitant CYP2C9 inhibitors: max Arthrotec 50mg twice daily. See full
labeling.
Children: <18yrs: not established.
Contraindications: Pregnancy (Cat.X). Aspirin allergy. Coronary artery bypass graft surgery. Active GI bleeding.
Warnings/Precautions: For women of childbearing potential: obtain negative serum pregnancy test within 2 weeks before start of therapy; begin Arthrotec therapy on 2nd or 3rd day of menstrual
period; maintain contraception during therapy; give oral and written warnings on risks in pregnancy. Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI
adverse events (eg, bleeding, ulceration, perforation). Advanced renal disease: not recommended. History of ulcer disease or GI bleeding. Edema. Heart failure. Hypertension. Pre-existing asthma.
Hepatic or renal dysfunction. Monitor BP, CBCs, blood chemistry, hepatic and renal function. Check ALT (SGPT) within 4-8 wks then periodically. Discontinue if signs/symptoms of liver or renal
disease develop, or if abnormal liver function tests persist or worsen. Hepatic porphyria. Dehydration. SLE. Elderly. Debilitated. Labor & delivery. Avoid in late pregnancy. Nursing mothers.
Interactions: Avoid magnesium-containing antacids, salicylates, aspirin, other NSAIDs (including COX-2 inhibitors). May be potentiated by CYP2C9 inhibitors (eg, voriconazole); caution. May
be antagonized by CYP2C9 inducers (eg, rifampin); caution. May antagonize ACE-inhibitors (coadministration may reduce renal function), diuretics. Possible nephrotoxicity with tacrolimus.
Monitor for digoxin, methotrexate, cyclosporine, lithium, warfarin toxicity. Hyper- or hypoglycemia possible with insulin, oral hypoglycemic agents. Increased risk of GI bleed with oral
corticosteroids, anticoagulants (monitor), alcohol, smoking, prolonged NSAID therapy. Increased serum potassium with [K.sup.+]-sparing diuretics. Caution with concomitant drugs that are
known to be hepatotoxic (eg, antibiotics, antiepileptics).
Adverse reactions: Abdominal pain, diarrhea, dyspepsia, nausea, flatulence, GI bleed/ulcer, other GI disturbances, rash (may be serious, eg, Stevens Johnson Syndrome; discontinue if occurs),
elevated transaminase levels, anemia; anaphylactic reactions, aseptic meningitis (rare), renal toxicity (w. long-term use). See full labeling re: risk of cardiovascular or GI events.
Generic availability: NO

How supplied: Arthrotec 50-60, 90; Arthrotec 75-60


AZULFIDINE EN-tabs Pfizer Rx
DMARD (salicylate-sulfonamide). Sulfasalazine 500mg; e-c tabs.
Indications: Rheumatoid arthritis or polyarticular JRA that has responded inadequately to salicylates or other NSAIDs.
Adults: Swallow whole after meals. Initially 500mg in the PM for 1 week, then 500mg in the AM & PM for 1 week, then 500mg in the AM and 1g in the PM for 1 week, then 1g in the AM and
PM in 2 evenly divided doses.
Children: Swallow whole after meals. <6yrs: not established. [greater than or equal to] 6yrs: initially 1/4 to 1/3 of maintenance dose; increase weekly. Maintenance: 30-50mg/kg per day in 2
evenly divided doses; max 2g/day.
Contraindications: Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.
Warnings/Precautions: Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated.
Monitor for signs/symptoms of infection before and after therapy; discontinue if serious infection develops. History of recurring or chronic infections. Underlying conditions or concomitant drugs
which may predispose to infections. Severe allergy. Asthma. G6PD deficiency. Monitor CBCs, differential WBC, LFTs before starting, every other week for 1st 3 months, then once monthly for
next 3 months, then once every 3 months; urinalysis, renal function, and serum sulfapyridine periodically; discontinue while awaiting blood test results. Maintain adequate hydration. Continue
medication after symptoms controlled. See full labeling for desensitizing regimen. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions: Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.
Adverse reactions: Nausea, dyspepsia, rash, headache, abdominal pain, vomiting, fever, dizziness, stomatitis, pruritus, abnormal liver function tests, leukopenia, thrombocytopenia, oligospermia,
infertility in men, hemolytic anemia, other blood dyscrasias, urine or skin discoloration, cyanosis; CNS, renal, or severe hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal
necrolysis, DRESS), hepatotoxicity. Children: also serum sickness reaction.
Generic availability: YES
How supplied: Tabs--100, 300
CATAFLAM Novartis Rx
NSAID (benzeneacetic acid deriv.) Diclofenac potassium 50mg; tabs.
Indications: Osteoarthritis. Rheumatoid arthritis. Ankylosing spondylitis.
Adults: Osteoarthritis: 50mg 2-3 times daily. Rheumatoid arthritis: 50mg 3-4 times daily. Ankylosing spondylitis: 25mg 4 times daily, may add 25mg at bedtime.
Children: Not recommended.
Contraindications: Aspirin allergy. Late pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Peptic ulcer. GI bleeding. Monitor AST/ALT within 4 weeks and then periodically; also blood, hepatic, and renal function in
chronic use. Edema. Cardiac failure. Hypertension. Hepatic porphyria. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Digoxin, methotrexate, cyclosporine, lithium toxicity. Antagonizes diuretics. May increase serum potassium level with [K.sup.+]-sparing diuretics. Avoid aspirin. Monitor oral
anticoagulants, insulin and sulfonylureas. Increased risk of GI bleed with alcohol.
Adverse reactions: Peptic ulcer, GI bleeding, elevated AST/ALT, abdominal discomfort, constipation, diarrhea, indigestion, nausea, abdominal distention, headache, dizziness, fluid retention, rash
(discontinue if occurs), pruritus, tinnitus. See literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: Tabs--100
CELEBREX Pfizer Rx
NSAID (COX-2 inhibitor). Celecoxib 50mg, 100mg, 200mg, 400mg; caps.
Indications: Osteoarthritis (OA). Rheumatoid arthritis (RA). Ankylosing spondylitis (AS). Juvenile rheumatoid arthritis (JRA).
Adults: [greater than or equal to] 18yrs: OA: 200mg once daily or 100mg twice daily. RA: 100-200mg twice daily. AS: 200mg in 1-2 divided doses; if no response after 6 weeks, 400mg once daily
may be tried. <50kg: start at lowest recommended dose.
Children: <2yrs: not recommended. May sprinkle capsule contents into applesauce. jRA: [greater than or equal to] 2yrs ([greater than or equal to] 10kg to [less than or equal to] 25kg): 50mg twice
daily; (>25kg): 100mg twice daily.
Contraindications: Sulfonamide or aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease or severe hepatic impairment: not recommended. Renal or liver dysfunction; reduce dose by 50% in moderate hepatic insufficiency (Child-Pugh
class B). Discontinue if liver disease or systemic effects (eg, eosinophilia, rash) develops. History or risk of GI bleed/ulcer (monitor). Fluid retention. Heart failure. Hypertension. Asthma.
Alcoholism. Dehydrated. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Caution with drugs that inhibit CYP2C9 (eg, fluconazole) or are metabolized by CYP2D6. May antagonize, or increase risk of renal failure with ACEIs, diuretics. Increased risk of GI
bleed with aspirin (except low-dose), corticosteroids, smoking, anticoagulants. May potentiate lithium. Monitor warfarin.
Adverse reactions: GI upset/pain, edema, pharyngitis, increase AST/ALT, Gl ulcer/ bleed; rare: intracranial bleed, liver failure; also children: headache, fever, cough. See literature re: risk of
cardiovascular events.
Generic availability: NO
How supplied: Caps 100mg, 200mg--100, 500; 50mg, 400mg--60
CIMZIA UCB Rx
Tumor necrosis factor blocker. Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free.
Indications: Treatment of adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), or active ankylosing spondylitis (AS).
Adults: Rotate inj site. Give by SC inj in abdomen or thigh. RA or PsA: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every other week.

Maintenance: may consider 400mg every 4 weeks. AS: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every 2 weeks or 400mg every 4 weeks.
Children: Not recommended.
Warnings/Precautions: Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Lymphoma and other malignancies.
Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat
latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs;
discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Perform periodic skin exams (esp. those
with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barre syndrome). CHF (monitor). Discontinue if lupus-like
syndrome with antibody formation or serious hypersensitivity reaction occurs. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions: Concurrent anakinra, abatacept, rituximab, natalizumab, live or attenuated vaccines, biological DMARDs, or other TNF blockers: not recommended. Immunosuppressants increase
risk of infection. May interfere with coagulation tests (eg, aPTT).
Adverse reactions: Upper respiratory infections, rash, UTI, arthralgia, other infections; rare: TB, HBV reactivation, hypertension, heart failure, back pain, hypersensitivity reactions, malignancies
(eg, lymphoma; esp. children), neurological disorders (seizures, optic neuritis, peripheral neuropathy), antibody formation, lupus-like syndrome.
Generic availability: NO
How supplied: Pack--1 (2 single-dose vials w. syringes, needles, supplies); Single-use prefilled syringes--2 (w. supplies); Prefilled Syringe Starter Kit--6 (w. supplies)
DAYPRO Pfizer Rx
NSAID (propionic acid deriv.). Oxaprozin 600mg; scored caplets.
Indications: Rheumatoid arthritis (RA). Osteoarthritis (OA). Juvenile rheumatoid arthritis (JRA).
Adults: RA ([greater than or equal to] 16 years) or OA: 1.2g once daily; max 1.8g or 26mg/kg daily, whichever is less, in divided doses. Low body weight, milder disease, or on dialysis: initially
600 mg once daily; max 1.2g daily.
Children: <6 years: not recommended. JRA: 6-16 years (22-31 kg): 600mg once daily; (32-54 kg): 900mg once daily; ([greater than or equal to] 55 kg): 1.2g once daily.
Contraindications: Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Renal or hepatic dysfunction. Discontinue if renal or hepatic disease develops. History of GI bleed/ulcer. Bleeding disorders.
Monitor CBC, hepatic, and renal function in chronic use; and for GI bleed/ulcer. Heart failure. Hypertension. Asthma. Alcoholism. Dehydrated. Elderly. Debilitated. Labor & delivery. Pregnancy
(Cat.C). Nursing mothers: not recommended.
Interactions: Potentiates methotrexate, lithium, protein bound drugs. Increased risk of GI bleed with aspirin, corticosteroids, smoking, anticoagulants. May antagonize, or increase risk of renal
failure with ACEIs, diuretics. Monitor oral anticoagulants, antihypertensives.
Adverse reactions: GI upset, CNS effects, tinnitus, blurred vision, dysuria, edema, photosensitivity, GI ulcer/bleed, blood dyscrasias, renal or hepatic dysfunction, rash (discontinue if occurs). See
literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: Caplets--100, 500
Diflunisal (various) Rx
Salicylate. Diflunisal 250mg, 500mg; tabs. Indications: Osteoarthritis. Rheumatoid arthritis.
Adults: 250-500mg twice daily; max 1.5g/day.
Children: Not recommended.
Contraindications: Aspirin allergy. Varicella or influenza in teenagers. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Active peptic ulcer or GI bleeding. History of GI disease. Cardiac failure. Hypertension. Impaired renal or hepatic function.
Volume depletion. Bleeding disorders. Sepsis. Diabetes. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C in 1st and 2nd trimesters).
Nursing mothers: not recommended.
Interactions: Avoid methotrexate, indomethacin. Oral anticoagulants potentiated. Increased acetaminophen and hydrochlorothiazide serum levels. Reduced absorption with antacids.
Adverse reactions: Peptic ulcer, GI bleeding, nausea, dyspepsia, GI pain, diarrhea, rash (discontinue if occurs), headache, dizziness, edema, nephritis. See literature re: risk of cardiovascular
disease.
How supplied: Contact supplier.
DUEXIS Horizon Pharma Rx
NSAID + [H.sub.2] blocker. Ibuprofen 800mg, famotidine 26.6mg; tabs.
Indications: Relief of signs/symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (ie, gastric and/or duodenal ulcer), in patients
who are taking ibuprofen for those indications.
Adults: Swallow whole. 1 tab three times daily. Use lowest effective dose for the shortest duration.
Children: Not recommended.
Contraindications: Aspirin allergy. Coronary artery bypass graft surgery. Late stage pregnancy ([greater than or equal to] 30 weeks gestation).
Warnings/Precautions: Increased risk of serious cardiovascular or GI events. Renal impairment (CrCl <50mL/min): not recommended. Hypertension; monitor BP Heart failure. Edema. History of
ulcer disease or GI bleeding. Active peptic ulcer. Inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease). Seizures. Hepatic dysfunction. Bleeding disorders. Monitor blood, hepatic
and renal function in chronic use. Discontinue if visual, rash, skin reactions, renal or liver dysfunction occurs. Asthma. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers:
not recommended.
Interactions: Increased risk of GI bleed with oral corticosteroids, aspirin, warfarin-type anticoagulants (monitor), alcohol, smoking. May antagonize ACE-inhibitors, diuretics. Increases lithium
levels. May increase toxicity of methotrexate. Caution with concomitant SSRIs. Delayed absorption with cholestyramine.
Adverse reactions: GI upset, constipation, upper abdominal pain, dyspepsia, headache, hemorrhage, dizziness; GI ulcer/bleed, elevated liver enzymes (discontinue if hepatotoxicity develops),
blurred vision, rash/ serious skin infections (discontinue if occurs), peripheral edema, anemia, hypertension, renal papillary necrosis, aseptic meningitis. See literature re: risk of cardiovascular
events.

Generic availability: NO
How supplied: Tabs--90
>ECOTRIN Prestige Brands OTC
Salicylate. Aspirin 81mg, 325mg, 500mg; e-c tabs.
Indications: Arthritic and rheumatic conditions.
Adults: Rheumatoid arthritis, arthritis and pleurisy of SLE: initially 3g daily in divided doses; target plasma salicylate level 150-30Omcg/mL. Osteoarthritis: up to 3g/day in divided doses.
Spondyloarthropathies: up to 4g/day in divided doses.
Children: JRA: initially 90-130mg/kg per day in divided doses; target plasma salicylate level 150-300mcg/mL.
Contraindications: NSAID allergy. Viral infection in children and teenagers. 3rd trimester pregnancy.
Warnings/Precautions: History of asthma or peptic ulcer. Severe hepatic or renal dysfunction. Bleeding disorders. Diabetes. Gout. Pregnancy, nursing mothers: not recommended.
Interactions: Potentiates anticoagulants, hypoglycemics, methotrexate, acetazolamide, valproic acid, highly protein-bound drugs. Urinary alkalinizers, antacids, corticosteroids may increase
excretion. May antagonize ACE inhibitors, 8-blockers, diuretics, uricosurics. Increased bleeding risk with NSAIDs or chronic, heavy alcohol use. NSAIDs increase risk of renal dysfunction.
Adverse reactions: GI upset/bleed, prolonged bleeding time, anaphylaxis, salicylism.
Generic availability: 81mg, 325mg (YES); 500mg (NO)
How supplied: Tabs 81mg--36, 120; 325mg--100, 250; 500mg--60, 150
ENBREL Amgen Rx
Tumor necrosis factor (TNF) blocker. Etanercept 25mg; per vial (pwd for SC inj after reconstitution; preservative-free; diluent contains benzyl alcohol); 50mg/mL prefilled syringe (soln for SC
inj; preservative free); 50mg/mL prefilled syringe SureClick autoinjector (soln for SC inj; preservative-free).
Indications: To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately to severely active
rheumatoid arthritis; to reduce signs/symptoms, inhibit progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis; for both: may be used
with or without methotrexate in patients who have not responded adequately to methotrexate alone. To reduce signs/ symptoms of: ankylosing spondylitis, and of moderately to severely active
polyarticular juvenile idiopathic arthritis (JIA).
Adults: Use prefilled syringe. Inject 50mg SC once weekly into thigh, abdomen, or upper arm; rotate inj sites.
Children: Inject SC into thigh, abdomen, or upper arm; rotate inj sites. <2yrs: not recommended. JIA: <63kg: 0.8mg/kg per week; max 50mg/week. [greater than or equal to] 63kg: may use 50mg
prefilled syringe or SureClick autoinjector.
Contraindications: Sepsis.
Warnings/Precautions: Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate
therapy. Chronic or history of recurring infections. Conditions that predispose to infection (eg, diabetes, immunosuppression). Travel to, or residence in, areas with endemic TB or mycoses.
Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active Tb (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs;
discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Suspend if significant exposure to varicella occurs (consider varicella
prophylaxis). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders (eg, multiple sclerosis, myelitis, optic neuritis),
seizures. Heart failure. Malignancies. Attempt to complete childhood immunizations first. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate to
severe alcoholic hepatitis. Latex allergy (syringe). Supervise 1st dose. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions: Concurrent cyclophosphamide, anakinra, abatacept, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection.
Adverse reactions: Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory disorders; worsening psoriasis; rare: CNS
demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella, headache, GI disturbances.
Generic availability: NO
How supplied: Multi-use vials--4 (w. supplies); Single-use prefilled syr (1mL)--4 (w. needles); Single-use prefilled SureClick autoinjector--4 (w. needles)
EXTRA STRENGTH BAYER OTC
Bayer Consumer
Salicylate. Aspirin 500mg; caplets; gelcaps.
Also: EXTRA STRENGTH BAYER OTC
PLUS
Aspirin 500mg; buffered with calcium carbonate; caplets.
Also: BAYER OTC
Aspirin 325mg; tabs; caplets; gelcaps.
Indications: Arthritic and rheumatic conditions.
Adults: Rheumatoid arthritis, arthritis and pleurisy of SLE: initially 3g daily in divided doses; target plasma salicylate level 150-300mcg/mL. Osteoarthritis: up to 3g/day in divided doses.
Spondyloarthropathies: up to 4g/day in divided doses.
Children: JRA: initially 90-130mg/kg per day in divided doses; target plasma salicylate level 150-300mcg/mL.
Contraindications: NSAID allergy. Viral infection in children and teenagers. 3rd trimester pregnancy.
Warnings/Precautions: History of asthma or peptic ulcer. Severe hepatic or renal dysfunction. Bleeding disorders. Diabetes. Gout. Pregnancy, nursing mothers: not recommended.
Interactions: Potentiates anticoagulants, hypoglycemics, methotrexate, acetazolamide, valproic acid, highly protein-bound drugs. Urinary alkalinizers, antacids, corticosteroids may increase
excretion. May antagonize ACE inhibitors, [beta]-blockers, diuretics, uricosurics. Increased bleeding risk with nSaIDs or chronic, heavy alcohol use. NSAIDs increase risk of renal dysfunction.
Adverse reactions: GI upset/bleed, prolonged bleeding time, anaphylaxis, salicylism.

Generic availability: YES


How supplied: Ext Str tabs, caplets, Plus--50; Ext Str gelcaps--40, 80; Bayer Tabs--12, 24, 50, 100, 200, 300, 365; Caplets--50, 100, 200
HUMIRA AbbVie Rx
Tumor necrosis factor (TNF) blocker. Adalimumab 10mg/0.2mL, 20mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free.
Indications: To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in moderately-toseverely active rheumatoid arthritis
(RA); may be used alone or with methotrexate (MTX) or DMARDs. To reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients [greater than
or equal to] 2yrs of age; may be used alone or with MTX. To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in active psoriatic arthritis; may be
used alone or with DMARDs. To reduce signs and symptoms of active ankylosing spondylitis.
Adults: Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. [greater than or equal to] 18yrs: 40mg every other week. May use with MTX, DMARDs, glucocorticoids, salicylates,
NSAIDs, or analgesics. RA (without MTX): may increase frequency to once weekly.
Children: <2yrs or <10kg: not recommended. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 2-17yrs: (10--<15kg): 10mg every other week (10mg prefilled syringe should be
used); (15--<30kg): 20mg every other week (20mg prefilled syringe should be used); ([greater than or equal to] 30kg): 40mg every other week. May use with MTX, glucocorticoids, salicylates,
NSAIDs, or analgesics.
Warnings/Precautions: Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Lymphoma and other
malignancies. Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or
mycoses. Test/ treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood
dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. CHF (monitor). Immunosuppression. Discontinue if lupuslike
syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders. Pediatric patients: follow up on current immunizations before starting therapy. Latex
allergy. Elderly. Pregnancy (Cat.B). Nursing mothers.
Interactions: Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection.
Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Adverse reactions: Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, hypertension,
neurological events, antibody formation, lupus-like syndrome.
Generic availability: NO
How supplied: Single-dose prefilled syringe--2; Single-dose prefilled pen (40mg)--2
Ibuprofen Tablets (various) Rx
NSAID (propionic acid deriv.). Ibuprofen 400mg, 600mg, 800mg.
Also: Ibuprofen Chewable Tablets OTC
Ibuprofen 50mg, 100mg; citrus flavor; contains phenylalanine.
Indications: Rheumatoid arthritis (RA). Osteoarthritis (OA). Juvenile arthritis (JRA).
Adults: RA, OA: 400-800mg 3-4 times daily; max 3.2g/day.
Children: JRA: 30-40mg/kg per day in 3-4 doses. May use 20mg/kg per day in 3-4 doses for milder disease.
Contraindications: Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgeiy.
Warnings/Precautions: Advanced renal disease: not recommended. History of upper GI disease. Active peptic ulcer. Impaired renal or hepatic function. Edema. Hypertension. Cardiac failure.
Bleeding disorders. Diabetes. Monitor blood, hepatic, renal, and ocular function in chronic use. Discontinue if visual or liver dysfunction occurs. Dehydration. Elderly. Debilitated. Pregnancy
(Cat.C). Nursing mothers: not recommended.
Interactions: Avoid aspirin. May increase bleeding with anticoagulants. Increases serum lithium levels. May increase toxicity of methotrexate. May decrease effect of furosemide, thiazide diuretics.
Increased risk of GI bleed with alcohol.
Adverse reactions: Peptic ulcer or perforation, GI bleeding, vision disorders, nausea, epigastric pain, heartburn, dizziness, rash (discontinue if occurs), edema, renal papillary necrosis, jaundice,
hepatitis. See literature re: risk of cardiovascular events. How supplied: Contact supplier.
Indomethacin (various) Rx
NSAID (indole deriv.). Indomethacin 25mg, 50mg; caps.
Also: Indomethacin Suppositories Rx
Indomethacin 50mg; rectal supp.
Also: INDOCIN SUSPENSION Iroko Rx
Indomethacin 25mg/5mL; pineapple-coconut mint flavor; alcohol 1%.
Indications: Moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Acute painful shoulder. Gouty arthritis.
Adults: Give with food or antacids. Use lowest effective dose. Acute painful shoulder: 75-150mg/day in 3-4 divided doses until inflammation controlled (usually 7-14 days). Acute gouty arthritis:
50mg 3 times daily until pain tolerable; then rapidly reduce dose to discontinue. Other conditions: initially 25mg 2-3 times daily. Increase if needed at weekly intervals by 25-50mg daily; max
200mg daily.
Children: <14yrs: usually not recommended. If risk warranted, give with food or antacids; [greater than or equal to] 2 yrs: 1-2mg/kg/day in divided doses; max 3-4mg/kg/day (or 150-200mg/day
whichever less).
Also: Indomethacin ER Rx
Indomethacin 75mg; ext-rel caps.
Indications: Moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Acute painful shoulder.
Adults: Give with food or antacids. Use lowest effective dose. Acute painful shoulder: 75-150mg/day (150mg dose: give as 75mg twice daily) until inflammation controlled (usually 7-14 days).
Other conditions: initially 75mg once daily; may increase to 75mg twice daily if tolerated; max 150mg/day.

Children: <14yrs: not recommended.


Contraindications: Aspirin allergy. Coronary artery bypass graft surgery. Supp: history of proctitis or recent rectal bleeding.
Warnings/Precautions: Advanced renal disease: not recommended. History of GI lesions. Impaired renal or hepatic function.
Heart failure. Hypertension. Edema. Sepsis. Volume depletion. Preexisting asthma. Epilepsy. Depression. Parkinsonism. Bleeding disorders. Monitor blood, hepatic, renal, and ocular function in
chronic use; monitor hepatic function in children. Discontinue if liver dysfunction occurs. Elderly. Debilitated. Pregnancy (Cat.C); avoid in late pregnancy. Nursing mothers: not recommended.
Interactions: Avoid salicylates, other NSAIDs, triamterene. Potentiated by diflunisal. Potentiates digoxin (monitor). Probenecid increases plasma levels. Increases serum lithium levels. Diuretics,
[beta]-blockers, ACE inhibitors (eg, captopril), angiotensin II antagonists (eg, losartan): reduced antihypertensive effect. Caution with cyclosporine, oral anticoagulants, methotrexate; monitor.
Adverse reactions: GI ulcers, bleeding or perforation, headache, nausea, dyspepsia, drowsiness, dizziness, edema, rash (discontinue if occurs), corneal deposits, retinopathy, hepatotoxicity,
nephritis, nephrotic syndrome. See literature re: risk of cardiovascular events. Supp: rectal irritation, tenesmus.
Generic availability: Caps, ER, supps (YES); susp (NO)
How supplied: Caps, ER, supps--contact supplier. Susp--237mL
MOBIC Boehringer Ingelheim Rx
NSAID (oxicam deriv.). Meloxicam 7.5mg, 15mg; tabs.
Also: MOBIC ORAL SUSPENSION Rx
Meloxicam 7.5mg/5mL; raspberry flavor.
Indications: Osteoarthritis. Rheumatoid arthritis. Juvenile rheumatoid arthritis.
Adults: [greater than or equal to] 18yrs: 7.5mg once daily; max 15mg once daily. Hemodialysis: max 7.5mg/day.
Children: <2yrs: not recommended. JRA: [greater than or equal to] 2yrs: 0.125mg/kg (max 7.5mg) once daily.
Contraindications: Aspirin allergy. Coronary artery bypass graft surgery.
Warnings/Precautions: NSAIDs may increase risk of serious cardiovascular thrombotic events, MI, stroke; may be fatal. Monitor for GI ulcer/bleed (risk is increased if history of GI bleed or ulcer,
extended or high-dose NSAID therapy, smokers, alcoholics, or if patient is otherwise at high risk). Severe renal disease (CrCl [less than or equal to] 20mL/min): not recommended. Women with
difficulties conceiving or undergoing investigation of infertility: not recommended. Discontinue if liver dysfunction develops. Monitor hemoglobin or hematocrit if signs of anemia occur. Bleeding
disorders. Renal or hepatic dysfunction. Dehydration. Fluid retention. Heart failure. Hypertension. Asthma. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C; Cat.D starting 30 weeks
gestation). Nursing mothers: not recommended.
Interactions: Concomitant Kayexalate with Mobic oral suspension (sorbitol): not recommended; intestinal necrosis possible. Increased risk of GI bleed with aspirin, oral corticosteroids,
anticoagulants. May antagonize or increase risk of renal failure with ACE inhibitors, diuretics. Monitor warfarin (may increase INR). May potentiate lithium. May enhance toxicity of
methotrexate, cyclosporine; use caution.
Adverse reactions: GI upset, anemia, headache, rash (discontinue if occurs), dizziness, edema, pruritus, GI ulcer/bleed, upper respiratory tract infections, elevated liver enzymes. Children:
abdominal pain, pyrexia. Generic availability: Tabs (YES); susp (NO) How supplied: Tabs--100; Susp--100mL
MOTRIN IB OTC
McNeil Consumer Healthcare
NSAID (propionic acid deriv.) Ibuprofen 200mg; gelcaps; caplets; tabs.
Indications: Minor arthritic pain.
Adults: 200-400mg every 4-6 hrs; max 1.2g/day.
Children: Use suspension form.
Contraindications: Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: GI, hepatic, renal disease. Dehydration. Pregnancy. Nursing mothers: not recommended.
Interactions: Avoid aspirin, other pain relievers. Increased risk of GI bleed with alcohol. Adverse reactions: GI upset, GI bleed, rash (discontinue if occurs). See literature re: risk of cardiovascular
events.
Generic availability: YES
How supplied: Gelcaps--24, 50, 100 Caplets--24, 50, 100, 165, 200 Tabs--24, 50, 100, 165
NAPRELAN Alvogen Rx
NSAID (arylacetic acid deriv.). Naproxen (as sodium) 375mg, 500mg, 750mg; controlled rel tabs.
Indications: Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Acute gout. Tendinitis. Bursitis.
Adults: Rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis: 750mg-1g once daily; max 1.5g once daily. Acute tendonitis or bursitis: 1g once daily, or 1.5g once daily for a limited
period; max 1g/day thereafter. Gout: 1-1.5g once daily for 1 day then 1g once daily until attack subsides.
Children: Not recommended.
Contraindications: Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Active peptic ulcer. History of GI disease. Impaired renal or hepatic function. Heart failure. Edema. Hypertension. Pre-existing
asthma. Bleeding disorders. Monitor blood, ocular, and liver function in chronic use. Discontinue if liver dysfunction occurs. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not
recommended.
Interactions: Avoid aspirin. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). Monitor oral anticoagulants. May antagonize
diuretics, antihypertensives. Increased renal toxicity with ACE inhibitors. Methotrexate excretion reduced. Increases lithium levels. Increased risk of GI bleed with alcohol.
Adverse reactions: GI upset, bleeding, or ulceration; headache, flu syndrome, constipation, abdominal pain, dizziness, paresthesias, insomnia, rash (discontinue if occurs), edema, hyperglycemia,
arthralgia, myalgia, renal dysfunction, blood dyscrasias, others. See literature re: risk of cardiovascular events.

Generic availability: NO
How supplied: Tabs 375mg--100; 500mg--75; 750mg--30; Dose card (10-day therapy)--20 (750mg x 6 tabs + 500mg x 14 tabs)
NAPROSYN Roche Rx
NSAID (arylacetic acid deriv.). Naproxen 250mg, 375mg, 500mg; tabs.
Also: NAPROSYN SUSPENSION Rx
Naproxen 125mg/5mL; pineapple-orange flavor.
Indications: Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Juvenile rheumatoid arthritis (JRA). Tendinitis. Bursitis. Acute gout.
Adults: Arthritis, spondylitis: 250-500mg twice daily; max 1.5g/day (up to 6 months). Tendinitis, bursitis: 500mg once, then 500mg twice daily or 250mg every 6-8 hrs; max (first day) 1.25g, then
max 1g/day. Acute gout: 750mg once, then 250mg every 8 hrs.
Children: <2yrs: not recommended. [greater than or equal to] 2yrs: JRA: 5mg/kg twice daily. Other uses: Doses of 2.5-5mg/kg/dose, max 15mg/kg/day have been used.
Also: EC-NAPROSYN Rx
Naproxen 375mg, 500mg; e-c tabs.
Indications: Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. JRA. Adults: Swallow whole. 375-500mg twice daily.
Children: <2yrs: not recommended. [greater than or equal to] 2yrs: use susp form.
Contraindications: Aspirin allergy. Coronaiy artery bypass graft surgery.
Warnings/Precautions: Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI adverse events (eg, bleeding, ulceration, perforation). Advanced renal disease:
not recommended. Active peptic ulcer. History of GI or inflammatory bowel disease. Impaired renal or hepatic function. Hypovolemia. Heart failure. Salt depletion. Edema. Hypertension.
Preexisting asthma. Bleeding disorders. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C); avoid in late pregnancy. Nursing mothers: not
recommended.
Interactions: Avoid concomitant aspirin. May potentiate protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Monitor oral anticoagulants. Increased risk of GI bleeding with oral
corticosteroids, SSRIs, smoking, alcohol. May antagonize diuretics, [beta]-blockers, ACEIs, ARBs or other antihypertensives. Increased renal toxicity with ACEIs or ARBs. Methotrexate
excretion reduced. Increases serum lithium levels. Probenecid increases plasma levels and delays elimination. Concomitant [H.sub.2] blockers, sucralfate, intensive antacid therapy: use immediaterelease forms of naproxen. Cholestyramine may delay absorption.
Adverse reactions: GI bleeding, peptic ulcer, constipation, heartburn, abdominal pain, nausea, headache, dizziness, drowsiness, pruritus, rash (discontinue if occurs), tinnitus, edema, nephritis,
nephrotic syndrome, jaundice, hepatitis. See full labeling re: risk of cardiovascular or GI events.
Generic availability: YES
How supplied: Tabs--100; Susp--pt; EC--100
NEORAL Novartis Rx
DMARD (immunosuppressant). Cyclosporine (modified) 25mg, 100mg; caps; contains alcohol.
Also: NEORAL ORAL SOLUTION Rx
Cyclosporine (modified) 100mg/mL; contains alcohol.
Indications: Severe, active rheumatoid arthritis unresponsive to methotrexate alone.
Adults: Give consistently with regard to meals and time of day. [greater than or equal to] 18yrs: 1.25mg/kg twice daily; may increase by 0.5-0.75mg/kg per day after 8 weeks and again after 12
weeks; max 4mg/kg per day (many patients on concomitant methotrexate can be treated with doses of 3mg/kg per day or less). Dilute soln in a glass of room temp orange or apple juice. Reduce
dose by 25-50% if adverse events (eg, hypertension or serum creatinine increases [greater than or equal to] 30% above baseline) occur. Renal or severe hepatic impairment: consider reducing dose.
Discontinue if adverse events are severe or persistent, or if no benefit by week 16.
Children: <18yrs: not established.
Contraindications: Renal impairment. Uncontrolled hypertension. Malignancies.
Warnings/Precautions: Be fully familiar with immunosuppressive therapy before prescribing. Not bioequivalent to all other forms of cyclosporine; do not interchange without physician
supervision. Increased risk of infections, lymphomas and other malignancies (eg, skin). Avoid sun or UV light exposure. Monitor renal and hepatic function, BP, CBC, serum magnesium,
potassium, uric acid, lipids (see full labeling for monitoring frequency). Reduce dose if hypertension occurs; do not attempt to manage medically. Elderly. Pregnancy (Cat.C). Nursing mothers: not
recommended.
Interactions: Avoid other nephrotoxic drugs (eg, ciprofloxacin, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus,
NSAIDs, colchicine), fibric acid derivatives. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azithromycin, azole antifungals, erythromycin,
clarithromycin, quinupristin/dalfopristin, boceprevir, telaprevir, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide; probably indinavir, saquinavir, nelfinavir,
ritonavir, imatinib, nefazodone, oral contraceptives). Avoid alcohol, grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, oxcarbazepine,
bosentan, phenobarbital, phenytoin, octreotide, ticlopidine, St. John's wort), orlistat. Avoid potassium-sparing diuretics. Concomitant repaglinide: monitor blood glucose. Concomitant aliskiren: not
recommended. Concomitant sirolimus: separate by 4 hours. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin (monitor), colchicine,
prednisolone, statins (reduce dose), ambrisentan, and anthracycline antibiotics. Gingival hyperplasia with nifedipine (avoid). Convulsions with high-dose methylprednisolone.
Adverse reactions: Renal dysfunction, hypertension, headache, GI disturbances, hirsutism, hypertrichosis, leg cramps, pain, tremor, paresthesia, edema, dizziness, gum hyperplasia, liver
dysfunction; increased risk of infections or malignancies, progressive multifocal leukoencephalopathy, hyperkalemia, thrombotic microangiopathy, possible encephalopathy.
Generic availability: YES
How supplied: Caps--30; Soln--50mL
PENNSAID Mallinckrodt Rx
NSAID (benzeneacetic acid deriv.). Diclofenac sodium 1.5%; topical soln.
Indications: To treat signs/symptoms of osteoarthritis of the knee(s).
Adults: Apply to clean, dry skin. Initially dispense 10 drops; spread evenly around front, back and sides of the knee; repeat until 40 drops have been applied and knee is completely covered with
solution. Usual dose: 40 drops/knee 4 times daily. Wash hands. Wait until area is diy before skin-to skin contact, dressing, or applying other topical products (eg, sunscreen, insect repellent, lotion,

moisturizer, cosmetics, medications).


Children: Not established.
Also: PENNSAID 2% Rx
Diclofenac sodium 2% (delivers 20mg per pump actuation); topical soln.
Adults: Apply to clean, dry skin. Prime pump prior to 1st use. Apply 40mg (2 pump actuations) evenly around front, back and sides of the knee. Usual dose: 40mg/knee 2 times daily. Wash hands.
Wait until area is dry before dressing or applying other topical products (eg, sunscreen, insect repellent, lotion, moisturizer, cosmetics, medications).
Children: Not established.
Contraindications: Aspirin or other NSAIDs allergy. Coronary artery bypass graft surgery.
Warnings/Precautions: Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI adverse events (eg, inflammation, bleeding, ulceration, perforation). History of
ulcer disease or Gl bleeding; monitor. Advanced renal disease: not recommended. Hepatic or renal dysfunction. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic and renal function
in long-term therapy. Measure ALT and/or AST within 4-8 wks after starting and periodically in long-term therapy. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal
liver or renal tests persist or worsen. Hypertension; monitor BP. Fluid retention. CHF. Dehydration. Do not apply to open wounds, infections, inflammations, exfoliative dermatitis. Discontinue if
rash or hypersensitivity occurs. Pre-existing asthma. Avoid eyes, mucous membranes, heat application, occlusive dressings, exercise, sunlight. Not a substitute for corticosteroids or to treat
corticosteroid insufficiency.
May mask signs of noninfectious, painful conditions. Use lowest effective dose for the shortest possible duration. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30wks gestation;
Cat.D: [greater than or equal to] 30wks gestation); avoid. Nursing mothers: not recommended.
Interactions: Avoid concomitant aspirin or oral NSAIDs. Increased risk of GI bleed with anticoagulants (monitor), oral corticosteroids, smoking, alcohol, or prolonged NSAID therapy. May
antagonize ACE inhibitors, diuretics; monitor closely. Caution with lithium or methotrexate; monitor for toxicity. Increased nephrotoxicity with cyclosporine; monitor renal function. Caution with
concomitant hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).
Adverse reactions: Application site reactions (dry skin, contact dermatitis, pruritus, vesicles), dyspepsia, abdominal pain, nausea, diarrhea, constipation, flatulence; edema, rash (may be serious; eg,
exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), anemia, anaphylactoid reactions, elevated AST/ALT, renal papillary necrosis and other renal injury (long-term use).
See full labeling: risk of cardiovascular and GI events.
Generic availability: NO
How supplied: Soln 1.5%--150mL; Pump 2%--112g
PLAQUENIL Covis Rx
DMARD (aminoquinoline). Hydroxychloroquine sulfate 200mg; tabs.
Indications: Refractory rheumatoid arthritis or lupus erythematosus.
Adults: Rheumatoid arthritis: initially 400-600mg daily with food or milk. Lupus: initially 400mg 1-2 times daily. Maintenance for both: 200-400mg daily.
Children: Not recommended.
Contraindications: Long-term use in children. Retinal or visual field changes.
Warnings/Precautions: Be fully familiar with this product's toxicity before use. Psoriasis. Porphyria. Hepatic dysfunction. Alcoholism. G6PD deficiency. Monitor ocular function, reflexes, and
blood in chronic use. Discontinue if blood dyscrasias, visual symptoms or muscular weakness occur or if ineffective after 6 months in rheumatoid arthritis. Pregnancy: not recommended. Nursing
mothers.
Interactions: Avoid other hepatotoxic or dermatotoxic drugs.
Adverse reactions: Irreversible retinopathy, blurred vision, corneal edema or deposits, visual field defects, irritability, neuromuscular dysfunction, hair bleaching, alopecia, pruritus, skin
pigmentation, rash, blood dyscrasias, anorexia, nausea, weight loss.
Generic availability: YES How supplied: Tabs--100
RHEUMATREX Stada Rx
DMARD (folic acid antagonist). Methotrexate sodium 2.5mg; unit-of-use weekly dose pack; scored tabs.
Indications: Severe recalcitrant rheumatoid arthritis or polyarticular-course juvenile rheumatoid arthritis.
Adults: Initially 7.5mg once per week as a single dose, or a course of three 2.5mg doses at 12-hour intervals once per week; max 20mg/week. May give test dose first. Children: <2yrs: not
recommended.
[greater than or equal to] 2yrs: initially 10mg/[m.sup.2] once weekly; max 20mg/[m.sup.2] per week.
Contraindications: Immunodeficiency. Blood dyscrasias. Alcoholism. Chronic liver disease. Pregnancy (Cat.X). Nursing mothers.
Warnings/Precautions: Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest
X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1-2 months, more often if increasing dose or predisposed to
toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at
least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal
impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or
discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Interactions: Avoid other hepatotoxic drugs, live virus vaccines. Caution with nephrotoxic agents. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid,
penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics, folic acid antagonists. Impaired response to immunization. May potentiate theophylline.
Antagonized by folic acid. Radiotherapy increases risk of soft tissue necrosis, osteonecrosis. Recall reactions after UV radiation.
Adverse reactions: Elevated liver enzymes, nausea, vomiting, stomatitis, thrombocytopenia, rash, pruritus, dermatitis, diarrhea, alopecia, leukopenia, pancytopenia, dizziness, hepatoxicity, bone
marrow suppression, GI toxicity, fibrosis, cirrhosis, tumor lysis syndrome, fatal skin reactions, opportunistic infections, cough, chest lesions.
Generic availability: YES
How supplied: Tabs 2.5mg (4-card dose pack)--5mg/week, 7.5mg/week, 10mg/week, 12.5mg/week, 15mg/week
TYLENOL ARTHRITIS OTC
McNeil Consumer Healthcare Analgesic/antipyretic. Acetaminophen 650mg; ext-rel caplets, geltabs.

Indications: Minor arthritic pain.


Adults: Swallow whole. >18yrs: 1.3g eveiy 8 hrs; max 4g/day; usual max 10 days. Children: [less than or equal to] 18yrs: not recommended.
Warnings/Precautions: Hepatic dysfunction. Pregnancy. Nursing mothers.
Interactions: Hepatotoxicity risk increased by chronic, heavy alcohol use.
Adverse reactions: Hepatotoxicity (overdosage).
Generic availability: NO
How supplied: Caplets--24, 50, 100, 150, 225; Geltabs--20, 40, 80
VIMOYO Horizon Pharma Rx
NSAID + proton pump inhibitor. Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; delayedrelease tabs.
Indications: Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to improve signs/symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric
ulcers.
Adults: Swallow whole. Take at least 30 mins before meals. [greater than or equal to] 18yrs: One 375mg/20mg or 500mg/20mg tab twice daily. Use lowest effective dose for the shortest duration.
Consider dose reduction in mild-to-moderate hepatic impairment.
Children: <18yrs: not established.
Contraindications: Aspirin allergy/triad. Coronary artery bypass surgery.
Warnings/Precautions: Increased risk of serious cardiovascular thrombotic events, MI, stroke, GI adverse events (bleeding, ulceration, perforation); may be fatal. Moderate-to-severe renal
impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease).
Hypertension; monitor BP. CHF. Edema. Bleeding disorders. Pre-existing asthma. Volume depleted. Impaired renal or hepatic function. Monitor blood, liver, and renal function in chronic use.
Discontinue if liver or renal dysfunction, acute interstitial nephritis, bleeding, or serious rash occurs. Gastric malignancy. Long-term therapy may lead to malabsorption/deficiency of Vit.
[B.sub.12] or atrophic gastritis. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term
therapy. May mask inflammation and fever. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation, Cat.D [greater than or equal to] 30 weeks gestation; avoid). Labor & delivery, infertility:
not recommended. Nursing mothers.
Interactions: Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: not recommended. Avoid concomitant nonaspirin NSAIDs or other naproxen-containing drugs. May potentiate
saquinavir (monitor; consider reducing saquinavir dose). May affect other protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Increases lithium and tacrolimus levels. Antagonizes
clopidogrel; consider alternative anti-platelets. Methotrexate excretion reduced (caution w. high doses). May antagonize diuretics, beta-blockers (eg, propranolol), ACEIs, ARBs. Increased renal
toxicity with cyclosporine, ACEIs, ARBs, diuretics. Increased risk of GI bleed with oral corticosteroids, smoking, alcohol, SSRIs. Monitor aspirin and oral anticoagulants. May affect CYP2C19
substrates (eg, diazepam), cilostazol (consider reducing dose), voriconazole. May affect absorption of pH-dependent drugs (eg, ketoconazole, erlotinib, mycophenolate mofetil, digoxin, iron salts).
Probenecid increases plasma levels and delays elimination. Delayed absorption with concomitant cholestyramine. May interfere with 5HIAA urinary assays and neuroendocrine diagnostic tests;
discontinue esomeprazole 14 days prior to CgA level assessment.
Adverse reactions: Gastritis, diarrhea, GI ulcers, upper abdominal pain, nausea, dyspepsia; renal papillary necrosis; rare: hypomagnesemia or Vit. [B.sub.12] deficiency (w. prolonged PPI therapy);
see full labeling re: risk of cardiovascular events, serious GI events, possible C. difficile-associated diarrhea.
Generic availability: NO
How supplied: Tabs--60
VOLTAREN GEL Endo Rx
NSAID (benzeneacetic acid deriv) Diclofenac sodium 1%; gel.
Indications: Relief of the pain of osteoarthritis of joints amenable to topical treatment (eg, knees, hands).
Adults: Use dosing card to apply gel. Lower extremities (eg, knees, ankles, feet): Apply 4g to the affected area 4 times daily; max: 16g/day. Upper extremities (eg, elbows, wrists, hands): Apply 2g
to the affected area 4 times daily; max: 8g/day. Total max dose over all affected joints: 32g/day. Do not wash treated hands for at least 1hr after application. Wait at least 10 minutes after
application before getting dressed. Use on spine, hip, or shoulder has not been evaluated.
Children: Not recommended.
Contraindications: Aspirin allergy. Late pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Do not apply to open wounds, infections, inflammations, exfoliative dermatitis. Avoid eyes, mucous membranes, external heat
and/or occlusive dressings, sunlight. Peptic ulcer. GI bleed. Asthma. CHF. Edema. Hypertension; monitor BP Monitor blood, hepatic, renal function in long-term use; discontinue if toxicity
develops. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Avoid concomitant topical products and medications (eg, sunscreens, cosmetics, lotions, moisturizers, insect repellents). Increased risk of GI effects with aspirin, oral NSAIDs,
corticosteroids, anticoagulants, alcohol, smoking. May antagonize diuretics, ACE-Inhibitors. Monitor for toxicity with lithium, methotrexate, cyclosporine. Caution with drugs that potentiate
hepatotoxicity (eg, antibiotics, antiepileptics).
Adverse reactions: Application site reactions (dermatitis, pruritus, erythema, paresthesia, dryness, vesicles, irritation);
GI bleed/ulceration, edema, rash (may be serious; eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactoid reactions, elevated AST/ALT. See literature re:
risk of cardiovascular events.
Generic availability: NO
How supplied: Gel--100g
VOLTAREN-XR Novartis Rx
NSAID (benzeneacetic acid deriv.) Diclofenac sodium 100mg; ext-rel tabs.
Indications: Chronic therapy of osteoarthritis or rheumatoid arthritis.
Adults: Osteoarthritis: 100mg once daily. Rheumatoid arthritis: 100mg once daily; rarely 100mg twice daily may be used.
Children: Not recommended.

Also: Diclofenac Sodium Delayed- Rx Release Tablets (various)


Diclofenac sodium 25mg, 50mg, 75mg; e-c tabs.
Indications: Acute or chronic therapy of osteoarthritis or rheumatoid arthritis. Ankylosing spondylitis.
Adults: Osteoarthritis: 50mg 2-3 times daily or 75mg twice daily. Rheumatoid arthritis: 50mg 3-4 times daily or 75mg twice daily. Ankylosing spondylitis: 25mg 4 times daily, with an additional
25mg at bedtime if necessary.
Children: Not recommended.
Contraindications: Aspirin allergy. Late pregnancy. Coronary artery bypass graft surgery.
Warnings/Precautions: Advanced renal disease: not recommended. Peptic ulcers and GI bleeding. Check SGPT/SGOT within 4 weeks and then periodically. Edema. Cardiac failure. Hypertension.
Bleeding disorders. Renal impairment. Hepatic porphyria. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not
recommended.
Interactions: Digoxin, methotrexate, cyclosporine, lithium toxicity. Hyper- and hypoglycemia with insulin and sulfonylureas. Reduced effect of diuretics. Increased serum potassium level with K+
sparing diuretics. Avoid aspirin. Monitor oral anticoagulants.
Adverse reactions: Peptic ulcers, GI bleeding, elevated SGPT or SGOT levels, anaphylactoid reactions, abdominal discomfort, constipation, diarrhea, indigestion, nausea, abdominal distention,
headache, dizziness, fluid retention, rash (discontinue if occurs), pruritus, tinnitus. See literature re: risk of cardiovascular events.
Generic availability: YES
How supplied: XR--100; Tabs--contact supplier
XELJANZ Pfizer Rx
Janus kinase (JAK) inhibitor. Tofacitinib 5mg; tabs.
Indications: Moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX); may be used as monotherapy or in
combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Adults: 5mg twice daily. Moderate-to-severe renal impairment or moderate hepatic impairment; concomitant potent CYP3A4 inhibitors, or drugs that result in both moderate CYP3A4 and potent
CYP2C19 inhibition: 5mg once daily. Concomitant potent CYP3A4 inducers: not recommended. Dose adjustments: see full labeling.
Children: Not established.
Warnings/Precautions: Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Active, serious, or localized infections: do not initiate
therapy. Chronic or history of recurring or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB
infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), or reactivation of herpes virus occurs; interrupt treatment if serious or
opportunistic infection, or sepsis develops. Known malignancy. History of GI perforations. Monitor lymphocytes at baseline, then every 3 months; neutrophils and hemoglobin at baseline, after 4-8
weeks, then every 3 months thereafter. Do not initiate therapy if lymphocytes <500cells/[mm.sup.3], ANC <1000cells/[mm.sup.3], or hemoglobin <9g/dL. Severe hepatic impairment: not
recommended. Routinely monitor liver enzymes; interrupt therapy if drug-induced liver injury suspected. Monitor lipids 4-8 weeks following initiation. Perform periodic skin exam in those with
skin cancer risk. Diabetes. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. Interactions: Concomitant live vaccines, biologic DMARDs or potent immunosuppressants (eg,
azathioprine, cyclosporine): not recommended.
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole), or drugs that result in both moderate CYP3A4 and potent CYP2C19 (eg, fluconazole) inhibition. Antagonized by potent CYP3A4
inducers (eg, rifampin); see Adults.
Adverse reactions: Upper respiratory tract infections, headache, diarrhea, nasopharyngitis; serious or opportunistic infections, TB, malignancies (eg, lymphoma), cytopenias, liver enzyme or lipid
elevations, non-melanoma skin cancer.
Generic availability: NO
How supplied: Tabs--28, 60, 180
ZORVOLEX Iroko Rx
NSAID (benzeneacetic acid derivative). Diclofenac 18mg, 35mg; hard gelatin caps. Indications: Osteoarthritis pain.
Adults: Use lowest effective dose for the shortest duration. Take on empty stomach. [greater than or equal to] 18yrs: 35mg three times daily. Hepatic impairment: start at lowest dose; discontinue if
efficacy is not achieved.
Children: <18yrs: not established.
Contraindications: Aspirin or other NSAID allergy. Coronaiy artery bypass graft surgery.
Warnings/Precautions: Not interchangeable to other forms of oral diclofenac. Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI adverse events (eg,
inflammation, bleeding, ulceration, perforation). History of ulcer disease or GI bleeding. Fluid retention. Heart failure. Hypertension; monitor BP closely. Advanced renal disease: not
recommended. Pre-existing asthma. Hepatic or renal dysfunction. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic and renal function in longterm therapy. Measure ALT and/or
AST within 4-8 weeks after starting and periodically in long-term therapy. Discontinue if signs/ symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen.
Dehydration. May mask signs of infection or painful conditions. Discontinue if rash or other signs of hypersensitivity occur. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks
gestation); (Cat.D: [greater than or equal to] 30 weeks gestation; avoid). Nursing mothers.
Interactions: Avoid concomitant aspirin. Increased risk of GI bleed with anticoagulants (monitor), oral corticosteroids, smoking, alcohol, or prolonged NSAID therapy. May antagonize ACE
inhibitors, diuretics; monitor closely. Caution with lithium or methotrexate; monitor for toxicity. Increased nephrotoxicity with cyclosporine; caution. May affect or be affected by CYP2C9
inhibitors or substrates. Caution with concomitant hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).
Adverse reactions: Edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, ALT/creatinine increase, dyspepsia;
anemia, cardiovascular events, GI ulcers, hepatotoxicity, hypertension, renal papillary necrosis, rash.
Generic availability: NO
How supplied: Caps--30, 90
Source Citation (MLA 7th Edition)
"8A Arthritis/rheumatic disorders." MPR Pharmacists' Edition Fall 2015: 118+. PowerSearch. Web. 23 Sept. 2015.
URL
http://go.galegroup.com/ps/i.do?id=GALE%7CA428275792&v=2.1&u=kpt07217&it=r&p=GPS&sw=w&asid=a9d259ad0b89885fb261381b7ea15071

Gale Document Number: GALE|A428275792

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