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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
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: 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,