mesalamine (Rx)

Brand and Other Names:Asacol HD, Pentasa, more...Delzicol, Lialda, Apriso
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, extended-release

  • 250mg (Pentasa)
  • 375mg (Apriso)
  • 500mg (Pentasa)

tablet, delayed-release

  • 400mg (Asacol)
  • 800mg (Asacol HD)
  • 1.2g (Lialda)

capsule, delayed-release

  • 400mg (Delzicol)

Ulcerative Colitis

Remission induction of active, mild to moderate disease

  • Asacol HD: 1.6 g PO three times daily
  • Delzicol: 800 mg PO three times daily 1 hr ac or 2 hr pc
  • Lialda: 2.4-4.8 g PO qDay with meal up to 8 weeks
  • Pentasa: 1 g PO four times daily for 8 weeks

Remission maintenance

  • Apriso: 1.5 g PO qDay in am
  • Delzicol: 1.6 g/day PO in divided doses 1 hr ac or 2 hr pc
  • Asacol: 1.6 g/day PO in divided doses 1 hr ac or 2 hr pc
  • Lialda: 2.4 g PO qDay with food
  • Pentasa: 1 g/day PO four times daily for up to 8 weeks

Crohn Disease (Off-label)

Remission induction of active, mild-to-moderate disease

Asacol HD: 1.6 g three times daily

Lialda: 2.4-4.8 g PO qDay with meal for up to 8 weeks

Pentasa: 1 g PO four times daily for 8 weeks

Dosage Forms & Strengths

tablet, delayed-release

  • 400mg (Asacol)
  • 1.2g (Lialda)

capsule, delayed-release

  • 400mg (Delzicol)

Ulcerative Colitis

≥5 years (Asacol or Delzicol)

  • Indicated for mildly to moderately active ulcerative colitis in children aged ≥5 yr
  • Duration of treatment: 6 weeks
  • 17 to <33 kg: 36-71 mg/kg/day PO divided twice daily; not to exceed 1.2 g/day
  • 33 to <54 kg: 37-61 mg/kg/day PO divided twice daily; not to exceed 2 g/day
  • 54 to 90 kg: 27-44 mg/kg/day PO divided twice daily; not to exceed 2.4 g/day

≥24 kg (Lialda)

  • Indicated for mildly to moderately active ulcerative colitis in children weighing ≥24 kg
  • Week 0 to 8
    • 24 to 35 kg: 2.4 g PO qDay
    • >35 to 50 kg: 3.6 g PO qDay
    • >50 kg: 4.8 g PO qDay
  • After Week 8
    • 24 to 35 kg: 1.2 g PO qDay
    • >35 kg: 2.4 g PO qDay
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Interactions

Interaction Checker

and mesalamine

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            Contraindicated (0)

              Serious - Use Alternative (9)

              • dexlansoprazole

                dexlansoprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • esomeprazole

                esomeprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • lansoprazole

                lansoprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • measles, mumps, rubella and varicella vaccine, live

                mesalamine, measles, mumps, rubella and varicella vaccine, live. Mechanism: unspecified interaction mechanism. Avoid or Use Alternate Drug. Risk of Reye's Syndrome with combination; avoid salicylate use for 6 wks after vaccination.

              • nizatidine

                nizatidine will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • omeprazole

                omeprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • pantoprazole

                pantoprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • rabeprazole

                rabeprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

              • varicella virus vaccine live

                mesalamine, varicella virus vaccine live. Mechanism: unspecified interaction mechanism. Avoid or Use Alternate Drug. Risk of Reye's Syndrome with combination; avoid salicylate use for 6 wks after vaccination.

              Monitor Closely (50)

              • aceclofenac

                mesalamine, aceclofenac. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • acemetacin

                mesalamine, acemetacin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • acetazolamide

                acetazolamide, mesalamine. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

                acetazolamide, mesalamine. Mechanism: passive renal tubular reabsorption due to increased pH. Use Caution/Monitor. Salicylate levels increased at moderate doses; risk of CNS toxicity. Salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • aspirin

                mesalamine, aspirin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • aspirin rectal

                mesalamine, aspirin rectal. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • aspirin/citric acid/sodium bicarbonate

                mesalamine, aspirin/citric acid/sodium bicarbonate. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • azathioprine

                mesalamine increases toxicity of azathioprine by Mechanism: unspecified interaction mechanism. Use Caution/Monitor. Increased risk for blood disorders.

              • brinzolamide

                brinzolamide, mesalamine. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

              • celecoxib

                mesalamine, celecoxib. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • choline magnesium trisalicylate

                mesalamine, choline magnesium trisalicylate. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • diclofenac

                mesalamine, diclofenac. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • didanosine

                didanosine decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Extended release mesalamine capsules should be given 1 hour before or 4 hours after administration of didanosine.

              • diflunisal

                mesalamine, diflunisal. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • etodolac

                mesalamine, etodolac. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • famotidine

                famotidine will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely.

              • fenbufen

                mesalamine, fenbufen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • fenoprofen

                mesalamine, fenoprofen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • flurbiprofen

                mesalamine, flurbiprofen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • griseofulvin

                griseofulvin decreases levels of mesalamine by unknown mechanism. Use Caution/Monitor.

              • ibuprofen

                mesalamine, ibuprofen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • ibuprofen IV

                mesalamine, ibuprofen IV. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • ibuprofen/famotidine

                ibuprofen/famotidine will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely.

              • indomethacin

                mesalamine, indomethacin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • ketoprofen

                mesalamine, ketoprofen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • ketorolac

                mesalamine, ketorolac. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • ketorolac intranasal

                mesalamine, ketorolac intranasal. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • lornoxicam

                mesalamine, lornoxicam. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • meclofenamate

                mesalamine, meclofenamate. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • mefenamic acid

                mesalamine, mefenamic acid. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • meloxicam

                mesalamine, meloxicam. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • methazolamide

                methazolamide, mesalamine. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

              • mycophenolate

                mesalamine will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • nabumetone

                mesalamine, nabumetone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • naproxen

                mesalamine, naproxen. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • oxaprozin

                mesalamine, oxaprozin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • parecoxib

                mesalamine, parecoxib. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • piroxicam

                mesalamine, piroxicam. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • pivmecillinam

                pivmecillinam, mesalamine. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • probenecid

                mesalamine will increase the level or effect of probenecid by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

                mesalamine decreases effects of probenecid by unknown mechanism. Use Caution/Monitor.

              • salicylates (non-asa)

                mesalamine, salicylates (non-asa). Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • salsalate

                mesalamine, salsalate. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • sodium zirconium cyclosilicate

                sodium zirconium cyclosilicate will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

              • sulfasalazine

                mesalamine, sulfasalazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • sulindac

                mesalamine, sulindac. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • temocillin

                temocillin, mesalamine. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • ticarcillin

                ticarcillin, mesalamine. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • tolfenamic acid

                mesalamine, tolfenamic acid. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • tolmetin

                mesalamine, tolmetin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive nephrotoxicity.

              • voclosporin

                voclosporin, mesalamine. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              • warfarin

                mesalamine decreases effects of warfarin by unknown mechanism. Use Caution/Monitor.

              Minor (90)

              • aceclofenac

                aceclofenac will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acemetacin

                acemetacin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acyclovir

                mesalamine will increase the level or effect of acyclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aluminum hydroxide

                aluminum hydroxide, mesalamine. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • aminohippurate sodium

                mesalamine will increase the level or effect of aminohippurate sodium by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin

                aspirin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin rectal

                aspirin rectal will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • balsalazide

                balsalazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • bendroflumethiazide

                bendroflumethiazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • budesonide

                budesonide decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • bumetanide

                mesalamine, bumetanide. Other (see comment). Minor/Significance Unknown. Comment: Salicylates are less likely than other NSAIDs to interact w/bumetanide.

              • calcium carbonate

                calcium carbonate, mesalamine. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • cefadroxil

                cefadroxil will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefamandole

                cefamandole will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefpirome

                cefpirome will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ceftibuten

                ceftibuten will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • celecoxib

                celecoxib will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cephalexin

                cephalexin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorothiazide

                chlorothiazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorpropamide

                mesalamine will increase the level or effect of chlorpropamide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                mesalamine increases effects of chlorpropamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • chlorthalidone

                chlorthalidone will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cortisone

                cortisone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • cyanocobalamin

                mesalamine decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cyclopenthiazide

                cyclopenthiazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • deflazacort

                deflazacort decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • dexamethasone

                dexamethasone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • diclofenac

                diclofenac will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • diflunisal

                diflunisal will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • entecavir

                mesalamine, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

              • ethanol

                ethanol increases toxicity of mesalamine by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI bleeding.

              • etodolac

                etodolac will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fenoprofen

                fenoprofen will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fludrocortisone

                fludrocortisone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • flurbiprofen

                flurbiprofen will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • folic acid

                mesalamine decreases levels of folic acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ganciclovir

                mesalamine will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • glimepiride

                mesalamine increases effects of glimepiride by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • glipizide

                mesalamine increases effects of glipizide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • glyburide

                mesalamine increases effects of glyburide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • hydrochlorothiazide

                hydrochlorothiazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • hydrocortisone

                hydrocortisone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • ibuprofen

                ibuprofen will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen IV

                ibuprofen IV will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indapamide

                indapamide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indomethacin

                indomethacin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • insulin aspart

                mesalamine increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin detemir

                mesalamine increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin glargine

                mesalamine increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin glulisine

                mesalamine increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin lispro

                mesalamine increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin NPH

                mesalamine increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin regular human

                mesalamine increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • ketoprofen

                ketoprofen will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac

                ketorolac will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac intranasal

                ketorolac intranasal will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • L-methylfolate

                mesalamine decreases levels of L-methylfolate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • lornoxicam

                lornoxicam will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meclofenamate

                meclofenamate will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mefenamic acid

                mefenamic acid will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meloxicam

                meloxicam will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methyclothiazide

                methyclothiazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methylprednisolone

                methylprednisolone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • metolazone

                metolazone will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • nabumetone

                nabumetone will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • naproxen

                naproxen will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • oxaprozin

                oxaprozin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • parecoxib

                parecoxib will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • piroxicam

                piroxicam will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • prednisolone

                prednisolone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • prednisone

                prednisone decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • rose hips

                rose hips will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                mesalamine decreases levels of rose hips by increasing renal clearance. Minor/Significance Unknown.

                rose hips increases levels of mesalamine by decreasing renal clearance. Minor/Significance Unknown.

              • salicylates (non-asa)

                salicylates (non-asa) will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salsalate

                salsalate will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sodium bicarbonate

                sodium bicarbonate, mesalamine. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • sodium citrate/citric acid

                sodium citrate/citric acid, mesalamine. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • sulfadiazine

                mesalamine increases levels of sulfadiazine by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfamethoxazole

                mesalamine increases levels of sulfamethoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfasalazine

                sulfasalazine will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulfisoxazole

                mesalamine increases levels of sulfisoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulindac

                sulindac will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolazamide

                mesalamine increases effects of tolazamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • tolbutamide

                mesalamine increases effects of tolbutamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • tolfenamic acid

                tolfenamic acid will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolmetin

                tolmetin will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

              • valganciclovir

                mesalamine will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • verapamil

                verapamil increases effects of mesalamine by unknown mechanism. Minor/Significance Unknown. Enhanced antiplatelet activity.

              • willow bark

                mesalamine will increase the level or effect of willow bark by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                willow bark increases effects of mesalamine by pharmacodynamic synergism. Minor/Significance Unknown. Willow bark contains salicylic acid, which may have additive effects/toxicity with salicylate drugs.

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              Adverse Effects

              1-10%

              Abdominal pain (4-8%)

              GI discomfort (4-8%)

              Headache (7%)

              Flatulence (1-6%)

              Nausea (1-6%)

              Fatigue (3%)

              Asthenia (3%)

              Malaise (3%)

              Weakness (3%)

              Fever (3%)

              Exacerbation of colitis (3%)

              Dizziness (2-3%)

              Rash (1-3%)

              Pruritus (1-3%)

              Acne (1-3%)

              Frequency Not Defined

              Pericarditis (rare)

              Pharyngitis

              Sensitivity reaction

              Cholestatic hepatitis

              Creatinine clearance decreased

              Flulike syndrome

              Discolored urine

              Renal Impairment

              Mesalamine-induced acute intolerance syndrome

              Hypersensitivity reactions

              Hepatic failure

              Postmarketing Reports

              Body as a whole: Lupus-like syndrome, drug fever

              Cardiac disorders: Pericarditis, pericardial effusion, myocarditis

              Gastrointestinal: Pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

              Hepatic: Jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

              Hematologic: Agranulocytosis, aplastic anemia, hepatotoxicity

              Immune system disorders: Anaphylactic reaction, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, toxic epidermal necrolysis (TEN)

              Musculoskeletal and connective tissue disorders: Myalgia

              Neurological/psychiatric: Peripheral neuropathy, Guillain-Barre syndrome, transverse myelitis, intracranial hypertension

              Renal disorders: Interstitial nephritis, renal failure, minimal change nephropathy, nephrogenic diabetes insipidus, nephrolithiasis

              Respiratory, thoracic and mediastinal disorders: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis), pleurisy/pleuritis

              Skin: Psoriasis, pyoderma gangrenosum, erythema nodosum, photosensitivity

              Urogenital: Reversible oligospermia

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              Warnings

              Contraindications

              Hypersensitivity to mesalamine or salicylates

              Breastfeeding

              Rectal suspension: Hypersensitivity to salicylates, aminosalicylates or to any ingredients in the suppository vehicle

              Children with chickenpox or flulike symptoms

              Cautions

              Sulfasalazine hypersensitivity, renal insufficiency, coagulation abnormalities, pyloric stenosis

              Use caution in active PUD, severe renal failure

              Do not use with lactulose or drugs that lower intestinal pH

              Although pericarditis rarely occurs, investigate any chest pain or dyspnea

              Oligospermia has been reported in males

              Hepatic failure may occur, particularly with preexisting liver impairment

              May lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetyl aminosalicylic acid; an alternative, selective assay for normetanephrine should be considered

              Worsening of colitis/IBD may occur following initiation of therapy

              Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, reported; cases of nephrolithiasis reported; mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT); ensure adequate fluid intake during treatment; evaluate renal function prior to initiation of therapy and periodically while on therapy

              Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function

              Acute intolerance syndrome may occur; symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritis, rash, conjunctivitis, and may be difficult to distinguish from an ulcerative colitis exacerbation; monitor for worsening symptoms; discontinue if acute intolerance syndrome suspected

              Hypersensitivity reactions, including myocarditis and pericarditis reported; evaluate patients immediately and discontinue if hypersensitivity reaction suspected

              Evaluate the risks and benefits in patients with known liver impairment

              Pyloric stenosis or other organic or functional obstruction in upper gastrointestinal tract may cause prolonged gastric retention of drug, which would delay mesalamine release in colon; avoid drug in patients at risk of upper gastrointestinal tract obstruction

              Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions; advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

              Phenylalanine can be harmful to patients with phenylketonuria (PKU); product contains phenylalanine, a component of aspartame; each 0.375 g capsule contains 0.56 mg of phenylalanine; before prescribing to a patient with PKU, consider combined daily amount of phenylalanine from all sources including this drug

              Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported with use of mesalamine; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

              Drug interaction overview

              • Concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase risk of nephrotoxicity; monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions
              • The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase risk for blood disorders, bone marrow failure, and associated complications; if concomitant use of drug and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts
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              Pregnancy & Lactation

              Pregnancy: Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk; no evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose

              Lactation: Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from underlying maternal conditions; mesalamine and its N-acetyl metabolite are present in human milk in undetectable to small amounts; there are limited reports of diarrhea in breastfed infants; there is no information on effects of drug on milk production; monitor breastfed infants for diarrhea

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Anti-inflammatory agent; mesalamine (5-aminosalicylic acid) is the active component of sulfasalazine, but specific MOA is unknown; probably inhibits prostaglandin and leukotriene synthesis and release in colon

              Absorption

              Bioavailability: Immediate-release is extensively and rapidly absorbed; extended-release 20-30% absorbed

              Onset: Improvement usually evident in 1 week-3 months

              Peak serum time: 4 hr (Apriso); 3 hr (Pentasa); 4-16 hr (Delzicol); 4-7 hr (rectal); 9-12 hr (Lialda); 8 hr (Mezavant); 4-12 hr (Asacol); 10-16 hr (Asacol HD)

              Distribution

              Protein bound: 43% (5-ASA); 78% (N-acetyl-5-ASA)

              Vd: 0.2 L/kg

              Metabolism

              Rapidly acetylated in colon wall and liver, independent of pt acetylator status, into N-acetyl-5-aminosalicylic acid

              Metabolites: N-acetyl-5-aminosalicylic acid (inactive)

              Elimination

              Half-life: 0.5-10 hr (5-ASA); 2-15 hr (N-acetyl-5-ASA )

              Excretion: Feces 72%; urine: 19-30%

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              Administration

              Instructions

              Apriso, Asacol HD: May take with or without food

              Delzicol: Take 1 hr before or 2 hr after meals

              Lialda: Take with food

              Do not substitute one Asacol HD 800 tablet for two mesalamine delayed-release 400 mg oral products

              Swallow whole; do not chew, break, or crush

              Patients unable to swallow tablet or capsule whole

              • Pentasa
                • Capsules may, alternatively, be opened and the entire contents sprinkled onto applesauce or yogurt
                • The entire contents should be consumed immediately; the capsules and capsule contents must not be crushed or chewed
              • Delzicol
                • For patients who are unable to swallow the capsules whole, carefully open the capsule(s) and swallow the contents (four 100 mg tablets)
                • Open the number of capsules required to make up a complete dose
                • There are 4 tablets per capsule; ensure all tablets per capsule are swallowed and no tablets are retained in the mouth
                • Swallow the tablets whole; do not cut, break, crush or chew the tablets
                • Intact, partially intact, and/or tablet shells have been reported in the stool; instruct patients to contact their physician if this occurs repeatedly
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              sfRowasa rectal
              -
              4 gram/60 mL enema
              sfRowasa rectal
              -
              4 gram/60 mL enema
              Canasa rectal
              -
              1,000 mg suppos
              mesalamine oral
              -
              0.375 gram capsule
              mesalamine oral
              -
              1.2 gram tablet
              mesalamine oral
              -
              800 mg tablet
              mesalamine oral
              -
              400 mg capsule
              mesalamine oral
              -
              400 mg capsule
              mesalamine oral
              -
              1.2 gram tablet
              mesalamine oral
              -
              1.2 gram tablet
              mesalamine oral
              -
              1.2 gram tablet
              mesalamine oral
              -
              0.375 gram capsule
              mesalamine rectal
              -
              1,000 mg suppos
              mesalamine rectal
              -
              1,000 mg suppos
              mesalamine rectal
              -
              4 gram/60 mL enema
              mesalamine rectal
              -
              4 gram/60 mL enema
              mesalamine rectal
              -
              4 gram/60 mL enema
              mesalamine rectal
              -
              4 gram/60 mL enema
              mesalamine rectal
              -
              1,000 mg suppos
              mesalamine rectal
              -
              1,000 mg suppos
              Delzicol oral
              -
              400 mg capsule
              Apriso oral
              -
              0.375 gram capsule
              Asacol HD oral
              -
              800 mg tablet
              Rowasa rectal
              -
              4 gram/60 mL enema
              Rowasa rectal
              -
              4 gram/60 mL enema
              Lialda oral
              -
              1.2 gram tablet
              Pentasa oral
              -
              250 mg capsule
              Pentasa oral
              -
              500 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              mesalamine oral

              MESALAMINE (5-AMINOSALICYLIC ACID)DELAYED-RELEASE TABS IN CAP-ORAL

              (me-SAL-a-meen)

              COMMON BRAND NAME(S): Delzicol

              USES: This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

              HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times daily.Swallow the capsule whole. Do not crush, chew, or break. Doing so can keep the drug from being released properly into the colon. If you have trouble swallowing the capsule, you may open the capsule and swallow the tablets found in the capsule. Do not cut, crush, chew, or break the tablets before swallowing. Be sure to swallow all of the tablets.Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones.The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. Different brands of this medication provide different amounts of medication. If you need to switch brands, ask your doctor how to do so safely.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition lasts or gets worse.

              SIDE EFFECTS: Stomach upset, nausea/vomiting, constipation, headache, or joint/muscle pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.You may sometimes see whole or partial tablets in your stool. If this happens often, tell your doctor. You may not be absorbing enough of the medication.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, mesalamine can worsen ulcerative colitis. Tell your doctor right away if your symptoms worsen after starting this medication (such as increased abdominal pain/cramping, bloody diarrhea, fever).Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine, blood in the urine), dark urine, nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, chest pain, shortness of breath.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking mesalamine, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as balsalazide, olsalazine); or to salicylates (such as aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach blockage (such as pyloric stenosis).This medication may make you more sensitive to the sun, especially if you have skin problems (such as atopic dermatitis, eczema). Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is similar to aspirin. Children and teenagers younger than 18 years should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking mesalamine increases the risk of Reye's syndrome, a rare but serious illness.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: dichlorphenamide.Mesalamine is very similar to balsalazide, olsalazine, and sulfasalazine. Do not use medications containing balsalazide, olsalazine, or sulfasalazine while using mesalamine.This medication may interfere with certain lab tests (such as urine normetanephrine levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing in the ears, confusion, rapid breathing, seizures.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. If your medication bottle comes with a desiccant, keep the desiccant in the bottle with the medication. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.