Dosing & Uses
Dosage Forms & Strengths
capsule, extended-release
- 250mg (Pentasa)
- 375mg (Apriso, generic)
- 500mg (Pentasa, generic)
tablet, delayed-release
- 1.2g (Lialda, generic)
capsule, delayed-release
- 400mg (Delzicol, generic)
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
Dosing Modifications
Renal impairment
- Renal function deteriorates while in therapy: Discontinue use
Dosage Forms & Strengths
tablet, delayed-release
- 1.2g (Lialda, generic)
capsule, delayed-release
- 400mg (Delzicol, generic)
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
Dosing Modifications
Renal impairment
- Renal function deteriorates while in therapy: Discontinue use
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 increases effects of warfarin by anticoagulation. 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.
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
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 renal function in all patients prior to initiation and periodically while on therapy; the risk of adverse reactions to this drug may be greater in patients with impaired renal function; mesalamine is known to be substantially excreted by the kidney; 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
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.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%
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Rowasa rectal - | 4 gram/60 mL enema |  | |
| Rowasa rectal - | 4 gram/60 mL enema |  | |
| Rowasa rectal - | 4 gram/60 mL enema |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 4 gram/60 mL enema |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 4 gram/60 mL enema |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine rectal - | 4 gram/60 mL enema |  | |
| mesalamine rectal - | 4 gram/60 mL enema |  | |
| mesalamine rectal - | 1,000 mg suppos |  | |
| mesalamine oral - | 800 mg tablet |  | |
| mesalamine oral - | 1.2 gram tablet |  | |
| mesalamine oral - | 1.2 gram tablet |  | |
| mesalamine oral - | 400 mg capsule |  | |
| mesalamine oral - | 1.2 gram tablet |  | |
| mesalamine oral - | 400 mg capsule |  | |
| mesalamine oral - | 0.375 gram capsule |  | |
| mesalamine oral - | 1.2 gram tablet |  | |
| mesalamine oral - | 0.375 gram capsule |  | |
| mesalamine oral - | 0.375 gram capsule |  | |
| Pentasa oral - | 500 mg capsule |  | |
| Pentasa oral - | 250 mg capsule |  | |
| Apriso oral - | 0.375 gram capsule | | |
| sfRowasa rectal - | 4 gram/60 mL enema |  | |
| sfRowasa rectal - | 4 gram/60 mL enema |  | |
| Delzicol oral - | 400 mg capsule | | |
| Lialda oral - | 1.2 gram tablet | | |
| Canasa rectal - | 1,000 mg suppos |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
mesalamine rectal
MESALAMINE (5-AMINOSALICYLIC ACID) ENEMA - RECTAL
(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)
COMMON BRAND NAME(S): Rowasa
USES: Mesalamine (also known as 5-aminosalicylic acid) is used to treat certain types of bowel disease (distal ulcerative colitis, proctosigmoiditis, proctitis). It does not cure these conditions, but it may relieve mild-to-moderate pain and decrease the frequency of diarrhea/bloody stools caused by irritation/swelling in the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using mesalamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication rectally as directed by your doctor, usually once daily at bedtime. The dosage is based on your medical condition and response to treatment.Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones.Visually inspect the contents of the bottle before use. The contents should be off-white to tan in color. A slight darkening of the medication is expected, but any enemas that turn dark brown should be discarded.This medication works best if you have a bowel movement before using it. Shake the bottle well. Holding the bottle at the neck, remove the cover from the applicator tip. Lie on your left side with your right knee bent. Insert the tip of the bottle into the rectum, pointing toward the navel. Gently and steadily squeeze out the entire contents of the bottle. Remove the bottle. Remain in position for 30 minutes. Throw away the empty bottle. Try to keep the medication in the rectum for 8 hours.This medication may stain surfaces that it touches (such as clothing, floor, and counter surfaces).Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.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, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor right away if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, severe/prolonged headache.Tell your doctor right away if you have any serious side effects, including: chest pain, shortness of breath, severe stomach/abdominal pain (especially if spreading to the back), yellowing eyes/skin, dark urine, signs of kidney problems (such as change in the amount of urine, blood in the urine).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: fever, swollen lymph nodes, 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 using 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 (such as sulfites), 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: asthma, kidney problems, liver disease, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis).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 just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about 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. Discuss the risks and benefits with 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.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: This medicine may be harmful if swallowed. 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.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver/kidney function) may be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use 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. Once the foil-wrapped unit of bottles is opened, use all enemas promptly as directed by your physician. 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 July 2023. Copyright(c) 2023 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.
Formulary
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