mesalamine rectal (Rx)

Brand and Other Names:Canasa, Rowasa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

rectal suppository

  • 1g (Canasa)

rectal suspension enema

  • 4g/60mL (Rowasa)

Active Ulcerative Colitis

Indicated for treatment of active, mild-to-moderate distal ulcerative colitis, including ulcerative proctosigmoiditis and ulcerative proctitis

Rowasa: 60 mL PR qHS for 3-6 weeks, retain for 8 hr

Ulcerative Proctitis

Indicated for treatment of active ulcerative proctitis

Canasa: Insert one (1 g) rectal suppository PR qHS for 3-6 weeks, retain for 1-3 hr or longer if possible

Other Indications & Uses

Off-label: Crohn disease

Safety and efficacy not established

Ulcerative Colitis (Orphan)

Canasa: Treatment of pediatric ulcerative colitis

Orphan indication sponsor

  • Axcan Pharma US, Inc; 22 Iverness Parkway; Birmingham, AL 35242
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Adverse Effects

1-10%

Dizziness (3%)

Rectal pain (1.8%)

Fever (1.2%)

Rash (1.2%)

Acne (1.2%)

Colitis (1.2%)

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Warnings

Contraindications

Hypersensitivity to mesalamine, excipients, salicylates, or aminosalicylates

Cautions

Use caution in patients with coagulation abnormalities, pyloric stenosis

Rare instances of pericarditis reported with mesalamine containing products; investigate any chest pain or dyspnea

Acute intolerance syndrome characterized by cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache, and a rash; monitor patients for worsening of these symptoms while on treatment; if acute intolerance syndrome suspected, promptly discontinue treatment

Follow instruction for use for rectal suppository and enema

For maximum benefit, retain rectal suppository for 1-3 hr; retain rectal suspension for 8 hr

Hepatic failure may occur, particularly with pre-existing liver disease who have been administered other products containing mesalamine; evaluate risks and benefits of using this product in patients with known 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

Consider monitoring complete blood cell counts and platelet counts in elderly patients during treatment, especially if used concomitantly with anticoagulants; in general, consider greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing therapy

Cases of nephrolithiasis reported with use of mesalamine, including stones of 100% mesalamine content; mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT); ensure adequate hydration during treatment

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

Renal impairment

  • Renal impairment, including minimal change disease, acute, and chronic interstitial nephritis, and renal failure, reported in patients given products that contain mesalamine or are converted to mesalamine; in animal studies, the kidney was the principal organ of mesalamine toxicity
  • Evaluate renal function prior to initiation of therapy and periodically while on therapy; evaluate risks and benefits of using this drug in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs

Hypersensitivity reactions

  • Hypersensitivity reported in patients taking sulfasalazine; some patients may have a similar reaction to this product or to other compounds that contain or are converted to mesalamine
  • As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities
  • Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present; discontinue this product if an alternative etiology for signs and symptoms cannot be established

Severe Cutaneous Adverse Reactions

  • 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 in association with use of this drug
  • Discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation
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Pregnancy & Lactation

Pregnancy

Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk

Animal data

  • 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

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

The lack of clinical data during lactation precludes a clear determination of the risk to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from the drug or from underlying maternal conditions

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 [5-ASA]) is the active component of sulfasalazine; specific MOA unknown, but thought to inhibit prostaglandin, TNF, and leukotriene synthesis/release in colon

Absorption

Suspension enema: Poor systemic absorption

Rectal suppository: Systemic absorption 15-38%

Peak plasma concentration: 353 ng/mL (mean concentration after 6 days)

Metabolism

Active drug, 5-aminosalicylic acid (5-ASA), is rapidly acetylated in colon wall and liver, independent of patient acetylator status, into N-acetyl-5-aminosalicylic acid (inactive)

Elimination

Half-life

  • Rectal: 1.5-5 hr
  • Metabolite (N-acetyl-5-salycylic acid): 6 hr

Excretion

  • Suspension enema: Principally excreted in feces during subsequent bowel movements; 10-30% in urine
  • Suppository: 80-90% in urine as metabolite
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Images

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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
mesalamine rectal

MESALAMINE (5-AMINOSALICYLIC ACID) ENEMA - RECTAL

(mess-AL-uh-meen)

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 provided by your pharmacist before you start using mesalamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Use this medication rectally once daily at bedtime, or as directed by your doctor. Dosage is based on your medical condition and response to therapy.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.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.A product that may interact with this drug is: dichlorphenamide.This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory 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.Laboratory and/or medical tests (such as kidney and liver function tests) should be performed regularly to monitor your progress or check for side effects. 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 April 2022. Copyright(c) 2022 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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.