mesalamine rectal (Rx)

Brand and Other Names:Canasa, Rowasa
  • Print

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
Next:

Adverse Effects

1-10%

Dizziness (3%)

Rectal pain (1.8%)

Fever (1.2%)

Rash (1.2%)

Acne (1.2%)

Colitis (1.2%)

Previous
Next:

Warnings

Contraindications

Hypersensitivity to mesalamine or salicylates

Active PUD

Severe renal failure

Breastfeeding

Rectal suspension: history of sulfite hypersensitivity

Adolescents with chicken pox or flu-like symptoms (risk of Reye syndrome)

Cautions

Sulfasalazine hypersensitivity, renal insufficiency, 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, and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required

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 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

Previous
Next:

Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk, caution advised

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.

Previous
Next:

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
Previous
Next:

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.

Previous
Next:

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.

Previous
Next:

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.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.