Mesalamine (rectal)

Mesalamine (rectal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Mesalamine (rectal) is an anti-inflammatory that is FDA approved for the treatment of mild to moderately active ulcerative proctitis. Common adverse reactions include dizziness,rectal pain, fever,acne and colitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• CANASA 1000 mg suppositories are indicated for the treatment of mild to moderately active ulcerative proctitis. Safety and effectiveness of Canasa beyond 6 weeks have not been established.

Dosage

• The dosage of CANASA 1000 mg suppositories is one rectal suppository once daily at bedtime.

• The suppository should be retained for one to three hours or longer, if possible. The usual course of therapy is from three to six weeks depending on symptoms and sigmoidoscopic findings.

• If a patient misses a dose of CANASA, it should be administered as soon as possible, unless it is almost time for next dose. Patients should not use two CANASA suppositories at the same time to make up for a missed dose.

DOSAGE FORMS AND STRENGTHS

• CANASA 1000 mg suppositories for rectal administration are available as bullet shaped, light tan to grey suppositories containing 1000 mg mesalamine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mesalamine (rectal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mesalamine (rectal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Mesalamine (rectal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mesalamine (rectal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mesalamine (rectal) in pediatric patients.

Contraindications

• CANASA suppositories are contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin).

Warnings

Renal Impairment

• Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiation of CANASA therapy and periodically while on therapy. Exercise caution when using CANASA in patients with known renal dysfunction or a history of renal disease. In animal studies, the kidney was the principal organ for toxicity .

Mesalamine-Induced Acute Intolerance Syndrome

• Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with CANASA.

Hypersensitivity Reactions

• Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to CANASA tablets or to other compounds that contain or are converted to mesalamine.

• Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with CANASA and other mesalamine medications. Caution should be taken in prescribing CANASA to patients with hypersensitivity to 5-ASA products.

Hepatic Impairment

• There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Caution should be exercised when administering CANASA to patients with liver disease.

Drug-Laboratories Test Interactions

• There have been several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.

Adverse Reactions

Clinical Trials Experience

• The most serious adverse reactions seen in CANASA clinical trials or with other products that contain or are metabolized to mesalamine are:

• Renal impairment, including renal failure
• Mesalamine-induced acute intolerance syndrome
• Hypersensitivity reactions
• Hepatic impairment, including hepatic failure

Clinical Trials Experience

• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• The most frequent adverse reactions observed in the double-blind placebo-controlled trials are summarized in the Table 1 below.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Mesalamine (rectal) in the drug label.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mesalamine (rectal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mesalamine (rectal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mesalamine (rectal) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Mesalamine (rectal) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Mesalamine (rectal) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Mesalamine (rectal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mesalamine (rectal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mesalamine (rectal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mesalamine (rectal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mesalamine (rectal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mesalamine (rectal) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Mesalamine (rectal) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Mesalamine (rectal) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Mesalamine (rectal) in the drug label.

Pharmacology

There is limited information regarding Mesalamine (rectal) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Mesalamine (rectal)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Mesalamine (rectal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mesalamine (rectal) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Mesalamine (rectal) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Mesalamine (rectal) in the drug label.

How Supplied

Storage

There is limited information regarding Mesalamine (rectal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Mesalamine (rectal) in the drug label.

Precautions with Alcohol

• Alcohol-Mesalamine (rectal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CANASA ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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