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)
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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 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

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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.

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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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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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  • 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.
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