* 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.
* Dosing Information
==Dosage==
:* Dosage
* The dosage of CANASA 1000 mg suppositories is one rectal suppository once daily at bedtime.
=====Condition2=====
* 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.
* Dosing Information
* 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
==DOSAGE FORMS AND STRENGTHS==
=====Condition3=====
* CANASA 1000 mg suppositories for rectal administration are available as bullet shaped, light tan to grey suppositories containing 1000 mg mesalamine.
* Dosing Information
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
:* Dosage
=====Condition4=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|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).
|offLabelPedNoGuideSupport======Condition1=====
|warnings='''Renal Impairment'''
* Dosing Information
* 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 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.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
'''Hypersensitivity Reactions'''
<!--Contraindications-->
* 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.
|contraindications=* Condition1
<!--Warnings-->
* 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.
|warnings=* Description
====Precautions====
'''Hepatic Impairment'''
* Description
* 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.
<!--Adverse Reactions-->
'''Drug-Laboratories Test Interactions'''
<!--Clinical Trials Experience-->
* 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.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
Line 196:
Line 79:
=====Cardiovascular=====
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* CANASA ®<ref>{{Cite web | title = mesalamine suppository | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89d91601-152b-4398-bebe-af1c023e9935 }}</ref>
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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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
There is limited information regarding Clinical Trial Experience of Mesalamine (rectal) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Mesalamine (rectal) in the drug label.