Canasa
(Mesalamine)Dosage & Administration
The recommended dosage of CANASA
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Canasa Prescribing Information
CANASA is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
The recommended dosage of CANASA
- Evaluate renal function prior to initiation of CANASA therapy [see Warnings and Precautions (5.1Renal Impairment
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity
[see Adverse Reactions (6.2), Nonclinical Toxicology (13.2)].Evaluate renal function prior to initiation of CANASA and periodically while on therapy.
Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Discontinue CANASA if renal function deteriorates while on therapy
[see Drug Interactions (7.1), Use in Specific Populations (8.6)].)]. - Do not cut or break the suppository.
- Retain the suppository for one to three hours or longer, if possible.
- Drink an adequate amount of fluids [see Warnings and Precautions (5.000000000000000e+007Nephrolithiasis
Cases of nephrolithiasis have been reported with the 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 with CANASA.
)] - If a dose of CANASA is missed, administer as soon as possible, unless it is almost time for next dose. Do not use two CANASA suppositories at the same time to make up for a missed dose.
- CANASA suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep CANASA away from these surfaces to prevent staining.
CANASA Suppository: 1000 mg mesalamine in a bullet shaped, light tan to grey suppository.
Clinical trials of CANASA did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as CANASA who were 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with CANASA. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing CANASA
CANASA is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle
Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to CANASA 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 CANASA if an alternative etiology for the signs and symptoms cannot be established.
The following adverse reactions have been identified during post-approval use of CANASA or other mesalamine-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Body as a Whole:drug fever, fatigue, lupus-like syndrome, medication residue
- Cardiac Disorders:myocarditis, pericarditis, pericardial effusion[see Warnings and Precautions (5.3)]
- Endocrine:Nephrogenic diabetes insipidus
- Eye disorders: eye swelling
- GastrointestinalDisorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting
- HepaticDisorders:cholestatic jaundice, hepatitis, jaundice, Kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure
- HematologicDisorders:agranulocytosis, aplastic anemia, thrombocytopenia
- Neurological/PsychiatricDisorders:Guillain-Barre syndrome, peripheral neuropathy, transverse myelitis, intracranial hypertension
- Renal Disorders:interstitial nephritis, renal failure, minimal change disease, nephrolithiasis[see Warnings and Precautions (5.1,5.7)]Urine discoloration occurring ex-vivo caused by contact of mesalamine, including inactive metabolite, with surfaces or water treated with hypochlorite containing bleach
○ - Respiratory, Thoracic and Mediastinal Disorders:hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis), pleuritis/pleurisy
- Skin andSubcutaneousTissueDisorder:alopecia, erythema, erythema nodosum, pruritus, psoriasis,pyoderma gangrenosum, urticaria, SJS/TEN, DRESS and AGEP[see Warnings and Precautions (5.5)]
- Urogenital:reversible oligospermia
The active ingredient in CANASA 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each CANASA rectal suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF.
The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is:
- RenalImpairment:Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue CANASA if renal function deteriorates. (,5.1Renal Impairment
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity
[see Adverse Reactions (6.2), Nonclinical Toxicology (13.2)].Evaluate renal function prior to initiation of CANASA and periodically while on therapy.
Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Discontinue CANASA if renal function deteriorates while on therapy
[see Drug Interactions (7.1), Use in Specific Populations (8.6)].,7.1Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory DrugsThe concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions
[see Warnings and Precautions (5.1)].)8.6Renal ImpairmentMesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on CANASA therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. Discontinue CANASA if renal function deteriorates while on therapy
[seeWarnings and Precautions (5.1),Adverse Reactions(6.2),Drug Interactions (7.1)]. - Mesalamine-Induced Acute Intolerance Syndrome:Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. ()5.2Mesalamine-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, malaise, pruritus, conjunctivitis, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with CANASA.
- Hypersensitivity Reactions, including Myocarditis and Pericarditis:Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ()5.3Hypersensitivity Reactions
Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to CANASA 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 CANASA if an alternative etiology for the signs and symptoms cannot be established.
- Hepatic Failure:Evaluate the risks and benefits in patients with known liver impairment. ()5.4HepaticFailure
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
- Severe Cutaneous Adverse Reactions:Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ()5.5Severe 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) have been reported in association with the use of mesalamine
[see Adverse Reactions (6.2)].Discontinue CANASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. - Photosensitivity:Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ()5.6Photosensitivity
In patients treated with mesalamine or sulfasalazine who have pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
- Nephrolithiasis:Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ()5.000000000000000e+007Nephrolithiasis
Cases of nephrolithiasis have been reported with the 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 with CANASA.
- Interaction with Laboratory Test for Urinary Normetanephrine:Spuriously elevated test results may occur with liquid chromatography with electrochemical detection in patients receiving CANASA; use alternative, selective assay for normetanephrine. ()5.000000000000000e+008Interactionwith Laboratory Test for Urinary Normetanephrine
Use of mesalamine may lead to spuriously 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-acetylaminosalicylic acid. Consider an alternative, selective assay for normetanephrine.