apriso
Apriso (Mesalamine) is an aminosalicylate used to treat Ulcerative Colitis, Proctitis, Sigmoid Diseases.
Mesalamine · by Salix
Available as a generic: Mesalamine
Key facts
- Active ingredient
- Mesalamine
- Drug class
- Aminosalicylate
- Form
- Capsule, extended release
- Strength
- Mesalamine 375MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ulcerative colitis, proctitis, sigmoid diseases
- Manufacturer
- Salix
- Half-life
- about 7 to 9 hours (apparent terminal half-life) (how long it stays in your system)
- What the pharmacy pays
- ~$26.72 for 30 — not your price
- FDA application
- NDA022301
What is Apriso?
From the FDA label:Each APRISO ® capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine. Chemical Structure
How to use
Dosage The recommended dosage in adults is 1.5 g (four 0.375 g capsules) orally once daily in the morning. Administration Instructions Evaluate renal function before initiating therapy with APRISO [see Warnings and Precautions ( 5.1 )]. Swallow APRISO capsules whole. Do not cut, break, crush or chew the capsules. Avoid co-administration of APRISO with antacids [see Drug Interactions ( 7.1 )]. Drink an adequate amount of fluids [see Warnings and Precautions ( 5.7 )]. Take APRISO without regard to meals [see Clinical Pharmacology ( 12.3 )]. Dosage The recommended dosage is 1.5 g (four 0.375 g capsules) once daily in the morning. ( 2 ) Administration Instructions Evaluate renal function before initiating therapy with APRISO. ( 2 ) Swallow the capsules whole. Do not cut, break, crush or chew the capsules. ( 2 ) Avoid co-administration with antacids. ( 2 , 7.1 ) Drink an adequate amount of fluids. ( 2 , 5.7 ) Take APRISO without regard to meals. ( 2 )
Side effects
The following clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [see Warnings and Precautions ( 5.1 )] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Hepatic Failure [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions ( 5.6 )] Nephrolithiasis [see Warnings and Precautions ( 5.7 )] Risks in Patients with Phenylketonuria [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥3%) are: headache, diarrhea, upper abdominal pain, nausea, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies 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 data described below reflect exposure to APRISO in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO was studied in two placebo-controlled trials (n=367 treated with…
Warnings
Important safety information
Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue if renal function deteriorates. ( 5.1 , 7.2 , 8.6 ) 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. ( 5.2 ) Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment. ( 5.4 ) 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. ( 5.5 ) Photosensitivity : Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 ) Nephrolithiasis: Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment. ( 5.7 ) Risks in Patients with Phenylketonuria : Contains phenylalanine. Before prescribing APRISO to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including APRISO. ( 5.8 ) Interference with Laboratory Tests : Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. ( 5.9 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as APRISO 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 APRISO therapy and periodically while on therapy. Evaluate the risks and benefits of using APRISO in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Discontinue APRISO if renal function deteriorates while on therapy [see Drug Interactions ( 7.2 ), Use in Specific Populations ( 8.6 )] . 5.2 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, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO. 5.3 Hypersensitivity Reactions Some patients have experienced a hypersensitivity reaction to sulfasalazine. Some patients may have a similar reaction to APRISO 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 APRISO if an alternative etiology for the signs and symptoms cannot be established. 5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits of using APRISO in patients with known liver impairment. 5.5 Severe 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 with the use of mesalamine [see Adverse Reactions (6.2) ] . Discontinue APRISO at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 Photosensitivity Patients with 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. 5.7 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with APRISO. 5.8 Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). APRISO contains phenylalanine, a component of aspartame. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine. Before prescribing APRISO to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including APRISO. 5.9 Interference with Laboratory Tests Use of APRISO 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 the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
Who should not take Apriso
APRISO is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of APRISO capsules [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 ), Description ( 11 )] . Known or suspected hypersensitivity to salicylates, aminosalicylates, or any component of APRISO capsules. ( 4 , 5.3 )
Overdose — what happens if you take too much
APRISO is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function. APRISO is a pH-dependent delayed-release product and this factor should be considered when treating a suspected overdose.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Nephrotoxic Agents including NSAIDs: Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.2 ) Azathioprine or 6-Mercaptopurine: Increased risk of blood disorders; monitor complete blood cell counts and platelet counts. ( 7.3 ) 7.1 Antacids Because the dissolution of the coating of the granules in APRISO capsules depends on pH, avoid co-administration of APRISO capsules with antacids [see Dosage and Administration (2) ] . 7.2 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal 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 )]. 7.3 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of APRISO and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.4 Interference with Urinary Normetanephrine Measurements Use of APRISO may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions ( 5.9 )] . Consider an alternative, selective assay for normetanephrine.
How long does Mesalamine stay in your body?
The elimination half-life of mesalamine is about 7 to 9 hours (apparent terminal half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent TERMINAL (elimination) half-life of mesalamine (5-ASA) itself, from the delayed-release tablet label after 2.4 g and 4.8 g doses; the per-dose table gives terminal-phase means of 8.56 h (1.2 g), 7.05 h (2.4 g) and 7.25 h (4.8 g), with very large between-person variability (standard deviations of 5-8 hours). Metabolite: the label reports the apparent terminal half-life of the major metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), as 8 to 12 hours — longer than the parent. Mesalamine suppository labels describe N-Ac-5-ASA as "the active metabolite," so the active material can persist somewhat longer than the parent figure alone suggests. Timing caveat: these are delayed-release oral products designed to release drug in the terminal ileum and colon, so absorption is slow and highly variable (median Tmax ~9-24 h depending on product, longer with a high-fat meal) — plasma drug can still be rising many hours after the dose, and the half-life alone does not describe how long drug is present. Older adults: increased age slows apparent elimination — terminal half-life averaged 5.68 h in subjects 18-35 vs 9.68 h at 65-75 and 8.67 h at 75+, with roughly 2-fold higher Cmax. Kidney impairment: the label states systemic exposure is inversely correlated with renal function (lower creatinine clearance, higher exposure); mesalamine is cleared mainly by the kidney as N-Ac-5-ASA. Liver impairment: this label does not state a hepatic-impairment half-life. Mesalamine is not a prodrug (it is the active moiety; sulfasalazine and balsalazide are prodrugs of it). Not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Mesalamine delayed-release tablets — FDA label, 12.3 Pharmacokinetics (DailyMed, Camber Pharmaceuticals, eff. 2024-02-15).
Drug class
How this class works, per Mesalamine (USAN) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Apriso ranks — best-rated aminosalicylate for:
Dosage forms
Capsule, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Apriso treat?
- Apriso (Mesalamine) may be used to treat ulcerative colitis, proctitis, sigmoid diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Apriso work?
- Apriso is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.
- How much does Apriso cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $26.72 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Azulfidine En-Tabs — about $5.92 on the same basis.
- Is there a coupon or discount for Apriso?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Apriso. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Apriso?
- Apriso is marketed by Salix. You can see Salix's full profile, rating, and other products on pharmaranks.
- Is Apriso a brand-name or generic drug?
- Apriso is a brand-name product with the active ingredient Mesalamine. Lower-cost generic equivalents containing Mesalamine are available — ask your pharmacist.
- Is Apriso available over the counter?
- No. Apriso is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Apriso come in?
- Apriso is currently marketed as capsule, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Apriso?
- Apriso is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
- Is Apriso FDA-registered?
- Apriso is on record with the U.S. FDA under application number NDA022301. You can verify this on its official FDA label.
- Is Apriso safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Apriso. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Apriso?
- Apriso's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [see Warnings and Precautions ( 5.1 )] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] H… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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