Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine extended-release capsules, USP are supplied as shown in the table: Strength Description Supplied As NDC Number 500 mg extended-release capsules, USP are hard gelatin having dark blue cap and body with “ RL36 ” printed on both cap and body in black ink containing off-white to light yellowish brown to dark yellowish brown colored pellets. bottles of 120 capsules NDC 63304-089-13 (with child-resistant closure) Store at 20 ° C to 25 ° C (68 ° F to 77 ° F). [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.; Package/Label Display Panel NDC 63304-089-13 Mesalamine Extended-Release Capsules, USP 500 mg Rx only 120 Capsules SUN PHARMA image description
- 16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine extended-release capsules, USP are supplied as shown in the table: Strength Description Supplied As NDC Number 500 mg extended-release capsules, USP are hard gelatin having dark blue cap and body with “ RL36 ” printed on both cap and body in black ink containing off-white to light yellowish brown to dark yellowish brown colored pellets. bottles of 120 capsules NDC 63304-089-13 (with child-resistant closure) Store at 20 ° C to 25 ° C (68 ° F to 77 ° F). [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.
- Package/Label Display Panel NDC 63304-089-13 Mesalamine Extended-Release Capsules, USP 500 mg Rx only 120 Capsules SUN PHARMA image description
Overview
Mesalamine extended-release capsules, USP for oral administration are an extended-release formulation of mesalamine, USP, an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name benzoic acid, 5-amino-2-hydroxy. It has a molecular weight of 153.14. The structural formula is: Each 500 mg mesalamine extended-release capsule, USP contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, colloidal silicon dioxide, diacetylated monoglyceride, ethylcellulose, hypromellose, stearic acid, sugar spheres (corn starch and sucrose), talc, and white wax. The capsule shell contains FD&C Blue 1, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains ferrosoferric oxide, potassium hydroxide, and shellac. Meets USP dissolution Test 4. image description
Indications & Usage
Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. Mesalamine extended-release capsules are an aminosalicylate indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. (1)
Dosage & Administration
Evaluate renal function prior to initiation of mesalamine extended-release capsules and periodically while on therapy [see Warnings and Precautions (5.1)] . Recommended Dosage The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis in adults is 1 g (2 mesalamine extended-release 500 mg capsules) administered orally four times daily. Administration Instructions Swallow mesalamine extended-release capsules whole; do not crush or chew. Alternatively, the capsule(s) may be opened and the entire contents sprinkled onto applesauce or yogurt. Consume the entire mixture immediately. Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7)] . Evaluate renal function prior to initiation of mesalamine extended-release capsules and periodically while on therapy. (2, 5.1) The recommended dosage is 1 g administered orally four times daily. (2) Swallow capsules whole; do not crush or chew. (2) Alternatively, the capsule(s) may be opened and the contents sprinkled onto applesauce or yogurt. (2) Drink an adequate amount of fluids. (2, 5.7)
Warnings & Precautions
• Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of mesalamine in patients with known renal impairment or taking nephrotoxic drug. Discontinue mesalamine if renal function deteriorates while on therapy. (5.1, 7.1, 8.6) • Mesalamine-Induced Acute Intolerance Syndrome: Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. (5.2) Hypersensitivity Reactions, including myocarditis and pericarditis : Discontinue mesalamine if a hypersensitivity reaction is suspected. (5.3) Hepatic Failure: Evaluate the risks and benefits of using mesalamine 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 : Avoid sun exposure if pre-existing skin conditions. (5.6) Nephrolithiasis: Cases of nephrolithiasis have been reported with the use of mesalamine. Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. (5.7) Interference with Laboratory Tests: Mesalamine may lead to elevated urinary normetanephrine test results. (5.8) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given mesalamine or other products that contain mesalamine or are converted to mesalamine. Evaluate the risks and benefits of using mesalamine in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Evaluate renal function in all patients prior to initiation and periodically while on therapy with mesalamine. Discontinue mesalamine if renal function deteriorates while on therapy [see Drug Interactions (7.1), 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. Symptoms include cramping, acute abdominal pain, bloody diarrhea, and 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 mesalamine. 5.3 Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine 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 mesalamine 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 other products containing mesalamine. Evaluate the risks and benefits of using mesalamine in patients with known liver impairment. 5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, such as 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 with the use of mesalamine [see Adverse Reactions (6.2)] . Discontinue mesalamine 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 hydration during treatment with mesalamine. 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 because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
Contraindications
Mesalamine extended-release capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or any ingredients of mesalamine extended-release capsules [see Warnings and Precautions (5.3)] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine extended-release capsules. (4, 5.3)
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the 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)] Most common adverse reactions are nausea and vomiting (1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. More than 2,100 patients were exposed to mesalamine in clinical trials of ulcerative colitis or another gastrointestinal condition. The most common adverse reactions (i.e., greater than or equal to 1%) were diarrhea (3%), headache (2%), nausea (2%), abdominal pain (2%), dyspepsia (2%), vomiting (2%), and rash (1%). The safety of mesalamine was evaluated in two randomized, double-blind, placebo-controlled, dose-response trials (UC-1 and UC-2) of 624 patients with mildly to moderately active ulcerative colitis for up to 8 weeks of treatment [see Clinical Studies (14)] . The most common adverse reaction was nausea and vomiting: 1% in the mesalamine group (N = 451) and 0% in the placebo group (N = 173). Withdrawal from therapy due to adverse reactions was 7% in the mesalamine group and 4% in the placebo group. The following adverse reactions, presented by body system, were reported in less than 1% of patients in UC-1, UC-2, and clinical trials for another gastrointestinal condition. Blood and lymphatic system disorders: thrombocythemia, thrombocytopenia Cardiac Disorders: palpitations, pericarditis, vasodilation Gastrointestinal Disorders: abdominal distention, constipation, duodenal ulcer, dysphagia, eructation, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, pancreatitis, rectal bleeding, stool abnormalities (color or texture change) General disorders and administration site conditions: fever, malaise Infections and infestations: oral moniliasis, conjunctivitis Investigations: GGTP increase, increased alkaline phosphatase, LDH increase, SGOT increase, SGPT increase, lipase increase, amylase increase Metabolism and nutritional disorders: anorexia, edema, thirst Musculoskeletal and connective tissue disorders: arthralgia, leg cramps, myalgia Nervous System Disorders: dizziness, insomnia, somnolence, paresthesia Psychiatric disorders: depression, asthenia Renal and urinary disorders: albuminuria, hematuria, urinary frequency Reproductive system and breast disorders: amenorrhea, breast pain, hypomenorrhea, menorrhagia, metrorrhagia Respiratory, Thoracic and Mediastinal Disorders: pulmonary infiltrates, one week after completion of an 8-week ulcerative colitis study, a 72-year-old male, with no previous history of pulmonary problems, developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis obliterans with organizing pneumonitis by a second physician. Skin and Subcutaneous Tissue Disorders: acne, alopecia, dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, pruritus, sweating, urticaria, ecchymosis, lichen planus 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of mesalamine. 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. Cardiac Disorders: chest pain, fatal myocarditis, pericarditis, T-wave abnormalities Hematologic Disorders: agranulocytosis, anemia, aplastic anemia, leukopenia, pancytopenia Hepatic Disorders: cirrhosis, jaundice, including cholestatic jaundice; hepatotoxicity, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome which included hepatic function changes was also reported. Immune System Disorders: anaphylactic reaction, angioedema, lupus-like syndrome, systemic lupus erythematosus Nervous System Disorders: intracranial hypertension Renal and Urinary Disorders: acute renal failure, chronic renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis, nephrotic syndrome [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 Reproductive System and Breast Disorders: reversible oligospermia Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis), interstitial lung disease, pleurisy/pleuritis, pneumonitis Skin and Subcutaneous Tissue Disorders: AGEP, DRESS, SJS/TEN [see Warnings and Precautions (5.5)]
Drug Interactions
Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs) : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. (7.1) Azathioprine or 6-Mercaptopurine: Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. (7.2) 7.1 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)] . 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of mesalamine and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference with Urinary Normetanephrine Measurements Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.8)] . Consider an alternative, selective assay for normetanephrine.
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