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Mesalamine
Overview
What is Mesalamine?
Mesalamine for oral administration is a controlled-release formulation of mesalamine, an aminosalicylate anti-inflammatory agent for gastrointestinal use. Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14.
The structural formula is:
Each 250 mg capsule contains 250 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains D and C Yellow #10, FD and C Blue #1, FD and C Green #3, gelatin, titanium dioxide, and other ingredients.
Each 500 mg capsule contains 500 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains FD and C Blue #1, gelatin, titanium dioxide, and other ingredients.
What does Mesalamine look like?
What are the available doses of Mesalamine?
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What should I talk to my health care provider before I take Mesalamine?
Sorry No records found
How should I use Mesalamine?
Mesalamine is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (4 Mesalamine 250 mg capsules or 2 Mesalamine 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration in controlled trials was up to 8 weeks.
What interacts with Mesalamine?
Mesalamine is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.
What are the warnings of Mesalamine?
Sorry No Records found
What are the precautions of Mesalamine?
General
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, 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. If acute intolerance syndrome is suspected, prompt withdrawal is required. If a rechallenge is performed later in order to validate the hypersensitivity, it should be carried out under close medical supervision at reduced dose and only if clearly needed.
Renal
What are the side effects of Mesalamine?
In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn's disease received Mesalamine therapy. Generally, Mesalamine therapy was well tolerated. The most common events (ie, greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).
In two domestic placebo-controlled trials involving over 600 ulcerative colitis patients, adverse events were fewer in Mesalamine-treated patients than in the placebo group (Mesalamine 14% vs placebo 18%) and were not dose-related. Events occurring at 1% or more are shown in the table below. Of these, only nausea and vomiting were more frequent in the Mesalamine group. Withdrawal from therapy due to adverse events was more common on placebo than Mesalamine (7% vs 4%).
Array
Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematological, liver, and kidney function.
The following adverse events, presented by body system, were reported infrequently (ie, less than 1%) during domestic ulcerative colitis and Crohn's disease trials. In many cases, the relationship to Mesalamine has not been established.
Gastrointestinal:
Dermatological:
Nervous System:
Cardiovascular:
Other:
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. A causal relationship between this event and mesalamine therapy has not been established.
Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with Mesalamine therapy.
Postmarketing Reports
Gastrointestinal:
Other:
What should I look out for while using Mesalamine?
Mesalamine is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.
What might happen if I take too much Mesalamine?
Single oral doses of mesalamine up to 5 g/kg in pigs or a single intravenous dose of mesalamine at 920 mg/kg in rats were not lethal.
There is no clinical experience with Mesalamine overdosage. Mesalamine is an aminosalicylate, and symptoms of salicylate toxicity may be possible, such as: tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting, and diarrhea. Severe intoxication with salicylates can lead to disruption of electrolyte balance and blood-pH, hyperthermia, and dehydration.
Treatment of Overdosage.
How should I store and handle Mesalamine?
Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Mesalamine controlled-release 250 mg capsules are supplied in bottles of 240 capsules (NDC 66993-410-24). Each green and blue capsule contains 250 mg of mesalamine in controlled-release beads. Mesalamine controlled-release capsules are identified with a pentagonal starburst logo and the number 2010 on the green portion and S429 250 mg on the blue portion of the capsules.Mesalamine controlled-release 500 mg capsules are supplied in bottles of 120 capsules (NDC 66993-411-32). Each blue capsule contains 500 mg of mesalamine in controlled-release beads. Mesalamine controlled-release capsules are identified with a pentagonal starburst logo and S429 500 mg on the capsules. Mesalamine controlled-release 250 mg capsules are supplied in bottles of 240 capsules (NDC 66993-410-24). Each green and blue capsule contains 250 mg of mesalamine in controlled-release beads. Mesalamine controlled-release capsules are identified with a pentagonal starburst logo and the number 2010 on the green portion and S429 250 mg on the blue portion of the capsules.Mesalamine controlled-release 500 mg capsules are supplied in bottles of 120 capsules (NDC 66993-411-32). Each blue capsule contains 500 mg of mesalamine in controlled-release beads. Mesalamine controlled-release capsules are identified with a pentagonal starburst logo and S429 500 mg on the capsules.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sulfasalazine is split by bacterial action in the colon into sulfapyridine (SP) and mesalamine (5-ASA). It is thought that the mesalamine component is therapeutically active in ulcerative colitis. The usual oral dose of sulfasalazine for active ulcerative colitis in adults is 2 to 4 g per day in divided doses. Four grams of sulfasalazine provide 1.6 g of free mesalamine to the colon.
The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, ie, prostanoids, and through the lipoxygenase pathways, ie, leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs), is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostagladin (PG) production in the colon.
Human Pharmacokinetics and Metabolism
Absorption.
Plasma mesalamine concentration peaked at approximately 1 mcg/mL 3 hours following a 1-g Mesalamine dose and declined in a biphasic manner. The literature describes a mean terminal half-life of 42 minutes for mesalamine following intravenous administration. Because of the continuous release and absorption of mesalamine from Mesalamine Capsules throughout the gastrointestinal tract, the true-elimination half-life cannot be determined after oral administration. N-acetylmesalamine, the major metabolite of mesalamine, peaked at approximately 3 hours at 1.8 mcg/mL, and its concentration followed a biphasic decline. Pharmacological activities of N-acetylmesalamine are unknown, and other metabolites have not been identified.
Oral mesalamine pharmacokinetics were nonlinear when Mesalamine capsules were dosed from 250 mg to 1 g four times daily, with steady-state mesalamine plasma concentrations increasing about nine times, from 0.14 mcg/mL to 1.21 mcg/mL, suggesting saturable first-pass metabolism. N-acetylmesalamine pharmacokinetics were linear.
Elimination.
Non-Clinical Toxicology
Mesalamine is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.Drug Interactions:
General
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, 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. If acute intolerance syndrome is suspected, prompt withdrawal is required. If a rechallenge is performed later in order to validate the hypersensitivity, it should be carried out under close medical supervision at reduced dose and only if clearly needed.
Renal
In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn's disease received Mesalamine therapy. Generally, Mesalamine therapy was well tolerated. The most common events (ie, greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).
In two domestic placebo-controlled trials involving over 600 ulcerative colitis patients, adverse events were fewer in Mesalamine-treated patients than in the placebo group (Mesalamine 14% vs placebo 18%) and were not dose-related. Events occurring at 1% or more are shown in the table below. Of these, only nausea and vomiting were more frequent in the Mesalamine group. Withdrawal from therapy due to adverse events was more common on placebo than Mesalamine (7% vs 4%).
Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematological, liver, and kidney function.
The following adverse events, presented by body system, were reported infrequently (ie, less than 1%) during domestic ulcerative colitis and Crohn's disease trials. In many cases, the relationship to Mesalamine has not been established.
Gastrointestinal:
Dermatological:
Nervous System:
Cardiovascular:
Other:
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. A causal relationship between this event and mesalamine therapy has not been established.
Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with Mesalamine therapy.
Postmarketing Reports
Gastrointestinal:
Other:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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