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Asacol
Overview
What is Asacol?
Each delayed-release tablet for oral administration contains 400 mg of mesalamine, an anti-inflammatory drug. The delayed-release tablets are coated with acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is:
What does Asacol look like?
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What are the available doses of Asacol?
Sorry No records found.
What should I talk to my health care provider before I take Asacol?
Sorry No records found
How should I use Asacol?
Asacol
For the treatment of mildly to moderately active ulcerative colitis:
What interacts with Asacol?
Asacol
Asacol
What are the warnings of Asacol?
Sorry No Records found
What are the precautions of Asacol?
General:
Asacol
Exacerbation of the symptoms of colitis has been reported in 3% of -treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of tablets as well as other mesalamine products. Symptoms usually abate when tablets are discontinued.
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to tablets or to other compounds which contain or are converted to mesalamine.
Renal:
Asacol
Therefore, caution should be exercised when using Asacol (or other compounds which contain or are converted to mesalamine or its metabolites) in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
Use in Hepatic Impairment:
Asacol
Information for Patients:
Asacol
Patients with ulcerative colitis should be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be substantially reduced by continued administration of at a maintenance dosage.
Drug Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Asacol
in vitro
Pregnancy: Teratogenic Effects:
Nursing Mothers:
Pediatric Use:
Asacol
Geriatric Use:
Asacol
Asacol
Asacol
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. As stated in the section, it is recommended that all patients have an evaluation of renal function prior to initiation of tablets and periodically while on therapy.
What are the side effects of Asacol?
Asacol
Asacol
In two short-term (6 weeks) placebo-controlled clinical studies involving 245 patients, 155 of whom were randomized to tablets, five (3.2%) of the patients discontinued therapy because of adverse events as compared to two (2.2%) of the placebo patients. Adverse reactions leading to withdrawal from tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
Adverse events occurring in -treated patients at a frequency of 2% or greater in the two short-term, double-blind, placebo-controlled trials mentioned above are listed in below. Overall, the incidence of adverse events seen with tablets was similar to placebo.
Of these adverse events, only rash showed a consistently higher frequency with increasing dose in these studies.
In a 6-month placebo-controlled maintenance trial involving 264 patients, 177 of whom were randomized to tablets, six (3.4%) of the patients discontinued therapy because of adverse events, as compared to four (4.6%) of the placebo patients. Adverse reactions leading to withdrawal from tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.
In the 6-month placebo-controlled maintenance trial, the incidence of adverse events seen with tablets was similar to that seen with placebo. In addition to events listed in , the following adverse events occurred in -treated patients at a frequency of 2% or greater in this study: abdominal enlargement, anxiety, bronchitis, ear disorder, ear pain, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, sinusitis, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.
In 3342 patients in uncontrolled clinical studies, the following adverse events occurred at a frequency of 5% or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis.
In addition to the adverse events listed above, the following events have been reported in clinical studies, literature reports, and postmarketing use of products which contain (or have been metabolized to) mesalamine. Because many of these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness or potential causal connection to mesalamine:
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Musculoskeletal:
Nervous:
Respiratory/Pulmonary:
Skin:
Special Senses:
Urogenital:
Laboratory Abnormalities:
| Placebo | Asacol | |
| Event | (n = 87) | (n = 152) |
| Headache | 36 | 35 |
| Abdominal pain | 14 | 18 |
| Eructation | 15 | 16 |
| Pain | 8 | 14 |
| Nausea | 15 | 13 |
| Pharyngitis | 9 | 11 |
| Dizziness | 8 | 8 |
| Asthenia | 15 | 7 |
| Diarrhea | 9 | 7 |
| Back pain | 5 | 7 |
| Fever | 8 | 6 |
| Rash | 3 | 6 |
| Dyspepsia | 1 | 6 |
| Rhinitis | 5 | 5 |
| Arthralgia | 3 | 5 |
| Hypertonia | 3 | 5 |
| Vomiting | 2 | 5 |
| Constipation | 1 | 5 |
| Flatulence | 7 | 3 |
| Dysmenorrhea | 3 | 3 |
| Chest pain | 2 | 3 |
| Chills | 2 | 3 |
| Flu syndrome | 2 | 3 |
| Peripheral edema | 2 | 3 |
| Myalgia | 1 | 3 |
| Sweating | 1 | 3 |
| Colitis exacerbation | 0 | 3 |
| Pruritus | 0 | 3 |
| Acne | 1 | 2 |
| Increased cough | 1 | 2 |
| Malaise | 1 | 2 |
| Arthritis | 0 | 2 |
| Conjunctivitis | 0 | 2 |
| Insomnia | 0 | 2 |
What should I look out for while using Asacol?
Asacol
Asacol
What might happen if I take too much Asacol?
Two cases of pediatric overdosage have been reported. A 3-year-old male who ingested 2 grams of tablets was treated with ipecac and activated charcoal; no adverse events occurred. Another 3-year-old male, approximately 16 kg, ingested an unknown amount of a maximum of 24 grams of crushed in solution (i.e., uncoated mesalamine); he was treated with orange juice and activated charcoal, and experienced no adverse events. In dogs, single doses of 6 grams of delayed-release tablets resulted in renal papillary necrosis but were not fatal. This was approximately 12.5 times the recommended human dose (based on a dose of 2.4 g/day in a 50 kg person). Single oral doses of uncoated mesalamine in mice and rats of 5000 mg/kg and 4595 mg/kg, respectively, or of 3000 mg/kg in cynomolgus monkeys, caused significant lethality.
How should I store and handle Asacol?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. AsacolThey are supplied by as follows:Store at controlled room temperature 20°- 25°C (68°- 77°F) [See USP].AsacolThey are supplied by as follows:Store at controlled room temperature 20°- 25°C (68°- 77°F) [See USP].AsacolThey are supplied by as follows:Store at controlled room temperature 20°- 25°C (68°- 77°F) [See USP].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacokinetics: Asacol
Asacol
Mesalamine from orally administered tablets appears to be more extensively absorbed than the mesalamine released from sulfasalazine. Maximum plasma levels of mesalamine and N-acetyl-5-aminosalicylic acid following multiple doses are about 1.5 to 2 times higher than those following an equivalent dose of mesalamine in the form of sulfasalazine. Combined mesalamine and N-acetyl-5-aminosalicylic acid AUC's and urine drug dose recoveries following multiple doses of tablets are about 1.3 to 1.5 times higher than those following an equivalent dose of mesalamine in the form of sulfasalazine.
The t for mesalamine and its metabolite, N-acetyl-5-aminosalicylic acid, is usually delayed, reflecting the delayed release, and ranges from 4 to 12 hours. The half-lives of elimination (t1/2) for mesalamine and N-acetyl-5-aminosalicylic acid are usually about 12 hours, but are variable, ranging from 2 to 15 hours. There is a large intersubject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their elimination half-lives following administration of tablets.
Non-Clinical Toxicology
AsacolAsacol
Drug Interactions:
General:
Asacol
Exacerbation of the symptoms of colitis has been reported in 3% of -treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of tablets as well as other mesalamine products. Symptoms usually abate when tablets are discontinued.
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to tablets or to other compounds which contain or are converted to mesalamine.
Asacol
Asacol
In two short-term (6 weeks) placebo-controlled clinical studies involving 245 patients, 155 of whom were randomized to tablets, five (3.2%) of the patients discontinued therapy because of adverse events as compared to two (2.2%) of the placebo patients. Adverse reactions leading to withdrawal from tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
Adverse events occurring in -treated patients at a frequency of 2% or greater in the two short-term, double-blind, placebo-controlled trials mentioned above are listed in below. Overall, the incidence of adverse events seen with tablets was similar to placebo.
Of these adverse events, only rash showed a consistently higher frequency with increasing dose in these studies.
In a 6-month placebo-controlled maintenance trial involving 264 patients, 177 of whom were randomized to tablets, six (3.4%) of the patients discontinued therapy because of adverse events, as compared to four (4.6%) of the placebo patients. Adverse reactions leading to withdrawal from tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.
In the 6-month placebo-controlled maintenance trial, the incidence of adverse events seen with tablets was similar to that seen with placebo. In addition to events listed in , the following adverse events occurred in -treated patients at a frequency of 2% or greater in this study: abdominal enlargement, anxiety, bronchitis, ear disorder, ear pain, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, sinusitis, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.
In 3342 patients in uncontrolled clinical studies, the following adverse events occurred at a frequency of 5% or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis.
In addition to the adverse events listed above, the following events have been reported in clinical studies, literature reports, and postmarketing use of products which contain (or have been metabolized to) mesalamine. Because many of these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness or potential causal connection to mesalamine:
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Musculoskeletal:
Nervous:
Respiratory/Pulmonary:
Skin:
Special Senses:
Urogenital:
Laboratory Abnormalities:
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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