***UPDATE, Asacol has largely been discontinued/rebranded and replaced with "Delzicol" Asacol / Asacol HD (also know as Masalazine or Mesalamine) is a relatively common medications that is prescribed for ulcerative colitis patients. Delzicol is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Delzicol is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Delzicol [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)]. In general, the nature and severity of reactions in the pediatric population was similar to those reported in adult populations of patients with ulcerative colitis. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their terminal half-lives following administration of DELZICOL. The average age of patients was 41 years and 49 % of patients were male. Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients taking products such as DELZICOL that contain mesalamine or are converted to mesalamine. Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. At the dosage of 2.4 grams per day, 21 of 43 (49%) patients using mesalamine delayed release tablets showed an improvement in sigmoidoscopic appearance of the bowel compared to 12 of 44 (27%) patients using placebo (p = 0.048). is indicated for the maintenance of remission of ulcerative colitis in adu lts. In Study 4, a randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 months duration, 87 patients were randomized to receive mesalamine delayed release tablets 1.6 grams per /day compared to 87 patients randomized to placebo. The safety and effectiveness of Delzicol in the maintenance of remission of ulcerative colitis in pediatric patients have not been established. (In the following, comparisons of animal dosing to recommended human dosing are based on body surface area and a 2.4 grams per day dose for a 60 kg person.). Mesalamine delayed-release tablets have been evaluated in 427 adults and 107 children with ulcerative colitis in these controlled studies. You are encouraged to report negative side effects of prescription drugs to the FDA. 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 of further absorption. Swallow the tablets whole; do not cut, break, crush or chew the tablets. Consider an alternative, selective assay for normetanephrine. Evaluate renal function prior to initiation of Delzicol and periodically while on therapy. Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy. Discontinue Delzicol if renal function deteriorates while on therapy. Evaluate renal function prior to initiation of DELZICOL. Instruct patients to swallow the DELZICOL capsules whole. Delzicol is indicated for the maintenance of remission of ulcerative colitis in adults. Check with your physician for additional information about side effects. Tell your doctor if you are pregnant or plan to become pregnant before using Delzicol. It is used to help keep ulcerative colitis flares from coming back. For adults, the recommended dosage of DELZICOL is 800 mg (two 400 mg capsules) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks [see Clinical Studies]. Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon. DELZICOL should be used during pregnancy only if clearly needed. Below is a description of the adverse reactions of mesalamine delayed-release tablets in these adequate and well-controlled studies. Below is a description of the results of the adequate and well-controlled studies of mesalamine delayed-release tablets for the treatment of mildly to moderately active ulcerative colitis in adults and pediatric patients 5 to 17 years of age and the maintenance of remission of ulcerative colitis in adults. Patients were considered treatment failures if they did not achieve success or dropped out due to adverse reaction or lack of efficacy. Instruct patients to stop taking Delzicol and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity, Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors, Instruct patients to maintain an adequate fluid intake during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine), Advise patients to inform their healthcare provider if they take iron-containing supplements, Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. The median [range] Tmax for mesalamine following Delzicol 400 mg capsule containing four 100 mg tablets was approximately 10 hours [5.5 48 hours], reflecting the delayed-release characteristics of the formulation. Tell your doctor all medications and supplements you use. Dosage was dependent on body weight. Rx Only, Lialda, Pentasa, Apriso, Asacol, +4 more, Lialda, Pentasa, Apriso, Azulfidine, Asacol, Asacol HD, Canasa, Rowasa, Dipentum, Azulfidine EN-tabs. Adverse reactions leading to withdrawal from mesalamine delayed-release tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. DELZICOL is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DESCRIPTION]. DELZICOL (mesalamine) delayed-release capsules are clear capsules and imprinted "WC 400mg" in black ink. Some patients may have a similar reaction to DELZICOL or to other compounds that contain or are converted to mesalamine. Inform patients that DELZICOL may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. . Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth. Instruct patients to stop taking Delzicol and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity, Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms, Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Mesalamine was not carcinogenic at dietary doses of up to 480 mg/kg/day in rats and 2000 mg/kg/day in mice, which are about 2.9 and 6.1 times the maximum recommended maintenance dose of DELZICOL of 1.6 grams per day or 26.7 mg/kg/day, based on 60 kg body weight, respectively, based on body surface area. Delzicol (mesalamine) delayed-release capsules are clear capsules and imprinted WC 400mg in black ink. The scoring system for determination of treatment efficacy included assessment of stool frequency, rectal bleeding, sigmoidoscopic findings, patients functional assessment, and physician global assessment. These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area. As you will find out by taking apart the capsules, it is simply Asacol with an extra soluble shell around it. Urogenital: Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia, reversible oligospermia. The safety of Delzicol has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets. In a study evaluating mesalamine delayed-release tablets in pediatric ulcerative colitis patients (Study 3), mean plasma concentrations of mesalamine (based on sparse sampling) were 820 to 988 ng/mL at the low dose level (that is, 1.2, 2 or 2.4 grams/day based on body weight strata of 17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg, respectively). Clinical studies supporting the use of mesalamine delayed release tablets in the maintenance of remission of ulcerative colitis in adults included a randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 months duration in 264 patients (Study 4) [see Clinical Studies]. The 4.8 grams per day dosage regimen is not recommended because greater efficacy was not demonstrated with this dosage compared to the 2.4 grams per day dosage [see Dosage and Administration (2.2)]. Reports from uncontrolled clinical studies and postmarketing experience suggest a higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) in subjects receiving mesalamine delayed-release tablets who are 65 years or older compared to younger patients taking mesalamine-containing products such as DELZICOL. Why Is Your Ulcerative Colitis Getting Worse. Symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis and rash. Yes, this is what counts for innovation in some corners of big pharma. swelling of your face, lips, tongue, or throat. In a dose-ranging pharmacokinetic study evaluating 30, 60 and 90 mg/kg per day doses of mesalamine delayed-release 400 mg tablets administered twice daily for four weeks, the mean Cavg values of mesalamine in pediatric ulcerative colitis patients ranged from approximately 400 ng/mL to 2100 ng/mL based on data from all dose levels. Available for Android and iOS devices. Inform patients that two Delzicol 400 mg capsules cannot be substituted for one mesalamine delayed-release 800 mg tablet. The number of patients using mesalamine delayed-release tablets 1.6 grams per day who maintained endoscopic remission of ulcerative colitis was 61 of 87 (70%) compared with 42 of 87 (48%) of placebo patients (p = 0.005). What Are the Best PsA Treatments for You? In a second randomized, double-blind, placebo-controlled clinical trial of 6 weeks duration in 87 patients (Study 2), patients received mesalamine delayed release tablets of 1.6 grams per day (400 mg four times a day; n=11) and 4.8 grams per day (1.2 grams four times a day; n=38), compared to placebo four times a day (n=38). We comply with the HONcode standard for trustworthy health information. Inform patients that Delzicol may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. The total content of iron is 16.4 mg at the maximum recommended daily dosage in adults [see Dosage and Administration (2.2)]. A pooled efficacy analysis of 4 maintenance trials compared mesalamine delayed release tablets at dosages of 0.8 to 2.8 grams per day, in divided doses ranging from twice daily to four times per day, with sulfasalazine, at dosages of 2 to 4 grams per day. Treatment success was seen in 59 of 98 (59%) patients using mesalamine delayed release tablets and 70 of 102 (69%) patients using sulfasalazine, a non-significant difference. Patients were considered treatment failures if they did not achieve success or dropped out due to adverse reaction or lack of efficacy. Skin: Alopecia, psoriasis, pyoderma gangrenosum, dry skin, erythema nodosum, urticaria, SJS/TEN, DRESS, and AGEP [see Warnings and Precautions (5.5)]. The mechanism of action of mesalamine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Instruct patients to stop taking DELZICOL and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see, Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [see, Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy. Adverse reactions leading to study withdrawal in patients using mesalamine delayed release tablets included (each in one patient): anxiety, stomatitis and asthenia. Delzicol should be swallowed whole without cutting, breaking, or chewing, and should be taken 1-2 hours after a meal. Open the number of capsules required to make up a complete dose. Each capsule contains four reddish-brown coated 100 mg mesalamine tablets. 400 mg Instruct patients to stop taking DELZICOL and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see, Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see, Instruct patients to maintain an adequate fluid intake during treatment in order to minimize the risk of, Advise patients to inform their healthcare provider if they take iron-containing supplements [see, Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. 2 2.1 Important Administration Instructions Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. DELZICOL (mesalamine) delayed-release capsules are clear capsules and imprinted WC 400mg in black ink. Description Mesalamine is an aminosalicylate. Consider an alternative, selective assay for normetanephrine. Included as part of the "PRECAUTIONS" Section. 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]. Advise patients to complete all blood tests ordered by their healthcare provider. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the capsules. Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. Discontinue Delzicol if an alternative etiology for the signs or symptoms cannot be established. Advise patients to complete all blood tests ordered by their healthcare provider [see. Since there is nothing to document the need for the food logic with Delzicol (other than they did not test it with food), I choose to follow it when possible, but will likely not always meet the suggested timing for the PM. Asacol is being discontinued! Doses of 170 and 360 mg/kg/day (about 0.7 and 1.5 times the recommended human dose based on body surface area) given to rats for six months produced papillary necrosis, papillary edema, tubular degeneration, tubular mineralization, and urothelial hyperplasia. Drug class: 5-aminosalicylates. Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion. Mesalamine and its N-acetyl metabolite are present in human milk. Success based on PUCAI was defined as either partial response (PUCAI reduction of greater than or equal to 20 points from Baseline to Week 6 with Week 6 score greater than or equal to 10) or complete response (PUCAI less than 10 at Week 6). Delzicol is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. 2 2.1 Important Administration Instructions Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. Delzicol (mesalamine) delayed-release capsules are available as clear capsules and imprinted with WC 400mg in black ink. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing Delzicol [see Use in Specific Populations (8.6)]. At Week 6, 73% of the patients in the low dosage group, and 70% of the patients in the high dosage group achieved success based on the TM-Mayo; 34% of the patients in the low dosage group and 43% of the patients in the high dosage group achieved complete response. In animal studies, the kidney was the principal organ of mesalamine toxicity [see ADVERSE REACTIONS, Nonclinical Toxicology]. Caution should be exercised when DELZICOL is administered to a nursing woman. These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area. If acute intolerance syndrome is suspected, promptly discontinue treatment with Delzicol. The serious adverse reactions consisted of sinusitis, adenovirus infection, and pancreatitis in one patient each in the low dosage group. In addition, significantly more patients in the mesalamine delayed release tablets 2.4 grams per day group showed improvement in rectal bleeding and stool frequency. Below is a description of the results of the adequate and well-controlled studies of mesalamine delayed-release tablets for the treatment of mildly to moderately active ulcerative colitis in adults and pediatric patients 5 to 17 years of age and the maintenance of remission of ulcerative colitis in adults. 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. All patients were divided by weight category (17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg) and randomly assigned to receive a low dosage (1.2, 2, and 2.4 grams per day for the respective weight category) or a high dosage (2, 3.6, and 4.8 grams per day). Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion. The safety and effectiveness of DELZICOL in the maintenance of remission of ulcerative colitis in pediatric patients have not been established. Its structural formula is: Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type B (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC). Gastrointestinal: Anorexia, pancreatitis, gastritis, increased appetite, cholecystitis, dry mouth, oral ulcers, perforated peptic ulcer, bloody diarrhea. In a randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 months duration in 264 patients (Study 4), patients received mesalamine delayed-release tablets of 0.8 grams per day (400 mg twice a day; n = 90) and 1.6 grams per day (400 mg four times a day; n = 87), compared to placebo four times a day (n = 87). The safety and effectiveness of DELZICOL for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. Success based on TM-Mayo was defined as either partial response (improvement from baseline in stool frequency or rectal bleeding subscores with no worsening in the other) or complete response (both stool frequency and rectal bleeding subscores equal 0). Nervous: Depression, somnolence, emotional lability, hyperesthesia, vertigo, confusion, tremor, peripheral neuropathy, transverse myelitis, Guillain-Barr syndrome, intracranial hypertension. Anemia and syncope occurred in one patient in the high dosage group. Generic name: mesalamine Delzicol (mesalamine) is an aminosalicylate used to treat mildly to moderately active ulcerative colitis (UC) and to maintain remission of UC. drugs a-z list Five patients were withdrawn from the study due to adverse reactions: 3 (7%) in the low dosage group (1 patient each with adenovirus infection, sclerosing cholangitis, and pancreatitis) and 2 patients (5%) in the high dosage group (1 patient with increased amylase and increased lipase, and 1 patient with upper abdominal pain). Advise patients to complete all blood tests ordered by their healthcare provider, Inform patients of the signs and symptoms of hypersensitivity reactions. What is Delzicol, you ask? Take DELZICOL capsules with or without food. Evaluate renal function prior to initiation of DELZICOL and periodically while on therapy. Mesalamine-Induced Acute Intolerance Syndrome [see. In a randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 months duration in 264 patients (Study 4), patients received mesalamine delayed-release tablets of 0.8 grams per day (400 mg twice a day; n = 90) and 1.6 grams per day (400 mg four times a day; n = 87), compared to placebo four times a day (n = 87). Twelve percent of the patients in the low dosage group (5 patients) and 2% of the patients in the high dosage group (1 patient) had serious adverse reactions. Delzicol comes as a delay-release capsule that only dissolves at a PH of 7 or greater, which means that the drug is released directly into the terminal ileum and colon beyond, where it anti-inflammatory action is needed. Ensure adequate fluid intake during treatment with DELZICOL. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Delzicol may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe stomach pain, stomach cramping, In prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. A randomized, double-blind, 6-week study of 2 dosage levels of mesalamine delayed-release 400 mg tablets (Study 3) was conducted in 82 pediatric patients 5 to 17 years of age with mildly to moderately active ulcerative colitis. Patients may have a similar reaction to Delzicol or to other organ ( e.g., renal liver. Years of age and older who have been administered mesalamine one patient in the of! May lead to electrolyte and blood pH imbalance and potentially to other (. 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