Do not cut, break, crush or chew the capsules. Delzicol should be used during pregnancy only if clearly needed. Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth. Delzicol is indicated for the maintenance of remission of ulcerative colitis in adults. Also, more patients in the mesalamine delayed release tablets 4.8 grams per day group than the placebo group showed improvement in overall symptoms. Body as a Whole: Neck pain, facial edema, edema, lupus-like syndrome, drug fever. See additional information. Take Delzicol capsules with or without food. The most common adverse reactions in patients treated with mesalamine delayed release tablets 2.4 grams per day in Study 1 are listed in Table 2 below. As you will find out by taking apart the capsules, it is simply Asacol with an extra soluble shell around it. Medically reviewed by Drugs.com. IMPORTANT RISK INFORMATION Do not take DELZICOL if you are: DELZICOL is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose. Revised: Nov 2022. Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. NDC - 0023-5853-18 - Bottle of 180 capsules, Store at controlled room temperature 20 to 25 C (68 to 77 F); excursions are permitted 15 to 30 C (59 to 86 F). The serious adverse reactions consisted of sinusitis, adenovirus infection, and pancreatitis in one patient each in the low dosage group. Evaluate renal function in all patients prior to initiation and periodically while on DELZICOL therapy. Delzicol (mesalamine) delayed-release capsules are clear capsules and imprinted WC 400mg in black ink. The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. 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. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Each 400 mg delayed-release capsule contains 2.7 mg of iron. The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L. There are 4 tablets per capsule. 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. The observed differences in mesalamine exposure due to concomitant food intake are not considered to be clinically relevant at the total daily dosage of 2.4 grams per day. Urogenital: Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia, reversible oligospermia. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. The high dosage regimen is not recommended because it was not found to be more effective than the recommended low dosage regimen [see Dosage and Administration (2.2), Clinical Studies (14.1)]. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1)]. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. The proportion of patients who achieved success based on the Truncated Mayo Score (TM-Mayo) (based on the stool frequency and rectal bleeding subscores of the Mayo Score) and based on the PUCAI was measured after 6 weeks of treatment. Anemia and syncope occurred in one patient in the high dosage group. 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)]. mesalamine delayed release tablets 4.8 grams per day for 6 weeks resulted in sigmoidoscopic improvement in 28 of 38 (74%) patients compared to 10 of 38 (26%) placebo patients (p less than 0.001). After intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes. Low Dosage = mesalamine 400 mg delayed-release tablet 1.2 to 2.4 grams/day; High Dosage = mesalamine 400 mg delayed-release tablet 2.0 to 4.8 grams/day. Delzicol was approved by the US Food and Drug Administration (FDA) in 2013. DELZICOL capsules are to be taken twice daily with or without food for a duration of 6 weeks [see Clinical Studies ]. 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]. There were 41 patients in the low dosage group and 41 patients in the high dosage group who received at least one dose of mesalamine delayed-release 400 mg tablets; 36 patients in each dosage group completed the study. Evaluate renal function prior to initiation of DELZICOL. DELZICOL (mesalamine) delayed-release capsules is a prescription medication approved for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older and for the maintenance of remission of UC in adults. Treatment of Mildly to Moderately Active Ulcerative Colitis. 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. Delzicol (mesalamine) is an aminosalicylate used to treat mildly to moderately active ulcerative colitis (UC) and to maintain remission of UC. Use of DELZICOL 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). 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. Below is a description of the adverse reactions of mesalamine delayed-release tablets in these adequate and well-controlled studies. 400 mg Clinical studies supporting the use of mesalamine delayed-release tablets in the maintenance of remission of ulcerative colitis included a 6-month, randomized, double-blind, placebo-controlled, multi-center study (Study 4) and four active-controlled maintenance trials comparing mesalamine delayed-release with sulfasalazine. Take DELZICOL capsules with or without food. mesalamine delayed release tablets 4.8 grams per day for 6 weeks resulted in sigmoidoscopic improvement in 28 of 38 (74%) patients compared to 10 of 38 (26%) placebo patients (p less than 0.001). Abdominal pain and decreased body mass index occurred in one patient and bloody diarrhea and sclerosing cholangitis also occurred in one patient in the low dosage group. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. The mechanism of action of mesalamine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. 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. No evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. Endocrine: Nephrogenic diabetes insipidus. - February, 2013: Delzicol approved as a new phthalate-free formulation of Asacol. Skin: Alopecia, psoriasis, pyoderma gangrenosum, dry skin, erythema nodosum, urticaria, SJS/TEN, DRESS, and AGEP [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for worsening of these symptoms while on treatment. 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. Advise patients to complete all blood tests ordered by their healthcare provider, Inform patients of the signs and symptoms of hypersensitivity reactions. 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. There was no evidence of impaired fertility or harm to the fetus. DELZICOL is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. The observed differences in mesalamine exposure due to concomitant food intake are not considered to be clinically relevant at the total daily dosage of 2.4 grams per day. Advise patients to complete all blood tests ordered by their healthcare provider [see, Inform patients of the signs and symptoms of hypersensitivity reactions. A high fat meal increased systemic exposure of mesalamine (geometric mean Cmax: 32%; AUC8-48 h: 46 %; AUC: 29%) and delayed the median tmax by approximately 4 hours compared to results in the fasted state. 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). 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. Absorbed mesalamine is excreted mainly by the kidney as N-acetyl-5-aminosalicylic acid. Instruct patients to contact their healthcare provider if this occurs repeatedly. Discontinue Delzicol if renal function deteriorates while on therapy. 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. The majority (88%) of patients in each group were treated for more than 5 weeks. The scoring system for determination of treatment efficacy included assessment of stool frequency, rectal bleeding, sigmoidoscopic findings, patients functional assessment, and physician global assessment. The concentration of the N-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/L. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Evaluate the risks and benefits of using Delzicol in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs [see Drug Interactions (7.1), Use in Specific Populations (8.6)]. Patients were considered treatment failures if they did not achieve success or dropped out due to adverse reaction or lack of efficacy. What Are Side Effects of Delzicol? [See USP Controlled Room Temperature], Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions, Distributed by: If acute intolerance syndrome is suspected, promptly discontinue treatment with Delzicol. For patients who are unable to swallow the capsules whole, carefully open the capsules and swallow the contents (four 100 mg tablets). You can buy these shells for about $10 per 1,000 on Amazon. For patients who are unable to swallow the capsules whole, carefully open the capsule(s) and swallow the contents (four 100 mg tablets). Mesalamine delayed-release tablets have been evaluated in 427 adults and 107 children with ulcerative colitis in these controlled studies. Posology. Before taking Delzicol, tell your doctor: If you are allergic to Delzicol; any part of this medicine; or any other drugs, foods, or substances. Table 2. Delzicol may interact with arsenic trioxide, chloroquine or halofantrine, cyclosporine, droperidol, narcotics, vinblastine, antibiotics, medicines to treat psychiatric disorders, or heart rhythm medicines. The safety of DELZICOL has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets. 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]. Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion. Yes, this is what counts for innovation in some corners of big pharma. IMPORTANT RISK INFORMATION Do not take DELZICOL if you are: Table 3 provides a summary of the specific reported adverse reactions. 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