Delzicol
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
DELZICOL® (mesalamine) delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 12 years of age and older.
DELZICOL® (mesalamine) delayed-release tablets are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of DELZICOL for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.
History
There is currently no drug history available for this drug.
Other Information
Each DELZICOL (mesalamine) delayed-release capsule for oral administration contains 400 mg of mesalamine, an aminosalicylate. DELZICOL (mesalamine) delayed-release capsules contain acrylic based resin, Eudragit S (methacrylic acid copolymer type B, NF), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is:
Mesalamine structural formula
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).
Sources
Delzicol Manufacturers
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Warner Chilcott (Us), Llc
![Delzicol (Mesalamine) Capsule, Delayed Release [Warner Chilcott (Us), Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Delzicol | Warner Chilcott (us), Llc
2.1 Dosage for Treatment of Mildly to Moderately Active Ulcerative ColitisAdults
For adults, the recommended dosage of DELZICOL is two 400 mg capsules to be taken three times daily (total daily dose of 2.4 grams), for a duration of 6 weeks [see Clinical Studies (14.1)].Pediatrics
Pediatric Dosage by Weight
For pediatric patients 12 years of age and older, the recommended total daily dose of DELZICOL is weight-based (up to maximum of 2.4 grams/day). DELZICOL capsules are to be taken twice daily with or without food for a duration of 6 weeks [see Clinical Studies (14.1)]. Weight Group
Daily Dose
(kg)
(mg/kg/day) Maximum Daily Dose
(grams/day) 17 to < 33 36 to 71 1.2 33 to < 54 37 to 61 2.0 54 to 90 27 to 44 2.4 2.2 Dosage for Maintenance of Remission of Ulcerative Colitis in AdultsFor the maintenance of remission of ulcerative colitis, the recommended dose of DELZICOL in adults is 1.6 g daily with or without food in divided doses [see Clinical Studies (14.2)].
2.3 Important Administration InstructionsDo not open, crush, break, or chew the capsules. Swallow whole with water.
Before prescribing DELZICOL capsules, children should be assessed for the ability to swallow capsules.
Two DELZICOL 400 mg capsules should not be substituted with one mesalamine delayed-release 800 mg tablet.
2.4 Testing Prior to DELZICOL AdministrationEvaluate renal function prior to initiation of DELZICOL [see Warnings and Precautions (5.1)].
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Carilion Materials Management
Delzicol | Carilion Materials Management
2.1 Dosage for Treatment of Mildly to Moderately Active Ulcerative ColitisFor adults, the recommended dosage of DELZICOL is two 400 mg capsules to be taken three times daily (total daily dose of 2.4 grams), for a duration of 6 weeks Adults
[see Clinical Studies ( )]. 14.1Pediatrics
Pediatric Dosage by Weight WeightGroup (kg) Daily Dose (mg/kg/day) Maximum Daily Dose (grams/day) 17 to < 33 36 to 71 1.2 33 to < 54 37 to 61 2.0 54 to 90 27 to 44 2.4 2.2 Dosage for Maintenance of Remission of Ulcerative Colitis in Adults
For pediatric patients 12 years of age and older, the recommended total daily dose of DELZICOL is weight-based (up to maximum of 2.4 grams/day). DELZICOL capsules are to be taken twice daily for a duration of 6 weeks [see Clinical Studies ( )]. 14.1For the maintenance of remission of ulcerative colitis, the recommended dose of DELZICOL in adults is 1.6 g daily, in divided doses . [see Clinical Studies ( )] 14.2
2.3 Important Administration InstructionsDo not open, crush, break, or chew the capsules. Swallow whole with water.
Before prescribing DELZICOL capsules, children should be assessed for the ability to swallow capsules. DELZICOL should be dosed at least 1 hour before a meal or 2 hours after a meal.
Two DELZICOL 400 mg capsules should not be substituted with one mesalamine delayed-release 800 mg tablet.
2.4 Testing Prior to DELZICOL AdministrationEvaluate renal function prior to initiation of DELZICOL [see Warnings and Precautions ( )]. 5.1
![Delzicol (Mesalamine) Capsule, Delayed Release [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3479cbf1-434e-417f-be73-7c75139013f0&name=68151-5652.jpg)
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