Delzicol
DELZICOL- mesalamine capsule, delayed release
Carilion Materials Management
1 INDICATIONS AND USAGE
1.1 Treatment of Mildly to Moderately Active Ulcerative Colitis
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.
1.2 Maintenance of Remission of Ulcerative Colitis in Adults
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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis
Adults
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 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 (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 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 Instructions
Do 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 Administration
Evaluate renal function prior to initiation of DELZICOL [see Warnings and Precautions (5.1)].
3 DOSAGE FORMS AND STRENGTHS
DELZICOL (mesalamine) delayed-release capsules are red capsules containing 400 mg mesalamine and imprinted with “WC 400mg” in white.
4 CONTRAINDICATIONS
DELZICOL is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL [see Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Renal Impairment
Renal impairment, including minimal change nephropathy, 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.
It is recommended that patients have an evaluation of renal function prior to initiation of DELZICOL and periodically while on therapy.
Prescribers should carefully evaluate the risks and benefits when using DELZICOL in patients with known renal impairment or history of renal disease [see Drug Interactions (7.1) and Nonclinical Toxicology (13.2)].
5.2 Mesalamine-Induced Acute Intolerance Syndrome
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with DELZICOL.
5.3 Hypersensitivity Reactions
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to DELZICOL or to other compounds that contain or are converted to mesalamine.
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with DELZICOL and other mesalamine medications. Caution should be taken in prescribing this medicine to patients with conditions predisposing them to the development of myocarditis or pericarditis.
5.4 Hepatic Failure
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering DELZICOL to patients with liver disease.
5.5 Prolonged Gastric Retention in Patients with Upper Gastrointestinal Obstruction
Organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of DELZICOL which would delay release of mesalamine in the colon.
6 ADVERSE REACTIONS
The most serious adverse reactions seen in DELZICOL clinical trials or with other products that contain or are metabolized to mesalamine are:
- Renal impairment, including renal failure [see Warnings and Precautions (5.1)]
- Acute intolerance syndrome [see Warnings and Precautions (5.2)]
- Hypersensitivity reactions [see Warnings and Precautions (5.3)]
- Hepatic failure [see Warnings and Precautions (5.4)]
The data presented in Section 6.1 are from clinical trials conducted with mesalamine delayed-release tablets. DELZICOL is bioequivalent to these mesalamine delayed-release tablets.
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