Delzicol

DELZICOL- mesalamine capsule, delayed release
Warner Chilcott (US), LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Mildly to Moderately Active Ulcerative Colitis

DELZICOL® is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

1.2 Maintenance of Remission of Ulcerative Colitis

DELZICOL® is indicated for the maintenance of remission of ulcerative colitis in adults.

2 DOSAGE AND ADMINISTRATION

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.
• Evaluate renal function prior to initiation of DELZICOL
• Take DELZICOL capsules with or without food.
• Swallow the capsules whole; do not cut, break, crush or chew the capsules.
• For patients who are unable to swallow the capsules whole, carefully open the capsule(s) and swallow the contents (four 100 mg tablets).
° Open the number of capsules required to make up a complete dose [see Dosage and Administration ( 2.2, 2.3)].
° There are 4 tablets per capsule. Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth.
° Swallow the tablets whole; do not cut, break, crush or chew the tablets.
• Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their physician if this occurs repeatedly. Protect DELZICOL capsules from moisture. Close the container tightly and leave any desiccant pouches present in the bottle along with the tablets.

2.2 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis

Adults
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 ( 14.1)].

Pediatrics For pediatric patients 5 years of age and older, the recommended total daily dosage of DELZICOL is weight-based (up to maximum of 2.4 grams per day) divided into two daily doses for a duration of 6 weeks (see Table 1).

Table 1. Pediatric Dosage by Weight
Weight Group (kg) Daily Dosage (mg/kg/day) Maximum Daily Dosage(grams per day) Morning Dosage Afternoon Dosage
17 to 32 36 to 71 1.2 two 400 mg capsules one 400 mg capsules
33 to 53 37 to 61 2 three 400 mg capsules two 400 mg capsules
54 to 90 27 to 44 2.4 three 400 mg capsules three 400 mg capsules

2.3 Dosage for Maintenance of Remission of Ulcerative Colitis

The recommended dosage of DELZICOL in adults is 1.6 grams (four 400 mg capsules) daily in two to four divided doses.

3 DOSAGE FORMS AND STRENGTHS

DELZICOL (mesalamine) delayed-release capsules are clear capsules and imprinted “WC 400mg” in black ink. Each capsule contains four reddish-brown coated 100 mg mesalamine tablets.

4 CONTRAINDICATIONS

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)].

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 [see Adverse Reactions ( 6.2) ].

Evaluate renal function prior to initiation of DELZICOL and periodically while on therapy.

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), 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. Monitor 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

Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to DELZICOL or to other compounds that contain or are converted to mesalamine.

As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue DELZICOL if an alternative etiology for the signs or symptoms cannot be established.

5.4 Hepatic Failure

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risk and benefits of using DELZICOL in patients with known liver impairment.

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 [see Warnings and Precautions ( 5.1)]
  • Mesalamine-Induced 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)]

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