Delzicol delayed-release capsules for treating and maintaining ulcerative colitis

Delzicol is a delayed-release capsule formulation of mesalamine used to treat and maintain remission in ulcerative colitis. It is approved for patients aged 12 years and older for active disease treatment, and for adults to maintain remission. Mesalamine acts topically in the colon to reduce inflammation.

Delzicol is indicated for:

• Treatment of mildly to moderately active ulcerative colitis in patients 12 years and older.
• Maintenance of remission of ulcerative colitis in adults.

The safety and effectiveness for maintenance of remission have not been established in pediatric patients.

mesalamine

Mesalamine, the active ingredient in Delzicol, works topically in the colon to reduce inflammation. It may block the production of inflammatory compounds like prostaglandins by inhibiting the cyclooxygenase pathway, helping to control ulcerative colitis symptoms.

Treatment of Mildly to Moderately Active Ulcerative Colitis

Adults: Take 800 mg (two 400 mg capsules) three times daily (total 2.4 grams per day) for 6 weeks, with or without food.

Pediatric patients 12 years and older: Dose is weight-based up to a maximum of 2.4 grams per day, taken twice daily for 6 weeks. Weight categories and doses are:

Maintenance of Remission of Ulcerative Colitis (Adults)

Take 1.6 grams daily in divided doses, with or without food.

Important Administration Instructions

• Swallow capsules whole with water; do not open, crush, break, or chew.
• Before prescribing to children, assess ability to swallow capsules.
• Two 400 mg capsules are not interchangeable with one 800 mg mesalamine delayed-release tablet.
• Evaluate renal function before and during treatment.

Delzicol is contraindicated in patients with known hypersensitivity to salicylates, aminosalicylates, or to any of the capsule ingredients.

Serious Warnings and Precautions

• Renal impairment: Assess kidney function before starting and periodically during treatment due to risk of nephropathy, interstitial nephritis, and renal failure.
• Mesalamine-induced acute intolerance syndrome: Symptoms like cramping, abdominal pain, bloody diarrhea, fever, headache, and rash can occur and may mimic ulcerative colitis flare. Monitor closely and discontinue if suspected.
• Hypersensitivity reactions: Use caution in patients allergic to sulfasalazine or salicylates. Rarely, myocarditis and pericarditis have been reported.
• Hepatic failure: Reported in patients with pre-existing liver disease; exercise caution.
• Gastrointestinal obstruction: Upper GI obstruction may delay capsule release and drug action.

Common Adverse Reactions (≥5% of adults)

• Abdominal pain
• Eructation (belching)
• General pain
• Back pain
• Rash
• Dyspepsia (indigestion)
• Rhinitis
• Flu syndrome
• Asthenia (weakness)
• Flatulence
• Vomiting
• Fever
• Arthralgia (joint pain)
• Constipation
• Gastrointestinal bleeding

Serious Adverse Effects

• Renal impairment including renal failure
• Acute intolerance syndrome
• Hypersensitivity reactions (including myocarditis, pericarditis)
• Hepatic failure

Other Reported Reactions

• Neck pain, facial edema, lupus-like syndrome, drug fever
• Gastrointestinal: pancreatitis, gastritis, oral ulcers, bloody diarrhea
• Hematologic abnormalities: agranulocytosis, aplastic anemia, thrombocytopenia
• Neurologic: depression, tremor, peripheral neuropathy, Guillain-Barré syndrome
• Respiratory: interstitial pneumonitis, eosinophilic pneumonia
• Skin: alopecia, psoriasis, erythema nodosum, urticaria
• Urinary: dysuria, hematuria

• Nephrotoxic agents (including NSAIDs): May increase risk of renal reactions; monitor kidney function closely.
• Azathioprine or 6-mercaptopurine: Concurrent use may increase risk of blood disorders.

Pregnancy

Delzicol is category B. Although limited human data show no increased risk of birth defects, the risks of preterm birth, stillbirth, and low birth weight may be related to underlying inflammatory bowel disease. Animal studies showed no fetal harm at doses higher than human use. Use only if clearly needed.

Lactation

Mesalamine and its metabolite are present in breast milk at low levels. Estimated infant exposure is low. Consider benefits of breastfeeding versus potential risks. Use with caution while nursing.

There is no specific antidote for Delzicol overdose. Treatment is supportive and symptomatic, including preventing further absorption, correcting fluid/electrolyte imbalances, and maintaining renal function. The delayed-release nature should be considered in management.