Delzicol

Delzicol (mesalamine) belongs to a class of drugs called aminosalicylates, which are used to treat gut inflammation. It helps to treat and prevent flare-ups of ulcerative colitis, a type of inflammatory bowel disease (IBD). Ulcerative colitis is an autoimmune disorder, which means that your own immune system attacks your gut, causing swelling and ulcers in your colon and rectum.

Delzicol reduces the inflammation caused by ulcerative colitis. It's thought its anti-inflammatory action comes from its ability to block the enzyme cyclooxygenase (COX) and inhibit prostaglandin production in the colon. COX and prostaglandins (a group of lipids) are both involved in generating an inflammatory response.

Delzicol comes as a delayed-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 its anti-inflammatory action is needed.

Delzicol was approved by the US Food and Drug Administration (FDA) in 2013. The brand name Delzicol has been discontinued, but generic mesalamine delayed-release tablets are available.

Delzicol is a prescription medication used for the:

• Treatment of mildly to moderately active ulcerative colitis in patients 5 years of ago and older
• Maintenance of remission in adults with ulcerative colitis

• Take Delzicol delay-release capsules exactly as your doctor tells you to.
• Take Delzicol with or without food.
• Swallow Delzicol capsules whole; do not cut, break, crush or chew.
• For patients who are unable to swallow the Delzicol capsules, the capsules can be opened and the inner tablets swallowed. There are four tablets inside each capsule. Swallow the tablets whole; do not cut, break, crush or chew.
• Drink an adequate amount of fluids with Delzicol.
• Delzicol is available as a 400mg delayed release capsule. Delzicol 400mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. Do not swap your Delzicol capsules for another mesalamine-containing medication unless instructed to do so by your healthcare professional.

Some patients with pre-existing skin conditions, such as atopic dermatitis or eczema may be more sensitive to sunlight. These people should avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors while taking Delzicol.

Do not take Delzicol if you are:

• Allergic to salicylates or aminosalicylates, such as aspirin or medications that contain aspirin.
• Allergic to any of the ingredients of Delzicol. See below for a full list of ingredients in Delzicol.

Before taking Delzicol, tell your doctor if you:

• Have or have had kidney problems
• Are allergic to sulfasalazine
• Have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)
• Take any iron-containing supplements
• Have or have had liver problems
• Have or have had a stomach blockage
• Have any other medical conditions

Delzicol may cause serious side effects, including:

• Kidney Problems. Your doctor may check to see how your kidneys are working before taking Delzicol.
• Acute Intolerance Syndrome and Other Allergic Reactions. Some people who use Delzicol can have allergic-type reactions, including acute intolerance syndrome. Other allergic reactions can cause heart problems, including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body, such as the kidneys, liver, and lungs. When this happens, it is usually in people who have had an allergic reaction to sulfasalazine. Stop using Delzicol and tell your doctor right away if you get any of these symptoms: cramping stomach (abdominal) pain bloody diarrhea fever headache chest pain a decrease in the amount of your urine shortness of breath eye inflammation fatigue rash
• Liver Failure. This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your doctor right away if you get any of these symptoms while using Delzicol: yellowing of your eyes itchy skin feeling very tired flu-like symptoms nausea vomiting
• Serious Skin Reactions. Some people who use Delzicol can have severe skin reactions. Stop using Delzicol and tell your doctor right away if you develop any of the following signs or symptoms of a severe skin reaction, including: blisters or peeling of your skin mouth sores blisters on your lips or around your mouth or eyes high fever flu-like symptoms enlarged lymph nodes skin rash.
• Sun Sensitivity. Delzicol can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. Try to limit your time in the sun. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight.
• Kidney Stones. Drink plenty of fluids when using Delzicol to decrease your chance of getting kidney stones. Call your doctor right away if you have any of these symptoms: severe pain in your side or your back blood in your urine.

The most common side effects of Delzicol include:

• Adults: belching, stomachache, constipation, dizziness, runny nose, back pain, rash, upset stomach, and flu symptoms.
• Children (5 to 17 years of age): inflammation of the nose and pharynx, headache, stomachache, dizziness, inflammation of the sinuses, rash, cough, diarrhea, tiredness, fever, and increased lipase.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Delzicol.

Urine discoloration: Your urine may turn reddish-brown if it comes into contact with bleach-treated water, such as in a toilet. This is a harmless reaction. You only need to tell your doctor if your urine is already discolored before it touches the toilet water.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

• The recommended dose of Delzicol for the treatment of mildly to moderately active Ulcerative Colitis is: Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks Pediatric Patients 5 years or older: See weight-based dosing table below; twice daily dosing for 6 weeks.Pediatric Delzicol Dose by Weight Weight (kg) Daily Dose(mg/kg/day) Maximum DailyDose(grams per day) Morning Dose Afternoon Dose 17 to 32 36 to 71 1.2 two 400 mg capsules one 400 mgcapsules 33 to 53 37 to 61 2 three 400 mg capsules two 400 mgcapsules 54 to 90 27 to 44 2.4 three 400 mg capsules three 400 mgcapsules
• The recommended dose of Delzicol for maintenance of remission of ulcerative colitis is: Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses.

Importantly, two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.

See the full prescribing information for further Delzicol dosing information.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Delzicol with nonsteroidal anti-inflammatory drugs (NSAIDs) may cause kidney problems. Taking Delzicol with azathioprine or 6-mercaptopurine may cause blood problems.

Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor may do certain tests during treatment with Delzicol to monitor for adverse reactions caused by drug interactions.

Tell your doctor if you are pregnant or plan to get pregnant. Talk to your doctor about the risk of taking Delzicol during pregnancy. There is limited information available about the safety of Delzicol during pregnancy. Delzicol should only be used during pregnancy if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed. Delzicol passes into human breast milk. Caution is advised when using Delzicol while you are nursing. Talk to your doctor about the best way to feed your baby while taking Delzicol.

Store Delzicol at room temperature 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F).

Keep Delzicol and other medications out of reach of children.

Active ingredient: mesalamine

Inactive ingredients: silicon dioxide, dibutyl sebacate, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate type A potato, talc and hypromelloses.

Delzicol is distributed by Allergan USA, Inc. Madison, NJ 07940.