Delzicol

• Warner Chilcott (US), LLC

You should not use mesalamine if you are allergic to it, or:

• if you are allergic to aspirin, sulfasalazine, or salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure mesalamine is safe for you, tell your doctor if you have:

• a stomach condition called pyloric stenosis;

• heart disease;

• kidney disease;

• liver disease; or

• a history of blockage in your digestive tract (stomach or intestines).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Mesalamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine and call your doctor at once if you have:

• severe stomach pain, cramping, bloody diarrhea;

• fever, headache, skin rash;

• chest pain, shortness of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• little or no urinating;

• swelling, rapid weight gain; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• mild stomach discomfort, gas;

• headache; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Delzicol. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine without checking with your doctor first.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

You should take the Lialda® tablets with food. All other brands of capsules and tablets can be taken with or without food.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it before swallowing.

Take the Asacol® HD tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you have trouble swallowing the Delzicol® capsule, carefully open the capsule and take out the 4 tablets. Swallow the tablets whole and make sure all 4 are taken at the same time as one dose. Do not cut, break, crush, or chew them.

The contents of the Pentasa® capsule may be sprinkled on applesauce or yogurt if needed. The mixture must be swallowed right away without chewing.

If you are taking the delayed-release capsule, extended-release capsule, or delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. Contact your doctor if this happens more often than 1 or 2 times.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of ulcerative colitis:
  • For long-acting oral dosage form (delayed-release capsules):
    • Adults—800 milligrams (mg) 3 times a day.
    • Children 5 years and older—Dose is based on body weight and must be determined by your doctor. The dose is usually not more than 2400 mg per day, divided in 2 doses.
    • Children younger than 5 years—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults—
      • For Asacol® HD: 1600 milligrams (mg) 3 times a day for 6 weeks.
      • For Lialda®: 2.4 to 4.8 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Adults—
      • For Apriso™: 1.5 grams once a day as a single dose in the morning.
      • For Pentasa®: 1 gram 4 times a day.
    • Children—Use and dose must be determined by your doctor.
• For prevention of ulcerative colitis:
  • For long-acting oral dosage form (delayed-release capsules):
    • Adults—1600 milligrams (mg) per day, taken in divided doses.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults—2.4 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release capsules and delayed-release tablets in a tightly-closed container to protect them from moisture.

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood or urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficult breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take antacids (eg, Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ capsules. Using these medicines together may change the amount of medicine that is released in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Use Delzicol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take with a full glass of water.
• Take with or without food.
• Swallow whole. Do not chew or crush.
• If you cannot swallow Delzicol whole, you may open the capsules and swallow the contents. Be sure to swallow the contents and that none stay in your mouth. Swallow the contents whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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.

2.1       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).  

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.

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)].