Swallow CREON capsules whole and take them with enough liquid to swallow them right away. symptoms of a rare but serious bowel disorder--severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period. If necessary, the capsule contents can also be sprinkled on soft acidic foods [see, Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with CREON [see, Instruct patients to notify their healthcare professional if they are breast feeding or are thinking of breast feeding during treatment with CREON [see, have a history of intestinal blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy). The Internet site that you have requested may not be optimized to your screen size. As a result, the site may contain information on pharmaceuticals that are not approved in other countries or region. Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations. Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. notice. Included as part of the PRECAUTIONS section. Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Inactive Ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate. Do not give CREON to other people to take, even if they have the same symptoms you have. Capsules shown are not actual size and do not represent exact color shade. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information site. Subject to any continuing obligations under applicable law or any relevant regulatory requirements, AbbVie expressly disclaims any obligation to disseminate, after the date of the posting of any document or announcement on this webpage, any updates or revisions to any statements in such documents or announcements in relation to the Offer to reflect any change in expectations or events, conditions or circumstances on which any such statements are based. Add 5 to 15 ml of lukewarm water to the powder mixture and stir well. Creon (pancrelipase) contains a combination of three enzymes (proteins): lipase, protease, and amylase. CREON is available in the strength of 3,000 USP units of lipase thus infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Current Gastroenterology Reports. Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving CREON and a macrolide antibiotic. drugs a-z list 2007; 9: 116-122. Call your doctor at once if you have: joint pain or swelling; or. Each CREON capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint “CREON 1212” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of: 100 capsules (NDC 0032-1212-01)250 capsules (NDC 0032-1212-07), 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase. CREON should not be crushed or chewed or mixed in foods having a pH greater than 4.5. Fibrosing colonopathy in cystic fibrosis: results of a case-control study. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies, oval, blue/orange, imprinted with CREON 1206, capsule, blue/clear, imprinted with CREON 1236, capsule, red/white, imprinted with APTALIS 15, capsule, green/white, imprinted with APTALIS 20, capsule, clear/orange, imprinted with McNEIL, MT 16. Postmarketing data from this formulation of CREON have been available since 2009. 6 FitzSimmons SC, Burkhart GA, Borowitz DS, et al. If you lost In Study 1, mean CFA was 89% with CREON treatment compared to 49% with placebo treatment. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. For patients with EPI due to cystic fibrosis, CREON offers the CFCareForward program, and for patients with EPI due to other conditions including chronic pancreatitis and pancreatectomy, there is the CREON On Course program. Patients should be advised that CREON delayed-release capsules and the capsule contents must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Give your child enough liquid to completely swallow the CREON contents or the CREON and food mixture. The mean difference in CNA was 37 percentage points in favor of CREON treatment with 95% CI: (31, 42) and p<0.001. Each CREON capsule is available as a two-piece gelatin capsule with blue opaque cap with imprint “CREON 1236” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of: 100 capsules (NDC 0032-3016-13)250 capsules (NDC 0032-3016-28). By clicking on the "I agree" box below, you certify that you will not forward, transmit, show or distribute (by any means including by electronic transmission) the Information to any person. When patients were switched from their usual pancreatic enzyme replacement therapy to CREON, they demonstrated similar spot fecal fat testing results; the clinical relevance of spot fecal fat testing has not been demonstrated. Active Ingredient: lipase, protease, amylase. Look in your child's mouth to make sure that all of the medicine has been swallowed. It is not known if CREON will harm your unborn baby. name, or trade dress in this site may be made without the prior You should not switch CREON with any other pancreatic enzyme product without first talking to your doctor. Patients should be instructed not to  increase the dosage on their own. What are the possible side effects of CREON? If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the Co-Pay card and patient must call 1-855-CARE4WD (227-3493) if enrolled in CFCareForward or 1-844-ONCREON (662-7366) if enrolled in CREON On Course to stop participation. The pancreatic enzymes in CREON are enteric-coated to minimize destruction or inactivation in gastric acid. Restrictions, including monthly maximums, may apply. If you forget to take CREON, call your doctor or wait until your next meal and take your usual number of capsules. The short-term efficacy of CREON was evaluated in three studies conducted in 103 patients with exocrine pancreatic insufficiency (EPI). Manufactured by: Abbott Laboratories GmbH, Hannover, Germany. I emphasize the importance of abstinence from smoking and alcohol as these can further damage the pancreas. The shells contain gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. AbbVie has expanded financial assistance to support qualifying* Doses of other pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with fibrosing colonopathy and colonic strictures in children less than 12 years of age [see WARNINGS AND PRECAUTIONS]. Creon (pancrelipase) is a combination of three enzymes: lipase, protease, and amylase, which are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars, used to replace these enzymes in conditions in which the pancreas is damaged, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts. The Internet site that you have requested may not be optimized to your screen size. If you are a healthcare provider and would like CREON co-pay cards, product samples, patient educational materials, and more, please click below. Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON were hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis. What should I tell my doctor before taking CREON? Do not store CREON that is mixed with food. An additional open-label, single-arm study assessed the short-term safety and tolerability of CREON in 18 infants and children, ages 4 months to 6 years, with EPI due to cystic fibrosis. Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1, 2, 3 If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. See additional information. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis.