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The active ingredient in Creon evaluated in clinical trials is lipase. Incompatibilities were either not assessed or not identified as part of the registration of this medicine. There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1, 2, 3, 4 Usually, half of the prescribed Creon dose for an individualized full meal should be given with each snack.
This Medication Guide summarizes the most important information about Creon.
Do not mix CREON capsule contents directly into formula or breast milk prior to administration [see Administration]. Swallow Creon capsules whole and take them with enough liquid to swallow them right away. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Creon (pancrelipase) contains a combination of three enzymes (proteins): lipase, protease, and amylase.
Ten patients had a history of pancreatectomy (7 were treated with Creon).
This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Continue, 2.
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.
Pancrelipase is a beige-white amorphous powder. CREON should be taken during meals or snacks, with sufficient fluid. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. The mean difference in CFA was 35 percentage points in favor of CREON treatment with 95% CI: (27, 44) and p<0.001.
In the placebo-controlled PEI studies, the CFA (%, mean ± SD) was higher with Creon treatment (83.0 ± 12.6%) as compared to placebo (62.6 ± 21.8%). Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
0032-1212-01, The most common adverse reactions (greater than or equal to 4%) in Studies 1 and 2 were vomiting, dizziness, and cough.
What should I tell my doctor before taking CREON? Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. Allergic reactions, including trouble with breathing, skin rashes, or swollen lips.
Biochemical Data Summary. The short-term safety and effectiveness of Creon were assessed in two randomized, double-blind, placebo-controlled, crossover studies of 49 patients with EPI due to cystic fibrosis, 25 of whom were pediatric patients. These are not all the side effects of Creon. Journal of the American Dietetic Association. Select one or more newsletters to continue. 5 Smyth RL, Ashby D, O'Hea U, et al. 2007; 9: 116-122. Ask your doctor about other foods you can mix with CREON. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. Please note that in warmer climates it may be necessary to store Creon capsules in the refrigerator. Swallow CREON capsules whole and take them with enough liquid to swallow them right away. Gastrointestinal disorders (including abdominal pain, diarrhea, flatulence, constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver enzymes have been reported with this formulation of CREON. These are not all the side effects of CREON. this version. units lipase, 16,000 Ph.Eur. Available for Android and iOS devices.
The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes. You may also report side effects to AbbVie Inc. at 1-800-633-9110. Dispense enclosed Medication Guide to each patient. The long-term safety profile of these products has been described in the medical literature.
The dose of Creon required is adjusted according to the fat content of the meal and the severity of the disease. Creon may also be used following surgical removal of the pancreas. Dosing of pediatric patients should be in accordance with recommended guidance from the Cystic Fibrosis Foundation Consensus Conferences [see Dosage and Administration (2.1)].
Store Creon at room temperature 59°F to 77°F (15°C to 25°C).
Give Creon prior to each feeding. This is achieved through optimal dietary intake using a diet without restriction of fat content (> 100 g fat per day if over five years of age), unless the patient is overweight.
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