Creon®
Safety and Tolerability
Creon® improves symptoms associated with PEI †
Creon® is effective and well-tolerated in patients with PEI, significantly improving patients' long-term nutritional status.1, 2
Study design: A 51-week, open-label extension of a 1-week, double-blind, randomized, placebo-controlled group study in India. Patients at least 18 years old with proven chronic pancreatitis and PEI (N=61), received Creon®40,000 at dose of 80,000 lipase units per main mean and 40,000 with snacks. 1
Abbreviations: PEI = Pancreatic Exocrine Insufficiency
References
- Ramesh H, et al. Pancreatology. 2013; 13:133-9.
- Löhr JM et al. United European Gastroenterology Journal 2017; 5(2): 153-99.
CREON® (Pancreatic Extract). Modified release capsules: General Sale (10,000 IU lipase) & Prescription Medicine (25,000 IU lipase); Modified release granules: General Sale (Micro 5,000 IU lipase). Indications: For treatment of conditions associated with pancreatic exocrine insufficiency (PEI), such as: cystic fibrosis (CF), chronic pancreatitis, post-pancreatectomy, post gastrointestinal bypass surgery, ductal obstruction of the pancreas or common bile duct. Contraindications: Hypersensitivity to porcine protein or to any of the excipients. Precautions: Fibrosing colonopathy, pregnancy, lactation. Adverse Effects: Abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, rash, pruritus, urticaria. Dosage & Administration: The dose required depends on the severity of disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. Always ensure adequate hydration of patients to avoid constipation. The capsules should be swallowed intact however when swallowing of capsules is difficult, the capsules may be opened and the minimicrospheres added to acidic soft food such as apple sauce, yoghurt or fruit juice with pH < 5.5, or taken with liquid such as fruit juice with pH < 5.5, e.g. apple, orange or pineapple juice. Rinse mouth out afterwards to ensure no product is retained in the mouth. Treatment of adult patients with PEI associated with nonCF conditions – Required dose for meals: 25,000 to 80,000 lipase units; Snacks: half of meal dose. Refer to data sheet for dose titration considerations. Treatment of paediatric and adult patients with CF - Children < 4 years: Starting dose of 1,000 lipase units/kg bodyweight per meal; Patients ≥ 4 years: Starting dose of 500 lipase units/kg bodyweight per meal. For CF patients, maximum dose of 4,000 lipase units/gram dietary fat intake. Creon® is a fully funded medicine. Before recommending this medicine, please refer to the full Data Sheet available from www.medsafe.govt.nz. Creon® is a Viatris company trade mark, Viatris Limited, Auckland. CRE-2023-0643. TAPS DA 2303MM-0712.