Last Updated on 2025 年 12 月 9 日 by 総合編集組
Creon (Pancrelipase) 2025 Comprehensive Guide: Pharmacokinetics, Indications, Real Patient Reviews & Taiwan Shortage Update
Creon® (pancrelipase delayed-release capsules) remains the global gold standard in pancreatic enzyme replacement therapy (PERT) for exocrine pancreatic insufficiency (EPI). Manufactured by AbbVie, this porcine-derived multi-enzyme preparation contains lipase, protease, and amylase in a unique acid-resistant minimicrosphere formulation designed to mimic physiological pancreatic secretion.
What Exactly is Creon? Creon is a prescription medication classified as pancrelipase, extracted and purified from porcine pancreatic glands. Each capsule contains hundreds of enteric-coated minimicrospheres (0.7–1.6 mm) that resist gastric acid degradation and release active enzymes only when duodenal pH exceeds 5.5 — exactly where natural pancreatic enzymes would act.
Unique Pharmacokinetics: Local Action, Zero Systemic Absorption Unlike most oral medications, Creon exhibits no measurable systemic bioavailability. According to the latest FDA label (2022, unchanged in 2025), the enzymes act locally within the gastrointestinal lumen. After completing digestion, they are themselves digested or excreted in feces. Traditional pharmacokinetic parameters (Cmax, AUC, t½) do not apply. This zero-absorption profile minimizes drug interactions and makes Creon safe during pregnancy (Category C, with extensive post-marketing safety data).
Mechanism of Action in Detail
- Gastric phase: The capsule shell dissolves rapidly; minimicrospheres remain intact in acidic environment.
- Duodenal phase: At pH ≥5.5, the enteric coating dissolves within minutes, releasing high concentrations of lipase (fat digestion), protease (protein breakdown), and amylase (carbohydrate hydrolysis).
- Result: Fat absorption coefficient improves from ~60% (untreated EPI) to 85–90% with proper dosing.
FDA-Approved Indications (On-Label Use) Creon is indicated for all ages with documented exocrine pancreatic insufficiency due to:
- Cystic Fibrosis (CF) – affects >85% of patients
- Chronic Pancreatitis – EPI prevalence >70–90% in advanced disease
- Pancreatectomy or pancreatic duct obstruction
- Other causes including Schwachman-Diamond syndrome and severe protein-calorie malnutrition states
Clinical Efficacy Evidence Over 30 randomized controlled trials and long-term registries confirm Creon significantly reduces steatorrhea, restores coefficient of fat absorption (CFA), promotes weight gain, and improves quality of life. In cystic fibrosis pediatric studies, adequate dosing correlates with normal growth velocity.
Dosing Guidelines (2025 Update)
- Adults: 500–2,500 lipase units/kg/meal (max 10,000 units/kg/day or 4,000 units/g fat/day)
- Infants: 2,000–4,000 units per 120 mL formula/breast milk
- Titrate according to stool fat content, weight trends, and dietary fat intake Capsules may be opened and sprinkled on soft acidic foods (pH <4.5) for children unable to swallow.
Real-World Patient Experiences (2025 Aggregated Reviews) From Drugs.com (average rating 6.4/10, n>1,200) and WebMD reviews: Positive themes (70%+ of reviews): • Dramatic reduction in oily, floating stools • Weight stabilization or gain after months of decline • Ability to enjoy high-fat meals again Negative themes (initial 1–2 weeks): • Temporary bloating, flatulence, abdominal discomfort • Learning curve for dose optimization • High cost in non-fully reimbursed regions
Taiwan 2025 Shortage Situation As of December 2025, Taiwan experienced a nationwide shortage of both Creon 25,000 and 40,000 due to global porcine pancreas supply constraints. The Taiwan FDA activated emergency importation protocols; patients are advised to contact major hospitals (NTUH, VGH) for allocation and never abruptly discontinue therapy.
Safety Profile & Contraindications Common (>1%): abdominal pain, flatulence, headache Rare but serious: fibrosing colonopathy (extremely high doses), hyperuricemia, allergic reactions to porcine proteins Absolute contraindications: known pork allergy, acute pancreatitis
Conclusion Creon represents a triumph of pharmaceutical bioengineering — delivering physiological enzyme replacement with minimal systemic risk. For the millions worldwide living with EPI, it is not merely a medication but a cornerstone of nutritional rehabilitation and improved quality of life. Always use under physician guidance and individualize dosing for optimal outcomes.
