Indications And Clinical Uses: For replacement therapy where digestion is not adequate due to pancreatic exocrine insufficiency as in cystic fibrosis, chronic pancreatitis, steatorrhea, post-pancreatectomy, post-gastrointestinal bypass surgery (e.g., gastroenterostomy) and ductal obstruction from neoplasm.
Contra-Indications: Patients with known hypersensitivity to porcine proteins or pancreatic enzymes. Do not use during the early stages of acute pancreatitis.
Perianal irritation, and rarely, inflammation, could occur when large doses are used.
Pregnancy and Lactation: There is inadequate evidence of safety in use during pregnancy and lactation.
Drug Interactions: None known.
Adverse Reactions: Adverse effects from pancreatin products are rare. Diarrhea, constipation, abdominal discomfort and nausea are the most commonly reported reactions, but are also often symptoms of the diseases treated. Also, with high doses, cases of hyperuricosuria, hyperuricemia or perianal irritation/inflammation have been reported.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Most cases respond to supportive measures, including stopping enzyme therapy and ensuring adequate rehydration.
Dosage And Administration: Initially 1 or 2 capsules with each meal and 1 capsule with each snack.
Dosage increases, if required, should be added slowly, with careful monitoring of response and symptomatology.
It is important to ensure adequate hydration of patients at all times during dosing with pancreatic enzymes.
The capsules should be swallowed whole. Where swallowing the capsules is difficult, they may be opened and the minimicrospheres taken with soft food or fluid. Any mixture of the minimicrospheres with food or liquids should be used immediately and not stored; otherwise dissolution of the enteric coating may occur.
To protect the enteric coating, the minimicrospheres must not be crushed or chewed.
The product should not be administered after the expiry date printed on the package.
Availability And Storage: Each opaque, brown/colorless-transparent, hard gelatin capsule, imprinted in white with SOLVAY and 1210, contains: buff-colored enteric-coated minimicrospheres of pancreatin 150 mg corresponding to lipase 10 000 USP units, amylase 33 200 USP units and proteases 37 500 USP units. Nonmedicinal ingredients: dibutyl phthalate, dimethicone 1 000, gelatin, iron oxide black, iron oxide red, iron oxide yellow, macrogol 4 000, methylhydroxypropylcellulose phthalate, paraffinum perliquidum and titanium dioxide. Gluten-, lactose- and tartrazine-free. Bottles of 100. Store in a tightly closed, light-resistant container at controlled room temperature (15 to 30°C). Protect from moisture. Do not refrigerate. Keep out of reach of children.
CREON® 10 Solvay Pharma Pancreatic Enzymes Digestant
Posted by RxMed