"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
CREON 20 (pancrelipase delayed-released capsules) Capsules are indicated for patients with pancreatic exocrine insufficiency as is often associated with:
DOSAGE AND ADMINISTRATION
Clinical experience should dictate initial starting dose. Doses should be taken during meals or snacks, not before or after. Do not take without food.
Adults and Children Over 6 Years Old
Usual initial starting dosage is one CREON 20 (pancrelipase delayed-released capsules) Capsule per meal or snack.
Children Under 6 Years Old
The exact dosage of CREON 20 (pancrelipase delayed-released capsules) Capsules should be selected based on clinical experience for this age group.
For cystic fibrosis patients, typical doses are 1,500 - 3,000 USP lipase units/kg/meal. Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status. Doses in excess of 6,000 USP lipase units/kg/meal are not recommended.
Dose increases, if required, should occur with careful monitoring of body weight and stool fat content. When changing strengths of pancreatic enzyme products, care should be taken to maintain equivalent lipase units for each divided dosage.
It is important to ensure adequate hydration of patients at all times while taking pancreatic enzymes.
Where swallowing of capsules is difficult, the capsules may be carefully opened and the MINIMICROSPHERES added to a small amount of soft food, with a pH less than 5.5. The soft food should be swallowed immediately without chewing and followed with a glass of water or juice to insure swallowing.
CREON 20 MINIMICROSPHERES (Pancrelipase Delayed-release Capsules, USP) are available in a two-piece gelatin capsule (orange opaque top half, natural transparent bottom half) imprinted in white with "SOLVAY" and "1220". Each capsule contains tan-colored delayed-release MINIMICROSPHERES of pancrelipase supplied in bottles of:
CREON 20 (pancrelipase delayed-released capsules) Capsules must be stored at 25ºC (77ºF); excursions permitted to 15°-30°C (59°- 86°F). [See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. DO NOT REFRIGERATE. Dispense in tight, light-resistant containers. For human consumption only.
Manufactured By: Solvay Pharmaceuticals GmbH, Hannover, Germany. Marketed by: Solvay Pharmaceuticals, Inc. Marietta, GA 30062. FDA Rev date: n/a
Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.
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