"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"...
(pancrelipase) Delayed-Release Capsules, USP
- Patient Information:
Details with Side Effects
CREON® 5 Capsules are orally administered and contain pancrelipase (lipase 5,000 USP Units, protease 18,750 USP Units and amylase 16,600 USP Units per capsule) which is of porcine pancreatic origin. Each CREON 5 (pancrelipase delayed-release minimicrospheres) Capsule is filled with 124 mg of delayed-release MINIMICROSPHERES®.
Inactive ingredients include dibutyl phthalate, dimethicone, hydroxypropylmethylcellulose phthalate, light mineral oil and polyethylene glycol. The capsule shells contain gelatin, red iron oxide, titanium dioxide, yellow iron oxide and FD & C blue No. 2. The capsule imprinting ink contains dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium dioxide.
What are the possible side effects of pancrelipase?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.
Less serious side effects may include:
- nausea or vomiting;
- mild stomach pain or upset;
- diarrhea or constipation;
- bloating or gas.
- greasy stools;
- rectal irritation;
- headache, dizziness;
- cough; or
What are the precautions when taking pancrelipase delayed-release minimicrospheres (Creon 5)?
Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas, gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).
If you have diabetes, pancrelipase may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust...
Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Creon 5 Information
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