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Pancrelipase (Creon)

Trade Name : Creon

AbbVie Inc.

CAPSULE, DELAYED RELEASE

Strength 1500030009500 [USP'U]/1[USP'U]/1[USP'U]/1

PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pancrelipase (Creon) which is also known as Creon and Manufactured by AbbVie Inc.. It is available in strength of 15000; 3000; 9500 [USP'U]/1; [USP'U]/1; [USP'U]/1 per ml. Read more

Pancrelipase (Creon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • CREON (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.
  • CREON is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. ()
  • CREON is not interchangeable with other pancrelipase products.
  • CREON is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of CREON should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below .
  • CREON is not interchangeable with any other pancrelipase product. ()
  • Do not crush or chew capsules and capsule contents. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food, e.g., applesauce. () Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. ()
  • Infants (up to 12 months)
  • Children Older than 12 Months and Younger than 4 Years
  • Children 4 Years and Older and Adults
  • Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy
  • The active ingredient in CREON evaluated in clinical trials is lipase. CREON is dosed by lipase units.
  • Other active ingredients include protease and amylase. Each CREON delayed-release capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
  • Delayed-Release Capsules: 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase ()
  • Delayed-Release Capsules: 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase ()
  • Delayed-Release Capsules: 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase ()
  • Delayed-Release Capsules: 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase ()
  • Delayed-Release Capsules: 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase ()
  • None.
  • None ()
  • No data
  • Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement in the treatment of cystic fibrosis patients. Exercise caution when doses of CREON exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). ()
  • To avoid irritation of oral mucosa, do not chew CREON or retain in the mouth. ()
  • Exercise caution when prescribing CREON to patients with gout, renal impairment, or hyperuricemia. ()
  • There is theoretical risk of viral transmission with all pancreatic enzyme products including CREON. ()
  • Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. ()
  • The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions .
  • p2823124
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Adverse reactions occurring in at least 2 cystic fibrosis patients (greater than or equal to 4%) receiving CREON are vomiting, dizziness, and cough. ()
  • Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON are hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis. ()
  • No drug interactions have been identified. No formal interaction studies have been conducted.
  • No data
  • There have been no reports of overdose in clinical trials or postmarketing surveillance with this formulation of CREON. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures . High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment .
  • CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
  • Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.
  • Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71u20131.60 mm in diameter).
  • The active ingredient evaluated in clinical trials is lipase. CREON is dosed by lipase units.
  • Other active ingredients include protease and amylase.
  • CREON contains the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.
  • 3,000 USP units of lipase;
  • 6,000 USP units of lipase;
  • 12,000 USP units of lipase;
  • 24,000 USP units of lipase;
  • 36,000 USP units of lipase;
  • No data
  • Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancrelipase.
  • The short-term efficacy of CREON was evaluated in three studies conducted in 103 patients with exocrine pancreatic insufficiency (EPI). Two studies were conducted in 49 patients with EPI due to cystic fibrosis (CF); one study was conducted in 54 patients with EPI due to chronic pancreatitis or pancreatectomy.
  • Journal of Pediatrics.
  • Journal of Pediatric Gastroenterology Nutrition.
  • Journal of the American Dietetic Association
  • Current Gastroenterology Reports.
  • Lancet.
  • New England Journal of Medicine.
  • CREON (pancrelipase) Delayed-Release Capsules
  • 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase
  • Each CREON capsule is available as a two piece hypromellose capsule with a white opaque cap with imprint u201cCREON 1203u201d and a white opaque body that contains tan colored, delayed-release pancrelipase supplied in bottles of:
  • CREON (pancrelipase) Delayed-Release Capsules
  • 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase
  • Each CREON capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint u201cCREON 1206u201d and a blue opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
  • CREON (pancrelipase) Delayed-Release Capsules
  • 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase
  • Each CREON capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint u201cCREON 1212u201d and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
  • CREON (pancrelipase) Delayed-Release Capsules
  • 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase
  • Each CREON capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint u201cCREON 1224u201d and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
  • CREON (pancrelipase) Delayed-Release Capsules
  • 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase
  • Each CREON capsule is available as a two-piece gelatin capsule with blue opaque cap with imprint u201cCREON 1236u201d and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
  • Storage and Handling
  • CREON must be stored at room temperature 15u00b0C to 25u00b0C (59u00b0F to 77u00b0F) and protected from moisture. Temperature excursions are permitted between 25u00b0C to 40u00b0C (77u00b0F and 104u00b0F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. between uses to .
  • Bottles of CREON 3,000 USP units of lipase must be stored and dispensed in the original container.
  • Do not crush CREON
  • See FDA-approved patient labeling (Medication Guide)
  • MEDICATION GUIDE
  • CREONu00aen- (kru0113 u2032u014fn)
  • (pancrelipase)
  • Delayed-Release Capsules
  • Read this Medication Guide before you start taking CREON and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
  • What is the most important information I should know about CREON?
  • CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. n n
  • Take CREON exactly as prescribed. Do not take more or less CREON than directed by your doctor.
  • What is CREON?
  • CREON is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. CREON may help your body use fats, proteins, and sugars from food.
  • CREON contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.
  • What should I tell my doctor before taking CREON?
  • Before taking CREON, tell your doctor about all your medical conditions, including if you:
  • Tell your doctor about all the medicines you take,
  • Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
  • How should I take CREON?
  • Giving CREON to infants (children up to 12 months)
  • Giving CREON to children and adults
  • What are the possible side effects of CREON?
  • CREON may cause serious side effects, including:
  • Call your doctor right away if you have any of these symptoms.
  • The most common side effects of CREON include:
  • Other Possible Side Effects:
  • CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the side effects of CREON. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • You may also report side effects to AbbVie Inc. at 1-800-633-9110.
  • How should I store CREON?
  • Keep CREON and all medicines out of the reach of children.
  • General information about CREON
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CREON for a condition for which it was not prescribed. Do not give CREON to other people to take, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about CREON. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about CREON that is written for healthcare professionals. For more information, go to www.creon-us.com or call toll-free [1-800-633-9110].
  • What are the ingredients in CREON?
  • Active Ingredient:
  • Inactive Ingredients:
  • The shells of the CREON 6,000 USP units of lipase, 12,000 USP units of lipase, and 24,000 USP units of lipase strengths contain: gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
  • In addition:
  • The shells for the CREON 3,000 USP units of lipase strength capsules contain titanium dioxide and hypromellose.
  • The shells of the CREON 6,000 USP units of lipase strength capsules contain FD&C Blue No. 2.
  • The shells of the CREON 12,000 USP units of lipase strength capsules contain black iron oxide.
  • The shells of the CREON 36,000 USP units of lipase strength capsules contain gelatin, titanium dioxide, sodium lauryl sulfate and FD&C Blue No. 2.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • AbbVie Inc.
  • North Chicago, IL 60064, U.S.A.
  • u00a9 2009-2019 AbbVie Inc.
  • 03-B979 November, 2019
  • NDC 0032-1203-70
  • 70 Capsules
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 3,000 USP Units, Protease 9,500 USP Units, Amylase 15,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • PHARMACIST: DISPENSE IN ORIGINAL CONTAINER
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • NDC 0032-1206-01
  • 100 Capsules
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 6,000 USP Units, Protease 19,000 USP Units, Amylase 30,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • 250 Capsules
  • NDC 0032-1206-07
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 6,000 USP Units, Protease 19,000 USP Units, Amylase 30,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • 250 Capsules
  • NDC 0032-1212-07
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 12,000 USP Units, Protease 38,000 USP Units, Amylase 60,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • 100 capsules
  • NDC 0032-1212-13
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 12,000 USP Units, Protease 38,000 USP Units, Amylase 60,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • PROFESSIONAL SAMPLE
  • NOT FOR SALE
  • Rx only
  • abbvie
  • 100 Capsules
  • NDC 0032-1224-01
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 24,000 USP Units, Protease 76,000 USP Units, Amylase 120,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • 100 Capsules
  • NDC 0032-3016-13
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 36,000 USP Units, Protease 114,000 USP Units, Amylase 180,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • abbvie
  • NDC 0032-3016-12
  • 12 Capsules
  • CREON (pancrelipase) Delayed-Release Capsules
  • DOSE BY LIPASE UNITS: Lipase 36,000 USP Units, Protease 114,000 USP Units, Amylase 180,000 USP Units
  • Each capsule contains pancrelipase in enteric-coated spheres.
  • Dispense enclosed Medication Guide to each patient.
  • Rx only
  • PROFESSIONAL SAMPLE
  • NOT FOR RESALE
  • abbvie

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