CREON- pancrelipase capsule, delayed release pellets

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O), PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50), PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

PANCRELIPASE LIPASE

Komposisi:

PANCRELIPASE LIPASE 12000 [USP'U]

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

CREON® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. None. Teratogenic effects Pregnancy Category C: Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CREON should be given to a pregnant woman only if clearly needed. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when

Ringkasan produk:

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 “CREON 1212” 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 up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture . Bottles of CREON 3,000 USP units of lipase must be stored and dispensed in the original container. Do not crush CREON delayed-release capsules or the capsule contents.

Status otorisasi:

New Drug Application

Selebaran informasi

Physicians Total Care, Inc.
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MEDICATION GUIDE
CREON® (krē ′ŏn)
(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. Call your
doctor right away if you have any
unusual or severe:
•
stomach area (abdominal) pain
•
bloating
•
trouble passing stool (having bowel movements)
•
nausea, vomiting, or diarrhea
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:
•
are allergic to pork (pig) products
•
have a history of intestinal blockage of your intestines, or scarring
or thickening of your bowel
wall (fibrosing colonopathy)
•
have gout, kidney disease, or high blood uric acid (hyperuricemia)
•
have trouble swallowing capsules
•
have any other medical condition
•
are pregnant or plan to become pregnant. It is not known if CREON will
harm your unborn baby.
•
are breast-feeding or plan

Karakteristik produk

CREON - PANCRELIPASE CAPSULE, DELAYED RELEASE PELLETS
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CREON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CREON.
CREON (PANCRELIPASE) DELAYED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Dosage and Administration, _Infants (up to 12 months)_ (2.1) 6/2011
Dosage and Administration (2.2) 6/2011
Dosage and Administration, _Infants (up to 12 months)_ (2.2) 6/2011
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
CREON is not interchangeable with any other pancrelipase product.
(2.1)
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. (2.1) Dosing
should not exceed the recommended maximum dosage
set forth by the Cystic Fibrosis Foundation Consensus Conferences
Guidelines. (2.2)
_Infants (up to 12 months)_
Prior to each feeding, infants may be given 3,000 lipase units (one
capsule) per 120 mL of formula or per breast-
feeding. (2.1)
Do not mix CREON capsule contents directly into formula or breast milk
prior to administration. (2.1)
_Children Older than 12 Months and Younger than 4 Years_
Begin with 1,000 lipase units/kg of body weight per meal for children
less than age 4 years to a maximum of 2,500 lipase
units/kg of body weight per meal (or less than or equal to 10,000
lipase units/kg of body weight per day), or less than
4,000 lipase units/g fat ingested per day. (2.2)
_Children 4 Years and Older and Adults_
Begin with 500 lipase units/kg of body weight per meal for those older
than age 4 years to a maximum of 2,500 lipase
units/kg of body weight per meal (or less than or equal to