PANCREAZE- pancrelipase lipase, pancrelipase amylase, and pancrelipase protease capsule, delayed release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

VIVUS LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. None. Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PANCREAZE and any potential adverse effects on the breastfed infant from PANCREAZE or from the underlying maternal condition. The safety and effectiveness of PANCREAZE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PANCREAZE for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 8 to 17 years of age (Study 1) along with supportive data from a randomized, investigator-blinded, dose-ranging study in 17 pediatric patients aged 6 to 30 months (Study 2). Both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients in these studies was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14)] . Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with PANCREAZE because some patients may be at risk of progressing to stricture formation. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation . [see Dosage and Administration (2.2)and Warnings and Precautions (5.1)] . Crushing or chewing PANCREAZE capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3)and Warnings and Precautions (5.2)]. Clinical studies of PANCREAZE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

Обзор продуктов:

PANCREAZE (pancrelipase) delayed-release capsules containing XXX-colored delayed-release pancrelipase are supplied as follows: Storage and Handling Store PANCREAZE at room temperature between 15ºC and 25ºC (59°F to 77°F), excursion permitted up to 40ºC (104°F) for 24 hours. After opening, keep bottle tightly closed between uses to protect from moisture. All PANCREAZE bottles contain a desiccant canister. Store and dispense PANCREAZE in the original container.

Статус Авторизация:

Biologic Licensing Application

тонкая брошюра

VIVUS LLC
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
2/2024
MEDICATION GUIDE
PANCREAZE ®(pan-kre-aze)
(pancrelipase)
delayed-release capsules
What is the most important information I should know about PANCREAZE?
PANCREAZE may increase your chance of having a rare bowel disorder
called fibrosing colonopathy
especially if taken at a high dose for a long time in children with
cystic fibrosis. 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 (constipation)
•
nausea, vomiting, or diarrhea
Take PANCREAZE exactly as prescribed by your doctor. Do not take more
PANCREAZE than directed
by your doctor.
What is PANCREAZE?
PANCREAZE is a prescription medicine used to treat people who cannot
digest food normally because
their pancreas does not make enough enzymes.
PANCREAZE contains a mixture of digestive enzymes including lipases,
proteases, and amylases from
pig pancreas.
PANCREAZE is safe and effective in adults and children.
Before taking PANCREAZE, tell your doctor about all your medical
conditions, including if you:
•
are allergic to pork (pig) products.
•
have a history of 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.
•
are breastfeeding or plan to breastfeed. It is not known if PANCREAZE
passes into your breast
milk. Talk to your doctor about the best way to feed your baby if you
take PANCREAZE.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines,
vitamins, or herbal supplements.
Know the medicines you take. Keep a list o

Характеристики продукта

PANCREAZE- PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE
PROTEASE CAPSULE, DELAYED RELEASE
VIVUS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANCREAZE
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANCREAZE
.
PANCREAZE
(PANCRELIPASE) DELAYED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
PANCREAZE
is indicated for the treatment of exocrine pancreatic insufficiency in
adult and pediatric
patients. ( 1)
DOSAGE AND ADMINISTRATION
Important Dosing Information ( 2.1)
PANCREAZE is a mixture of enzymes including lipases, proteases, and
amylases and dosing is based
on lipase units. Dosing scheme based on actual body weight or fat
ingestion.
Individualize the dosage based on clinical symptoms, the degree of
steatorrhea present, and the fat
content of the diet.
Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day,
or 4,000 lipase units/g fat
ingested/day in adult and pediatric patients greater than 12 months of
age without further
investigation. ( 5.1)
The total daily dosage in adult and pediatric patients greater than 12
months of age should reflect
approximately three meals plus two or three snacks per day. With each
snack, administer
approximately half the prescribed dose for a meal.
Do not substitute other pancreatic enzyme products for PANCREAZE. When
switching from another
pancreatic enzyme product to PANCREAZE, monitor patients for clinical
symptoms of exocrine
pancreatic insufficiency and titrate the dosage as needed.
Recommended Dosage ( 2.2):
_Adult and Pediatric Patients Greater than 12 Months_: The recommended
initial starting dosage is:
500 lipase units/kg/meal for adult and pediatric patients greater than
12 months to less than 4 years.
1,000 lipase units/kg/meal for pediatric patients 4 years and older.
Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase
units/kg/day, or less than 4,000
lipase units/g fat ingested/day. Higher dosages may be administere