BUDESONIDE capsule, coated pellets

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

から入手可能:

Zydus Lifesciences Limited

INN（国際名）:

BUDESONIDE

構図:

BUDESONIDE 3 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. Budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. Budesonide extended-release capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred [see Adverse Reactions (6.2)]. Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations [see Clinical Considerations]. In animal reproduction studies with pregnant rats and rabbits, a

製品概要:

Budesonide Extended-Release Capsules (Enteric Coated) 3 mg are white to off-white, free flowing pellets, filled in size '1' hard gelatin capsules having opaque light-orange colored cap printed with "720" in black ink and opaque white body and are supplied as follows: NDC 70771-1075-3 in bottle of 30 capsules NDC 70771-1075-9 in bottle of 90 capsules NDC 70771-1075-1 in bottle of 100 capsules NDC 70771-1075-5 in bottle of 500 capsules NDC 70771-1075-0 in bottle of 1000 capsules NDC 70771-1075-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

BUDESONIDE - BUDESONIDE CAPSULE, COATED PELLETS
ZYDUS LIFESCIENCES LIMITED
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BUDESONIDE DELAYED-RELEASE CAPSULES (ENTERIC COATED)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1075-1 in bottle of 100 capsules
Budesonide Delayed-Release Capsules (Enteric Coated) 3 mg
100 capsules
Rx only
BUDESONIDE
budesonide capsule, coated pellets
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1075
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
BUDESONIDE
3 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
ORANGE (OPAQUE LIGHT-ORANGE) , WHITE (OPAQUE WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
19mm
FLAVOR
IMPRINT CODE
720
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1075-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
06/08/2017
2
NDC:70771-
1075-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
06/08/2017
3
NDC:70771-
1075-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
06/08/2017
4
NDC:70771-
1075-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
06/08/2017
5
NDC:70771-
1075-0
1000 in 1 BOTTLE; Type 0: Not