מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Zydus Lifesciences Limited
BUDESONIDE
BUDESONIDE 3 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
BUDESONIDE - BUDESONIDE CAPSULE, COATED PELLETS ZYDUS LIFESCIENCES LIMITED ---------- 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 קרא את המסמך השלם