BROMOCRIPTINE MESYLATE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE - UNII:3A64E3G5ZO)

Disponible depuis:

Zydus Lifesciences Limited

DCI (Dénomination commune internationale):

BROMOCRIPTINE MESYLATE

Composition:

BROMOCRIPTINE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Bromocriptine mesylate tablets and capsules are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate tablets and/or capsules therapy may be used to reduce the tumor mass prior to surgery. Bromocriptine mesylate tablets and capsules therapy is indicated in the treatment of acromegaly. Bromocriptine therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may no

Descriptif du produit:

Bromocriptine Mesylate Capsules USP, 5 mg are white to off-white powder filled in size "3" empty Cellulose capsules with tan colored cap printed with "ZA 17" in black ink and white colored body printed with "5 mg" in black ink and are supplied as follows: NDC 65841-654-06 in bottle of 30 capsules NDC 65841-654-01 in bottle of 100 capsules Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]; in tight, light-resistant container. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Rev.: 02/17

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BROMOCRIPTINE MESYLATE - BROMOCRIPTINE MESYLATE CAPSULE
ZYDUS LIFESCIENCES LIMITED
----------
BROMOCRIPTINE MESYLATE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-654-01 in bottle of 100 Capsules
Bromocriptine Mesylate Capsules USP, 5 mg
R only
100 Capsules
BROMOCRIPTINE MESYLATE
bromocriptine mesylate capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-654
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE -
UNII:3A64E3G5Z O)
BROMOCRIPTINE
5 mg
x
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
CARRAGEENAN (UNII: 5C69YCD2YJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALEIC ACID (UNII: 91XW058U2C)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
BROWN (TAN) , WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
16mm
FLAVOR
IMPRINT CODE
Z A17;5mg
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-654-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
01/23/2009
2
NDC:65841-654-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/23/2009
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078899
01/23/2009
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
Zydus Lifesciences Limited
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(65841-654) , MANUFACTURE(65841