TAMSULOSIN HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)

Verfügbar ab:

Zydus Lifesciences Limited

INN (Internationale Bezeichnung):

TAMSULOSIN HYDROCHLORIDE

Zusammensetzung:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14) ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see ADVERSE REACTIONS (6.2) ]. Teratogenic Effects , Pregnancy Category B. Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin hydrochloride capsules are not indicated for use in women. Tamsulosin hydrochloride

Produktbesonderheiten:

Tamsulosin Hydrochloride Capsules USP, 0.4 mg are white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink and peach colored body printed with "0.4 mg" in black ink and are supplied as follows: NDC 65841-695-06 in bottle of 30 capsules NDC 65841-695-14 in bottle of 60 capsules NDC 65841-695-16 in bottle of 90 capsules      NDC 65841-695-01 in bottle of 100 capsules NDC 65841-695-05 in bottle of 500 capsules NDC 65841-695-10 in bottle of 1000 capsules NDC 65841-695-30 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
ZYDUS LIFESCIENCES LIMITED
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TAMSULOSIN HYDROCHLORIDE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-695-01 in bottle of 100 Capsules
Tamsulosin Hydrochloride Capsules USP, 0.4 mg
R only
100 Capsules
TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-695
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
x
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN -
UNII:G3P28OML5I)
TAMSULOSIN
HYDROCHLORIDE
0.4 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GELATIN (UNII: 2G86QN327L)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
GREEN (GREEN) , ORANGE (PEACH)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
18mm
FLAVOR
IMPRINT CODE
Z A;18;0;4mg
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
695-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
2
NDC:65841-
695-14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
3
NDC:65841-
695-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
4
NDC:65841-
695-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
5
NDC:65841-
695-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
6
NDC:65841-
695-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/27/2010
7
NDC:65841-
695-77
10 in 1 CARTON
04/27/2010
7
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
C