FINASTERIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)

Available from:

Zydus Lifesciences Limited

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: -Improve symptoms -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets  administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score). Finasteride tablets are not approved for the prevention of prostate cancer. Finasteride tablets are contraindicated in the following: - Hypersensitivity to any component of this medication. - Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pre

Product summary:

Finasteride Tablets USP, 5 mg are blue-colored, round, biconvex, film-coated tablets imprinted with "ZE 56" in black ink on one side and plain on other side and are supplied as follows: NDC 70771-1152-3 in bottles of 30 tablets NDC 70771-1152-1 in bottles of 100 tablets NDC 70771-1152-0 in bottle of 1000 tablets NDC 70771-1152-4 unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage  and  Handling: Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Protect from light. Keep container tightly closed.   Dispense in a tight, light-resistant container. Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus [see  Warnings  and  Precautions  (5.3) , Use  in  Specific  Populations  (8.1)  and  Patient  Counseling  Information  (17.2)].  

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
Cadila Healthcare Limited
----------
Patient Information
Finasteride [fin-AS-tur-eyed] Tablets USP
Finasteride is for use by men only.
Please read this leaflet before you start taking finasteride. Also,
read it each time you renew your
prescription, just in case anything has changed. Remember, this
leaflet does not take the place of careful
discussions with your doctor. You and your doctor should discuss
finasteride when you start taking your
medication and at regular checkups.
What is finasteride?
Finasteride is a medication used to treat symptoms of benign prostatic
hyperplasia (BPH) in men with an
enlarged prostate. Finasteride may also be used to reduce the risk of
a sudden inability to pass urine and the
need for surgery related to BPH in men with an enlarged prostate.
Finasteride may be prescribed along with another medicine, an
alpha-blocker called doxazosin, to help you
better manage your BPH symptoms.
Who should NOT take finasteride?
Finasteride is for use by MEN only.
Do Not Take Finasteride if you are:
•
a woman who is pregnant or may potentially be pregnant. Finasteride
may harm your unborn baby.
Do not touch or handle crushed or broken finasteride tablets (see "A
warning about finasteride and
pregnancy").
•
allergic to finasteride or any of the ingredients in finasteride. See
the end of this leaflet for a complete
list of ingredients in finasteride.
A warning about finasteride and pregnancy:
Women who are or may potentially be pregnant must not use finasteride.
They should also not handle
crushed or broken tablets of finasteride. Finasteride tablets are
coated and will prevent contact with the active
ingredient during normal handling, provided that the tablets are not
broken or crushed.
If a woman who is pregnant with a male baby absorbs the active
ingredient in finasteride after oral use or
through the skin, it may cause the male baby to be born with
abnormalities of the sex organs. If a woman
who is pregnant comes into contact with the active ingredi

Summary of Product characteristics

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
FINASTERIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1152-0 in bottle of 1000 tablets
Finasteride Tablets USP, 5 mg
R only
1000 tablets
FINASTERIDE
finasteride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1152
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
FINASTERIDE
5 mg
x
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PRODUCT CHARACTERISTICS
COLOR
BLUE (blue)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z E;56
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1152-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
2
NDC:70771-
1152-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
3
NDC:70771-
1152-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
4
NDC:70771-
1152-4
10 in 1 CARTON
12/05/2017
4
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078900
12/05/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
Zydus Lifesciences Limited
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Lim