Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Zydus Lifesciences Limited
FINASTERIDE
FINASTERIDE 5 mg
ORAL
PRESCRIPTION DRUG
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
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)].
Abbreviated New Drug Application
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 Izlasiet visu dokumentu
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 Izlasiet visu dokumentu