Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Ascend Laboratories, LLC
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 acute urinary retention - 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 is 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 females 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
Finasteride tablets, USP 5 mg are available as blue colored, 7 mm round, biconvex, film coated tablets, marked “F5” on one side and plain on other side. They are supplied as follows: NDC 67877-288-30, bottles of 30 tablets NDC 67877-288-90, bottles of 90 tablets NDC 67877-288-01, bottles of 100 tablets NDC 67877-288-05, bottles of 500 tablets NDC 67877-288-10, bottles of 1000 tablets NDC 67877-288-33, Carton pack of 10 unit-dose tablets Storage and Handling Store at room temperatures 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Females 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) and Use in Specific Populations (8.1)] .
Abbreviated New Drug Application
Ascend Laboratories, LLC ---------- Finasteride Tablets, USP (fi na’ ste ride) Patient Information about Finasteride Tablets, USP Finasteride tablets are for use by men only. Please read this leaflet before you start taking finasteride tablets. 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 tablets when you start taking your medication and at regular checkups. What are finasteride tablets? Finasteride tablets are a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Finasteride tablets may also be used to reduce the risk of the need for surgery related to BPH in men with an enlarged prostate. Finasteride tablets 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 tablets? Finasteride tablets are for use by MEN only. Do Not Take finasteride tablets if you are: • a woman who is pregnant or may potentially be pregnant. Finasteride tablets may harm your unborn baby. Do not touch or handle crushed or broken finasteride tablets (see "A warning about finasteride tablets and pregnancy"). • allergic to finasteride or any of the ingredients in finasteride tablets. See the end of this leaflet for a complete list of ingredients in finasteride tablets. A warning about finasteride tablets and pregnancy: Women who are or may potentially be pregnant must not use finasteride tablets. They should also not handle crushed or broken tablets of finasteride tablets. 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 tablets after oral use or through the skin, it may cause the male baby to be born with abn Izlasiet visu dokumentu
FINASTERIDE - FINASTERIDE TABLET, FILM COATED ASCEND LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FINASTERIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS. FINASTERIDE TABLETS FOR ORAL USE. INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention 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 is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score) (1.2). LIMITATIONS OF USE: Finasteride tablets are not approved for the prevention of prostate cancer (1.3). DOSAGE AND ADMINISTRATION Finasteride tablets may be administered with or without meals (2). Monotherapy: One tablet (5 mg) taken once a day (2.1). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin (2.2). DOSAGE FORMS AND STRENGTHS 5-mg film-coated tablets (3). CONTRAINDICATIONS Hypersensitivity to any components of this product (4). Females who are or may potentially be pregnant (4, 5.3, 8.1, 16). WARNINGS AND PRECAUTIONS Finasteride tablets reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride tablets may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1). Finasteride tablets may increase the risk of high-grade prostate cancer (5.2, 6.1). Females should not handle crushed or broken finasteride tablets when th Izlasiet visu dokumentu