Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Proficient Rx LP
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: Risk Summary Finasteride tablets are contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride tablets may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see Warnings
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 71205-767-30, bottles of 30 tablets NDC 71205-767-60, bottles of 60 tablets NDC 71205-767-90, bottles of 90 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
Proficient Rx LP ---------- 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 abnormaliti Đọc toàn bộ tài liệu
FINASTERIDE- FINASTERIDE TABLET, FILM COATED PROFICIENT RX LP ---------- 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): • • • 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 • • • • • ADVERSE REACTIONS THE DRUG-RELATED ADVERSE REACTIONS, REPORTED IN ≥1% IN PATIENTS TREATED WITH FINASTERIDE TABLETS AND GREATER THAN IN PATIENTS TREATED WITH PLACEBO OVER A 4-YEAR STUDY ARE: IMPOTENCE, DECREASED LIBIDO, DECREASED VOLUME OF EJACULATE, BREAST ENLARGEMENT, BREAST TENDERNESS AND RASH (6.1).TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES, LLC AT 1-877-ASC-RX01 (877-272-7901) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 2/2023 Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery includ Đọc toàn bộ tài liệu