FINASTERIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (الاسم الدولي):

FINASTERIDE

تركيب:

FINASTERIDE 5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Finasteride is 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 is 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 DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (See also WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS and PRECAUTIONS, Information for Patients and Pregnancy.) In female rats, low doses of finasterid

ملخص المنتج:

Finasteride Tablets, USP 5 mg are blue, round, biconvex film-coated tablets, with “F5” on one side and “” on the other. Available in bottles of 30’s (NDC 63739-495-41), 90’s (NDC 63739-495-43) and 100’s (NDC 63739-495-40). Store at 20 to 25°C (68 to 77°F) with excursions permitted between 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. 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 the male fetus (see CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS; PRECAUTIONS, Pregnancy and HOW SUPPLIED). Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with finasteride. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride (see ADVERSE REACTIONS). Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported (see ADVERSE REACTIONS). Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride. Manufactured by: Intas Pharmaceuticals Ltd. Ahmedabad, India- 382210 Code: Guj/Drugs/1339 Distributed by: McKesson Packaging Services, A business unit of McKesson Corporation, 7101 Weddington Rd, Concord, NC 28027 IS-495-M80-01-B 10 9009 0 624669 Rev. 08/10 Patient Package Insert PATIENT INFORMATION ABOUT FINASTERIDE TABLETS, USP 5 mg (fin-AS-tur-eyed) 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. Why your doctor has prescribed finasteride? Your doctor has prescribed finasteride because you have a medical condition called benign prostatic hyperplasia or BPH. This occurs only in men. What is BPH? BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as: In some men, BPH can lead to serious problems, including urinary tract infections, as well as the need for surgery. Treatment options for BPH There are three main treatment options for symptoms of BPH: There are two main treatment options to reduce the risk of serious problems due to BPH: What finasteride does Finasteride lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Finasteride will help reduce the risk of the need for surgery. However, since each case of BPH is different, you should know that: What you need to know while taking finasteride • You must see your doctor regularly. While taking finasteride, you must have regular checkups. Follow your doctor's advice about when to have these checkups. • About side effects. Like all prescription drugs, finasteride may cause side effects. Side effects due to finasteride may include impotence (an inability to have an erection) or less desire for sex. Some men taking finasteride may have changes or problems with ejaculation, such as a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to interfere with normal sexual function. In some cases these side effects went away while the patient continued to take finasteride. In addition, some men may have breast enlargement and/or tenderness. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Some men have reported allergic reactions such as rash, itching, hives, and swelling of the lips and face. Rarely, testicular pain has been reported. You should discuss side effects with your doctor before taking finasteride and anytime you think you are having a side effect. • Checking for prostate cancer . Your doctor has prescribed finasteride for symptomatic BPH and not for cancer — but a man can have BPH and prostate cancer at the same time. Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks should continue while you take finasteride. Finasteride is not a treatment for prostate cancer. • About Prostate-Specific Antigen (PSA). Your doctor may have done a blood test called PSA. Finasteride can alter PSA values. For more information, talk to your doctor. • A warning about finasteride and pregnancy. Finasteride is for use by MEN only. Women who are or may potentially be pregnant must not use finasteride. They should also not handle crushed or broken tablets of finasteride. 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. 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 comes into contact with the active ingredient in finasteride, a doctor should be consulted. Remember, these warnings apply only when the woman is pregnant or could potentially be pregnant. How to take finasteride Follow your doctor's advice about how to take finasteride. You must take it every day. You may take it with or between meals. To avoid forgetting to take finasteride, it may be helpful to take it at the same time every day. Do not share finasteride with anyone else; it was prescribed only for you. Keep finasteride and all medicines out of the reach of children. FOR MORE INFORMATION ABOUT ‘finasteride’ AND BPH, TALK WITH YOUR DOCTOR. IN ADDITION, TALK TO YOUR PHARMACIST OR OTHER HEALTH CARE PROVIDER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088. Manufactured by: Intas Pharmaceuticals Ltd. Ahmedabad, India- 382210 Code: Guj/Drugs/1339 Distributed by: McKesson Packaging Services, A business unit of McKesson Corporation, 7101 Weddington Rd, Concord, NC 28027 IS-495-M80-01-B 10 9009 0 624669 Rev. 08/10

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
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FINASTERIDE TABLETS, USP
RX ONLY
DESCRIPTION
Finasteride, a synthetic 4-azasteroid compound, is a specific
inhibitor of steroid Type II 5α-reductase,
an intracellular enzyme that converts the androgen testosterone into
5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide,
_N_-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The
empirical formula of finasteride is C
H N O and its molecular weight is 372.55. Its structural
formula is:
Finasteride is a white crystalline powder with a melting point near
250°C. It is freely soluble in
chloroform and in lower alcohol solvents, but is practically insoluble
in water.
Finasteride tablets for oral administration are film-coated tablets
that contain 5 mg of finasteride and the
following inactive ingredients: FD&C Blue #2 Aluminum Lake,
hypromellose, lactose monohydrate,
lauryl macrogolglycerides, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
pregelatinized starch, sodium starch glycolate and titanium dioxide.
CLINICAL PHARMACOLOGY
The development and enlargement of the prostate gland is dependent on
the potent androgen, 5 α -
dihydrotestosterone (DHT). Type II 5 α −reductase metabolizes
testosterone to DHT in the prostate
gland, liver and skin. DHT induces androgenic effects by binding to
androgen receptors in the cell
nuclei of these organs.
Finasteride is a competitive and specific inhibitor of Type II
5α-reductase with which it slowly forms a
stable enzyme complex. Turnover from this complex is extremely slow (t
~30 days). This has been
demonstrated both _in vivo _and _in vitro_. Finasteride has no
affinity for the androgen receptor. In man, the 5
α -reduced steroid metabolites in blood and urine are decreased after
administration of finasteride.
In man, a single 5-mg oral dose of finasteride produces a rapid
reduction in serum DHT concentration,
with the maximum effect observed 8 hours after the first