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:

New Horizon Rx Group, LLC

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets USP, 5 mg 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

Product summary:

Finasteride tablets USP, 5 mg: blue, 7 mm, round, biconvex, film coated tablets, marked ‘F5’ on one side and plain on other side. They are supplied as follows: NDC 58517-200-30 Bottles of 30 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Women should not handle crushed or broken finasteride tablets USP, 5 mg 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, EXPOSURE OF WOMEN —RISK TO MALE FETUS, and PRECAUTIONS, Information for Patients and Pregnancy). Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 Manufactured By: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210, INDIA. 10 6584 2 626710 Rev. 11/13 Patient Information about Finasteride Tablets USP, 5 mg (fin-AS-tur-eyed) Finasteride Tablets USP, 5 mg is for use by men only. Please read this leaflet before you start taking finasteride tablets USP, 5 mg. 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 USP, 5 mg when you start taking your medication and at regular checkups. What is finasteride tablets USP, 5 mg? Finasteride tablets USP, 5 mg 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. Who should NOT take finasteride tablets USP, 5 mg? Finasteride Tablets USP, 5 mg is for use by MEN only. Do Not Take finasteride tablets USP, 5 mg if you are: 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 finasteride tablets USP, 5 mg. Finasteride Tablets USP, 5 mg 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 USP, 5 mg 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 ingredient in finasteride tablets USP, 5 mg, a doctor should be consulted. How should I take finasteride tablets USP, 5 mg? Follow your doctor's instruction. What are the possible side effects of finasteride tablets USP, 5 mg? The most common side effects of finasteride tablets USP, 5 mg include: In addition, the following have been reported in general use with finasteride tablets USP, 5 mg: You should discuss side effects with your doctor before taking finasteride tablets USP, 5 mg and anytime you think you are having a side effect. These are not all the possible side effects with finasteride tablets USP, 5 mg. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at: 1-800-FDA-1088. What you need to know while taking finasteride tablets USP, 5 mg How should I store finasteride tablets USP, 5 mg? Finasteride Tablets USP, 5 mg are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. Keep finasteride tablets USP, 5 mg and all medications out of the reach of children. Do not give your finasteride tablets USP, 5 mg to anyone else. It has been prescribed only for you. What are the ingredients in finasteride tablets USP, 5 mg? Active ingredients: finasteride Inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD & C Blue # 2 aluminum lake and polyethylene glycol. What is BPH? BPH is an enlargement of the prostate gland. 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. What finasteride tablets USP, 5 mg does Finasteride Tablets USP, 5 mg lowers levels of a hormone called DHT (dihydrotestosterone), which is a 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 Tablets USP, 5 mg will help reduce the risk of developing a sudden inability to pass urine and the need for surgery related to an enlarged prostate. However, since each case of BPH is different, you should know that: Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 Manufactured by: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210, INDIA. 10 6584 2 626710 Rev. 11/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
NEW HORIZON RX GROUP, LLC
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FINASTERIDE TABLETS
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,17ß)-.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 USP for oral administration are film-coated
tablets that contain 5 mg of finasteride
and the following inactive ingredients: lactose monohydrate,
microcrystalline cellulose, pregelatinized
starch, sodium starch glycolate, hypromellose, titanium dioxide,
magnesium stearate, lauryl
macrogolglycerides, FD&C Blue # 2 aluminum lake and polyethylene
glycol.
CLINICAL PHARMACOLOGY
The development and enlargement of the prostate gland is dependent on
the potent androgen, 5α-
dihydrotestosterone (DHT). Type II 5α-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
5α-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 dose. The
suppression of DHT is maintained
thro