Finasteride (Finasteride)

Trade Name : Finasteride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 5 mg/1

FINASTERIDE 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Finasteride (Finasteride) which is also known as Finasteride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Finasteride (Finasteride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Finasteride tablets are a 5u03b1-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ():
Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed u2265 4 point increase in American Urological Association (AUA) symptom score) ().
Limitations of Use:

Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

Finasteride tablets may be administered with or without meals.
Finasteride tablets may be administered with or without meals ().
Monotherapy: One tablet (5 mg) taken once a day ().
Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ().

5 mg blue, film-coated, capsule-shaped, unscored tablets, debossed u201c93u201d on one side and u201c7355u201d on the other side.
5 mg film-coated tablets ().

Finasteride tablets are contraindicated in the following:
Hypersensitivity to any components of this product ().
Women who are or may potentially be pregnant (, , , ).

No data

Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride 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 5u03b1-reductase inhibitor ().
Finasteride may increase the risk of high-grade prostate cancer (, ).
Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (, , ).
Finasteride is not indicated for use in pediatric patients or women (, , , , ).
Prior to initiating treatment with finasteride for BPH, consideration should be given to other urological conditions that may cause similar symptoms ().

The drug-related adverse reactions, reported in u2265 1% in patients treated with finasteride 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 ().
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

No data

Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.
Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m (400 mg/kg) and 5900 mg/m (1000 mg/kg), respectively.

Finasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5u03b1-reductase, an intracellular enzyme that converts the androgen testosterone into 5u03b1-dihydrotestosterone (DHT).
Finasteride, USP is 4-azaandrost-1-ene-17-carboxamide, -(1,1-dimethylethyl)-3-oxo-,(5u03b1,17u03b2)-. Its structural formula is:
CHNO M.W. 372.55
Finasteride, USP is a white to off-white crystalline powder with a melting point near 250u00b0C. 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, USP and the following inactive ingredients: FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, sodium lauryl sulphate, sodium starch glycolate type A potato, and titanium dioxide.

No data

No evidence of a tumorigenic effect was observed in a 24 month study in Sprague-Dawley rats receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses produced respective systemic exposure in rats of 111 and 274 times those observed in man receiving the recommended human dose of 5 mg/day. All exposure calculations were based on calculated AUC for animals and mean AUC for man (0.4 mcgu2022hr/mL).
In a 19 month carcinogenicity study in CD-1 mice, a statistically significant (p u2264 0.05) increase in the incidence of testicular Leydig cell adenomas was observed at 228 times the human exposure (250 mg/kg/day). In mice at 23 times the human exposure, estimated (25 mg/kg/day) and in rats at 39 times the human exposure (40 mg/kg/day) an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells and an increase in serum LH levels (2 to 3 fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either rats or dogs treated with finasteride for 1 year at 30 and 350 times (20 mg/kg/day and 45 mg/kg/day, respectively) or in mice treated for 19 months at 2.3 times the human exposure, estimated (2.5 mg/kg/day).
No evidence of mutagenicity was observed in an bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an alkaline elution assay. In an chromosome aberration assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. These concentrations correspond to 4000 to 5000 times the peak plasma levels in man given a total dose of 5 mg. In an chromosome aberration assay in mice, no treatment-related increase in chromosome aberration was observed with finasteride at the maximum tolerated dose of 250 mg/kg/day (228 times the human exposure) as determined in the carcinogenicity studies.
In sexually mature male rabbits treated with finasteride at 543 times the human exposure (80 mg/kg/day) for up to 12 weeks, no effect on fertility, sperm count, or ejaculate volume was seen. In sexually mature male rats treated with 61 times the human exposure (80 mg/kg/day), there were no significant effects on fertility after 6 or 12 weeks of treatment; however, when treatment was continued for up to 24 or 30 weeks, there was an apparent decrease in fertility, fecundity and an associated significant decrease in the weights of the seminal vesicles and prostate. All these effects were reversible within 6 weeks of discontinuation of treatment. No drug-related effect on testes or on mating performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is secondary to its effect on accessory sex organs (prostate and seminal vesicles) resulting in failure to form a seminal plug. The seminal plug is essential for normal fertility in rats and is not relevant in man.

No data

Finasteride Tablets USP, 5 mg are available as blue, film-coated, capsule-shaped, unscored tablets, debossed u201c93u201d on one side and u201c7355u201d on the other side, in bottles of 30, 90, and 500 tablets.
NDC 0093-7355-56 bottle of 30.NDC 0093-7355-98 bottle of 90.NDC 0093-7355-05 bottle of 500.
Storage and Handling
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed.
Women should not handle crushed or broken finasteride tablets USP when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride, USP and the subsequent potential risk to a male fetus [].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

See FDA-Approved Patient Labeling (Patient Information).

ABOUT FINASTERIDE (fin-AS-tur-eyed) TABLETS USP, 5 mg
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 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 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 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 abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in finasteride tablets, a doctor should be consulted.
How should I take finasteride tablets?
Follow your doctor's instruction.
What are the possible side effects of finasteride tablets?
Finasteride tablets may increase the chance of a more serious form of prostate cancer.
The most common side effects of finasteride tablets include:
The following have been reported in general use with finasteride tablets and/or finasteride at lower doses:
You should discuss side effects with your doctor before taking finasteride tablets and anytime you think you are having a side effect. These are not all the possible side effects with finasteride tablets. 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:
How should I store finasteride tablets?
Keep finasteride tablets and all medications out of the reach of children.
Do not give your finasteride tablets to anyone else. They have been prescribed only for you.
For more information call 1-888-838-2872.
What are the ingredients in finasteride tablets USP?
Active ingredients:
Inactive ingredients:
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 do:
Finasteride tablets lower 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 will help reduce the need for surgery related to an enlarged prostate. However, since each case of BPH is different, you should know that:
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. L 10/2016

No data

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Finasteride (Finasteride)

Trade Name : Finasteride

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Finasteride (Finasteride)

Trade Name : Finasteride

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

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US NDC

Canadian DIN

Swiss Drugs

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