Finasteride (Proscar)

Trade Name : PROSCAR

Merck Sharp & Dohme Corp.

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 (Proscar) which is also known as PROSCAR and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 5 mg/1 per ml. Read more

Finasteride (Proscar) 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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About GNH

No data

PROSCAR, is a 5u03b1-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ():
PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed u22654 point increase in American Urological Association (AUA) symptom score) ().
Limitations of Use

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.

PROSCAR may be administered with or without meals.
PROSCAR may be administered with or without meals ().
Monotherapy: One tablet (5u00a0mg) taken once a day ().
Combination with Doxazosin: One tablet (5u00a0mg) taken once a day in combination with the alpha-blocker doxazosinu00a0 ().

5-mg blue, modified apple-shaped, film-coated tablets, with the code MSDu00a072 on one side and PROSCAR on the other.
5-mg film-coated tablets ().

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

No data

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

The drug-related adverse reactions, reported in u22651% in patients treated with PROSCAR 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 ().

No data

No data

Patients have received single doses of PROSCAR up to 400u00a0mg and multiple doses of PROSCAR up to 80u00a0mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with PROSCAR 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.

PROSCAR (finasteride), 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 is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5u03b1,17u00df)-. The empirical formula of finasteride is CHNO and its molecular weight is 372.55. Its structural formula is:
Finasteride is a 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.
PROSCAR (finasteride) tablets for oral administration are film-coated tablets that contain 5u00a0mg of finasteride and the following inactive ingredients: hydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl cellulose LF, hydroxypropyl methylcellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and yellow iron oxide.

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 160u00a0mg/kg/day in males and 320u00a0mg/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 5u00a0mg/day. All exposure calculations were based on calculated AUCn for animals and mean AUCn for man (0.4u00a0u03bcgu2022hr/mL).
In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (pu22640.05) 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 1u00a0year at 30 and 350 times (20 mg/kg/day and 45 mg/kg/day, respectively) or in mice treated for 19u00a0months 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 4000-5000 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 250u00a0mg/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 12u00a0weeks, 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 12u00a0weeks of treatment; however, when treatment was continued for up to 24 or 30u00a0weeks, 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 6u00a0weeks 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

No. 3094u00a0u2014 PROSCAR tablets 5u00a0mg are blue, modified apple-shaped, film-coated tablets, with the code MSDu00a072 on one side and PROSCAR on the other. They are supplied as follows:
NDC 0006-0072-31 unit of use bottles of 30
NDC 0006-0072-58 unit of use bottles of 100.
Storage and Handling
Store at room temperatures below 30u00b0C (86u00b0F). Protect from light and keep container tightly closed.
Women should not handle crushed or broken PROSCAR 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 .

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1992, 1995, 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk0906-5t-1309r011

PROSCAR (finasteride) Tablets Patient Information about PROSCAR (Prahs-car)
PROSCAR is for use by men only.
Please read this leaflet before you start taking PROSCAR. 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 PROSCAR when you start taking your medication and at regular checkups.
Arrayn- What is PROSCAR?
PROSCAR is a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. PROSCAR 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.
PROSCAR may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help you better manage your BPH symptoms.
Who should NOT take PROSCAR?
PROSCAR is for use by MEN only.
Do Not Take PROSCAR if you are:
A warning about PROSCAR and pregnancy:
Women who are or may potentially be pregnant must not use PROSCAR. They should also not handle crushed or broken tablets of PROSCAR. PROSCAR 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 PROSCAR 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 PROSCAR, a doctor should be consulted.
How should I take PROSCAR?
Follow your doctor's instruction.
What are the possible side effects of PROSCAR?
PROSCAR may increase the chance of a more serious form of prostate cancer.
The most common side effects of PROSCAR include:
The following have been reported in general use with PROSCAR and/or finasteride at lower doses:
You should discuss side effects with your doctor before taking PROSCAR and anytime you think you are having a side effect. These are not all the possible side effects with PROSCAR. 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 PROSCAR:
How should I store PROSCAR?
Keep PROSCAR and all medications out of the reach of children.
Do not give your PROSCAR tablets to anyone else. It has been prescribed only for you.
For more information call 1-800-622-4477.
What are the ingredients in PROSCAR?
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, a sudden inability to pass urine (acute urinary retention), as well as the need for surgery.
What PROSCAR does:
PROSCAR 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. PROSCAR 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:

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1992, 1995, 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 09/2013
usppi-mk0906-5t-1309r011

NDC 0006-0072-31
Proscarn (finasteride) Tablets
5 mg
WARNING: PROSCAR (finasteride) shouldnot be used by women or children.Women who are or may potentially bepregnant must not use PROSCAR. Theyshould also not handle crushed or brokentablets of PROSCAR. (See Package Insert.)
Rx only
30 Tablets

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Finasteride (Proscar)

Trade Name : PROSCAR

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 (Proscar)

Trade Name : PROSCAR

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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