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Finasteride (Finasteride)

Trade Name : Finasteride

KAISER FOUNDATION HOSPITALS

TABLET

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 KAISER FOUNDATION HOSPITALS. 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usage, Limitations of Use n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a006/2011 n nn
  • Warnings and Precautions, Increased Risk of High-Grade Prostate Cancer n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a006/2011n nn
  • Finasteride tablets USP, is a 5u03b1-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to n n n : n nn
  • Finasteride tablets USP 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) n n n .n n n n
  • Limitations of Use
  • Improve symptoms
  • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.u00a0u00a0
  • Finasteride tablets USP may be administered with or without meals.
  • Finasteride tablets USP may be administered with or without meals n n n . n nn
  • Monotherapy: One tablet (5 mg) taken once a day n n n .n nn
  • Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin n n n . n nn
  • Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with u2018Hu2019 on one side u201837u2019 on other side.
  • 5 mg film-coated tablets n n n .n nn
  • Finasteride tablets USP are contraindicated in the following:
  • Hypersensitivity to any components of this product n n n . n nn
  • Women who are or may potentially be pregnant (n n n ,n n n n n , n n n , n n n ). n nn
  • No data
  • Finasteride tablets USP reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride tablets USP 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 n n n . n n n
  • Finasteride tablets USP may increase the risk of high-grade prostate cancer (n n n ,n n n ). n n n
  • Women should not handle crushed or broken finasteride tablets USP when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (n n n , n n n , n n n ). n n n
  • Finasteride tablets USP are not indicated for use in pediatric patients or women (n n n , n n n , n n n , n n n , n n n ). n n n
  • Prior to initiating treatment with finasteride tablets USP for BPH, u00a0 consideration should be given to other urological conditions that u00a0 may cause similar symptoms (5.6).
  • In clinical studies, finasteride tablets USP reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals.
  • For interpretation of serial PSAs in men taking finasteride tablets USP, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on finasteride tablets USP may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5u03b1-reductase inhibitor. Non-compliance with finasteride tablets USP therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride tablets USP for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. These adjustments preserve the utility of PSA to detect prostate cancer in men treated with finasteride tablets USP.
  • Finasteride tablets USP may also cause decreases in serum PSA in the presence of u00a0u00a0prostate cancer.
  • The ratio of free to total PSA (percent free PSA) remains constant even under the influence of finasteride tablets USP. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary.
  • Men aged 55 and over with a normal digital rectal examination and PSA u22643.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8 to 10 prostate cancer (finasteride 1.8% vs placebo 1.1%). [See Indications and Usage n n n and Adverse Reactions n n n .] Similar results were observed in a 4-year placebo-controlled clinical trial with another 5u03b1-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo). 5u03b1reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5u03b1-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established. n nn
  • 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 and the subsequent potential risk to a male fetus. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. [See Contraindicationsn n n , Use in Specific Populations n n n , Clinical Pharmacology n n n , How Supplied/Storage and Handling n n n and Patient Counseling Information n n n .] n nn
  • Finasteride tablets USP is not indicated for use in pediatric patients [see Use in Specific Populations n n n and Clinical Pharmacology n n n ] or women [see also Warnings and Precautionsn n n , Use in Specific Populationsn n n , Clinical Pharmacology n n n , How Supplied/Storage and Handlingn n n and Patient Counseling Information n n n ]. n nn
  • Treatment with finasteride tablets USP for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks.
  • u00a0 u00a0Prior to initiating treatment with finasteride tablets USP, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.
  • u00a0u00a0u00a0u00a0u00a0u00a0 Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for finasteride therapy.
  • The drug-related adverse reactions, reported in u22651% in patients treated with finasteride tablets USP 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 n n n . n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • Patients have received single doses of finasteride tablets USP up to 400 mg and multiple doses of finasteride tablets USP up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride tablets USP can be recommended.
  • Significant lethality was observed in male and female mice at single oral doses of 1500 mg/mn n n (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/mn n n (400 mg/kg) and 5900 mg/mn n n (1000 mg/kg), respectively. n nn
  • 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 is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5u03b1,17u03b2)-. The empirical formula of finasteride is Cn n n Hn n n Nn n n On n n and its molecular weight is 372.55. Its structural formula is:n nn
  • 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.
  • 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, docusate sodium, magnesium stearate, opadry blue (FD&C blue #2 aluminium lake, hypromellose, talc, titanium dioxide, 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 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 AUCn n n for animals and mean AUCn n n for man (0.4 mcgu2022hr/mL).n nn
  • 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 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 in vitro bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro 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 in vivo 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 withinu00a06 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. n n n n
  • No data
  • Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with u2018Hu2019 on one side u201837u2019 on other side. They are supplied as follows:u00a0u00a0u00a0
  • Bottles of 2160 NDC 0179-0175-88
  • 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 and the subsequent potential risk to a male fetus [see Warnings and Precautionsn n n ), Use in Specific Populations n n n and Patient Counseling Information n n n ]. n nn
  • [See FDA-Approved Patient Labeling (Patient Information) .]
  • Finasteride Tablets USP
  • Arrayn- Patient Information about n- Finasteride Tablets USP
  • (fin-AS-tur-eyed)
  • Finasteride Tablets USP are for use by men only.
  • Please read this leaflet before you start taking finasteride tablets USP. 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 when you start taking your medication and at regular checkups.
  • What aren- finasteride tablets USP?
  • Array
  • Finasteride tablets USP may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help you better manage your BPH symptoms.
  • Who should NOT taken- finasteride tablets USP?
  • Array
  • Do Not Take finasteride tablets USP if you are:
  • A warning about finasteride tablets USP and pregnancy:
  • Array
  • If a woman who is pregnant with a male baby absorbs the active ingredient in finasteride tablets USP 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, a doctor should be consulted.
  • How should I taken- finasteride tablets USP?
  • Array
  • What are the possible side effects ofn- finasteride tablets USP?
  • Array
  • The most common side effects of finasteride tablets USP include:
  • The following have been reported in general use with finasteride tablets USP and/or finasteride at lower doses:
  • In addition, the following have been reported in general use with finasteride tablets USP:
  • You should discuss side effects with your doctor before taking finasteride tablets USP and anytime you think you are having a side effect. These are not all the possible side effects with finasteride tablets USP. 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 takingn- finasteride tablets USP:
  • How should I storen- finasteride tablets USP?
  • Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
  • Array
  • Do not give your finasteride tablets USP to anyone else. It has been prescribed only for you. For more information call 1-888-375-3784.
  • What are the ingredients inn- finasteride tablets USP?
  • Arrayn- Active ingredients:
  • Inactive ingredients:
  • What is BPH?
  • Array
  • In some men, BPH can lead to serious problems, including urinary tract infections, as well as the need for surgery
  • What finasteride tablets USP does:
  • Array
  • To reorder additional Patient Information Leaflets, contact Dr. Reddy's Customer Service at 1-866-733-3952.
  • Rx Only
  • Manufactured by
  • Hetero Labs Limited
  • Jeedimetla,
  • Hyderabad - 500 055, INDIA
  • Manufactured for
  • Dr. Reddy's Laboratories Limited
  • Bachupally - 500 090, INDIA
  • Revised:October 2012
  • Array
  • Repackaged By:
  • Kaiser Foundation Hospitals
  • Livermore, CA 94551
  • Array
  • Finasteride Tablets USP, 5 mg - Container Label

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