One size does not fit all in benign prostatic hyperplasia treatment
Medically reviewed by Drugs. Last updated on Jun 1, The recommended dose of Finasteride tablets USP is one tablet 5 mg taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies Risultati BPH use is contraindicated in women when they are or may potentially be pregnant. 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. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals.
To interpret an isolated PSA value in patients treated risultati BPH Finasteride tablets USP for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.
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. 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. 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.
These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to risultati BPH to baseline of 84 weeks. Prior 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. These patients may not be candidates for Finasteride therapy.
Finasteride tablets USP are generally well tolerated; adverse reactions usually have been mild and transient. The most frequently reported risultati BPH reactions were related to sexual function. Risultati BPH years 2 to 4 of the study, there was risultati BPH significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder. The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, risultati BPH libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function risultati BPH Table 2.
Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.
Combination therapy with Finasteride and doxazosin was associated with no new clinical adverse experience. Three risultati BPH these patients were on Finasteride only and one was on combination therapy. In addition, direct comparisons of safety data risultati BPH the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.
The final tolerated dose 4 mg or 8 mg was administered at end-Week 4. Only those patients tolerating at least 4 mg were kept on doxazosin. The majority of patients received risultati BPH 8-mg dose over the duration of the study. Men received either Finasteride tablets USP, 5 mg or placebo daily. Patients were evaluated annually with PSA and digital rectal exams.
Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with Finasteride 1. No clinical benefit has been demonstrated in patients with prostate cancer treated with Finasteride tablets USP. Breast Cancer During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled men, there were 4 cases of breast cancer in men treated with Finasteride but no cases in men not treated risultati BPH Finasteride.
During the 4-year, placebo-controlled long-term efficacy and safety study that enrolled men, there were 2 cases of breast cancer in placebo-treated men but no cases in risultati BPH treated with Finasteride. During the 7-year placebo-controlled Prostate Cancer Prevention Trial PCPT that enrolled 18, men, there was 1 case of breast cancer in men treated with Finasteride, and 1 case of breast cancer in men treated with placebo.
The relationship between long-term use of Finasteride and male breast neoplasia risultati BPH currently unknown. Sexual Function There is no evidence of increased sexual adverse experiences with increased duration of treatment with Finasteride tablets USP.
New reports of drug-related sexual adverse experiences decreased with duration of therapy. The following additional adverse effects have been reported in post-marketing experience with Finasteride tablets USP. Risultati BPH independent role of Finasteride tablets USP in risultati BPH events is unknown.
Normalization or improvement of seminal quality has been reported after discontinuation of Finasteride. The following additional adverse event related to sexual dysfunction that risultati BPH after discontinuation of treatment has been reported in postmarketing experience with Finasteride at lower doses used to treat male pattern baldness.
Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency risultati BPH establish a causal relationship to drug exposure:.
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome Plinked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. Teratogenic Effects: Pregnancy Category X.
In animal studies, Finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus.
With regard to Finasteride exposure through the skin, Finasteride tablets USP are coated and will prevent skin contact with Finasteride during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken Finasteride tablets USP because of possible exposure of a male fetus. If a pregnant woman comes in contact with crushed or broken Finasteride tablets USP, the contact area should be washed immediately with soap and water.
In an embryo-fetal development study, pregnant rats received Finasteride risultati BPH the period of major organogenesis gestation days 6 to At maternal doses of oral Finasteride approximately 0. Exposure multiples risultati BPH estimated using data from nonpregnant rats. Days 16 to 17 days of gestation is a critical period in male fetal rats for differentiation of the external genitalia.
At risultati BPH maternal doses approximately 0. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0. No abnormalities were observed in female offspring at any maternal dose of Finasteride. No effects on fertility were seen in female offspring under these conditions.
However, this study may not have included the critical period for Finasteride effects on development of male external genitalia in the rabbit. The fetal effects of maternal Risultati BPH exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey gestation days 20 toin a species and development period more predictive of specific effects in humans than the studies in rats and rabbits. No other abnormalities were observed in male fetuses and no Finasteride-related abnormalities were observed risultati BPH female fetuses at any dose.
Finasteride tablets USP is risultati BPH indicated for use in women. It is not known whether Finasteride is excreted in human milk. Finasteride tablets USP is not indicated for use in pediatric patients. Safety and risultati BPH in pediatric patients have not been established. Of the total number of subjects included in a long-term efficacy and safety study, and subjects were 65 and over and 75 and over, respectively.
Risultati BPH overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly risultati BPH Clinical Pharmacology Caution should be exercised in the risultati BPH of Risultati BPH tablets USP in those patients with liver function abnormalities, as Finasteride risultati BPH metabolized extensively in the liver [see Clinical Pharmacology No dosage adjustment risultati BPH necessary in patients with renal impairment [see Clinical Pharmacology Until further experience is obtained, no specific treatment for an overdose with Finasteride tablets USP can be recommended.
Its structural formula is:. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Risultati BPH botanical source of the Pregelatinized Starch is Maize. Risultati BPH induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.
Risultati BPH has been demonstrated both in vivo and in vitro. Finasteride has no affinity for the androgen receptor. In man, a single 5-mg oral dose of Finasteride tablets USP produces a rapid reduction in serum DHT concentration, with the maximum effect observed 8 hours after the first dose.
The suppression risultati BPH DHT is maintained throughout the hour dosing interval and with continued treatment. In healthy volunteers, treatment with Finasteride tablets USP did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.
In patients with BPH, Finasteride tablets USP has no risultati BPH on circulating levels of cortisol, prolactin, thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile i.
These individuals have a small prostate gland throughout life and do not develop BPH. Intraprostatic content risultati BPH PSA was also decreased. In healthy male volunteers treated with Finasteride tablets USP for 14 days, discontinuation of therapy risultati BPH in a return of DHT levels to pretreatment levels in approximately 2 weeks. Bioavailability of Finasteride was not affected by food. There is a slow accumulation phase for Finasteride after multiple dosing. Mean trough concentrations after 17 days of dosing were 6.
Finasteride has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF. Thus, based on a 5 mL ejaculate volume, the amount of Finasteride in semen was estimated to be to fold less than the dose of Finasteride 5 mcg that had no risultati BPH on circulating DHT levels in men [see also Use in Specific Populations 8.
Metabolism Finasteride is extensively metabolized in the liver, primarily via the cytochrome P 3A4 enzyme subfamily. Finasteride is not indicated for use in pediatric patients [see Warnings and Precautions 5. Gender Finasteride is risultati BPH indicated for use in women [see Contraindications 4Warnings and Precautions 5.
No dosage adjustment is necessary in the elderly. Although the elimination rate of Finasteride is decreased in the risultati BPH, these findings are of no risultati BPH significance. Hepatic Impairment The effect of hepatic impairment on Finasteride pharmacokinetics has not been studied. Caution should be exercised in the administration of Finasteride tablets USP in those patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver.
Renal Impairment No dosage adjustment is necessary in patients with renal impairment.