effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.nelfinavirMinor (1)nelfinavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nevirapineMonitor Closely (1)nevirapine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.nifedipineMinor (1)nifedipine will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nilotinibMinor (1)nilotinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.oxcarbazepineMinor (1)oxcarbazepine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.pentobarbitalMinor (1)pentobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenobarbitalMinor (1)phenobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenytoinMinor (1)phenytoin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.posaconazoleMinor (1)posaconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.prednisoneMinor (1)prednisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.primidoneMinor (1)primidone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.quinupristin/dalfopristinMinor (1)quinupristin/dalfopristin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.rifabutinMonitor Closely (1)rifabutin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifampinMonitor Closely (1)rifampin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifapentineMinor (1)rifapentine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.ritonavirMinor (1)ritonavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.rufinamideMinor (1)rufinamide will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.saw palmettoMinor (1)saw palmetto increases effects of finasteride by pharmacodynamic synergism. Minor/Significance Unknown.secobarbitalMinor (1)secobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.St John's WortMonitor Closely (1)St John's Wort will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.topiramateMinor (1)topiramate will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.verapamilMinor (1)verapamil will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.voriconazoleMinor (1)voriconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.zafirlukastMinor (1)zafirlukast will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. 1-10% Erectile dysfunction (1.3-8.1%) Decrease libido (1.8-6.4%) Breast enlargement (0.5-1.8%) Ejaculation disorder (0.8-1.2%) <1% Breast tenderness (0.4-0.7%) Rash (0.5%) Postmarketing Reports Neoplasms: Male breast cancer Breast disorders: Breast tenderness and enlargement Nervous system/psychiatric: Depression, suicidal ideation and behavior Hypersensitivity reactions: Rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face) Reproductive system: Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain, hematospermia, blood in semen Contraindications Hypersensitivity Women of childbearing potential Cautions Use with caution with obstructive uropathy; carefully monitor patients with large residual urinary volume or severely diminished urinary flow Use caution in liver disease May cause decreased serum PSA in presence of prostate cancer; increases in PSA levels from nadir while on finasteride may signal the presence of prostate cancer and should be carefully evaluated (even if PSA value within normal range) Pregnant and potentially pregnant women should not handle crushed or broken tablets or semen of male partner; may have negative impact in fetal development Rare reports of male breast cancer observed with use; any breast tenderness, enlargement, pain, lumps, nipple discharge or any other type of breast changes should be reported immediately to healthcare provider 5-ARIs and prostate cancer risk June 9, 2011: Recent data from 2 large, randomized, controlled trials observed a reduction in overall incidence of prostate cancer but an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs) The 2 trials are the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial The revised prescribing information recommends that prior to initiating therapy with 5-ARIs, appropriate evaluation should be performed to rule out other urologic conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH) A minimum of 6 months may be necessary to assess response in BPH Pregnancy Therapy is contraindicated in pregnant females and not indicated for use in females; based on animal studies and mechanism of action, drug may cause abnormal development of external genitalia in a male fetus if administered to pregnant female Animal data In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during period of major organogenesis at doses approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day) Finasteride is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of potential hazard to male fetus Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency; females could be exposed to finasteride through contact with crushed or broken finasteride tablets or semen from a male partner taking finasteride With regard to finasteride exposure through skin, finasteride tablets are coated and will prevent skin contact with finasteride during normal handling if tablets have not been crushed or broken Females who are pregnant or may potentially be pregnant should not handle crushed or broken tablets because of possible exposure of a male fetus; with regard to potential finasteride exposure through semen Three studies have been conducted that measured finasteride concentrations in semen in men receiving 5 mg/day finasteride; in these studies the highest amount of finasteride in semen was estimated to be 50-to 100-fold less than dose of finasteride (5 μg) that had no effect on circulating DHT levels in men Reproductive potential Females: Drug not indicated for use in females Males: Treatment 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 normal range and were reversible upon discontinuation of therapy with average time to return to baseline of 84 weeks There have been postmarketing reports of male infertility and/or poor seminal quality; normalization or improvement of seminal quality has been reported after discontinuation of finasteride Lactation Drug is not indicated for use in femalesPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Competitive and specific inhibitor of type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into DHT In humans, finasteride preferably inhibits the type II isozyme. Using native tissues (scalp and prostate) In men with male pattern hair loss (androgenetic alopecia), the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp; administration decreases scalp and serum DHT concentrations in these men May also interrupt a key factor in the development of androgenetic alopecia in those patients genetically predisposed Absorption Bioavailability: 65% Onset: 6 months (BPH); >3 months (hair loss) Peak plasma time: 2-6 hours Distribution Protein bound: 90% Vd: 76 L Metabolism Hepatic CYP3A4 Metabolites: t-butyl side chain monohydroxylate, monocarboxylic acid metabolite (active) Elimination Half-life: 6 hours Excretion: Feces (57%); urine (39%) BRAND FORM. UNIT PRICE PILL IMAGE Propecia oral- 1 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 1 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 1 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 1 mg tabletfinasteride oral- 1 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 5 mg tabletfinasteride oral- 1 mg tabletfinasteride oral- 1 mg tabletProscar oral- 5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationfinasteride oral FINASTERIDE (HAIR GROWTH) - ORAL (fin-AST-er-ide) COMMON BRAND NAME(S): Propecia USES: This medication is used to treat male pattern baldness (androgenetic alopecia) at the crown and in the middle of the scalp. It should be used by adult men only.This medication works by decreasing the amount of a natural body hormone (DHT). Decreasing the amount of DHT leads to increased hair regrowth and slower hair loss. Hair growth on other parts of the body is not affected by finasteride.Women and children should not use this medication.Finasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking finasteride and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once a day.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. It may cause abnormal sex organ development in an unborn male infant.Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day. It may take up to 3 months to notice a benefit.You must continue to take this medication to maintain your hair growth. When you stop taking finasteride, any gain in hair quantity is generally lost within 12 months.Tell your doctor if your condition does not improve or if it gets worse. SIDE EFFECTS: Decreased sexual ability/desire may occur. In some men, this medication can decrease the amount of semen released during sex. This is harmless, but has continued in some men even after stopping treatment. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to