level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.lumefantrineMinor (1)lumefantrine will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.marijuanaMinor (1)marijuana will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.methylprednisoloneMinor (1)methylprednisolone will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.metronidazoleMinor (1)metronidazole will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.miconazole vaginalMinor (1)miconazole vaginal will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nefazodoneMonitor Closely (1)nefazodone will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.nelfinavirMinor (1)nelfinavir will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nevirapineMinor (1)nevirapine will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nifedipineMinor (1)nifedipine will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nilotinibMinor (1)nilotinib will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.oxcarbazepineMinor (1)oxcarbazepine will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.pentobarbitalMinor (1)pentobarbital will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenobarbitalMinor (1)phenobarbital will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenytoinMinor (1)phenytoin will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.posaconazoleMinor (1)posaconazole will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.prednisoneMinor (1)prednisone will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.primidoneMinor (1)primidone will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.quinupristin/dalfopristinMinor (1)quinupristin/dalfopristin will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.ribociclibMonitor Closely (1)ribociclib will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifabutinMonitor Closely (1)rifabutin will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifampinMonitor Closely (1)rifampin will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifapentineMinor (1)rifapentine will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.ritonavirMinor (1)ritonavir will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.rufinamideMinor (1)rufinamide will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.secobarbitalMinor (1)secobarbital will decrease the level or effect of dutasteride 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 dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.topiramateMinor (1)topiramate will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.verapamilMinor (1)verapamil will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.voriconazoleMinor (1)voriconazole will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.zafirlukastMinor (1)zafirlukast will increase the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Adverse reactions decrease with duration of treatment, except for gynecomastia 1-10% Impotence Decreased libido Ejaculation disorder Breast disorders <1% Dizziness Frequency Not Defined Cardiac failure Prostate cancer (high grade) Postmarketing Reports Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema Neoplasms: Male breast cancer Psychiatric disorders: Depressed mood Reproductive system and breast disorders: Testicular pain and testicular swelling Contraindications Hypersensitivity Women Children Cautions Prior to initiating treatment, rule out other urologic conditions Obstructive uropathy, liver disease Patient should not donate blood until 6 months after last dose of dutasteride Dutasteride lowers serum PSA 40-50%; establish new baseline PSA after 3-6 months of treatment Monitor for cardiac changes or cardiac failure Capsules should not be handled by women who are pregnant or may be pregnant; drug can be absorbed through skin and could result in unintended fetal exposure and potential risk to a male fetus; if a pregnant woman comes in contact with leaking dutasteride capsules, the contact area should be washed immediately with soap and water; drug can be absorbed through skin based on animal studies 5-ARIs and prostate cancer risk June 9, 2011: Recent data from 2 large, randomized, controlled trials observed 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 Pregnancy Contraindicated for use in pregnancy because it may cause harm to male fetus; not indicated for use in women Drug is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia; abnormalities in genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion; these results are similar to observations in male infants with genetic 5 alpha-reductase deficiency In animal reproduction studies, drug inhibited normal development of external genitalia in male offspring when given to rats or rabbits during organogenesis at less than maximum recommended human dose (MRHD) of 0.5 mg daily, in absence of maternal toxicity; at 15 times the MRHD, prolonged pregnancy, decreased reproductive organ weights, and delayed puberty in male offspring were observed in rats, with no-effect levels less than the MRHD of 0.5 mg daily; increased placental weights in rabbits were also observed, with no-effect levels < MRHD of 0.5 mg daily Although dutasteride is secreted into human semen, drug concentration in human female partner is approximately 100 times less than concentrations producing abnormalities of male genitalia in animal studies; in monkeys dosed during organogenesis at blood concentrations comparable to or above levels to which a human female partner is estimated to be exposed, male offspring external genitalia was not adversely affected; no feminization occurred in male offspring of untreated female rats mated to treated male rats even though detectable blood levels of dutasteride were observed in the female rats Reproductive Potential The effects of 0.5 mg/day on semen characteristics were evaluated in normal volunteers at 52 weeks, the mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in placebo group; sperm concentration and sperm morphology were unaffected; after 24 weeks of follow-up, the mean percent change in total sperm count in dutasteride group remained 23% lower than baseline While mean values for all semen parameters at all timepoints remained within normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at 24-week follow-up; clinical significance of dutasteride’s effect on semen characteristics for an individual patient’s fertility not known Lactation Not indicated for use in women; there is no information available on presence of drug in human milk, effects on breastfed child, or on milk productionPregnancy 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 Selective inhibitor of type 1 and type 2 isoforms of 5-alpha-reductase; suppresses serum dihydrotestosterone levels by inhibiting the conversion of testosterone to dihydrotestosterone Absorption Bioavailability: 60% Onset: 1-2 weeks Peak plasma time: 2-3 hours Distribution Protein bound: 99% Vd: 300-500 L Metabolism Hepatic P450 enzyme CYP3A4 & CYP3A5 Metabolites, major: 4'-hydroxydutasteride, 6-hydroxydutasteride (as active as parent), 1,2'-dihydrodutasteride Elimination Half-life: 5 weeks (at steady state) Excretion: Feces (40%), urine (<1%) BRAND FORM. UNIT PRICE PILL IMAGE dutasteride oral- 0.5 mg capsuledutasteride oral- 0.5 mg capsuledutasteride oral- 0.5 mg capsuledutasteride oral- 0.5 mg capsuledutasteride oral- 0.5 mg capsuledutasteride oral- 0.5 mg capsuleAvodart oral- 0.5 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationdutasteride oral DUTASTERIDE - ORAL (due-TAST-er-ide) COMMON BRAND NAME(S): Avodart USES: This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH.Dutasteride 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.This medication should not be used by women or children. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication 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 daily. Swallow the medication whole. Do not crush or chew the capsules.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.It may take 3 to 6 months to notice an improvement in symptoms. Tell your doctor if your symptoms do not improve or if they worsen. SIDE EFFECTS: Sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm), testicle pain/swelling, increased breast size, or breast tenderness may occur. Sexual problems have 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.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 FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking dutasteride, tell your doctor or pharmacist if you are allergic to it; or to finasteride; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not donate blood while you are taking this medication and for at least 6 months after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details. DRUG INTERACTIONS: Drug interactions may change how your medications work or