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Digoxin Avodart does not alter the avodart steady-state pharmacokinetics of avodart digoxin when administered concomitantly at avodart a dose.5 professional mg/day professional for 3 weeks see Clinical Pharmacology (12.3). If a woman who is pregnant with avodart a male professional professional baby gets enough avodart in avodart her body by avodart swallowing or touching avodart, the male baby may professional be born with avodart sex organs that are not normal. Pediatric Use Avodart is contraindicated for use in professional pediatric patients. Avodart - Clinical Pharmacology Mechanism of professional Action Dutasteride inhibits the conversion of professional testosterone avodart to dihydrotestosterone (DHT). Impairment of professional Fertility Treatment of avodart sexually mature male rats with dutasteride.1- to 110-fold the mrhd (animal doses.05, 10, 50, and avodart 500 mg/kg/day for up to 31 weeks) resulted in professional dose- and time-dependent decreases in avodart fertility; reduced cauda epididymal. Immune System Disorders Hypersensitivity reactions, including rash, pruritus, urticaria, professional localized edema, avodart serious skin reactions, and angioedema. Adverse Reactions Reported in 1 of avodart Subjects over a 24-Month Period and More Frequently in the Group Receiving Avodart than the Placebo Group (Randomized, Double-blind, Placebo-controlled Trials Pooled) by Time of professional Onset Adverse Reaction Adverse Reaction Time of Onset Months 06 Months. In professional a fertility study in female rats, oral administration of dutasteride at doses.05,.5,.5, and 30 mg/kg/day resulted in reduced litter size, increased embryo resorption, and feminization of male fetuses (decreased anogenital distance). There is no specific antidote for dutasteride. Drug Interactions drug interactions Cytochrome P450 3A Inhibitors Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. Mean prostatic tissue concentrations of testosterone were significantly higher avodart in the dutasteride group compared with placebo (2,073 and 93 pg/g, respectively,.001). Digoxin avodart does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose.5 mg/day for 3 weeks see clinical pharmacology. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis A 2-year carcinogenicity study was professional conducted in B6C3F1 mice at doses of 3, 35, 250, and 500 mg/kg/day for males and 3, 35, and 250 mg/kg/day for females; an increased incidence. For patients undergoing PSA screening, increases in PSA levels while on treatment with avodart may signal the presence of prostate cancer and should be evaluated by a healthcare provider see warnings AND precautions. (These calculations are based on blood levels of parent drug which are achieved at 32 to 186 times the daily doses administered to pregnant monkeys on a ng/kg basis). In addition, the 15-hydroxydutasteride metabolite avodart was formed by CYP3A4. Capsules should be swallowed whole and not chewed or opened. This Patient Information has been approved by the.S. Inactive ingredients : butylated hydroxytoluene, ferric oxide (yellow gelatin (from certified BSE-free bovine sources glycerin, mono- di- glycerides of caprylic/capric acid, titanium dioxide, and edible red ink. Only trace amounts of unchanged dutasteride were found in urine ( 1). Overall, 1,623 subjects received monotherapy with avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. The professional most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction avodart (1.5). You may report side effects to FDA at 1-800-FDA-1088. In a trial of healthy subjects (n 26) receiving dutasteride.5 mg/day for 12 months, semen dutasteride concentrations averaged.4 ng/mL (range:.4 to 14 ng/mL) at 12 months and, similar to serum, achieved steady-state concentrations at 6 months. Exposure Of Women - Risk To Male Fetus Inform patients that avodart capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent. The highest measured semen concentration of dutasteride in treated men was 14 ng/mL. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1.8 for Avodart versus.2 for placebo,.001; 57 reduction in risk, avodart 95 avodart CI: 38 to 71) and with a statistically significantly lower incidence. You may report side effects to FDA at 1-800- FDA-1088. You should not donate avodart blood while taking avodart or for 6 months after you professional have stopped avodart. Each Avodart soft gelatin capsule, administered orally, avodart contains.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. A blood test called PSA (prostate-specific antigen ) is sometimes used to see if professional you might have prostate cancer. Table 1 summarizes clinical adverse reactions reported in at least 1 of subjects receiving avodart and at a higher incidence than subjects receiving placebo. Dutasteride does not bind to the human androgen receptor. Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Alpha-Adrenergic professional Antagonists The administration of avodart in combination with tamsulosin avodart or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. Monotherapy Over 4,300 male subjects with BPH avodart were randomly assigned to receive placebo.5-mg daily doses of avodart in 3 identical 2-year, placebo-controlled, avodart double-blind, Phase 3 treatment trials, each followed by a 2-year open-label extension. Avodart is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to, dHT. Increased Risk of High-grade Prostate Cancer. Allergic to other 5 alpha-reductase inhibitors, for example, proscar (finasteride) tablets. Nursing Mothers avodart is contraindicated for use in women professional of childbearing potential, including nursing women. No clinically significant changes in adrenal hormone responses to adrenocorticotropic hormone (acth) stimulation were observed professional in a subset population (n 13) of the 1-year healthy volunteer trial. Specific Populations Pediatric: Dutasteride pharmacokinetics have not been investigated in subjects younger than 18 years. Statistically significant differences (avodart versus placebo) were noted at the earliest posttreatment prostate volume measurement in each trial (Month 1, Month 3, or Month 6) and continued through Month. Pregnant avodart generic women should not touch avodart capsules. Subjects were randomized to receive placebo (n 4,126).5-mg daily doses of avodart (n 4,105) for up to 4 years. The increase in maximum urine flow rate seen during the first 2 years professional of double-blind treatment was maintained throughout an additional 2 years of open-label extension trials. Subjects were randomized to receive placebo (n 4,126).5-mg daily doses of Avodart (n 4,105) for up to 4 years. The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters has not been evaluated. After 1 and 2 weeks of daily dosing with dutasteride.5 mg, median serum DHT concentrations were reduced by 85 and 90, avodart respectively. AVT:12PI pharmacist-detach here AND give instructions TO patient professional patient information Avodart (av dart) (dutasteride) capsules Avodart is for use by men only. Swallow Avodart capsules whole. When the drug is administered with food, the maximum serum concentrations were reduced by 10. Dosage Forms and Strengths.5-mg, opaque, dull yellow, gelatin capsules imprinted with GX CE2 in red ink on one side. In this single-dose trial, dutasteride half-life increased with age (approximately 170 hours in men aged 20 to 49 years, approximately 260 hours in men aged 50 to 69 years, and approximately 300 hours in men older than 70 years). Who should NOT take Avodart? Most of the 2,340 subjects in the trial extensions completed 2 additional years of open-label treatment (71). To interpret serial PSAs in men taking avodart, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration. In contrast, no decrease in clearance was seen when amlodipine, another calcium channel antagonist that is not a CYP3A4 inhibitor, was coadministered with dutasteride (7, n 4). Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. 7 Fulda, Leipziger Str. Overdosage Contraindications overdose In volunteer trials, single doses of dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. To interpret an isolated PSA value in a man treated with avodart for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated e free-to-total PSA ratio (percent free PSA) remains constant, even under the influence of avodart. Safety and effectiveness in pediatric patients have not been established. Other Effects Plasma lipid panel and bone mineral density were evaluated following 52 weeks of dutasteride.5 mg once daily in healthy volunteers. Based on the highest measured semen concentration of dutasteride in treated men (14 ng/mL these doses represent.8 to 16 times the potential maximum exposure of a 50-kg human female to 5 mL semen daily from a dutasteride-treated man, assuming 100 absorption. Store Avodart capsules at room temperature (59F to 86F or 15C to 30C). Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11) compared with those receiving avodart (2) or tamsulosin (4) as monotherapy. The baseline score was approximately.4 units for each treatment group. The median increase in serum testosterone was 19 at both 1 and 2 years, 26 at 3 years, and 22 at 4 years, but the mean and median levels remained within the physiologic range. In men with prostate volumes 40 cc, the mean decrease was -3.8 units for dutasteride and -.6 units for placebo, with a mean difference between the 2 treatment groups of -2.2 at Month. These trials were prospectively designed to evaluate effects on symptoms based on prostate size at baseline. Store at 25oC (77oF excursions permitted to 15-30oC (59-86oF) see USP Controlled Room Temperature. These data suggest that avodart arrests the disease process of BPH in men with an enlarged prostate. Use In Specific Populations Pregnancy Pregnancy Category X avodart is contraindicated for use in women of childbearing potential and during pregnancy. At.05-fold the expected clinical exposure (animal dose.05 mg/kg/day evidence of feminization was limited to a small, but statistically significant, decrease in anogenital distance. The median percentage changes from baseline within the dutasteride group were.9 for testosterone at 8 weeks and.4 for thyroid-stimulating hormone at 52 weeks. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 2-year carcinogenicity study was conducted in B6C3F1 mice at doses of 3, 35, 250, and 500 mg/kg/day for males and 3, 35, and 250 mg/kg/day for females; an increased incidence of benign hepatocellular. An increase in stillborn pups was observed at 111 times the mrhd, and reduced fetal body weight was observed at doses of about 15 times the mrhd (animal dose.5 mg/kg/day). Increases in your PSA levels while on treatment with Avodart (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider. Monotherapy The recommended dose of avodart is 1 capsule (0.5 mg) taken once daily. Avodart is a registered trademark of the GSK group of companies. In an oral pre- and post-natal development study in rats, dutasteride doses.05,.5,.5, or 30 mg/kg/day were administered. Pediatric patients see Use In Specific Populations. What are the ingredients in Avodart? In subjects with BPH treated with dutasteride in a large randomized, double-blind, placebo-controlled trial, there avodart was a median percent increase in luteinizing avodart hair loss hormone of 12 at 6 months and 19 at both 12 and 24 months. Avodart is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention (a complete blockage of urine flow reduce the risk of the need for BPH-related professional surgery. Gender: Avodart is contraindicated in pregnancy and women of childbearing potential and is not indicated for use in other women see Contraindications (4 Warnings and Precautions (5.1). For more information, go to m or call. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. The pharmacokinetics and pharmacodynamics of dutasteride were evaluated in 36 healthy male subjects aged between 24 and 87 years following administration of a single 5-mg dose of dutasteride. In this study, the major human metabolites were tested for carcinogenicity at approximately 1 to 3 times the expected clinical exposure. Medication Guide patient information avodart (av o dart) (dutasteride) capsules avodart is for use by men only. Immune System Disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema. No clinically significant changes in adrenal hormone responses to adrenocorticotropic hormone (acth) stimulation were observed in a subset population (n 13) of the 1-year healthy volunteer trial. Overall, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. Dutasteride is chemically designated as (5,17)-N-2,5 The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula: Dutasteride is a white to pale yellow powder with a melting point of 242 to 250C. At Month 12, the mean increase in Qmax across the 3 trials pooled was.6 mL/sec for Avodart and.7 mL/sec for placebo; the mean difference (dutasteride minus placebo) was.8 mL/sec (range:.7.0 mL/sec in each of the 3 trials,.001). It is not known whether rabbits or rhesus monkeys produce any of the major human metabolites. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90 were white. Effect On Acute Urinary Retention And The Need For BPH-Related Surgery Efficacy was also assessed after 2 years of treatment by the incidence of AUR requiring catheterization and BPH-related urological surgical intervention. In patients with BPH treated with 5 mg/day of dutasteride or placebo for up to 12 weeks prior to transurethral resection of the prostate, mean DHT concentrations in prostatic tissue were significantly lower in the dutasteride group compared with. DIncludes erectile dysfunction and disturbance in sexual arousal. Unequivocal evidence of feminization of the genitalia (i.e., decreased anogenital distance, avodart generic increased incidence of hypospadias, nipple development) of male offspring occurred at 14- to 90-fold the mrhd (animal doses.5 mg/kg/day or greater). Avodart may be administered with or without food. Avodart may affect the way other medicines work, and other medicines may affect how Avodart works. In a rabbit embryo-fetal study, doses 28- to 93-fold the mrhd (animal doses of 30, 100, and 200 mg/kg/day) were administered orally during the period of major organogenesis (gestation days 7 to 29) to encompass the late period of external genitalia development. During avodart the double-blind treatment period, 2,167 male subjects were exposed to Avodart, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. Effect On Semen Characteristics The effects of dutasteride.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n 27 dutasteride, n 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At Month 48 the mean changes from baseline (SD) in ipss total symptom scores were -6.3 (7.40) for combination, -5.3 (7.14) for Avodart, and -3.8 (7.74) for tamsulosin, with a mean difference between combination and Avodart of -0.96 units.

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