under no circumstances [29:<0.001). The combination therapy also resulted in a trend toward reduction in the incidence of distant metastases (27% vs 36% at 4 years, P = 0.058). Median disease-free survival was significantly increased in patients who received complete hormonal therapy combined with radiation as compared to those patients who received radiation alone (4.4 vs 2.6 years, P> <0.001). Inclusion of normal PSA level as a criterion for disease-free survival also resulted in significantly increased median disease-free survival in patients receiving the combination therapy (2.7 vs 1.5 years, P> <0.001). Stage D 2 Prostatic Carcinoma To study the effects of combination therapy in metastatic disease, 617 patients (311 leuprolide + flutamide, 306 leuprolide + placebo) with previously untreated advanced prostatic carcinoma were enrolled in a large multicentered, controlled clinical trial. Three and one-half years after the study was initiated, median survival had been reached. The median actuarial survival time was 34.9 months for patients treated with leuprolide and flutamide versus 27.9 months for patients treated with leuprolide alone. This 7-month increment represents a 25% improvement in overall survival time with the flutamide therapy. Analysis of progression-free survival showed a 2.6-month improvement in patients who received leuprolide plus flutamide, a 19% increment over leuprolide and placebo. Indications and Usage for Eulexin Eulexin Capsules are indicated for use in combination with LHRH agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin Capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin Capsules should be initiated with the LHRH-agonist and continued until progression. Contraindications Eulexin Capsules are contraindicated in patients who are hypersensitive to flutamide or any component of this preparation. Eulexin Capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment). Warnings Hepatic Injury SEE BOXED WARNING . Use in Women Eulexin Capsules are for use only in men. This product has no indication for women, and should not be used in this population, particularly for nonserious or nonlife-threatening conditions. Fetal Toxicity Flutamide may cause fetal harm when administered to a pregnant woman (see Pregnancy ). Aniline Toxicity One metabolite of flutamide is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia, and cholestatic jaundice have been observed in both animals and humans after flutamide administration. In patients susceptible to aniline toxicity (eg, persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, and smokers), monitoring of methemoglobin levels should be considered. Precautions General In clinical trials, gynecomastia occurred in 9% of patients receiving flutamide together with medical castration. Information for Patients Patients should be informed that Eulexin Capsules and the drug used for medical castration should be administered concomitantly, and that they should not interrupt their dosing or stop taking these medications without consulting their physician. Laboratory Tests Regular assessment of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient's response. If PSA levels rise significantly and consistently during Eulexin therapy the patients should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment period free of antiandrogen while continuing the LHRH analogue may be considered. Drug Interactions Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after flutamide was initiated. Therefore, close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin Capsules are administered concomitantly with warfarin. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 1-year dietary study in male rats, interstitial cell adenomas of the testes were present in 49% to 75% of all treated rats (daily doses of 10, 30, and 50 mg/kg/day were administered). These produced plasma C max values that are 1-, 2- to 3-, and 4-fold, respectively, those associated with therapeutic doses in humans. In male rats similarly dosed for 1 year, tumors were still present after 1 year of a drug-free period, but the incidences were 43% to 47%. In a 2-year carcinogenicity study in male rats, daily administration of flutamide at these same doses produced testicular interstitial cell adenomas in 91% to 95% of all treated rats as opposed to 11% of untreated control rats. Mammary adenomas, adeno carcinomas, and fibroadenomas were increased in treated male rats at exposure levels that were 1- to 4-fold those observed during therapeutic dosing in humans. There are likewise reports of malignant breast neoplasms in men treated with Eulexin Capsules (see ADVERSE REACTIONS section). Flutamide did not demonstrate DNA modifying activity in the Ames Salmonella /microsome Mutagenesis Assay. Dominant lethal tests in rats were negative. Reduced sperm counts were observed during a 6-week study of flutamide monotherapy in normal human volunteers. Flutamide did not affect estrous cycles or interfere with the mating behavior of male and female rats when the drug was administered at 25 and 75 mg/kg/day prior to mating. Males treated with 150 mg/kg/day (30 times the minimum effective antiandrogenic dose) failed to mate; mating behavior returned to normal after dosing was stopped. Conception rates were decreased in all dosing groups. Suppression of spermatogenesis was observed in rats dosed for 52 weeks at approximately 3, 8, or 17 times the human dose and in dogs dosed for 78 weeks at 1.4, 2.3, and 3.7 times the human dose. Animal Toxicology Serious cardiac lesions were observed in 2/10 beagle dogs receiving 25 mg/kg/day for 78 weeks and 3/16 receiving 40 mg/kg/day for 2 4 years. These lesions, indicative of chronic injury and repair processes, included chronic myxomatous degeneration, intraatrial fibrosis, myocardial acidophilic degeneration, vasculitis, and perivasculitis. The doses at which these lesions occurred were associated with 2-hydroxyflutamide levels that were 1- to 12-fold greater than those observed in humans at therapeutic levels. Pregnancy Pregnancy Category D There was decreased 24-hour survival in the offspring of pregnant rats treated with flutamide at doses of 30, 100, or 200 mg/kg/day (approximately 3, 9, and 19 times the human dose). A slight increase in minor variations in the development of the sternebrae and vertebrae was seen in fetuses of rats treated with two higher doses. Feminization of the male rats also occurred at the two higher dose levels. There was a decreased survival rate in the offspring of rabbits receiving the highest dose (15 mg/kg/day, equal to 1.4 times the human dose). Adverse Reactions Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin Capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below. Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) (n=231) (n=235) (n=231) (n=235) Goserelin acetate implant + Eulexin + Radiation Radiation Only Goserelin acetate implant + Eulexin + Radiation Radiation Only % All % All % All % All Rectum/ Large Bowel 80 76 Diarrhea 36 40 Cystitis 16 16 Bladder 58 60 Rectal Bleeding 14 20 Skin 37 37 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Stage D 2 Metastatic Carcinoma The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + LHRH agonist versus placebo + LHRH agonist. The most frequently reported (greater than 5%) adverse experiences during treatment with Eulexin Capsules in combination with an LHRH agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table. (n=294) (n=285) Flutamide + LHRH agonist Placebo + LHRH agonist % All % All Hot Flashes 61 57 Loss of Libido 36 31 Impotence 33 29 Diarrhea 12 4 Nausea/Vomiting 11 10 Gynecomastia 9 11 Other 7 9 Other GI 6 4 As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone. The only notable difference was the higher incidence of diarrhea in the flutamide + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than 1%. In addition, the following adverse reactions were reported during treatment with flutamide + LHRH agonist. Cardiovascular System: hypertension in 1% of patients. Central Nervous System: CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients. Gastrointestinal System: anorexia 4%, and other GI disorders occurred in 6% of patients. Hematopoietic System: anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients. Liver and Biliary System: hepatitis and jaundice in less than 1% of patients. Skin: irritation at the injection site and rash occurred in 3% of patients. Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients. In addition, the following spontaneous adverse experiences have been reported during the marketing of flutamide: hemolytic anemia, macrocytic anemia, methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis), and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the flutamide and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis. The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide. Malignant breast neoplasms have occurred rarely in male patients being treated with Eulexin Capsules. Abnormal Laboratory Test Values Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported. Overdosage In animal studies with flutamide alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia. Clinical trials have been conducted with flutamide in doses up to 1500 mg per day for periods up to 36 weeks with no serious adverse effects reported. Those adverse reactions reported included gynecomastia, breast tenderness, and some increases in SGOT. The single dose of flutamide ordinarily associated with symptoms of overdose or considered to be life threatening has not been established. Flutamide is highly protein bound and is not cleared by hemodialysis. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Eulexin Dosage and Administration The recommended dosage is 2 capsules 3 times a day at 8-hour intervals for a total daily dose of 750 mg. How is Eulexin Supplied Eulexin Capsules, 125 mg, are available as opaque, two-toned brown capsules, imprinted with "Schering 525". They are supplied as follows: NDC 0085-0525-05 - Bottles of 500 NDC 0085-0525-03 - Unit Dose packages of 100 (10 10's) NDC 0085-0525-06 - Bottles of 180 Store between 2 and 30 C (36 and 86 F). Protect the Unit Dose packages from excessive moisture. Rev. 12/00 18822440T B-16887692 Copyright 1989, 1996, 1999, Schering Corporation. All rights reserved. Eulexin flutamide capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-0525 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength flutamide (flutamide) flutamide 125 mg Inactive Ingredients Ingredient Name Strength corn starch lactose magnesium stearate povidone sodium lauryl sulfate Product Characteristics Color BROWN (Opaque, two-toned brown) Score no score Shape CAPSULE Size 8mm Flavor Imprint Code Schering;525 Contains Coating false Symbol false Packaging # Item Code Package Description 1 NDC:0085-0525-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE 2 NDC:0085-0525-06 180 CAPSULE (180 CAPSULE) in 1 BOTTLE 3 NDC:0085-0525-03 100 CAPSULE (100 CAPSULE) in 1 PACKAGE Labeler - Schering Corporation Revised: 05/2006 Schering Corporation Next Interactions Print this page Add to My Med List More about Eulexin (flutamide) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: antiandrogens Consumer resources Eulexin Eulexin (Advanced Reading) Professional resources Eulexin (AHFS Monograph) Flutamide (FDA) Related treatment guides Hirsutism Prostate Cancer> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 1989 Drug Class Antiandrogens Hormones / antineoplastics Related Drugs antiandrogens bicalutamide , Casodex , Xtandi , enzalutamide , flutamide , nilutamide hormones / antineoplastics anastrozole , tamoxifen , letrozole , Evista , Arimidex , raloxifene Prostate Cancer estradiol , Premarin , Estrace , bicalutamide , Casodex , Eligard , Xtandi , Zytiga , leuprolide , Taxotere , More... Hirsutism spironolactone , Aldactone , Vaniqa , flutamide , eflornithine topical , More... Eulexin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Eulexin Images Eulexin 125 mg (SCHERING 525 SCHERING 525) View larger images} } recognize
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