AVODART may cause serious side effects, including: Get medical help right away if you have these serious allergic reactions. Use this medication regularly to get the most benefit from it. You may opt-out of email communications at any time by clicking on Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Viagra basics The active drug in Viagra is sildenafil. Qmax was approximately 10 mL/sec at baseline across the 3 pivotal trials. Many people using this medication do not have serious side effects. The capsules should not be handled by a woman who is pregnant or who may become pregnant. Store at room temperature away from moisture and heat. What should I know about storage and disposal of this medication? If a woman who is pregnant with a male baby gets enough VIAGRA is available by prescription only in 25 mg, 50 mg, and 100 mg tablets. Dutasteride and tamsulosin should never be taken by a woman, a child, or a teenager. These data suggest that AVODART arrests the disease process of BPH in men with an enlarged prostate. Statistically significant differences (AVODART versus placebo) were noted at the earliest post-treatment prostate volume measurement in each trial (Month 1, Month 3, or Month 6) and continued through Month 24. Aspirin Low Strength (aspirin) Cialis (tadalafil) Claritin (loratadine) CoQ10 (ubiquinone) Crestor (rosuvastatin) Eliquis (apixaban) Fish Oil (omega-3 polyunsaturated fatty acids) Flomax (tamsulosin) Glucosamine & Chondroitin with MSM (chondroitin / glucosamine / methylsulfonylmethane) The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver. http://www.upandaway.org. Increased placental weights in rabbits were also observed, with no-effect levels less than the MRHD of 0.5 mg daily (see Data). It may harm them. It may slightly increase the risk of developing a very serious form of prostate cancer. Figure 1: AUA-SI Scorea Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled). 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. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle dutasteride and tamsulosin capsules. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use of this site constitutes acceptance of eHealthMe.com's terms of service and privacy policy. Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). It works by reducing the size of the enlarged prostate. The mean age was 63 years and 91% were white. Approximately 52% of subjects had previous exposure to 5 alpha-reductaseinhibitor or alpha-adrenergicantagonist treatment. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. A second embryo-fetal development study in rabbits dosed throughout pregnancy (organogenesis and later period of external genitalia development [Gestation Days 6 to 29]) at 0.3 times the MRHD (doses of 0.05 mg/kg/day or greater, with no no-effect level), also produced evidence of feminization of the genitalia in male fetuses and increased placental weights at all doses in the absence of maternal toxicity. In healthy volunteers, 52 weeks of treatment with dutasteride 0.5 mg/day (n = 26) resulted in no clinically significant change compared with placebo (n = 23) in sex hormone-binding globulin, estradiol, luteinizing hormone, follicle-stimulating hormone, thyroxine (free T4), and dehydroepiandrosterone. The phase IV clinical study analyzes what interactions people who take Viagra and Dutasteride have. AVODART is not indicated for use in women. provider or pharmacist. The additional improvement in Qmax of combination therapy over monotherapy with AVODART was no longer statistically significant at Month 48. Medically reviewed by Drugs.com on Jun 11, 2021. It works by reducing the size of the enlarged prostate. If you notice other effects not listed above, contact your doctor or pharmacist. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. Consult your pharmacist or local waste disposal company. Usual Adult Dose for Benign Prostatic Hyperplasia: Dutasteride 0.5 mg-Tamsulosin 0.4 mg orally once a day approximately 30 minutes after the same meal each dayUse: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. Dutasteride capsules may soften and leak if stored at high temperatures. If a pregnant woman or woman of childbearing potential comes in The change in dutasteride exposure is not considered to be clinically significant. Taking dutasteride may increase the risk that you will develop high-grade prostate cancer (a type of prostate cancer that spreads and grows more quickly than other types of prostate cancer). Figure 2: Percent of Subjects Developing Acute Urinary Retention over a 24-Month Period (Randomized, Double-blind, Placebo-Controlled Trials Pooled), Figure 3: Percent of Subjects Having Surgery for Benign Prostatic Hyperplasia over a 24-Month Period (Randomized, Double-blind, Placebo-Controlled Trials Pooled). Do not double the dose to catch up. symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: What should I tell my healthcare provider before taking AVODART? Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Histological evaluation of the genital papilla of fetuses revealed evidence of feminization of the male fetus as well as fused skull bones and increased placental weights at all doses in the absence of maternal toxicity. Safety and effectiveness in pediatric patients have not been established. Included as part of the PRECAUTIONS section. URL of this page: https://medlineplus.gov/druginfo/meds/a603001.html. The pharmacokinetics of dutasteride in women have not been studied. Keep a list of them to show your healthcare provider and pharmacist WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. Dosage form: oral capsule (0.5 mg-0.4 mg) The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in healthy men throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. Adult males with genetically inherited type 2 5 alpha-reductase deficiency also have decreased DHT levels. It is also important information to carry with you in case of emergencies. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. At Month 24, the mean percent change in prostate volume across the 3 trials pooled was -26.7% for dutasteride and -2.2% for placebo with a mean difference of -24.5% (range: -24.0% to -25.1% in each of the 3 trials, P <0.001). AVODART capsules may become deformed and/or discolored if kept at high temperatures. In vitro studies showed that dutasteride is metabolized by the CYP3A4 and CYP3A5 isoenzymes. Dutasteride was administered on Gestation Days 20 to 100 (during organogenesis) at doses of 400, 780, 1,325, or 2,010 ng/day (12 monkeys/group). This medicine can cause birth defects. We comply with the HONcode standard for trustworthy health information. Symptoms were quantified using the first 7 questions of the International Prostate Symptom Score (IPSS) (identical to the AUA-SI). called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. (dutasteride) capsules. The phase IV clinical study analyzes what interactions people who take Viagra and Dutasteride have. Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. effect of AVODART on male fertility is not known. ChildrenUse is not recommended. This medicine is not for use by women. some men have fewer problems and symptoms after 3 months of treatment with AVODART, a treatment Do not give AVODART to other people, The study uses data from the FDA. Review/update the However, you should not flush this medication down the toilet. Stop using dutasteride and tamsulosin and call your doctor at once if you have: a light-headed feeling, like you might pass out; or. 2011]. The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Dutasteride. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products. Inform patients that AVODART capsules should not be handled by women who are pregnant or may potentially be pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Do not stop taking dutasteride without talking to your doctor. They are both oral tablets, taken daily, that work by inhibiting the 5-alpha-reductase enzyme that is responsible for converting testosterone to DHT. It blocks an enzyme which is necessary to change testosterone to another hormone that causes the prostate to grow. All rights reserved. Do not use AVODART if your capsules are deformed, discolored, or leaking. It is not known whether rabbits or rhesus monkeys produce any of the major human metabolites. Call your doctor for medical advice about side effects. 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. Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. Statistically significant, baseline-adjusted mean increases compared with placebo were observed for total testosterone at 8 weeks (97.1 ng/dL, P <0.003) and thyroid-stimulating hormone at 52 weeks (0.4 mcIU/mL, P <0.05). However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. provider about your medical condition or your treatment. Doses of 2.5 mg/kg/day and greater also resulted in prolonged gestation in the parental females, an increase in time to balano-preputial separation in male offspring, a decrease in time to vaginal patency for female offspring, and a decrease in prostate and seminal vesicle weights in male offspring. 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. Take this medicine exactly as directed by your doctor. Dutasteride use is contraindicated in women who are pregnant. Call your doctor for medical advice about side effects. All rights reserved. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90% were white. BPH is also known as enlarged prostate. Warnings Using this medicine may increase your risk of developing prostate cancer. Subjects receiving dutasteride achieved statistically significant improvement in symptoms versus placebo by Month 3 in 1 trial and by Month 12 in the other 2 pivotal trials. Generic name: dutasteride and tamsulosin [doo-TAS-ter-ide-and-tam-soo-LOE-sin] Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Dutasteride was tested for genotoxicity in a bacterial mutagenesis assay (Ames test), a chromosomal aberration assay in Chinese hamster ovary cells, and a micronucleus assay in rats. You may report side effects to FDA at 1-800-FDA-1088. Written by Cerner Multum. Detailed Dutasteride / tamsulosin dosage information, Dutasteride / tamsulosin drug interactions. Similar changes were seen at Month 48: -27.3% (24.91) for combination therapy, -28.0% (25.74) for AVODART, and +4.6% (35.45) for tamsulosin. Selected from data included with permission and copyrighted by First Databank, Inc. AVODART is not approved for the prevention of prostate cancer. AHFS Patient Medication Information. Keep all appointments with your doctor and the laboratory. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving AVODART, no adjustment to its value appears necessary. Queens of the Stone Age will bring Phantogram, Viagra Boys, the Armed, and Savages' Jehnny Beth on their fall North American tour. medicines may affect how AVODART works. home you should know that you should not donate blood while you are taking dutasteride and for 6 months after you stop taking this medication. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. No causal relationship between AVODART alone or in combination with tamsulosin and cardiac failure has been established. Swallow the medication whole. Avodart is sometimes given with another medication called tamsulosin (Flomax). This survey is being conducted by the WebMD marketing sciences department. Women, especially those who are or may become pregnant, should not handle dutasteride capsules. Dispose of any capsules that are deformed, discolored, or leaky. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. An increase in stillborn pups was observed in dams treated at 30 mg/kg/day (approximately 111 times the MRHD), with a no-effect level of 12.5 mg/kg/day. DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Avoid taking medicines for erectile dysfunction (sildenafil, avanafil, Viagra, Cialis, and others). If you have any questions, ask your doctor or pharmacist. 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. inability to have or maintain an erection, changes in the breasts such as increased size, lumps, pain, or nipple discharge. * Approximation only. Dutasteride and tamsulosin can affect your pupils. Compared with placebo, AVODART was associated with a statistically significantly lower incidence of AUR (1.8% for AVODART versus 4.2% for placebo, P <0.001; 57% reduction in risk, [95% CI: 38% to 71%]) and with a statistically significantly lower incidence of surgery (2.2% for AVODART versus 4.1% for placebo, P <0.001; 48% reduction in risk, [95% CI: 26% to 63%]). Overall, 1,623 subjects received monotherapy with AVODART; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. Skip the missed dose if it is almost time for your next dose. If you Dutasteride is an oral synthetic 4-azasteroid commonly marketed under . should not touch AVODART capsules. The clinical significance of the effect of dutasteride on semen characteristics for an individual patients fertility is not known [see Use In Specific Populations]. This will prevent the possibility of your blood being given to a pregnant woman. Dutasteride is highly bound to plasma albumin (99.0%) and alpha-1 acid glycoprotein (96.6%). Subjects were aged at least 50 years with a serum PSA 1.5 ng/mL and <10 ng/mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index (AUA-SI). Common side effects of dutasteride and tamsulosin may include: decreased amount of semen released during sex; impotence (trouble getting or keeping an erection); This is not a complete list of side effects and others may occur. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. breast tenderness or enlargement. If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date. In case of overdose, call the poison control helpline at 1-800-222-1222. AVODART may harm your unborn baby. At Month 24, the mean decrease from baseline was -3.8 units for dutasteride and -1.7 units for placebo with a mean difference of -2.1 (range: -1.9 to -2.2 units in each of the 3 trials, P <0.001). period of at least 6 months is usually necessary to see if AVODART will work for you. Common interactions include drug ineffective among males. Read and follow these instructions carefully. information highlighted below and resubmit the form. See the end of this leaflet for a AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. The effect of race on dutasteride pharmacokinetics has not been studied. Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No dose adjustment is necessary in the elderly. DUODART contains the active ingredients dutasteride and tamsulosin hydrochloride. Dutasteride blocks the action of an enzyme called 5-alpha-reductase. Do not double doses. It works by blocking the production of a natural substance that enlarges the prostate. 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. RxList does not provide medical advice, diagnosis or treatment. sex organs that are not normal. Table 2: Adverse Reactions Reported over a 48-Month Period in 1% of Subjects and More Frequently in the Coadministration Therapy Group than the Groups Receiving Monotherapy with AVODART or Tamsulosin (CombAT) by Time of Onset. See Figure 7. Photo: Andreas Neumann. No adjustment in dosage is anticipated for patients with renal impairment (see section 5.2). Patients should always ask their doctors for medical advice about adverse events. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. DHT is the hormone associated with male pattern hair loss and prostate gland . Dutasteride is a 5-alpha reductase inhibitors. Absolute bioavailability in 5 healthy subjects is approximately 60% (range: 40% to 94%). If we combine this information with your protected You are encouraged to report adverse events related to Viatris products by calling 1-877-446-3679 (U.S. only). generic drugs) are not considered. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%). In an embryo-fetal development study in rats, oral administration of dutasteride at 10 times less than the MRHD of 0.5 mg daily (based on average blood levels in men) resulted in feminization of male genitalia in the fetus (decreased anogenital distance at 0.05 mg/kg/day, with a lack of a no-effect level) in the absence of maternal toxicity. The incidence of cardiac failure in subjects taking AVODART was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. In a study of healthy subjects (n = 26) receiving dutasteride 0.5 mg/day for 12 months, semen dutasteride concentrations averaged 3.4 ng/mL (range, 0.4 to 14 ng/mL) at 12 months and, It may take 3 to 6 months to notice an improvement in symptoms. Things to remember when you fill your prescription. Version: 5.01. tamsulosin, finasteride, Flomax, tadalafil, prazosin, Cialis. information and will only use or disclose that information as set forth in our notice of Do not take more or less of it or take it more often than prescribed by your doctor. 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 the placebo group. If it is near the time of the next dose, skip the missed dose. After 4 years of treatment, combination therapy with AVODART and tamsulosin did not provide benefit over monotherapy with AVODART in reducing the incidence of AUR or BPH-related surgery. The mean prostate volume at trial entry was approximately 54 cc. The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Dutasteride does not bind to the human androgen receptor. 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 [see Nonclinical Toxicology]. Figure 4: Prostate Volume Percent Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled). Your doctor will order certain lab tests to check your body's response to dutasteride. Most of the 4,325 subjects randomly assigned to receive either dutasteride or placebo completed 2 years of double-blind treatment (70% and 67%, respectively). In men with prostate volumes 40 cc, the mean decrease was -3.8 units for dutasteride and -1.6 units for placebo, with a mean difference between the 2 treatment groups of -2.2 at Month 24. This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. At Month 12, the mean percent change in prostate volume across the 3 trials pooled was -24.7% for dutasteride and -3.4% for placebo; the mean difference (dutasteride minus placebo) was -21.3% (range: -21.0% to -21.6% in each of the 3 trials, P <0.001). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Common interactions include drug ineffective among males. Call your doctor if you miss your doses for several days in a row. Why it's used Dutasteride is used to treat benign prostatic hyperplasia (BPH), which is also called enlarged prostate. Available for Android and iOS devices. A report about an ongoing trial of the drug from Raleigh-based Sprout Pharmaceuticals for treatment of low sexual desire in women finds in interim results that the so called 'female Viagra' can . Advise men that AVODART may affect sperm characteristics but the effect on fertility is unknown [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Of service and privacy policy and privacy policy this survey is being conducted by the WebMD marketing department. Rabbits were also observed, with no-effect levels less than the MRHD of 0.5 mg (! 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