FLOMAX Ressources

Application Information

This drug has been submitted to the FDA under the reference 020579/001.

Names and composition

"FLOMAX" is the commercial name of a drug composed of TAMSULOSIN HYDROCHLORIDE.

Answered questions

What is diference between FloMax and Advodart?
I am 56 and have been having trouble with irregular stream. which is better for me? NO INS. Asked by Marlyn Magnett 3 months ago.

flomax Side effects What are the most common side effects associated with FLOMAX? Important Safety Information FLOMAX is approved to treat male urinary symptoms due to BPH. Only your doctor can tell if your symptoms are due to BPH and not another condition such as prostate cancer. Common side effects of FLOMAX are runny nose, dizziness and decrease in semen. A sudden decrease in blood pressure may occur upon standing, rarely resulting in fainting. So when starting FLOMAX, avoid situations where injury could result. If considering cataract surgery, tell your eye surgeon you have taken FLOMAX capsules. Can I take FLOMAX while I'm using other medications? FLOMAX can be taken with these common antihypertensive (high blood pressure) and cardiovascular (heart disease) medications without dosage adjustment: atenolol enalapril nifedipine However, there are some medications that should be used with caution when taking FLOMAX, such as: warfarin (a blood-thinning medication also known as Coumadin®) cimetidine (a medication that treats ulcers) Always tell your doctor what prescription and over-the-counter drugs, vitamins and/or dietary supplements you are taking. This is important so that your doctor can avoid prescribing medications that may negatively interact with each other. avodart SIDE EFFECTS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Most adverse reactions were mild or moderate and generally resolved while on treatment in both the AVODART and placebo groups. The most common adverse events leading to withdrawal in both treatment groups were associated with the reproductive system. Over 4,300 male subjects with BPH were randomly assigned to receive placebo or 0.5-mg daily doses of AVODART in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each with 2-year open-label extensions. During 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. When including the open-label extensions, 1,009 male subjects were exposed to AVODART for 3 years and 812 were exposed for 4 years. The population was aged 47 to 94 years (mean age, 66 years) and greater than 90% Caucasian. Over the 2-year double-blind treatment period, 376 subjects (9% of each treatment group) were withdrawn from the studies due to adverse experiences, most commonly associated with the reproductive system, with similar findings during the 2-year open-label extensions. Withdrawals due to adverse events considered by the investigator to have a reasonable possibility of being caused by the study medication occurred in 4% of the subjects receiving AVODART and in 3% of the subjects receiving placebo. Table 1 summarizes clinical adverse reactions that were reported by the investigator as drug-related in at least 1% of subjects receiving AVODART and at a higher incidence than subjects receiving placebo. Table 1. Drug-Related Adverse Events* Reported in ≥1% Subjects Over a 24-Month Period and More Frequently in the Dutasteride Group Than the Placebo Group (Pivotal Studies Pooled) Adverse Event Onset Adverse Events Month 0-6 Month 7-12 Month 13-18 Month 19-24 Dutasteride (n) (n = 2,167) (n = 1,901) (n = 1,725) (n = 1,605) Placebo (n) (n = 2,158) (n = 1,922) (n = 1,714) (n = 1,555) Impotence Dutasteride 4.7% 1.4% 1.0% 0.8% Placebo 1.7% 1.5% 0.5% 0.9% Decreased libido Dutasteride 3.0% 0.7% 0.3% 0.3% Placebo 1.4% 0.6% 0.2% 0.1% Ejaculation disorder Dutasteride 1.4% 0.5% 0.5% 0.1% Placebo 0.5% 0.3% 0.1% 0.0% Gynecomastia† Dutasteride 0.5% 0.8% 1.1% 0.6% Placebo 0.2% 0.3% 0.3% 0.1% *A drug-related adverse event is one considered by the investigator to have a reasonable possibility of being caused by the study medication. In assessing causality, investigators were asked to select from 1 of 2 options: reasonably related to study medication or unrelated to study medication. † Includes breast tenderness and breast enlargement. Long-Term Treatment (Up to 4 Years) There is no evidence of increased drug-related sexual adverse events (impotence, decreased libido and ejaculation disorder) or gynecomastia with increased duration of treatment. The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown. Postmarketing Experience The following adverse reactions have been identified during postapproval use of AVODART. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) potential causal connection to AVODART. · allergic reactions, including rash, pruritus, urticaria, and localized edema. DRUG INTERACTIONS Care should be taken when administering dutasteride to patients taking potent, chronic CYP3A4 inhibitors (see PRECAUTIONS: Use with Potent CYP3A4 Inhibitors). Dutasteride does not inhibit the in vitro metabolism of model substrates for the major human cyto-chrome P450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1,000 ng/mL, 25 times greater than steady-state serum concentrations in humans. In vitro studies demonstrate that dutasteride does not displace warfarin, diazepam, or phenytoin from plasma protein binding sites, nor do these model compounds displace dutasteride. Digoxin: In a study of 20healthy volunteers, AVODART did not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks. Warfarin: In a study of 23 healthy volunteers, 3 weeks of treatment with AVODART 0.5 mg/day did not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time when administered with warfarin. Alpha-Adrenergic Blocking Agents: In a single sequence, crossover study in healthy volunteers, the administration of tamsulosin or terazosin in combination with AVODART had no effect on the steady-state pharmacokinetics of either alpha-adrenergic blocker. The percent change in DHT concentrations was similar for AVODART alone compared with the combination treatment. A clinical trial was conducted in which dutasteride and tamsulosin were administered concomitantly for 24 weeks followed by 12 weeks of treatment with either the dutasteride and tamsulosin combination or dutasteride monotherapy. Results from the second phase of the trial revealed no excess of serious adverse events or discontinuations due to adverse events in the combination group compared to the dutasteride monotherapy group. Calcium Channel Antagonists: In a population pharmacokinetics analysis, a decrease in clearance of dutasteride was noted when co-administered with the CYP3A4 inhibitors verapamil (-37%, n = 6) and diltiazem (-44%, n = 5). In contrast, no decrease in clearance was seen when amlodipine, another calcium channel antagonist that is not a CYP3A4 inhibitor, was co-administered with dutasteride (+7%, n = 4). The decrease in clearance and subsequent increase in exposure to dutasteride in the presence of ver-apamil and diltiazem is not considered to be clinically significant. No dose adjustment is recommended. Cholestyramine: Administration of a single 5-mg dose of AVODART followed 1 hour later by 12 g cholestyramine did not affect the relative bioavailability of dutasteride in 12 normal volunteers. Other Concomitant Therapy: Although specific interaction studies were not performed with other compounds, approximately 90% of the subjects in the 3 Phase III pivotal efficacy studies receiving AVODART were taking other medications concomitantly. No clinically significant adverse interactions could be attributed to the combination of AVODART and concurrent therapy when AVODART was co-administered with anti-hyperlipidemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors, and quinolone antibiotics. Drug/Laboratory Test Interactions Effects on Prostate-Specific Antigen: PSA levels generally decrease in patients treated with AVODART as the prostate volume decreases. In approximately one-half of the subjects, a 20% decrease in PSA is seen within the first month of therapy. After 6 months of therapy, PSA levels stabilize to a new baseline that is approximately 50% of the pre-treatment value. Results of subjects treated with AVODART for up to 2 years indicate this 50% reduction in PSA is maintained. Therefore, a new baseline PSA concentration should be established after 3 to 6months of treatment with AVODART (see PRECAUTIONS: Effects on PSA and Prostate Cancer Detection). Hormone Levels: 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 dehydro-epiandrosterone. Statistically significant, baseline-adjusted mean increases compared with placebo were observed for total testosterone at 8weeks (97.1 ng/dL, p<0.003) and thyroid-stimulating hormone (TSH) at 52weeks (0.4 mcIU/mL, p<0.05). T Answered by Rossana Schlick 3 months ago.

Flomax 0.5 Mg Answered by Reyna Midcap 3 months ago.


Does Flomax work well. Side effects?
Asked by Wen Scaiano 3 months ago.

google flomax and you'll get a synopsis of what flomax is supposed to do, its side effects, and adverse affects. but i have been on flomax or its equivalents for over six years and have been fine with it. some people report much greater urinary flow and output volume then i have experienced but then i have had positive results taking it. saw palmetto an natural herb is supposed to do the same thing but in actually controlled scientific studies just recently published, saw palmetto does not produce significantly equivalent results. flomax and a few other of those type drugs are designer drugs and therefore usually cost more. i switched to hytrin(terrazosin), costs me $9 for a 90 day supply through express scripts a US pharmacy corporation, not a producer, a supplier, and i have been fine with it for the last four years. the reason i take it is BPH, benign prostatic hypertrophy, and that is usually why a male is prescribed flomax or one of the other designer drugs. of course check with your doctor, i prefer registered pharmacists really, they are much more knowledgeable about use of drugs and alternative replacements, then go to your doctor. Answered by Alverta Trajillo 3 months ago.


Anyone who has or had Flomax?
i just asked a copy of blood test says the PSA, TOTAL 1.9 Asked by Magali Willcott 3 months ago.

My husband just did physical exam after maybe several years ago. He's 36. He claims that he has frequent urinary. The physical exam resulted that his prostate is little higher by 3 points. The doctor prescribed Flomax and gave some sample. He does have frequent urinary, but he drinks water a lot. I mean A LOT!! He doesn't smoke and he doesn't drink alcohol. Before we buy that prescription, I want to do some research. I found that this med is expensive and could have bad side effect. I don't really want my husband to take that med. Can anyone suggest or knows on what level is prostate need serious treatment? I'd rather put him on diet or alternative herb or something. Thanks! Answered by Noelia Roessler 3 months ago.

he drinks a lot of water, i mean a lot is a beer mug full of water. he can drinks two of those after meal. and he only drinks cold water. in one day maybe he drinks around 6-10 glass of beer mug. if we go out eating in restaurant at least he asks three times for refill. what i'm worry is the side affect of reducing the production of semen since we're trying to have a baby. Answered by Colin Lindgren 3 months ago.

Flomax treats BPH,(enlarged prostate). It does not treat nor cure prostate cancer. Like the previous poster said, it aids in the frequency of having to urinate. The prostate rating you refer to is likely the PSA. 3 is a little high, but it isn't just the reading that matters, it is the velocity of the increase of that reading that should be cause for concern. The doctor should have done a DRE and if he felt anything that was abnormal, had it biopsied. I tried Flomax and I didn't like it. It will likely affect the production of semen and can cause dizziness. There is another med, uroxitral, of something like that. Both are used for the same purpose. Best thing to do is just follow the doctors instructions. If he has problems tolorating the med, see if they can adjust the dosage or go to another medicine. Answered by Rocio Gaser 3 months ago.

Flowmax helps to relieve difficulty and frequency of small amounts of urination caused by an enlarged prostate which can be a pain in the butt during the night. You should have told us exactly how many glasses of water he drinks in a day. The more you drink the more you pee. You didn't say exactly what his PSA blood test was. Four and below is a pretty good indicater he doesn't have prostate cancer. I didn't dig the part whare you said that you wished he wouldn't take this medicine. Are you smarter than his Dr? Herbs, bugs and dried bones don't shrink the male prostate gland. The only noticeable drawback of taking Flowmax is a slight decrease in ejaculation quantity. It does not kill orgasms either. Don't pass judgement on a medicine you'll never take. If you really want the scoop about Flowmax both of you go see a Urologist. Answered by Crista Hickam 3 months ago.

Trust your doctor's diagnosis and use the prescribed medicine if you can afford it. If your husband has an enlarged prostate gland and his PSA is normal (0 - 4), this would be the correct treatment. If the PSA is in the range 5 - 10 there is a possibility that there will need to be a referral to a urologist for a prostatic biopsy. Above 10 is usually a danger sign, but I doubt if the PSA level is that high because your doctor would have suspected a more serious problem straight away. Answered by Colton Hatlee 3 months ago.

well, it's not the frequent urinary problem so much as it is having the urge to go and having to 'force' it out. That indicates a swollen prostate. And you don't say if he has the 'forcing' issue. His PSA is up a little. The doctor is being cautious. There are side effects, for sure, among them sexual side effects. You've done your homework. I would discuss this with your husband, and both of you head back to the doctor for a consultation about any alternative treatments. But also understand that Flomax may be the best treatment. Answered by Lashaun Creach 3 months ago.


Would Flomax help a man without a prostate?
I have looked it up - that's why I'm trying to see if anyone knows something I missed. Asked by Ashlee Lipan 3 months ago.

My father was given the drug when in physical rehab so he ouldn't need to get up to pee at night. He remained on the drug when transferred to assisted living and a new doctor. recently, I put 2 and 2 together and realized his prostate was removed 20 years ago and Flomax is designed for a swollen prostate...is there anyone who can confirm this drug wouldn't be of much help to his having to pee at night? Answered by Bettina Montes 3 months ago.

Hi, Flomax is prescribed for urinary problems caused by a condition known as benign prostatic hyperplasia, also known as enlarged prostate. As your father has had a prostatectomy (removal of prostate), I can't understand why this was prescribed, it's impossible for a prostate which isn't there to cause urological problems. You'll have to assume that whoever prescribed it hasn't read his patient history. Get a second opinion off another (better) doctor who actually reads patient histories; it wouldn't be a bad idea to have an ultrasound of the area where the prostate was, to check for abnormal growths and/or get your dad tested for diabetes mellitus or insipidus, any of these could explain night-time urinary problems. The only reason I can think of to prescribe Flomax to a patient who's had a prostatectomy, is for the treatment of sexual disorder known as post-prostatectomy dysorgasmia (problems with orgasm). Answered by Luanne Norgaard 3 months ago.

Real weird:looked the drug up on Google and there is mentioning of not needing to pee at night. Look it up yourself.Type:Flomax and see the working of it. Colors Answered by Sherwood Morn 3 months ago.

call the doctor Answered by Chanel Gowens 3 months ago.


Has anyone ever taken Flomax?
I am taking it right now for an inlarged prostate, and I was just wondering if the probably gets better, or does it stay with you for the rest of your life? Do I have to continue taking this for the rest of my life? Asked by Candelaria Dominski 3 months ago.

I took Flomax too. Not for an enlarged prostate but for prostatitis. I had trouble with dizziness on Flomax so my urologist switched me over to Uroxotrol. Ask your doctor about Uroxotrol. For me, it's even better than Flomax because it gives you all the benefits without the side effects that Flomax can have(dizziness and problems with ejaculation). And you'll probably have to be on it for a while. Maybe forever. It's better than feeling like you got to pee every hour. Answered by Paula Gaydosh 3 months ago.

I have been taking it for past 3 years .From what my doctor tells me it is something I will be on for life unless I have my prostate removed. The only thing I don't like about it is that you can end up with retrograde ejaculation with is when you have a climaxs during sex your sperm goes into your bladder and not out of your penis. The feeling of climax is not the same and hate it Sorry Answered by Earle Leiendecker 3 months ago.

I took a few and forget to take it when the doctor recommended. I'm mostly into alternative meds and self medication so I've been taking Saw Palmetto tablets. Chemical meds have Too many side effects. Answered by Sandi Pinchback 3 months ago.


Has any women been given Flomax for kidney stones?
Since this is a drug for men is it as safe as the Dr. says Asked by Emmett Hoegerl 3 months ago.

Flomax is typically utilized in men with voiding problems due to an enlarged prostate. It works by relaxing muscle tissue within the prostate but also around the opending of the bladder. The same muscle tissue is present at the opening of the bladder in women and occassionally flomax is used to try to relax these muscles to improve urination. The use of flomax for women is likely appropriate and I hope it is helpful. Answered by Darci Stalley 3 months ago.

I could not simply take a seat round and do not anything like my medical professionals urged. They did not desire me to do some thing or to take herbs or natural therapies, however I had to take a look at anything - they simply desired me to do dialysis! This application allowed me to take manipulate of my wellness. I went from Stage four to Stage three kidney sickness. It used to be convenient to do and my BUN, creatinine and anemia are all in larger levels. Reversing Your Kidney Disease? Answered by Tara Vital 3 months ago.

I couldn't just sit around and do nothing like my doctors suggested. They didn't want me to do anything or to take herbs or herbal remedies, but I had to try something - they just wanted me to do dialysis! This program allowed me to take control of my health. I went from Stage 4 to Stage 3 kidney disease. It was easy to do and my BUN, creatinine and anemia are all in better ranges. Reversing Your Kidney Disease? Answered by Cecilia Ludvigson 3 months ago.


Any other generic BPH Prostate medications other than Flomax?
I decided to try Flowmax for the usual BPH symtoms because there is a generic version. However, after almost 4 weeks, it doesn't seem to help with my symptoms. Are there any other generic medications out there for the usual symptoms - going frequently, weak stream, etc? Asked by Theo Montalgo 3 months ago.

Flomax is to help you urinate easier and improve the flow as is suggested by the name but it doesn't do anything to cure BPH. It only relieves the symptoms of BPH, which is an enlarged prostate gland. They have two medications that are supposed to shrink the prostate, the older one you can get in a generic is Proscar and the newer one is Avodart, which is basically the same thing but more expensive. Neither one works very good in my opinion but even if they do, it takes 6 months or longer before you'll see any difference. If your prostate is too large and interferes with your urination you might need a procedure called the Green Light Laser. It's a surgical procedure but is not as invasive as the older TURP which was actually terrible. I take a medicine called Hytrin and it works well for me and you can get it at Walmart for 10 bucks for a 90 day supply. (prescription med) Answered by Delma Magaldi 3 months ago.


Is the medicine flomax bad for women and does it make you hallucinate?
Asked by Maynard Muna 3 months ago.

Side Effects of Flomax Flomax All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flomax: Back pain; cough; decreased sexual ability; diarrhea; dizziness; drowsiness; headache; light-headedness; runny or stuffy nose; sinus inflammation; trouble sleeping; weakness. Seek medical attention right away if any of these SEVERE side effects occur when using Flomax: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision; chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe of persistent dizziness or light-headedness; shortness of breath. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. Answered by Carmelo Hairell 3 months ago.


Avodart, Flomax, & Uroxatral for BPH (Enlarged prostate)?
If you have an enlarged prostate and a Dr has described one of these medicines do you have to take them for the rest of your life? And don't say ask your Dr. I forgot to ask him. Anybody have any experience with these meds? My Dr gave me Uroxatral. I did not like the long list of side effects of Avodart... Asked by Hope Sarchett 3 months ago.

If you have an enlarged prostate and a Dr has described one of these medicines do you have to take them for the rest of your life? And don't say ask your Dr. I forgot to ask him. Anybody have any experience with these meds? My Dr gave me Uroxatral. I did not like the long list of side effects of Avodart and Flomax. Thanks Answered by Lorie Keay 3 months ago.

Flomax is a good drug with minimal side effects. It allows you to pass urine more easily by relaxing the muscles around the base of the bladder. It has no effect on prostatic size. Avodart prevents the conversion of testosterone to dihydrotesterone and will over 6-12 months decrease the size of your prostate Uroxatral is similar to flomax except its in slow release form. If you are having physical problems passing urine this is your best bet Answered by Talitha Mattiello 3 months ago.


Why does sperm output diminish when you take flomax?
When I,m on Flomax I don't produce any sperm. Asked by Zenaida Graddy 3 months ago.

I'm not sure if it was Flomax or not, but following a kidney stone event I took something to basically reduce the irritation in my bladder from the stone and blood being it in...which also had the side-effect of producing an internal ejaculation. Instead of ejaculating externally, the semen was ejaculated into my bladder. A rather odd sensation. As the irritated bladder symptoms cleared, I stopped taking the medicine and the situation returned to normal. As I said, I can't recall for sure if this was Flomax or not, but read the literature that comes with the prescription closely and it might give you the answers you seek. Answered by Sharonda Peeler 3 months ago.

SOME of the known side effects of Flomax: Decreased interest in sexual intercourse Decreased sexual drive or performance Drowsiness Inability to have or keep an erection Increased cough Loss in sexual ability, desire, drive, or performance Nausea Pain or tenderness around the eyes and cheekbones Sleepiness or unusual drowsiness Tooth disorder Trouble sleeping Incidence not knownConstipation Hives or welts Redness of the skin Skin rash Vomiting Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Answered by Titus Simmelink 3 months ago.

u need to visit a doctor ! i heard there is one in the garage with ur mother Answered by Marty Budak 3 months ago.


Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020579/001 FLOMAX TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020579/001 FLOMAX TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
077630/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
078015/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
078225/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
078801/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
078938/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
090377/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
090408/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
090931/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
202010/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
202433/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG
204645/001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE/ORAL 0.4MG

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