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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Tamsulosin Hydrochloride
Brand Name
Tamsulosin Hydrochloride
Generic Name
Tamsulosin Hydrochloride
Active Ingredient
TamsulosinCategory
5-alpha Reductase Inhibitor [EPC]
Salt Form
Hydrochloride
Variants
59
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .4 mg/1 | CAPSULE | ORAL | 63629-4346 |
| .4 mg/1 | CAPSULE | ORAL | 68071-4443 |
| .4 mg/1 | CAPSULE | ORAL | 70518-0179 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Tamsulosin Hydrochloride, you must consult a qualified healthcare professional.
| .4 mg/1 | CAPSULE | ORAL | 71205-217 |
| .4 mg/1 | CAPSULE | ORAL | 71335-0398 |
| .4 mg/1 | CAPSULE | ORAL | 71335-1784 |
| .4 mg/1 | CAPSULE | ORAL | 72162-2502 |
| .4 mg/1 | CAPSULE | ORAL | 0615-8055 |
| .4 mg/1 | CAPSULE | ORAL | 33342-159 |
| .4 mg/1 | CAPSULE | ORAL | 51655-832 |
| .4 mg/1 | CAPSULE | ORAL | 63187-358 |
| .4 mg/1 | CAPSULE | ORAL | 63187-469 |
+ 38 more variants
Detailed information about Tamsulosin Hydrochloride
Tamsulosin is a selective alpha-1 adrenoceptor antagonist used primarily to improve urination in men with benign prostatic hyperplasia (BPH). It works by relaxing the smooth muscles of the prostate and bladder neck.
The standard recommended dose of tamsulosin hydrochloride for the treatment of BPH is 0.4 mg taken once daily. This dose is effective for the majority of patients and provides a balance between symptom relief and the risk of side effects.
In some instances, if a patient does not respond adequately to the 0.4 mg dose after two to four weeks of consistent treatment, a healthcare provider may increase the dosage to 0.8 mg once daily. It is important to note that the 0.8 mg dose increases the likelihood of side effects, such as dizziness and abnormal ejaculation. If the 0.8 mg dose is discontinued or interrupted for several days, therapy should be restarted at the 0.4 mg dose to allow the body to re-acclimatize to the medication.
Tamsulosin is not approved for use in pediatric patients. Clinical trials have been conducted to evaluate the use of tamsulosin in children with certain bladder conditions (such as neurogenic bladder), but these studies failed to demonstrate significant efficacy over placebo. Consequently, the safety and effectiveness of tamsulosin in individuals under the age of 18 have not been established.
For patients with mild to moderate renal impairment (creatinine clearance between 10 and 70 mL/min), no dosage adjustment is typically required. Tamsulosin has not been extensively studied in patients with end-stage renal disease (creatinine clearance < 10 mL/min), and such patients should be treated with extreme caution.
In patients with mild to moderate hepatic impairment (Child-Pugh scores A and B), dosage adjustments are generally not necessary. However, tamsulosin has not been studied in patients with severe hepatic impairment (Child-Pugh score C), and its use in this population is generally not recommended due to the drug's extensive liver metabolism.
Clinical studies have shown that the pharmacokinetic profile of tamsulosin is similar in younger and older men. However, elderly patients may be more sensitive to the blood-pressure-lowering effects of alpha-blockers, increasing the risk of falls. Healthcare providers typically monitor older patients more closely during the initiation of therapy.
To get the most benefit from tamsulosin and reduce the risk of side effects, follow these specific instructions:
If you miss a dose of tamsulosin, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Never take two doses at the same time to make up for a missed one. If you stop taking tamsulosin for several days, contact your healthcare provider before restarting, as you may need to begin again at the lowest dose.
An overdose of tamsulosin can lead to a significant drop in blood pressure (hypotension). Symptoms of an overdose may include severe dizziness, fainting (syncope), rapid heart rate, or blurred vision. If an overdose is suspected, seek emergency medical attention immediately. Treatment typically involves cardiovascular support, including keeping the patient in a supine (lying down) position to help restore blood pressure and, in severe cases, the administration of intravenous fluids.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as your symptoms may return or you may experience adverse effects.
As with any medication, tamsulosin can cause side effects, although not everyone will experience them. The most frequently reported side effects are generally mild and often diminish as the body adjusts to the medication. Common side effects include:
Tamsulosin is specifically designed for the treatment of BPH in men and is not intended for use as a blood pressure medication. Patients should be aware that while tamsulosin is generally well-tolerated, it requires careful monitoring, particularly during the first few weeks of treatment. It is vital to inform all healthcare providers, including dentists and eye surgeons, that you are taking tamsulosin.
No FDA black box warnings for Tamsulosin. However, the lack of a black box warning does not imply the drug is without risk. The most significant clinical warnings involve cardiovascular effects and surgical complications.
Certain medications should never be used in combination with tamsulosin due to the risk of severe, life-threatening interactions:
There are specific circumstances under which tamsulosin must never be used:
These are conditions where the use of tamsulosin requires a careful risk-benefit analysis by a healthcare professional:
Tamsulosin is not indicated for use in women. It is classified by the FDA as Pregnancy Category B (under the old system). Animal studies using doses much higher than the human equivalent did not show evidence of fetal harm or impaired fertility. However, there are no adequate and well-controlled studies in pregnant women. Tamsulosin is not intended for use during pregnancy or for fertility treatments.
Tamsulosin is not indicated for use in women; therefore, its passage into human breast milk has not been studied. It is unknown if the drug or its metabolites are excreted in milk or what effect they might have on a nursing infant. In animal studies (rats), tamsulosin was found to be excreted in milk.
Tamsulosin is not approved for use in children. A large, randomized, double-blind, placebo-controlled study in children aged 2 to 16 with neurogenic bladder failed to show that tamsulosin was more effective than a placebo in reducing leak point pressure. Because of this lack of efficacy, tamsulosin is not recommended for pediatric patients.
Tamsulosin is a selective antagonist of alpha-1A and alpha-1D adrenoceptors. In the human prostate, approximately 70% of the alpha-1 receptors are of the alpha-1A subtype. By selectively blocking these receptors, tamsulosin inhibits the contraction of smooth muscle in the prostate gland and the bladder neck. This results in a decrease in urethral pressure and an increase in the diameter of the urethral lumen, facilitating easier urination. Unlike non-selective alpha-blockers like doxazosin, tamsulosin has a much lower affinity for alpha-1B receptors, which are primarily located in the vascular smooth muscle. This selectivity is the reason tamsulosin has a lower incidence of cardiovascular side effects compared to older medications in the same class.
The pharmacodynamic effect of tamsulosin is characterized by an improvement in urine flow (Qmax) and a reduction in both obstructive and irritative BPH symptoms. The onset of action is relatively rapid, with many patients noticing an improvement in symptoms within 48 hours to one week of starting the 0.4 mg dose. The effect is maintained throughout the 24-hour dosing interval. Tolerance (loss of effect over time) has not been observed in long-term clinical trials.
Common questions about Tamsulosin Hydrochloride
Tamsulosin is primarily used to treat the symptoms of an enlarged prostate, a condition known as Benign Prostatic Hyperplasia (BPH). It works by relaxing the muscles in the prostate and the opening of the bladder, which helps urine flow more easily. Many men find that it reduces the need to wake up at night to urinate and strengthens their urinary stream. While its main use is for BPH, doctors sometimes prescribe it off-label to help patients pass kidney stones. It is important to note that tamsulosin treats the symptoms of BPH but does not actually shrink the prostate itself. Always consult your healthcare provider to see if this medication is appropriate for your specific urinary symptoms.
The most common side effects of tamsulosin include dizziness, headache, and a runny or stuffy nose. Many men also experience abnormal ejaculation, such as a decrease in the amount of semen or semen entering the bladder instead of exiting the body. Dizziness is most common when you first start the medication or when your dose is increased, often occurring when you stand up quickly. These side effects are usually mild and may improve as your body gets used to the medicine. However, if they become bothersome or persistent, you should discuss them with your doctor. Most of these effects, including changes in ejaculation, are completely reversible if the medication is stopped.
It is generally advised to limit or avoid alcohol while taking tamsulosin. Both tamsulosin and alcohol can lower your blood pressure and cause vasodilation (widening of the blood vessels). When combined, they can lead to a significant drop in blood pressure, resulting in severe dizziness, lightheadedness, or even fainting. This increases the risk of accidental falls and injuries, particularly in older adults. If you do choose to drink, it is important to do so in moderation and be very careful when standing up or moving around. Discuss your alcohol consumption habits with your healthcare provider to understand your specific risks.
Tamsulosin is not intended for use in women and is specifically indicated for the treatment of BPH in men. Therefore, it is not used during pregnancy. Animal studies have not shown direct harm to a fetus at very high doses, but there is no clinical data on its safety in pregnant women. If a woman were to accidentally ingest tamsulosin, she should contact a healthcare provider or poison control center immediately. The drug is not approved for any condition in women that would require its use during pregnancy. Men taking tamsulosin do not need to worry about the drug affecting a pregnancy through their semen.
Many patients begin to notice an improvement in their urinary symptoms within 48 hours of starting tamsulosin. However, it may take up to two to four weeks of consistent daily use to reach the full therapeutic benefit of the medication. Your doctor will likely schedule a follow-up appointment after a few weeks to assess how well the drug is working for you. If your symptoms do not improve after a month, your doctor may consider increasing the dose or exploring other treatment options. It is important to take the medication every day as prescribed, even if you do not feel an immediate change on the first day.
You should not stop taking tamsulosin without first consulting your healthcare provider. If you stop the medication suddenly, your BPH symptoms, such as difficulty urinating or frequent nighttime trips to the bathroom, will likely return within a few days. Furthermore, if you stop taking tamsulosin for several days and then restart it, you may experience a recurrence of the "first-dose effect," which includes severe dizziness and a risk of fainting. If you need to stop the medication for a medical procedure or due to side effects, your doctor will provide a plan for how to safely discontinue or restart the therapy. Consistency is vital for the long-term management of BPH.
If you miss a dose of tamsulosin, take it as soon as you remember, provided it is 30 minutes after a meal as usually directed. If it is almost time for your next dose, skip the missed dose and simply take your next scheduled dose at the regular time. Do not take two doses at once to make up for the one you missed, as this significantly increases your risk of low blood pressure and dizziness. If you miss your doses for several days in a row, you must contact your doctor before restarting. They may advise you to restart at the lower 0.4 mg dose to ensure your body tolerates the medication safely.
Weight gain is not a commonly reported side effect of tamsulosin in clinical trials. Most men taking the medication do not experience significant changes in their body weight. However, some patients may experience peripheral edema (swelling of the ankles or feet), which can occasionally feel like weight gain or bloating. If you notice rapid or unusual weight gain while taking tamsulosin, it is more likely related to other health conditions or medications you may be taking. You should report any significant swelling or unexplained weight changes to your healthcare provider for a thorough evaluation.
Tamsulosin can interact with several other medications, so it is crucial to provide your doctor with a full list of everything you take. It is particularly important to mention if you take blood pressure medications or drugs for erectile dysfunction (like Viagra or Cialis), as these can cause your blood pressure to drop too low when combined with tamsulosin. Additionally, certain antifungal or HIV medications can interfere with how your body breaks down tamsulosin, leading to dangerously high levels of the drug in your system. Your pharmacist can also perform a drug interaction check to ensure that tamsulosin is safe to take with your current regimen.
Yes, tamsulosin is widely available as a generic medication (tamsulosin hydrochloride). The generic version is bioequivalent to the brand-name drug Flomax, meaning it contains the same active ingredient and works the same way in the body. Generic tamsulosin is typically much more affordable than the brand-name version and is covered by most insurance plans and Medicare. When you fill your prescription, the pharmacy may provide the generic version unless your doctor specifically requests the brand name. Both the generic and brand-name versions are effective for managing the symptoms of an enlarged prostate.
These side effects occur in a smaller percentage of the population but are still well-documented in clinical literature:
> Warning: Stop taking Tamsulosin and call your doctor or seek emergency care immediately if you experience any of the following:
For most men, tamsulosin is safe for long-term use, and many remain on the medication for years to manage BPH symptoms. Long-term studies have not indicated a significant increase in toxicity over time. However, the risk of Intraoperative Floppy Iris Syndrome (IFIS) remains a lifelong concern for any patient who has ever taken tamsulosin, even if they have discontinued the drug years prior to eye surgery. Patients should also be monitored for the continued efficacy of the drug, as BPH is a progressive condition that may eventually require surgical intervention despite medical therapy.
There are currently no FDA black box warnings for tamsulosin. However, the medication does carry significant warnings regarding orthostatic hypotension and its impact on cataract surgery (IFIS).
Report any unusual symptoms or side effects to your healthcare provider. Monitoring your response to the medication helps your doctor ensure that the benefits of treatment continue to outweigh the risks.
There are no specific blood tests required solely for monitoring tamsulosin levels. However, healthcare providers typically perform the following as part of standard BPH management:
Because tamsulosin can cause dizziness, lightheadedness, and blurred vision, patients should exercise extreme caution when driving, operating heavy machinery, or performing dangerous tasks until they know how the medication affects them. This is especially important during the first 24 to 48 hours of treatment.
Alcohol can exacerbate the blood-pressure-lowering effects of tamsulosin. Consuming alcohol while taking this medication significantly increases the risk of dizziness, fainting, and falls. It is generally recommended to limit or avoid alcohol consumption while on tamsulosin.
If tamsulosin is discontinued for several days, the symptoms of BPH will likely return. There is no "withdrawal syndrome" in the traditional sense, but the body will lose its adaptation to the drug's effect on blood pressure. If you stop taking the medication for more than a few days, you should consult your doctor before restarting, as you will likely need to start at the 0.4 mg dose again to avoid severe dizziness.
> Important: Discuss all your medical conditions, including any history of low blood pressure or upcoming eye surgeries, with your healthcare provider before starting Tamsulosin.
Tamsulosin does not typically interfere with common laboratory tests, including the PSA (Prostate-Specific Antigen) test. Unlike 5-alpha reductase inhibitors (like finasteride), tamsulosin does not lower PSA levels, meaning it does not "mask" the detection of prostate cancer in lab results.
For each major interaction, the management strategy usually involves either avoiding the combination, adjusting the dose, or increasing the frequency of blood pressure monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to prevent dangerous drug-drug interactions.
While there is no direct chemical link between tamsulosin and sulfonamides (sulfa drugs), there have been rare clinical reports of patients with sulfa allergies experiencing allergic reactions to tamsulosin. If you have had a severe, life-threatening reaction to a sulfa drug (such as Bactrim), your doctor will evaluate whether tamsulosin is safe for you or if an alternative class of medication is more appropriate.
> Important: Your healthcare provider will evaluate your complete medical history, including allergies and organ function, before prescribing Tamsulosin to ensure your safety.
The majority of patients taking tamsulosin are over the age of 65. While the drug's effectiveness is similar across age groups, geriatric patients are at a significantly higher risk for falls and fractures related to orthostatic hypotension (dizziness upon standing). Older patients are also more likely to be taking multiple medications (polypharmacy), increasing the risk of drug interactions. Healthcare providers often advise older patients to be particularly careful when getting out of bed at night.
For most patients with kidney disease, tamsulosin is safe. No dose adjustment is needed for those with mild-to-moderate renal impairment. However, tamsulosin is not removed by hemodialysis due to its high protein binding. Patients with end-stage renal disease require very close monitoring if tamsulosin is prescribed.
Patients with mild to moderate liver impairment (Child-Pugh A and B) do not require dose adjustments. The liver has a high capacity for metabolizing tamsulosin, and even with moderate impairment, the drug levels remain within a safe range. However, for those with severe liver failure, the drug should be avoided as the risk of accumulation and toxicity is high.
> Important: Special populations require individualized medical assessment to ensure that the dosage and monitoring are appropriate for their specific physiological needs.
|---|---|
| Bioavailability | >90% (Fasting) |
| Protein Binding | 94% to 99% (Alpha-1 acid glycoprotein) |
| Half-life | 9 to 15 hours |
| Tmax | 4 to 5 hours (Fasting); 6 to 7 hours (Fed) |
| Metabolism | Hepatic (CYP3A4, CYP2D6) |
| Excretion | Renal 76%, Fecal 21% |
Tamsulosin is classified as an Alpha-1 Adrenoceptor Antagonist. It is part of the therapeutic category of Urologicals and Genitourinary agents. Related medications in this class include Alfuzosin, Silodosin, Terazosin, and Doxazosin. Silodosin and Alfuzosin share tamsulosin's uroselectivity, whereas Terazosin and Doxazosin are non-selective and are also used to treat hypertension.