Tamsulosin 0.4mg Capsules
It is used to treat the signs of an enlarged prostate. If you have been given this drug for some other reason, talk with your doctor for more information.
Drug Class
Alpha-1 adrenergic antagonist
Pharmacologic Class
Alpha-1A adrenergic blocker
Pregnancy Category
Not applicable (primarily used in men)
FDA Approved
Apr 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tamsulosin is a medication used to treat symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) in men. It works by relaxing the muscles in the prostate and bladder, which helps urine flow more easily and reduces urinary symptoms like frequent urination, urgency, and difficulty starting urination.
How to Use This Medicine
Taking Your Medication
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your dose 30 minutes after the same meal every day to maintain a consistent routine.
Swallow the medication whole; do not chew, open, or crush it.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs.
Missing a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
If you miss taking your medication for several days in a row, consult your doctor before restarting your medication regimen.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your dose 30 minutes after the same meal every day to maintain a consistent routine.
Swallow the medication whole; do not chew, open, or crush it.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs.
Missing a Dose
If you miss a dose, follow these guidelines:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
If you miss taking your medication for several days in a row, consult your doctor before restarting your medication regimen.
Lifestyle & Tips
- Take the capsule whole; do not crush, chew, or open it.
- Take the medication approximately 30 minutes after the same meal each day to ensure consistent absorption.
- Be aware of potential dizziness or lightheadedness, especially when standing up quickly from a sitting or lying position. This is more common when first starting the medication or increasing the dose.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how the medication affects you.
- Limit alcohol consumption, as it can worsen dizziness or lightheadedness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.4 mg orally once daily, approximately 30 minutes after the same meal each day.
Dose Range:
0.4 - 0.8 mg
Condition-Specific Dosing:
Benign Prostatic Hyperplasia (BPH):
Initial dose: 0.4 mg once daily. May be increased to 0.8 mg once daily after 2-4 weeks if response is inadequate.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Use with caution (CrCl < 10 mL/min); studies are limited.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Use with caution; studies are limited in patients with severe hepatic impairment.
Pharmacology
Mechanism of Action
Tamsulosin is an alpha-1A adrenergic receptor antagonist. It selectively blocks alpha-1A adrenergic receptors in the prostate, prostatic capsule, bladder neck, and prostatic urethra. Blockade of these receptors leads to relaxation of the smooth muscle in these tissues, thereby decreasing urethral resistance and improving urine flow and reducing symptoms of benign prostatic hyperplasia (BPH).
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90% (capsule)
Tmax:
4-5 hours (fasted), 6-7 hours (with food)
FoodEffect:
Absorption is increased and prolonged when taken with food. Tamsulosin should be taken approximately 30 minutes following the same meal each day.
Distribution:
Vd:
Approximately 16 L
ProteinBinding:
>99% (primarily to alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
5-7 hours (single dose), 9-15 hours (multiple doses)
Clearance:
Approximately 0.13 L/hr/kg
ExcretionRoute:
Urine (approximately 76%), feces (approximately 21%)
Unchanged:
Approximately 9% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 week (for symptomatic improvement)
PeakEffect:
Approximately 2-4 weeks (for maximal symptomatic improvement)
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Fever, chills, or sore throat
Ejaculation problems
Painful erection (hard penis) or an erection lasting longer than 4 hours, which may occur even when not having sex. If left untreated, this can lead to lasting sexual problems and potentially permanent impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Headache
Back pain
Diarrhea
Dizziness, tiredness, or weakness
Runny nose
* Throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Fever, chills, or sore throat
Ejaculation problems
Painful erection (hard penis) or an erection lasting longer than 4 hours, which may occur even when not having sex. If left untreated, this can lead to lasting sexual problems and potentially permanent impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Headache
Back pain
Diarrhea
Dizziness, tiredness, or weakness
Runny nose
* Throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (syncope)
- Chest pain
- Prolonged, painful erection (priapism) lasting more than 4 hours â seek immediate medical attention.
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, should not be taken with this drug. Your doctor or pharmacist can help you determine if any of your medications are incompatible with this drug.
If you are using a medication similar to this one, as this may not be suitable. If you are unsure, consult your doctor or pharmacist for guidance.
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations, so it is vital to discuss your options with your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, should not be taken with this drug. Your doctor or pharmacist can help you determine if any of your medications are incompatible with this drug.
If you are using a medication similar to this one, as this may not be suitable. If you are unsure, consult your doctor or pharmacist for guidance.
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations, so it is vital to discuss your options with your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from a sitting or lying down position to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
If you are scheduled to undergo cataract surgery or any other eye procedure, consult with your doctor beforehand. Additionally, monitor your blood pressure as instructed by your healthcare provider.
For patients taking this medication for an enlarged prostate, it is crucial to follow your doctor's recommendations for regular rectal exams (to assess the prostate gland) and blood tests (PSA tests).
If you have a known allergy to sulfa (sulfonamide) medications, discuss this with your doctor before taking this medication.
Special Considerations for Children
This medication is not approved for use in children. However, in some cases, your child's doctor may determine that the benefits of taking this medication outweigh the potential risks. If your child has been prescribed this medication, consult with their doctor to understand the benefits and risks associated with its use. If you have questions or concerns about giving this medication to your child, discuss them with their doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from a sitting or lying down position to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
If you are scheduled to undergo cataract surgery or any other eye procedure, consult with your doctor beforehand. Additionally, monitor your blood pressure as instructed by your healthcare provider.
For patients taking this medication for an enlarged prostate, it is crucial to follow your doctor's recommendations for regular rectal exams (to assess the prostate gland) and blood tests (PSA tests).
If you have a known allergy to sulfa (sulfonamide) medications, discuss this with your doctor before taking this medication.
Special Considerations for Children
This medication is not approved for use in children. However, in some cases, your child's doctor may determine that the benefits of taking this medication outweigh the potential risks. If your child has been prescribed this medication, consult with their doctor to understand the benefits and risks associated with its use. If you have questions or concerns about giving this medication to your child, discuss them with their doctor.
Overdose Information
Overdose Symptoms:
- Severe hypotension (low blood pressure)
- Dizziness
- Weakness
- Fainting
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Support cardiovascular function, keep patient supine, and administer vasopressors if needed. Dialysis is unlikely to be beneficial due to high protein binding.
Drug Interactions
Contraindicated Interactions
- Concurrent use with other alpha-adrenergic blocking agents (due to potential for severe hypotension).
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole): May significantly increase tamsulosin exposure, leading to increased risk of adverse effects including hypotension. Avoid concomitant use.
- Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): May significantly increase tamsulosin exposure. Use with caution.
- PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil): Concomitant use may lead to additive hypotensive effects. Use with caution, especially at the start of therapy with either drug.
- Other alpha-blockers (e.g., doxazosin, terazosin, alfuzosin, silodosin): Increased risk of hypotension.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem): May increase tamsulosin exposure. Use with caution.
- Moderate CYP2D6 inhibitors (e.g., bupropion): May increase tamsulosin exposure. Use with caution.
Minor Interactions
- Warfarin: Limited data suggest no significant interaction, but caution is advised due to high protein binding of tamsulosin.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for orthostatic hypotension risk.
Timing: Prior to initiation of therapy.
Digital Rectal Exam (DRE) and Prostate-Specific Antigen (PSA) testing
Rationale: To rule out prostate cancer, as BPH and prostate cancer can coexist.
Timing: Prior to initiation of therapy, as per standard BPH management guidelines.
Routine Monitoring
Blood Pressure (BP), especially orthostatic BP
Frequency: Periodically, especially during dose titration and if symptoms of orthostatic hypotension occur.
Target: Maintain within patient's normal range, minimize symptomatic orthostasis.
Action Threshold: Significant symptomatic orthostatic hypotension (e.g., dizziness, lightheadedness, syncope) warrants dose reduction or discontinuation.
BPH symptom assessment (e.g., AUA Symptom Index)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Improvement in symptom score.
Action Threshold: Lack of symptomatic improvement after adequate trial (e.g., 4-8 weeks at target dose) may warrant re-evaluation or alternative therapy.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Syncope (fainting)
- Orthostatic hypotension (drop in BP upon standing)
- Priapism (prolonged, painful erection)
- Intraoperative Floppy Iris Syndrome (IFIS) during cataract or glaucoma surgery
Special Patient Groups
Pregnancy
Tamsulosin is not indicated for use in women. There are no data on the use of tamsulosin in pregnant women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Tamsulosin is not indicated for use in women. It is unknown whether tamsulosin is excreted in human milk.
Infant Risk:
Not applicable
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Tamsulosin is not indicated for use in pediatric patients.
Geriatric Use
No dosage adjustment is necessary in elderly patients. However, elderly patients may be more susceptible to orthostatic hypotension. Monitor blood pressure carefully.
Clinical Information
Clinical Pearls
- Tamsulosin is associated with Intraoperative Floppy Iris Syndrome (IFIS) during cataract or glaucoma surgery. Patients should inform their ophthalmologist that they are taking or have taken tamsulosin, even if discontinued, as IFIS can occur weeks to months after discontinuation.
- Advise patients to take the medication consistently with the same meal each day to optimize absorption and minimize variability.
- Orthostatic hypotension is a common side effect, especially with the first dose or dose increases. Advise patients to rise slowly from a sitting or lying position.
- Priapism (prolonged, painful erection) is a rare but serious side effect requiring immediate medical attention.
- Tamsulosin does not shrink the prostate or prevent prostate cancer; it only helps relieve BPH symptoms.
Alternative Therapies
- Other alpha-1 adrenergic blockers (e.g., alfuzosin, silodosin, doxazosin, terazosin)
- 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) - primarily for larger prostates or to prevent progression
- Combination therapy (e.g., alpha-blocker + 5-alpha reductase inhibitor)
- Anticholinergics (e.g., tolterodine, solifenacin) - for overactive bladder symptoms that may coexist with BPH
- Beta-3 adrenergic agonists (e.g., mirabegron) - for overactive bladder symptoms
- Surgical interventions (e.g., Transurethral Resection of the Prostate (TURP), UroLift, Rezum)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$30 per 30 capsules (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.