Tamsulosin

Tamsulosin is a prescription medication used to treat the symptoms of enlarged prostate, known medically as benign prostatic hyperplasia (BPH). Tamsulosin belongs to a group of drugs called alpha blockers. Unlike other BPH medicines, tamsulosin does not shrink the prostate. It works by relaxing the muscles in the bladder and prostate so urine can flow easily.

This medication comes as a capsule that is taken by mouth once a day. It should be taken 30 minutes after the same meal each day. Swallow tamsulosin capsules whole. Do not crush, chew, or open tamsulosin capsules.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. It is not known if tamsulosin will harm your unborn baby. This medication should not be taken during pregnancy. Tell your doctor if you become pregnant while taking tamsulosin.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication.

In the U.S.

• Flomax

Available Dosage Forms:

• Capsule

Therapeutic Class: Benign Prostatic Hypertrophy Agent

Pharmacologic Class: Tamsulosin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tamsulosin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tamsulosin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Tamsulosin is not indicated for use in the pediatric population.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tamsulosin in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tamsulosin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tamsulosin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir

Using tamsulosin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Paroxetine
• Posaconazole
• Ritonavir
• Saquinavir
• Tadalafil
• Telaprevir
• Telithromycin
• Voriconazole

Using tamsulosin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Atenolol
• Avanafil
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Cimetidine
• Dilevalol
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Sildenafil
• Sotalol
• Talinolol
• Tertatolol
• Timolol
• Vardenafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of tamsulosin. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to sulfa drugs—Increased allergic reaction risk in patients with this condition.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination

• Chest pain

• Dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of constant movement of self or surroundings
• painful or prolonged erection of the penis
• sensation of spinning

• Blistering, peeling, or loosening of the skin
• blurred vision
• confusion
• diarrhea
• difficult or labored breathing
• fast, pounding, or irregular heartbeat or pulse
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• tightness of the chest
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal ejaculation
• back pain
• body aches or pain
• congestion
• headache
• lack or loss of strength
• sneezing
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

• 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

• Constipation
• hives or welts, skin rash
• redness of the skin
• 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.

• In men, it is used to treat the signs of an enlarged prostate.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Change in sex ability.
• Back pain.
• Cough.
• Loose stools (diarrhea).
• Dizziness.
• Runny nose.
• Stuffy nose.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Tamsulosin Hydrochloride Capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension.

Capsule: 0.4 mg, White to off white pellets filled in hard gelatin capsule size " 1" Olive green opaque cap & orange opaque body imprinted with "TAM' on cap & " 0.4 mg” on body in black ink.

Pregnancy

Teratogenic Effects, Pregnancy Category B.
Administration of Tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of Tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin Hydrochloride Capsules are not indicated for use in women.

Labor & Delivery

Nursing Mothers

Tamsulosin Hydrochloride Capsules are not indicated for use in women.

Pediatric Use

Tamsulosin Hydrochloride Capsules are not indicated for use in pediatric populations.
Efficacy and positive benefit/risk of Tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm H2O) associated with known neurological disorder (e.g., spina bifida). Patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg Tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm H2O. In a randomized, double-blind, placebo controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving Tamsulosin hydrochloride and placebo. In an open-label, 12-month safety study,
87 patients were treated with Tamsulosin hydrochloride. The most frequently reported adverse events (<5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation.

Geriatric Use

Of the total number of subjects (1783) in clinical studies of Tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)].

Renal Impairment

Patients with renal impairment do not require an adjustment in Tamsulosin Hydrochloride Capsules dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m2) have not been studied [see Clinical Pharmacology (12.3)].

Hepatic Impairment

Patients with moderate hepatic impairment do not require an adjustment in Tamsulosin Hydrochloride Capsules dosage. Tamsulosin Hydrochloride Capsules has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

Mechanism of Action

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck.

Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in the human prostate. At least three discrete alpha1 adrenoceptor subtypes have been identified: alpha1A, alpha1B, and alpha1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1 receptors in the human prostate are of the alpha1A subtype. Tamsulosin Hydrochloride Capsules  are not intended for use as an antihypertensive drug.

Pharmacodynamics

Urologic pharmacodynamic effects have been evaluated in neurologically impaired pediatric patients and in adults with BPH [see Use in Specific Populations (8.4) and Clinical Studies(14)].

Pharmacokinetics

The pharmacokinetics of Tamsulosin hydrochloride have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg.


Absorption
Absorption of Tamsulosin hydrochloride from Tamsulosin Hydrochloride Capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions. Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with achievement of steady-state concentrations by the fifth day of once-a-day dosing.

Effect of Food
The time to maximum concentration (Tmax) is reached by 4 to 5 hours under fasting conditions and by 6 to 7 hours when Tamsulosin Hydrochloride Capsules are administered with food. Taking Tamsulosin Hydrochloride Capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations (Cmax) compared to fed conditions (Figure 1).

Figure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-Dose Administration of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted and Fed Conditions (n=8)

The effects of food on the pharmacokinetics of Tamsulosin hydrochloride are consistent regardless of whether a Tamsulosin Hydrochloride Capsules is taken with a light breakfast or a high-fat breakfast (Table 2).

Table 2 Mean (± S.D.) Pharmacokinetic Parameters Following Tamsulosin Hydrochloride Capsules 0.4 mg Once Daily or 0.8 mg Once Daily with a Light Breakfast, High-Fat Breakfast or Fasted

Cmin = observed minimum concentration

Cmax = observed maximum Tamsulosin hydrochloride plasma concentration

Tmax = median time-to-maximum concentration

T1/2 = observed half-life

AUCt= area under the Tamsulosin hydrochloride plasma time curve over the dosing interval.

Distribution

The mean steady-state apparent volume of distribution of Tamsulosin hydrochloride after intravenous administration to 10 healthy male adults was 16 L, which is suggestive of distribution into extracellular fluids in the body.

Tamsulosin hydrochloride is extensively bound to human plasma proteins (94% to 99%), primarily alpha1 acid glycoprotein (AAG), with linear binding over a wide concentration range (20 to 600 ng/mL). The results of two-way in vitro studies indicate that the binding of Tamsulosin hydrochloride to human plasma proteins is not affected by amitriptyline, diclofenac, glyburide, simvastatin plus simvastatin-hydroxy acid metabolite, warfarin, diazepam, propranolol, trichlormethiazide, or chlormadinone. Likewise, Tamsulosin hydrochloride had no effect on the extent of binding of these drugs.

Metabolism

There is no enantiomeric bioconversion from Tamsulosin hydrochloride [R(-) isomer] to the S(+) isomer in humans. Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged. However, the pharmacokinetic profile of the metabolites in humans has not been established. Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6 as well as via some minor participation of other CYP isoenzymes. Inhibition of hepatic drug-metabolizing enzymes may lead to increased exposure to Tamsulosin [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. The metabolites of Tamsulosin hydrochloride undergo extensive conjugation to glucuronide or sulfate prior to renal excretion.

Incubations with human liver microsomes showed no evidence of clinically significant metabolic interactions between Tamsulosin hydrochloride and amitriptyline, albuterol (beta agonist), glyburide (glibenclamide) and finasteride (5alpha-reductase inhibitor for treatment of BPH). However, results of the in vitro testing of the Tamsulosin hydrochloride interaction with diclofenac and warfarin were equivocal.

Excretion

On administration of the radiolabeled dose of Tamsulosin hydrochloride to 4 healthy volunteers, 97% of the administered radioactivity was recovered, with urine (76%) representing the primary route of excretion compared to feces (21%) over 168 hours.

Following intravenous or oral administration of an immediate-release formulation, the elimination half-life of Tamsulosin hydrochloride in plasma ranged from 5 to 7 hours. Because of absorption rate-controlled pharmacokinetics with Tamsulosin Hydrochloride Capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin hydrochloride undergoes restrictive clearance in humans, with a relatively low systemic clearance (2.88 L/h).

Specific Populations

Pediatric Use

Tamsulosin Hydrochloride Capsules are not indicated for use in pediatric populations [see Use in Specific Populations (8.4)].

Geriatric (Age) Use

Cross-study comparison of Tamsulosin Hydrochloride Capsules overall exposure (AUC) and half-life indicates that the pharmacokinetic disposition of Tamsulosin hydrochloride may be slightly prolonged in geriatric males compared to young, healthy male volunteers. Intrinsic clearance is independent of Tamsulosin hydrochloride binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects of age 55 to 75 years compared to subjects of age 20 to 32 years [see Use in Specific Populations (8.5)].

Renal Impairment

The pharmacokinetics of Tamsulosin hydrochloride have been compared in 6 subjects with mild-moderate (30 ≤CLcr <70 mL/min/1.73 m2) or moderate-severe (10 ≤CLcr <30 mL/min/1.73 m2) renal impairment and 6 normal subjects (CLcr >90 mL/min/1.73 m2). While a change in the overall plasma concentration of Tamsulosin hydrochloride was observed as the result of altered binding to AAG, the unbound (active) concentration of Tamsulosin hydrochloride, as well as the intrinsic clearance, remained relatively constant. Therefore, patients with renal impairment do not require an adjustment in Tamsulosin Hydrochloride Capsules dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m2) have not been studied [see Use in Specific Populations (8.6)].

Hepatic Impairment

The pharmacokinetics of Tamsulosin hydrochloride have been compared in 8 subjects with moderate hepatic impairment (Child-Pugh’s classification: Grades A and B) and 8 normal subjects. While a change in the overall plasma concentration of Tamsulosin hydrochloride was observed as the result of altered binding to AAG, the unbound (active) concentration of Tamsulosin hydrochloride does not change significantly, with only a modest (32%) change in intrinsic clearance of unbound Tamsulosin hydrochloride.

Therefore, patients with moderate hepatic impairment do not require an adjustment in Tamsulosin Hydrochloride Capsules dosage. Tamsulosin Hydrochloride Capsules has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

Drug Interactions

Cytochrome P450 Inhibition

Strong and Moderate Inhibitors of CYP3A4 or CYP2D6 

The effects of ketoconazole (a strong inhibitor of CYP3A4) at 400 mg once daily for 5 days on the pharmacokinetics of a single Tamsulosin Hydrochloride Capsules 0.4 mg dose was investigated in 24 healthy volunteers (age range 23 to 47 years). Concomitant treatment with ketoconazole resulted in an increase in the Cmax and AUC of Tamsulosin by a factor of 2.2 and 2.8, respectively [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of Tamsulosin Hydrochloride Capsules have not been evaluated [see Warnings and Precautions (5.2) and Drug Interactions(7.1)].

The effects of paroxetine (a strong inhibitor of CYP2D6) at 20 mg once daily for 9 days on the pharmacokinetics of a single Tamsulosin Hydrochloride Capsules 0.4 mg dose was investigated in 24 healthy volunteers (age range 23 to 47 years). Concomitant treatment with paroxetine resulted in an increase in the Cmax and AUC of Tamsulosin by a factor of 1.3 and 1.6, respectively [ see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. A similar increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). A fraction of the population (about 7% of Caucasians and 2% of African Americans) are CYP2D6 PMs. Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in Tamsulosin exposure exists when Tamsulosin Hydrochloride Capsules 0.4 mg is co-administered with strong CYP3A4 inhibitors in CYP2D6 PMs, Tamsulosin Hydrochloride Capsules 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of Tamsulosin Hydrochloride Capsules have not been evaluated [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

The effects of co-administration of both a CYP3A4 and a CYP2D6 inhibitor with Tamsulosin Hydrochloride Capsules  have not been evaluated.However, there is a potential for significant increase in Tamsulosin exposure when Tamsulosin Hydrochloride Capsules 0.4 mg is co-administered with a combination of both CYP3A4 and CYP2D6 inhibitors [see Warnings and Precautions (5.2) and Drug Interactions(7.1)].

Cimetidine

The effects of cimetidine at the highest recommended dose (400 mg every 6 hours for 6 days) on the pharmacokinetics of a single Tamsulosin Hydrochloride Capsules 0.4 mg dose was investigated in 10 healthy volunteers (age range 21 to 38 years). Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of Tamsulosin hydrochloride, which resulted in a moderate increase in Tamsulosin hydrochloride AUC (44%) [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

Other Alpha Adrenergic Blocking Agents

The pharmacokinetic and pharmacodynamic interactions between Tamsulosin Hydrochloride Capsules and other alpha adrenergic blocking agents have not been determined; however, interactions between Tamsulosin Hydrochloride Capsules and other alpha adrenergic blocking agents may be expected [see Warnings and Precautions (5.2) and Drug Interactions(7.2)].

PDE5 Inhibitors

Caution is advised when alpha adrenergic blocking agents, including Tamsulosin Hydrochloride Capsules, are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.2) and Drug Interactions (7.3)].

Warfarin

A definitive drug-drug interaction study between Tamsulosin hydrochloride and warfarin was not conducted. Results from limited in vitro and in vivo studies are inconclusive. Therefore, caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride Capsules [see Warnings and Precautions (5.2) and Drug Interactions (7.4)].

Nifedipine, Atenolol, Enalapril

In three studies in hypertensive subjects (age range 47 to 79 years) whose blood pressure was controlled with stable doses of nifedipine,atenolol, or enalapril for at least 3 months, Tamsulosin Hydrochloride Capsules 0.4 mg for 7 days followed by Tamsulosin Hydrochloride Capsules 0.8 mg for another 7 days (n=8 per study) resulted in no clinically significant effects on blood pressure and pulse rate compared to placebo (n=4 per study). Therefore, dosage adjustments are not necessary when Tamsulosin Hydrochloride Capsules are administered concomitantly with nifedipine,atenolol, or enalapril [see Drug Interactions(7.5)].

Digoxin and Theophylline

In two studies in healthy volunteers (n=10 per study; age range 19 to 39 years) receiving Tamsulosin Hydrochloride Capsules 0.4 mg/day for 2 days, followed by Tamsulosin Hydrochloride Capsules 0.8 mg/day for 5 to 8 days, single intravenous doses of digoxin 0.5 mg or theophylline 5 mg/kg resulted in no change in the pharmacokinetics of digoxin or theophylline. Therefore, dosage adjustments are not necessary when a Tamsulosin Hydrochloride Capsules  is administered concomitantly with digoxin or theophylline [see Drug Interactions(7.6)].

Furosemide

The pharmacokinetic and pharmacodynamic interaction between Tamsulosin Hydrochloride Capsules 0.8 mg/day (steady-state) and furosemide 20 mg intravenously (single dose) was evaluated in 10 healthy volunteers (age range 21 to 40 years). Tamsulosin Hydrochloride Capsules had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in Tamsulosin hydrochloride Cmax and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the Tamsulosin Hydrochloride Capsules dosage [see Drug Interactions (7.7)].

Tamsulosin Hydrochloride Capsules, USP 0.4 mg are supplied in high density polyethylene bottles containing 30, 60,100,500 and 1000 hard gelatin capsules and Alu-Alu blisters containing 100 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with “TAM” on cap & “0.4 mg” on body in black ink. Tamsulosin Hydrochloride Capsules, USP 0.4 mg,

Bottles of 30's:  NDC 67877-450-30

Bottles of 60's:  NDC 67877-450-60

Bottles of 100's:  NDC 67877-450-01

Bottles of 500's:  NDC 67877-450-05

Bottles of 1000's:  NDC 67877-450-10

Carton  of Blister pack (10 x 10's): NDC 67877-450-38

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep Tamsulosin Hydrochloride Capsules, USP and all medicines out of reach of children.

Tamsulosin Hydrochloride Capsules 0.4 mg
Read the Patient Information that comes with Tamsulosin Hydrochloride Capsules before you start taking it and each time you refill your prescription.

The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.
What is Tamsulosin Hydrochloride Capsules?

Tamsulosin Hydrochloride Capsules is a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition your doctor may refer to as an enlarged prostate.

• Tamsulosin Hydrochloride Capsules is not for women.
• Tamsulosin Hydrochloride Capsules is not for children.

Who should not take Tamsulosin Hydrochloride Capsules?
Do not take Tamsulosin Hydrochloride Capsules  if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Tamsulosin Hydrochloride Capsules.


What should I tell my doctor before using Tamsulosin Hydrochloride Capsules?
Before taking Tamsulosin Hydrochloride Capsules, tell your doctor about all your medical conditions, including:

• any kidney or liver problems.
• any history of low blood pressure.
• any allergies to sulfa or any other medicines.
• if you are planning to have cataract or glaucoma surgery.

Tell your doctor about all the medicines you take, including:

• any prescription medicines, including blood pressure medicines.
• any non-prescription medicines, including vitamins and herbal supplements.

Some of your other medicines may affect the way Tamsulosin Hydrochloride Capsules work. Especially tell your doctor if you take a medicine for high blood pressure. You should not take Tamsulosin Hydrochloride Capsules if you are already taking certain blood pressure medicines.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tamsulosin Hydrochloride Capsules?

• Take Tamsulosin Hydrochloride Capsules exactly as prescribed by your doctor.
• Do not crush, chew, or open Tamsulosin Hydrochloride Capsules.
• Take Tamsulosin Hydrochloride Capsules one time each day, about 30 minutes after the same meal each day. For example, you may take Tamsulosin Hydrochloride Capsules 30 minutes after dinner each day.
• If you miss a dose of Tamsulosin Hydrochloride Capsules, take it as soon as you remember. If you miss your dose for the whole day, continue with your next dose on your regular schedule. Do not take two doses at the same time.
• If you stop or forget to take Tamsulosin Hydrochloride Capsules for several days, talk with your doctor before starting again.
• If you take more Tamsulosin Hydrochloride Capsules than prescribed, call your doctor right away.

What are the possible side effects of Tamsulosin Hydrochloride Capsules?
Possible side effects of Tamsulosin Hydrochloride Capsules may include:

• Decreased blood pressure when changing positions. Tamsulosin Hydrochloride Capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses.

Symptoms may include:

• fainting
• dizziness
• lightheadedness

Change positions slowly from lying down to sitting up or from a sitting to a standing position until you learn how you react to Tamsulosin Hydrochloride Capsules. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms are severe or do not improve, call your doctor.

• Allergic reactions. Make your doctor aware of any allergic reactions you may experience while taking Tamsulosin Hydrochloride Capsules.

Allergic reactions may include:

• rash
• itching
• hives

Rare and more serious allergic reactions may also occur. Get medical help right away if you have any of the following reactions:

• swelling of face, tongue, or throat
• difficulty breathing
• blistering of the skin
• A painful erection that will not go away. Tamsulosin Hydrochloride Capsules can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.
• Eye problems during cataract  or glaucoma surgery. During cataract or glaucoma surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Tamsulosin Hydrochloride Capsules. If you need to have cataract or glaucoma surgery, be sure to tell your surgeon if you take or have taken Tamsulosin Hydrochloride Capsules.

Common side effects of Tamsulosin Hydrochloride Capsules may include:

• runny nose
• dizziness
• decreased semen

These are not all the possible side effects with Tamsulosin Hydrochloride Capsules. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

What should I avoid while taking Tamsulosin Hydrochloride Capsules?

Avoid driving, operating machinery, or other dangerous activities, until you know how Tamsulosin Hydrochloride Capsules affects you. Tamsulosin Hydrochloride Capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. See "What are the possible side effects of Tamsulosin Hydrochloride Capsules?"

How do I store Tamsulosin Hydrochloride Capsules?

Store Tamsulosin Hydrochloride Capsules at Room Temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules.

Keep Tamsulosin Hydrochloride Capsules and all medicines out of the reach of children.

General information

This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. Do not give Tamsulosin Hydrochloride Capsules to other people, even if they have the same symptoms that you have. It may harm them.

While taking Tamsulosin Hydrochloride Capsules, you must have regular checkups. Follow your doctor's advice about when to have these checkups.

BPH can occur with other more serious conditions, including prostate cancer. Therefore, ask your doctor about screening for prostate cancer prior to treatment with Tamsulosin Hydrochloride Capsules and at regular intervals afterwards.

This patient information leaflet summarizes the most important information about Tamsulosin Hydrochloride Capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Tamsulosin Hydrochloride Capsules that is written for health professionals. For more information call Ascend Laboratories LLC at 1-877-ASC-RX01 (877-272-7901).

What are the ingredients in Tamsulosin Hydrochloride Capsules?

• Active Ingredient: Tamsulosin hydrochloride
• Inactive Ingredients: microcrystalline cellulose, Eudragit L30D-55 dispersion, hypromellose, triacetin ,calcium stearate, talc,iron oxide red,iron oxide yellow,FD&C blue 2,titanium dioxide,gelatin and trace amounts of black edible ink (containing:shellac,dehydrated alcohol,isopropyl alcohol,butyl alcohol,propylene glycol,strong ammonia solution,black iron oxide and potassium hydroxide).

Manufactured by:

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 0705

Revised: December 2016

PT 2257-02 

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
30 Capsules
NDC 67877-450-30

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
60 Capsules
NDC 67877-450-60

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
100 Capsules
NDC 67877-450-01

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
500 Capsules
NDC 67877-450-05

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
1000 Capsules
NDC 67887-450-10

Tamsulosin Hydrochloride Capsules, USP 0.4 mg
100 Capsules (10 x 10's Blister Packs)
NDC 67877-450-38

Concerns related to adverse effects:

• Angina: Discontinue if symptoms of angina occur or worsen.

• Floppy iris syndrome: Intraoperative floppy iris syndrome (IFIS) is characterized by a combination of flaccid iris that billows with intraoperative currents, progressive intraoperative miosis despite dilation, and potential iris prolapse. IFIS has been observed in cataract and glaucoma surgery patients who were on or were previously treated with alpha1-blockers, particularly with tamsulosin use (Abdel-Aziz, 2009); in some cases, patients had discontinued the alpha1-blocker 5 weeks to 9 months prior to the surgery. The benefit of discontinuing alpha-blocker therapy prior to cataract or glaucoma surgery has not been established. IFIS may increase the risk of ocular complications during and after surgery. May require modifications to surgical technique; instruct patients to inform ophthalmologist of current or previous alpha1-blocker use when considering eye surgery. Initiation of tamsulosin therapy in patients with planned cataract or glaucoma surgery is not recommended.

• Orthostatic hypotension/syncope: May cause significant orthostatic hypotension and syncope, especially with first dose; anticipate a similar effect if therapy is interrupted for a few days, if dosage is rapidly increased, or if another antihypertensive drug (particularly vasodilators) or a PDE-5 inhibitor (eg, sildenafil, tadalafil, vardenafil) is introduced. “First-dose” orthostatic hypotension may occur 4-8 hours after dosing; may be dose related. Patients should be cautioned about performing hazardous tasks, driving, or operating heavy machinery when starting new therapy or adjusting dosage upward.

• Priapism: Priapism has been associated with use (rarely).

• Sulfonamide allergy: Rarely, patients with a sulfa allergy have also developed an allergic reaction to tamsulosin; avoid use when previous reaction has been severe or life-threatening.

Disease-related concerns:

• Heart failure: In a scientific statement from the American Heart Association, tamsulosin has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]).

• Prostate cancer: It is recommended to rule out prostatic carcinoma with screening before beginning therapy and then screen at regular intervals.

Concurrent drug therapy issues:

• Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Limitation of use: Not intended for use as an antihypertensive drug.

Blood pressure; urinary symptoms

Tamsulosin (Flomax) is an alpha-blocker that relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Tamsulosin is not approved for use in women or children.

Data not available

• Administer at the same time each day, half an hour after the same meal (for example, half an hour after breakfast). Take exactly as directed by your doctor. Do not increase or decrease the dosage without his or her advice.
• Do not crush, chew or open tamsulosin capsules.
• If, for any reason, you need to stop taking tamsulosin capsules for a few days, you should restart therapy with the 0.4mg dose, even if you have been taking the 0.8mg dose. Talk to your doctor about this.
• Stand up slowly when going from a sitting or lying down position. Tamsulosin may cause a drop in blood pressure which may cause symptoms such as dizziness and increase your risk of falls. Remove any fall hazards in your home (such as rugs) and talk to your doctor if you are experiencing severe dizziness every time you stand up.
• Do not drive or operate machinery if tamsulosin makes you dizzy or impairs your judgment. Alcohol may enhance this effect and is best avoided.
• Seek urgent medical advice if you develop any symptoms of an allergic reaction such as swelling of face, tongue, or throat; difficulty breathing; or a skin rash.
• It is not uncommon for prostate cancer to coexist with BPH. Talk to your doctor about screening for prostate cancer.
• Talk to your doctor or pharmacist before taking any other medications while you are taking tamsulosin.