Tamsulosin

{{DrugProjectFormSinglePage |authorTag=

Vignesh Ponnusamy, M.B.B.S. [1]

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an

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alpha1 adrenoceptor antagonist

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benign prostatic hyperplasia

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headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision

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• Content

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Benign Prostatic Hyperplasia (BPH)

• FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. FLOMAX capsules should not be crushed, chewed or opened.

• For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].

• If FLOMAX capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

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Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tamsulosin in adult patients.

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Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tamsulosin in adult patients.

|fdaLIADPed=

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Tamsulosin in pediatric patients.

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Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tamsulosin in pediatric patients.

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Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tamsulosin in pediatric patients.

|contraindications=

• FLOMAX capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of FLOMAX capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)].

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Precautions

• Orthostasis

• The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in FLOMAX capsule-treated patients than in placebo recipients. As with other alpha adrenergic blocking agents there is a potential risk of syncope [see Adverse Reactions (6.1)]. Patients beginning treatment with FLOMAX capsules should be cautioned to avoid situations in which injury could result should syncope occur.

• Drug Interactions

• Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. FLOMAX capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
• FLOMAX capsules should be used with caution in combination with cimetidine, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
• FLOMAX capsules should not be used in combination with other alpha adrenergic blocking agents [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
• Caution is advised when alpha adrenergic blocking agents including FLOMAX 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 Drug Interactions (7.3) and Clinical Pharmacology (12.3)].
• Caution should be exercised with concomitant administration of warfarin and FLOMAX capsules [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)].

• Priapism

• Rarely (probably less than 1 in 50,000 patients), tamsulosin, like other alpha1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.

• Screening for Prostate Cancer

• Prostate cancer and BPH frequently co-exist; therefore, patients should be screened for the presence of prostate cancer prior to treatment with FLOMAX capsules and at regular intervals afterwards.

• Intraoperative Floppy Iris Syndrome

• Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients on or previously treated with alpha1 blockers, including FLOMAX capsules [see Adverse Reactions (6.2)].
• Most reports were in patients taking the alpha1 blocker when IFIS occurred, but in some cases, the alpha1 blocker had been stopped prior to surgery. In most of these cases, the alpha1 blocker had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patient had been off the alpha1 blocker for a longer period (5 weeks to 9 months). IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.
• IFIS may increase the risk of eye complications during and after the operation. The benefit of stopping alpha1 blocker therapy prior to cataract or glaucoma surgery has not been established. The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended.

• Sulfa Allergy

• In patients with sulfa allergy, allergic reaction to FLOMAX capsules has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering FLOMAX capsules.

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• Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

• The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg FLOMAX capsules were used. These studies evaluated safety in 1783 patients treated with FLOMAX capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either FLOMAX capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men.

T1

• Signs and Symptoms of Orthostasis

• In the two U.S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and by no patients in the placebo group. Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and 0.6% of patients (3 of 493) in the placebo group. Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group, and 10% of patients (50 of 493) in the placebo group. Vertigo was reported by 0.6% of patients (3 of 502) in the 0.4 mg group, 1% of patients (5 of 492) in the 0.8 mg group, and by 0.6% of patients (3 of 493) in the placebo group.
• Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met one or more of the following criteria: (1) a decrease in systolic blood pressure of ≥20 mmHg upon standing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure ≥10 mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test; (3) an increase in pulse rate of ≥20 bpm upon standing with a standing pulse rate ≥100 bpm during the orthostatic test; and (4) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test.
• Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of 498) who received FLOMAX capsules 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. At 8 hours post-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received FLOMAX capsules 0.4 mg once daily and 4% (9 of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the first week of Study 1).
• In Studies 1 and 2, at least one positive orthostatic test result was observed during the course of these studies for 81 of the 502 patients (16%) in the FLOMAX capsules 0.4 mg once-daily group, 92 of the 491 patients (19%) in the FLOMAX capsules 0.8 mg once-daily group, and 54 of the 493 patients (11%) in the placebo group.
• Because orthostasis was detected more frequently in FLOMAX capsule-treated patients than in placebo recipients, there is a potential risk of syncope [see Warnings and Precautions (5.1)].

• Abnormal Ejaculation

• Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease. As shown in Table 1, abnormal ejaculation was associated with FLOMAX capsules administration and was dose-related in the U.S. studies. Withdrawal from these clinical studies of FLOMAX capsules because of abnormal ejaculation was also dose-dependent, with 8 of 492 patients (1.6%) in the 0.8 mg group and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation.

• Laboratory Tests

• No laboratory test interactions with FLOMAX capsules are known. Treatment with FLOMAX capsules for up to 12 months had no significant effect on prostate-specific antigen (PSA).

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• The following adverse reactions have been identified during post-approval use of FLOMAX capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to FLOMAX capsules.

• Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema, and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of dyspnea, palpitations, hypotension, atrial fibrillation, arrhythmia, tachycardia, skin desquamation including reports of Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative, constipation, vomiting, dry mouth, visual impairment, and epistaxis have been received during the postmarketing period.

• During cataract and glaucoma surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha1 blocker therapy.

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• Cytochrome P450 Inhibition

• Strong and Moderate Inhibitors of CYP3A4 or CYP2D6
• Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
• Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) 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 FLOMAX have not been evaluated [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].
• Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) 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 Clinical Pharmacology (12.3)]. A similar increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when FLOMAX 0.4 mg is co-administered with strong CYP3A4 inhibitors in CYP2D6 PMs, FLOMAX 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 Clinical Pharmacology (12.3)].
• The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of FLOMAX have not been evaluated [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].
• The effects of co-administration of both a CYP3A4 and a CYP2D6 inhibitor with FLOMAX capsules have not been evaluated. However, there is a potential for significant increase in tamsulosin exposure when FLOMAX 0.4 mg is co-administered with a combination of both CYP3A4 and CYP2D6 inhibitors [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

• Cimetidine

• 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 Clinical Pharmacology (12.3)].

• Other Alpha Adrenergic Blocking Agents

• The pharmacokinetic and pharmacodynamic interactions between FLOMAX capsules and other alpha adrenergic blocking agents have not been determined; however, interactions between FLOMAX capsules and other alpha adrenergic blocking agents may be expected [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

• PDE5 Inhibitors

• Caution is advised when alpha adrenergic blocking agents including FLOMAX 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 Clinical Pharmacology (12.3)].

• 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. Caution should be exercised with concomitant administration of warfarin and FLOMAX capsules [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

• Nifedipine, Atenolol, Enalapril

• Dosage adjustments are not necessary when FLOMAX capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3)].

• Digoxin and Theophylline

• Dosage adjustments are not necessary when a FLOMAX capsule is administered concomitantly with digoxin or theophylline [see Clinical Pharmacology (12.3)].

• Furosemide

• FLOMAX 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 FLOMAX capsules dosage [see Clinical Pharmacology (12.3)].

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• 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. FLOMAX capsules are not indicated for use in women.

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• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tamsulosin in women who are pregnant.

|useInLaborDelivery= There is no FDA guidance on use of Tamsulosin during labor and delivery.

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• FLOMAX capsules are not indicated for use in women.

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• FLOMAX 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.

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• 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)].

|useInGender= There is no FDA guidance on the use of Tamsulosin with respect to specific gender populations.

|useInRace= There is no FDA guidance on the use of Tamsulosin with respect to specific racial populations.

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• Patients with renal impairment do not require an adjustment in FLOMAX capsules dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m2) have not been studied.

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• Patients with moderate hepatic impairment do not require an adjustment in FLOMAX capsules dosage. FLOMAX has not been studied in patients with severe hepatic impairment.

|useInReproPotential= There is no FDA guidance on the use of Tamsulosin in women of reproductive potentials and males.

|useInImmunocomp= There is no FDA guidance one the use of Tamsulosin in patients who are immunocompromised.

|administration=

• Oral

|monitoring=

There is limited information regarding Monitoring of Tamsulosin in the drug label.

|IVCompat=

There is limited information regarding IV Compatibility of Tamsulosin in the drug label.

|overdose=

Acute Overdose

• Should overdosage of FLOMAX capsules lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

Chronic Overdose

There is limited information regarding Chronic Overdose of Tamsulosin in the drug label.

|drugBox=

{{Drugbox2 | verifiedrevid = 461746753 | IUPAC_name = (R)-5-(2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl)-2-methoxybenzene-1-sulfonamide | image = Tamsulosin00.png | width = 250 | image2 = Tamsulosin000.png | tradename = Flomax | Drugs.com = Monograph | MedlinePlus = a698012 | licence_US = Tamsulosin | pregnancy_AU = B2 | pregnancy_US = B | legal_AU = S4 | legal_UK = POM | legal_US = Rx-only | routes_of_administration = oral

| bioavailability = 100% (oral) | metabolism = hepatic | elimination_half-life = 9–13 hours | excretion = 76% renal

| CASNo_Ref =  ^Y | CAS_number_Ref =  ^Y | CAS_number = 106133-20-4 | ATC_prefix = G04 | ATC_suffix = CA02 | PubChem = 129211 | IUPHAR_ligand = 488 | DrugBank_Ref =  ^Y

| DrugBank = DB00706

| ChemSpiderID_Ref =  ^Y | ChemSpiderID = 114457 | UNII_Ref =  ^Y | UNII = G3P28OML5I | KEGG_Ref =  ^Y | KEGG = D08560 | ChEBI_Ref =  ^Y | ChEBI = 9398 | ChEMBL_Ref =  ^Y | ChEMBL = 836

| C=20 | H=28 | N=2 | O=5 | S=1 | molecular_weight = 408.51 | smiles = CCOc1ccccc1OCCN[C@@H](C)Cc1ccc(OC)c(c1)S(=O)(=O)N | StdInChI_Ref =  ^Y | StdInChI = 1S/C20H28N2O5S/c1-4-26-17-7-5-6-8-18(17)27-12-11-22-15(2)13-16-9-10-19(25-3)20(14-16)28(21,23)24/h5-10,14-15,22H,4,11-13H2,1-3H3,(H2,21,23,24)/t15-/m1/s1 | StdInChIKey_Ref =  ^Y | StdInChIKey = DRHKJLXJIQTDTD-OAHLLOKOSA-N }}

|mechAction=

• 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.

• FLOMAX capsules are not intended for use as an antihypertensive drug.

|structure=

• Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.

• Tamsulosin hydrochloride is (-)-(R)-5-[2-[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether.

• The empirical formula of tamsulosin hydrochloride is C20H28N2O5S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:

This image is provided by the National Library of Medicine.

• Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid copolymer dispersion, talc, polysorbate 80, sodium lauryl sulfate, colloidal silicon dioxide, gelatin, titanium dioxide, FD&C blue No. 2, iron oxide, propylene glycol, and shellac.

|PD=

There is limited information regarding Pharmacodynamics of Tamsulosin in the drug label.

|PK=

There is limited information regarding Pharmacokinetics of Tamsulosin in the drug label.

|nonClinToxic=

There is limited information regarding Nonclinical Toxicology of Tamsulosin in the drug label.

|clinicalStudies=

There is limited information regarding Clinical Studies of Tamsulosin in the drug label.

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|fdaPatientInfo=

There is limited information regarding Patient Counseling Information of Tamsulosin in the drug label.

|alcohol=

• Alcohol-Tamsulosin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

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• ®

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• A® — B®

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