Your activity: 7536 p.v.
< Back
your limit has been reached. plz Donate us to allow your ip full access, Email: [email protected]

Tamsulosin: Drug information

Tamsulosin: Drug information
(For additional information see "Tamsulosin: Patient drug information" and see "Tamsulosin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Flomax
Brand Names: Canada
  • APO-Tamsulosin CR;
  • Flomax CR;
  • RATIO-Tamsulosin [DSC];
  • SANDOZ Tamsulosin;
  • SANDOZ Tamsulosin CR;
  • TEVA-Tamsulosin CR;
  • TEVA-Tamsulosin [DSC]
Pharmacologic Category
  • Alpha 1 Blocker
Dosing: Adult

Note: Tamsulosin capsules should be administered ~30 minutes following the same meal each day. The controlled-release (oral controlled absorption system [OCAS]) tablet formulation [Canadian product] should be administered at the same time each day with or without food.

Benign prostatic hyperplasia

Benign prostatic hyperplasia (monotherapy or combination therapy):

Note : In patients with moderate to severe predominant storage lower urinary tract symptoms, use in combination with beta-3 agonist or anticholinergic agent. In patients with a significantly enlarged prostate (prostate volume >30 mL, prostate-specific antigen >1.5 ng/dL, or palpable prostate enlargement on digital rectal exam), use in combination with 5-alpha reductase inhibitor (AUA [Lerner 2021]).

Oral:

Capsule: Initial and maintenance: 0.4 mg once daily. If response is inadequate after 2 to 4 weeks, may increase to 0.8 mg once daily. If therapy is discontinued or interrupted for several days, restart with 0.4 mg once daily.

Controlled-release tablet [Canadian product]: Initial and maximum dose: 0.4 mg once daily.

Chronic prostatitis/chronic pelvic pain syndrome in males

Chronic prostatitis/chronic pelvic pain syndrome in males (off-label use): Oral: Initial: 0.4 mg once daily for 6 weeks as part of an appropriate combination regimen (Pontari 2020; Thakkinstian 2012). If response to initial therapy is inadequate, referral to a urologist is recommended (Anothaisintawee 2011; Nickel 2012; Pontari 2020).

Lower urinary tract symptoms in males

Lower urinary tract symptoms in males (off-label use): Bladder outlet obstruction and low postvoid residual: Oral: Initial: 0.4 mg once daily; may combine with an anticholinergic agent if symptoms of overactive bladder persist (Athanasopoulos 2003; Dimitropoulos 2015; Drake 2015; Van Kerrebroeck 2013).

Ureteral calculi expulsion

Ureteral calculi expulsion (off-label use):

Medical expulsive therapy for distal (lower) ureteral calculi to facilitate spontaneous stone passage: Stones >5 and ≤10 mm: Oral: 0.4 mg once daily until stone passage occurs or for up to 4 weeks (Ahmed 2010; Campschroer 2014; Hollingsworth 2016; Ye 2017).

Adjunctive therapy following shock wave lithotripsy to facilitate clearance of residual stones: Oral: 0.4 mg once daily; initiate therapy immediately after extracorporeal shock wave lithotripsy; duration of therapy in trials ranged from 14 days to 3 months (Agrawal 2009; Chen 2015; Falahatkar 2011; Vicentini 2011).

Ureteral stent-related urinary symptoms, treatment

Ureteral stent-related urinary symptoms, treatment (off-label use): Oral: 0.4 mg once daily; treatment was initiated following stent placement and duration of therapy in trials ranged from 1 to 6 weeks (Damiano 2008; Wang 2009a; Wang 2009b; Yakoubi 2011); may also be given in combination with an anticholinergic agent (Dellis 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl ≥10 mL/minute: No dosage adjustment necessary (Koiso 1996; Miyazawa 2001; Wolzt 1998; manufacturer’s labeling).

CrCl <10 mL/minute: No dosage adjustment likely to be necessary (has not been studied); use with caution (expert opinion).

Hemodialysis, intermittent (thrice weekly): Unlikely to be dialyzed (highly protein bound): No dosage adjustment likely to be necessary (has not been studied); use with caution (expert opinion).

Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment likely to be necessary (has not been studied); use with caution (expert opinion).

Dosing: Hepatic Impairment: Adult

Mild-to-moderate impairment: No dosage adjustment is necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Pediatric

(For additional information see "Tamsulosin: Pediatric drug information")

Nephrolithiasis, distal stones: Limited data available; optimal dose not established (Mokhless 2012; Tasian 2014):

Children 2 to 4 years: Oral: 0.2 or 0.4 mg once daily at bedtime

Children >4 years and Adolescents: Oral: 0.4 mg once daily at bedtime

Dosing based on two studies. The larger was a multi-institutional retrospective cohort study of pediatric patients with stones up to 10 mm; patients received either tamsulosin 0.4 mg once daily (n=99, median age: 14.8 years) or analgesics alone (n=175). Spontaneous stone passage was higher in the treatment group (55% vs 44%, p=0.03); treatment group was older and had smaller, more distal stones. When adjusted for stone size and location as part of analysis of 99 case matched pairs, success was also higher in the treatment group (OR 3.31, 95% CI: 1.49 to 7.34) (Tasian 2014). The smaller study was a prospective, randomized controlled trial of pediatric patients with stones up to 12 mm; patients received either tamsulosin 0.4 mg once daily (0.2 mg if ≤4 years old) (n=33, age: 2 to 15 years) or placebo (n=28). In this study, 45% of the treatment group had previously received either extracorporeal shock wave lithotripsy (ESWL) or percutaneous nephrolithotomy, but none in the control group had received these therapies; however, stone size at the start of treatment was similar between groups. Treatment resulted in higher expulsion rate (87.8% vs 64.2%, p<0.01), less days to expulsion (mean: 8.2 vs 14.5 days, p<0.001), less pain episodes (mean: 1.4 vs 2.2, p<0.02) and less need for analgesia (mean: 0.7 vs 1.4, p<0.02) (Mokhless 2012). In both studies, tamsulosin was well tolerated and there were no reported adverse effects.

Primary bladder neck dysfunction: Limited data available: Children ≥3 years and Adolescents: Oral: Initial dose: 0.2 mg once daily, increase by 0.2 mg increments based on response (symptoms and urodynamic studies) and tolerability. Mean effective dose: 0.4 mg daily; maximum reported daily dose: 0.8 mg/day. Dosing based on two trials evaluating treatment with alpha blockers, including over 50 pediatric patients who received tamsulosin. Treatment resulted in improved urine flow rates and decreased post-void residual urine volume; values returned to pretreatment levels when therapy was discontinued. Tamsulosin was well tolerated with no major adverse effects and benefits continued for at least 3 years (Donohoe 2005; Van Batavia 2010).

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific recommendations. Based on experience in adult male patients with CrCl ≥10 mL/minute, data suggest no adjustment needed; for more severe renal impairment, use has not been studied.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations. Based on experience in adult male patients with mild to moderate hepatic impairment, data suggest no adjustment needed; for more severe hepatic impairment, use has not been studied.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Flomax: 0.4 mg [contains fd&c blue #2 (indigotine)]

Generic: 0.4 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral:

Generic: 0.4 mg

Tablet Extended Release 24 Hour, Oral:

Flomax CR: 0.4 mg

Generic: 0.4 mg

Administration: Adult

Oral: Administer capsules 30 minutes after the same mealtime each day. Capsules should be swallowed whole; do not crush, chew, or open. The controlled-release tablet [Canadian product] should be administered at the same time each day with or without food, and should be swallowed whole.

Administration: Pediatric

Oral: Per the manufacturer, capsules should be swallowed whole; do not crush, chew, or open. In pediatric trials, capsules were opened and the contents mixed with food (eg, yogurt or pudding) or juice (Donohoe 2005; Tasian 2014).

Use: Labeled Indications

Benign prostatic hyperplasia: Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Limitations of use: Not indicated for the treatment of hypertension.

Use: Off-Label: Adult

Chronic prostatitis/chronic pelvic pain syndrome in males; Lower urinary tract symptoms in males; Ureteral calculi expulsion; Ureteral stent-related urinary symptoms, treatment

Medication Safety Issues
Sound-alike/look-alike issues:

Flomax may be confused with Flonase, Flovent, Foltx, Fosamax

Tamsulosin may be confused with tacrolimus, tamoxifen, terazosin

International issues:

Flomax [US, Canada, and multiple international markets] may be confused with Flomox brand name for cefcapene [Japan]; Volmax brand name for salbutamol [multiple international markets]

Flomax: Brand name for tamsulosin [US, Canada, and multiple international markets], but also the brand name for morniflumate [Italy]

Adverse Reactions (Significant): Considerations
Floppy iris syndrome

Intraoperative floppy iris syndrome has been reported in patients with current or prior use of alpha-1 blockers, particularly tamsulosin, undergoing cataract or glaucoma surgery (Ref).

Mechanism: Unclear; may be related to a combination of the pharmacologic action (ie, inhibition of the iris dilator smooth muscle contraction) and long-term smooth muscle atrophy from accumulation in iris pigment epithelial cells (Ref).

Onset: Varied; may occur with current (within a few weeks of initiation) or prior use (years following discontinuation) (Ref).

Risk factors:

• Individual alpha-1 blocker (particularly tamsulosin) (Ref).

• Hypertension may be an independent risk factor (Ref).

Orthostatic hypotension

Use may cause orthostatic hypotension, dizziness, and vertigo.

Mechanism: Dose-related; related to the pharmacologic action (ie, inhibition of vascular smooth muscle contraction) (Ref).

Onset: Rapid; “first dose” orthostatic hypotension may occur 4 to 8 hours after dose.

Risk factors:

• Individual alpha-1 blocker (tamsulosin among lowest risk) (Ref)

• First dose or restart after dose interruption (Ref)

• Rapid increase in dose

• Concomitant antihypertensives (especially vasodilators) (Ref)

• Concomitant phosphodiesterase-5 inhibitors (eg, sildenafil)

• Alcohol use (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Orthostatic hypotension (by orthostatic testing: first dose: 6% to 7% [placebo: 3% to 4%], chronic use: 16% to 19% [placebo: 11%]; symptomatic: <1% [placebo: 0%])

Genitourinary: Ejaculation failure (8% to 18%)

Infection: Infection (9% to 11%)

Nervous system: Dizziness (15% to 17% [placebo: 10%]), headache (19% to 21%)

Respiratory: Rhinitis (13% to 18%)

1% to 10%:

Endocrine & metabolic: Decreased libido (2%)

Gastrointestinal: Diarrhea (6%), nausea (4%)

Nervous system: Drowsiness (3% to 4%), insomnia (1% to 2%), vertigo (1% [placebo: 0.6%])

Neuromuscular & skeletal: Asthenia (8% to 9%), back pain (7% to 8%)

Ophthalmic: Blurred vision (≤2%)

Respiratory: Increased cough (3% to 5%), pharyngitis (6%), sinusitis (4%)

Postmarketing:

Cardiovascular: Atrial fibrillation, tachycardia

Dermatologic: Contact dermatitis (Lijnen 2003), erythema multiforme (Hu 2019), exfoliative dermatitis, skin photosensitivity (Tan 2018), Stevens-Johnson syndrome

Gastrointestinal: Constipation, vomiting, xerostomia

Genitourinary: Priapism (Marconi 2019)

Hypersensitivity: Angioedema, fixed drug eruption (Montazer 2020)

Ophthalmic: Choroidal detachment (Kerimoglu 2010), intraoperative floppy iris syndrome (in patients undergoing cataract or glaucoma surgery) (Keklikci 2009)

Respiratory: Dyspnea, epistaxis

Contraindications

Hypersensitivity (eg, angioedema, rash, urticaria, pruritus, respiratory symptoms) to tamsulosin or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with strong CYP3A4 inhibitors (including ketoconazole)

Warnings/Precautions

Concerns related to adverse effects:

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

• 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]).

Warnings: Additional Pediatric Considerations

Tamsulosin has been well tolerated in pediatric patients during trials when used for management of nephrolithiasis and primary bladder neck dysfunction (Donohoe 2005; Mokhless 2012; Tasian 2014; Van Batavia 2010). Studies using tamsulosin for the management of elevated detrusor leak point pressure in pediatric patients (ages 2 to 16 years) with a known neurological disorder (eg, spina bifida) failed to show efficacy.

Metabolism/Transport Effects

Substrate of CYP2D6 (major), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Alpha-/Beta-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Alpha1-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Risk X: Avoid combination

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta-Blockers: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Risk C: Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Calcium Channel Blockers: Alpha1-Blockers may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tamsulosin. Risk X: Avoid combination

Dapoxetine: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: Alpha1-Blockers (Uroselective) may enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Rilmenidine: Alpha1-Blockers may enhance the hypotensive effect of Rilmenidine. Risk C: Monitor therapy

Food Interactions

Capsules: Fasting increases bioavailability by 30% and peak concentration 40% to 70%. Management: Administer 30 minutes after the same meal each day. Note: The controlled-release tablet formulation [Canadian product] is not affected by food and can be taken with or without food at the same time each day.

Reproductive Considerations

Ejaculation failure, ejaculation disorder, retrograde ejaculation, and decreased ejaculation has been associated with use of tamsulosin.

Pregnancy Considerations

Information related to the use of tamsulosin for ureteral calculi expulsion in pregnancy is limited (Bailey 2016; Theriault 2020). Other treatments such as stents or ureteroscopy, are currently recommended if stone removal is needed (AUA/ES [Assimos 2016]; EAU [Türk 2019]; Lloyd 2016).

Breastfeeding Considerations

It is not known if tamsulosin is present in breast milk.

Monitoring Parameters

International Prostate Symptom Score (baseline and 4 to 12 weeks after treatment initiation); urinalysis (baseline); BP; prostate cancer screening prior to initiation and then as directed; mental alertness; objective and subjective signs of relief of benign prostatic hyperplasia and lower urinary tract symptoms (AUA [Lerner 2021]; manufacturer’s labeling).

Mechanism of Action

Tamsulosin is an antagonist of alpha1A-adrenoreceptors in the prostate. Smooth muscle tone in the prostate is mediated by alpha1A-adrenoreceptors; blocking them leads to relaxation of smooth muscle in the bladder neck and prostate causing an improvement of urine flow and decreased symptoms of BPH. Approximately 75% of the alpha1-receptors in the prostate are of the alpha1A subtype.

Pharmacokinetics

Note: Pharmacokinetics in pediatric patients (ages 2 to 16 years) were found to be similar to adult values (Tsuda 2010).

Absorption: >90%

Distribution: Vd: 16 L

Protein binding: 94% to 99%, primarily to alpha-1 acid glycoprotein (AAG)

Metabolism: Hepatic (extensive) via CYP3A4 and 2D6; metabolites undergo extensive conjugation to glucuronide or sulfate

Bioavailability: Fasting: 30% increase

Steady-state: By the fifth day of once-daily dosing

Half-life elimination: Healthy volunteers: 9 to 13 hours; Target population: 14 to 15 hours

Time to peak: Fasting: 4 to 5 hours; With food: 6 to 7 hours

Excretion: Urine (76%, <10% as unchanged drug); feces (21%)

Pharmacokinetics: Additional Considerations

Geriatric: AUC is 40% higher in subjects 55 to 75 years of age compared with subjects 20 to 32 years of age.

Pricing: US

Capsules (Flomax Oral)

0.4 mg (per each): $11.12

Capsules (Tamsulosin HCl Oral)

0.4 mg (per each): $4.20 - $4.22

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Adenorm (UA);
  • Alna (AT, DE);
  • Bazetham (HR);
  • Bestflo (LK);
  • Comadex (EC);
  • Contiflo OD (QA, ZW);
  • Curepro XR (EG);
  • Expros (FI);
  • Eziflo (BD);
  • Flectone XL (GB);
  • Flomax (BB, TR, ZA);
  • Flomaxtra (AU);
  • Flomaxtra XL (GB);
  • Flosin (LV, UA);
  • Flosure (LK);
  • Fokusin (LV, RO);
  • Gotam (IN);
  • Harnal (CN, HK, ID, JP, MY, SG, TH);
  • Harnal D (PH);
  • Harnal OCAS (PH, VN);
  • Harnalidge D (TW);
  • Harusin SR (KR);
  • Inreq (ES);
  • Josir (FR);
  • Kirnom (IE);
  • Libert (CR, DO, GT, HN, NI, PA, SV);
  • Losiprost (EG);
  • Lostam (EC);
  • Lutsnal (KR);
  • Maxflow (LK);
  • Maxrin (LK);
  • Mecir (FR);
  • Mingo (LB);
  • Omexel (FR);
  • Omic (BE, LU);
  • Omix Ocas (CH);
  • Omnexel (IE);
  • Omnic (AE, AR, BH, BR, CL, CO, CZ, DE, DK, EE, EG, ES, FI, GR, HR, HU, IL, IS, IT, JO, KW, LT, MT, NL, NO, PE, PL, PT, QA, RO, RU, SA, SI, SK, UA);
  • Omnic OCAS (CY, EG, KW, LB, QA, SA);
  • Omnic Tocas (BG);
  • Omnistad (DK);
  • Omsal (LV, ZA);
  • Palnac (JP);
  • Petyme (GB);
  • Pimax (PH);
  • Pinexel PR (MT);
  • Promnix (IL);
  • Prosta-Tab PR (BH);
  • Protam (NL);
  • Prozelax (PH);
  • Ranomax (BE);
  • Sasolin (BD);
  • Sebrane (ES);
  • Secotex (AR, BR, CL, CO, CR, DO, GT, HN, MX, NI, PA, PE, PY, SV, UY, VE);
  • Secotex OCAS (CR, DO, EC, GT, HN, NI, PA, SV);
  • Sulosin (KR);
  • Sultam (PH);
  • Tabphyn MR (GB);
  • Talusin (LB);
  • Taluso (NL);
  • Tamic (EG);
  • Tamlosin (TW);
  • Tamlosin SR (KR);
  • Tamnexyl (IE);
  • Tamnic (IE);
  • Tamodof (VN);
  • Tamsin (LK);
  • Tamsnal SR (KR);
  • Tamsol (BD);
  • Tamsu (IE);
  • Tamsul (ZA);
  • Tamsulid (UA);
  • Tamsulin (IL, KW);
  • Tamsulo (KR);
  • Tamsulon (CR, DO, EC, GT, HN, NI, PA, SV);
  • Tamsustad (HK, VN);
  • Tamunal (KR);
  • Tarunal (KR);
  • Urilax (PH);
  • Urimax (IN, PH, VE);
  • Urnal (TW);
  • Uroflo (BD);
  • Uroflow (TH);
  • Urostad (LV);
  • Urotams SR (KR);
  • Xalgetz (VN);
  • Zotan (TW);
  • Zuantrip (ES)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Abdel-Aziz S, Mamalis N. Intraoperative floppy iris syndrome. Curr Opin Ophthalmol. 2009;20(1):37-41. doi:10.1097/ICU.0b013e32831bc0ad [PubMed 19077827]
  2. Agrawal M, Gupta M, Gupta A, Agrawal A, Sarkari A, Lavania P. Prospective randomized trial comparing efficacy of alfuzosin and tamsulosin in management of lower ureteral stones. Urology. 2009;73(4):706-709. doi:10.1016/j.urology.2008.11.013 [PubMed 19193417]
  3. Ahmed AF, Al-Sayed AY. Tamsulosin versus alfuzosin in the treatment of patients with distal ureteral stones: Prospective, randomized, comparative study. Korean J Urol. 2010;51(3):193-197. doi:10.4111/kju.2010.51.3.193. [PubMed 20414396]
  4. Anothaisintawee T, Attia J, Nickel JC, et al. Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA. 2011;305(1):78-86. doi:10.1001/jama.2010.1913 [PubMed 21205969]
  5. Assimos D, Krambeck A, Miller NL, et al. Surgical management of stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016;196(4):1153-1160. doi:10.1016/j.juro.2016.05.090 [PubMed 27238616]
  6. Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003;169(6):2253-2256. doi:10.1097/01.ju.0000067541.73285.eb [PubMed 12771763]
  7. Bailey G, Vaughan L, Rose C, et al. Perinatal outcomes with tamsulosin therapy for symptomatic urolithiasis. J Urol. 2016;195(1):99-103. doi:10.1016/j.juro.2015.06.097. [PubMed 26144335]
  8. Campschroer T, Zhu Y, Duijvesz D, Grobbee DE, Lock MT. Alpha-blockers as medical expulsive therapy for ureteral stones. Cochrane Database Syst Rev. 2014;(4):CD008509. doi:10.1002/14651858.CD008509.pub2 [PubMed 24691989]
  9. Campschroer T, Zhu X, Vernooij RW, Lock MT. Alpha-blockers as medical expulsive therapy for ureteral stones. Cochrane Database Syst Rev. 2018;4:CD008509. doi:10.1002/14651858.CD008509.pub3 [PubMed 29620795]
  10. Chen K, Mi H, Xu G, et al. The efficacy and safety of tamsulosin combined with extracorporeal shockwave lithotripsy for urolithiasis: A systematic review and meta-analysis of randomized controlled trials. J Endourol. 2015;29(10):1166-1176. doi:10.1089/end.2015.0098 [PubMed 25915454]
  11. Cheung CM, Awan MA, Sandramouli S. Prevalence and clinical findings of tamsulosin-associated intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2006;32(8):1336-1339. doi:10.1016/j.jcrs.2006.03.034 [PubMed 16863971]
  12. Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D'Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008;22(4):651-656. doi:10.1089/end.2007.0257 [PubMed 18338955]
  13. Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, solifenacin, and their combination for the treatment of stent-related symptoms: A randomized controlled study. J Endourol. 2017;31(1):100-109. doi: 10.1089/end.2016.0663 [PubMed 27809592]
  14. Dimitropoulos K, Gravas S. Solifenacin/tamsulosin fixed-dose combination therapy to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia. Drug Des Devel Ther. 2015;9:1707-1716. doi:10.2147/DDDT.S53184 [PubMed 25834406]
  15. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol. 1999;36(1):1-13. doi:10.1159/000019919 [PubMed 10364649]
  16. Donohoe JM, Combs AJ, Glassberg KI. Primary bladder neck dysfunction in children and adolescents II: results of treatment with alpha-adrenergic antagonists. J Urol. 2005;173(1):212-216. doi:10.1097/01.ju.0000135735.49099.8c [PubMed 15592078]
  17. Drake MJ, Chapple C, Sokol R, et al; NEPTUNE Study Group. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. Eur Urol. 2015;67(2):262-270. doi:10.1016/j.eururo.2014.07.013 [PubMed 25070148]
  18. Falahatkar S, Khosropanah I, Vajary AD, Bateni ZH, Khosropanah D, Allahkhah A. Is there a role for tamsulosin after shock wave lithotripsy in the treatment of renal and ureteral calculi? J Endourol. 2011;25(3):495-498. doi:10.1089/end.2010.0439 [PubMed 21166579]
  19. Fan B, Yang D, Wang J, et al. Can tamsulosin facilitate expulsion of ureteral stones? A meta-analysis of randomized controlled trials. Int J Urol. 2013;20(8):818-830. doi:10.1111/iju.12048 [PubMed 23278872]
  20. Flomax (tamsulosin) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis US LLC; January 2019.
  21. Flomax CR (tamsulosin) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; August 2019.
  22. Furyk JS, Chu K, Banks C, et al. Distal ureteric stones and tamsulosin: A double-blind, placebo-controlled, randomized, multicenter trial. Ann Emerg Med. 2016;67(1):86-95.e2. doi:10.1016/j.annemergmed.2015.06.001 [PubMed 26194935]
  23. Hollingsworth JM, Canales BK, Rogers MA, et al. Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis. BMJ. 2016;355:i6112. doi:10.1136/bmj.i6112 [PubMed 27908918]
  24. Hu L, Dong J, Zhang S. Tamsulosin-Associated Erythema Multiforme-Like Eruption. Am J Ther. 2019 Aug 16. doi:10.1097/MJT.0000000000001059 [PubMed 31513023]
  25. Keklikci U, Isen K, Unlu K, Celik Y, Karahan M. Incidence, clinical findings and management of intraoperative floppy iris syndrome associated with tamsulosin. Acta Ophthalmol. 2009;87(3):306-309. doi:10.1111/j.1755-3768.2008.01246.x [PubMed 18384448]
  26. Kerimoglu H, Zengin N, Ozturk B, Gunduz K. Unilateral chemosis, acute onset myopia and choroidal detachment following the use of tamsulosin. Acta Ophthalmol. 2010;88(2):e20-e21. doi:10.1111/j.1755-3768.2008.01503.x [PubMed 19302075]
  27. Koiso K, Akaza H, Kikuchi K, et al. Pharmacokinetics of tamsulosin hydrochloride in patients with renal impairment: effects of alpha 1-acid glycoprotein. J Clin Pharmacol. 1996;36(11):1029-1038. doi:10.1177/009127009603601107 [PubMed 8973992]
  28. Lerner LB, McVary KT, Barry MJ, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part I-initial work-up and medical management. J Urol. 2021;206(4):806-817. doi:10.1097/JU.0000000000002183 [PubMed 34384237]
  29. Lijnen RL, de Graaf L. Systemic contact dermatitis from tamsulosin. Contact Dermatitis. 2003;49(1):50-51. doi:10.1111/j.0105-1873.2003.0120k.x [PubMed 14641131]
  30. Lloyd GL, Lim A, Hamoui N, et al. The use of medical expulsive therapy during pregnancy: a worldwide perspective among experts. J Endourol. 2016;30(3):354-358. doi:10.1089/end.2015.0587 [PubMed 26482104]
  31. Marconi M, Pavez P, San Francisco I, Narvaez P. Priapism induced by use of tamsulosin: A case report and review of the literature. Arch Ital Urol Androl. 2019;91(3). doi:10.4081/aiua.2019.3.193 [PubMed 31577106]
  32. Miyazawa Y, Blum RA, Schentag JJ, et al. Pharmacokinetics and safety of tamsulosin in subjects with normal and impaired renal or hepatic function. Current Therapeutic Research. 2001;62(9):603-621. doi:10.1016/S0011-393X(01)80067-9
  33. Mokhless I, Zahran AR, Youssif M, Fahmy A. Tamsulosin for the management of distal ureteral stones in children: a prospective randomized study. J Pediatr Urol. 2012;8(5):544-548. doi:10.1016/j.jpurol.2011.09.008 [PubMed 22099477]
  34. Montazer F, Jahani Amiri K, Mofarrah R, Ahmadi A, Nouripour B, Mofarrah R. A first case of fixed drug eruption due to tamsulosin. J Cosmet Dermatol. 2020;19(5):1143-1145. doi:10.1111/jocd.13125 [PubMed 31541583]
  35. Nickel JC, Touma N. α-Blockers for the treatment of chronic prostatitis/chronic pelvic pain syndrome: An update on current clinical evidence. Rev Urol. 2012;14(3-4):56-64. [PubMed 23526487]
  36. Oelke M, Gericke A, Michel MC. Cardiovascular and ocular safety of α1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms. Expert Opin Drug Saf. 2014;13(9):1187-1197. doi:10.1517/14740338.2014.936376 [PubMed 25073735]
  37. Page RL 2nd, O'Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2016;134(6):e32-e69. doi:10.1161/CIR.0000000000000426 [PubMed 27400984]
  38. Paśko P, Rodacki T, Domagała-Rodacka R, Owczarek D. Interactions between medications employed in treating benign prostatic hyperplasia and food - A short review. Biomed Pharmacother. 2016;83:1141-1145. doi:10.1016/j.biopha.2016.08.021 [PubMed 27551761]
  39. Pontari, M. Chronic prostatitis and chronic pelvic pain syndrome. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 1, 2020.
  40. Preminger GM, Tiselius HG, Assimos DG, et al; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007;178(6):2418-2434. doi: 10.1016/j.juro.2007.09.107 [PubMed 17993340]
  41. Ramsey E, Ramsey BL 3rd, Childers J. Floppy iris syndrome: a drug-related complication of cataract surgery. JAAPA. 2012;25(5):37-38, 41. doi:10.1097/01720610-201205000-00007 [PubMed 22712147]
  42. Schulman C. Hypertrophie bénigne de la prostate: quel traitement, pour qui? [Benign hypertrophy of the prostate: which treatment, for whom?] [in French]. Rev Med Brux. 1999;20(4):A212-A218. [PubMed 10523895]
  43. Tan CK, Yap KB. Tamsulosin-induced photosensitivity rash. Singapore Med J. 2018;59(6):336-337. doi:10.11622/smedj.2018072 [PubMed 29974124]
  44. Tan YK, Cha DY, and Gupta M, "Management of Stones in Abnormal Situations," Urol Clin North Am, 2013, 40(1):79-97. [PubMed 23177637]
  45. Tasian GE, Cost NG, Granberg CF, et al. Tamsulosin and spontaneous passage of ureteral stones in children: a multi-institutional cohort study. J Urol. 2014;192(2):506-511. [PubMed 24518765]
  46. Thakkinstian A, Attia J, Anothaisintawee T, Nickel JC. α-blockers, antibiotics and anti-inflammatories have a role in the management of chronic prostatitis/chronic pelvic pain syndrome. BJU Int. 2012;110(7):1014‐1022. doi:10.1111/j.1464-410X.2012.11088.x [PubMed 22471591]
  47. Theriault B, Morin F, Cloutier J. Safety and efficacy of Tamsulosin as medical expulsive therapy in pregnancy. World J Urol. 2020;38(9):2301-2306. doi:10.1007/s00345-019-03022-z [PubMed 31768615]
  48. Tsuda Y, Tatami S, Yamamura N, et al. Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. Br J Clin Pharmacol. 2010;70(1):88-101. [PubMed 20642551]
  49. Van Batavia JP, Combs AJ, Horowitz M, Glassberg KI. Primary bladder neck dysfunction in children and adolescents III: results of long-term alpha-blocker therapy. J Urol. 2010;183(2):724-730. [PubMed 20022041]
  50. Van Kerrebroeck P, Haab F, Angulo JC, et al. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013;64(3):398-407. [PubMed 23537687]
  51. Vicentini FC, Mazzucchi E, Brito AH, Chedid Neto EA, Danilovic A, Srougi M. Adjuvant tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for renal stones: a double blind, randomized, placebo-controlled trial. Urology. 2011;78(5):1016-1021. [PubMed 21802124]
  52. Wang CJ, Huang SW, Chang CH. Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study. Urol Res. 2009a;37(3):147-152. [PubMed 19277623]
  53. Wang CJ, Huang SW, Chang CH. Effects of tamsulosin on lower urinary tract symptoms due to double-J stent: a prospective study. Urol Int. 2009b;83(1):66-69. [PubMed 19641362]
  54. Wolzt M, Fabrizii V, Dorner GT, et al. Pharmacokinetics of tamsulosin in subjects with normal and varying degrees of impaired renal function: an open-label single-dose and multiple-dose study. Eur J Clin Pharmacol. 1998;54(4):367-373. doi:10.1007/s002280050477 [PubMed 9696967]
  55. Yakoubi R, Lemdani M, Monga M, Villers A, Koenig P. Is there a role for α-blockers in ureteral stent related symptoms? A systematic review and meta-analysis. J Urol. 2011;186(3):928-934. [PubMed 21791359]
  56. Ye Z, Yang H, Li H, et al. A multicentre, prospective, randomized trial: comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy for distal ureteric stones with renal colic. BJU Int. 2011;108(2):276-279. [PubMed 21083640]
  57. Ye Z, Zeng G, Yang H, et al. Efficacy and safety of tamsulosin in medical expulsive therapy for distal ureteral stones with renal colic: a multicenter, randomized, double-blind, placebo-controlled trial [published online November 12, 2017]. Eur Urol. doi: 10.1016/j.eururo.2017.10.033 [PubMed 29137830]
Topic 9654 Version 364.0