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Tamsulosina
Tamsulosina
(For additional information see "Tamsulosin: Patient drug information" and see "Tamsulosin: Pediatric drug
information")
For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
Flomax
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.
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 (off-label use): Oral: Initial:
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Tamsulosin: Drug information
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 (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).
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).
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.
CrCl ≥10 mL/minute: No dosage adjustment necessary (Koiso 1996; Miyazawa 2001;
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Tamsulosin: Drug information
CrCl <10 mL/minute: No dosage adjustment likely to be necessary (has not been
studied); use with caution (expert opinion).
Dosing: Pediatric
Nephrolithiasis, distal stones: Limited data available; optimal dose not established
(Mokhless 2012; Tasian 2014):
Children >4 years and Adolescents: Oral: 0.4 mg once daily at bedtime
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: Geriatric
Refer to adult dosing.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult
specific product labeling.
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Tamsulosin: Drug information
Generic: 0.4 mg
Generic: 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).
Chronic prostatitis/chronic pelvic pain syndrome in males; Lower urinary tract symptoms in
males; Ureteral calculi expulsion; Ureteral stent-related urinary symptoms, treatment
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]
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).
Onset: Varied; may occur with current (within a few weeks of initiation) or prior use
(years following discontinuation) (Ref).
Risk factors:
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Tamsulosin: Drug information
Orthostatic hypotension
Onset: Rapid; “first dose” orthostatic hypotension may occur 4 to 8 hours after dose.
Risk factors:
Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless
otherwise specified.
>10%:
Nervous system: Dizziness (15% to 17% [placebo: 10%]), headache (19% to 21%)
1% to 10%:
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Tamsulosin: Drug information
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%)
Postmarketing:
Contraindications
Warnings/Precautions
• 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:
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
(For additional information: Launch drug interactions program)
Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with
Inhibitors). Risk X: Avoid combination
Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with
Inhibitors). Risk C: Monitor therapy
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
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may
enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).
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
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
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
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Tamsulosin: Drug information
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
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
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Tamsulosin: Drug information
C: Monitor therapy
Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with
Inhibitors). 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).
Breast-Feeding Considerations
It is not known if tamsulosin is present in breast milk.
Monitoring Parameters
Blood pressure; urinary symptoms; prostate cancer screening prior to initiation and then as
directed; mental alertness.
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.
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Tamsulosin: Drug information
Absorption: >90%
Distribution: Vd: 16 L
Metabolism: Hepatic (extensive) via CYP3A4 and 2D6; metabolites undergo extensive
conjugation to glucuronide or sulfate
Geriatric: AUC is 40% higher in subjects 55 to 75 years of age compared with subjects 20 to
32 years of age.
Pricing: US
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.
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Tamsulosin: Drug information
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.
REFERENCES
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]
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]
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]
- Page 16 of 21 -
Tamsulosin: Drug information
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]
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.
- Page 17 of 21 -
Tamsulosin: Drug information
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. 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]
29. 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]
30. 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]
31. 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
32. 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]
33. Montazer F, Jahani Amiri K, Mofarrah R, Ahmadi A, Nouripour B, Mofarrah R. A first case of
- Page 18 of 21 -
Tamsulosin: Drug information
38. 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.
39. 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]
40. 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]
41. 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]
42. Tan CK, Yap KB. Tamsulosin-induced photosensitivity rash. Singapore Med J.
2018;59(6):336-337. doi:10.11622/smedj.2018072 [PubMed 29974124]
43. Tan YK, Cha DY, and Gupta M, "Management of Stones in Abnormal Situations," Urol Clin
- Page 19 of 21 -
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Tamsulosin: Drug information
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]
54. 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]
55. 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]
56. 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]
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