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 2 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 (Ref).
Ureteral calculi expulsion: Limited data available; optimal dose not established:
Children 2 to 4 years: Oral: 0.4 mg once daily; a lower dose of 0.2 mg has also been reported; however, this dosage form may not be available in some countries including the United States and Canada (Ref).
Children >4 years and Adolescents: Oral: 0.4 mg once daily (Ref).
Dosing based on limited prospective and retrospective trials and 2 meta-analyses that evaluated the efficacy of alpha-adrenergic blockers for facilitation of spontaneous stone passage in pediatric patients with distal urolithiasis (stones were generally ≤12 mm); compared with placebo, tamsulosin was associated with greater expulsion rate and decreased expulsion time (Ref).
There are no pediatric-specific recommendations. Based on experience in adult patients with CrCl ≥10 mL/minute, data suggest no adjustment needed; for more severe renal impairment, use has not been studied.
There are no pediatric-specific recommendations. Based on experience in adult patients with mild to moderate hepatic impairment, data suggest no adjustment needed; for more severe hepatic impairment, use has not been studied.
(For additional information see "Tamsulosin: Drug information")
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/mL, or palpable prostate enlargement on digital rectal exam), use in combination with 5-alpha reductase inhibitor (Ref).
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]: 0.4 mg once daily.
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 (Ref).
Ureteral stone(s) expulsion (off-label use):
Note: Consider for use in patients with ureteral stones >5 and ≤10 mm (Ref). Although most evidence exists for distal ureteral stones, given the low side effect profile of alpha-blockers, may consider use in patients with stones in any location of ureter (Ref).
Oral: 0.4 mg once daily until stone passage or for up to 4 weeks (Ref).
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 (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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 (Ref).
CrCl <10 mL/minute: No dosage adjustment likely to be necessary (has not been studied); use with caution (Ref).
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 (Ref).
Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment likely to be necessary (has not been studied); use with caution (Ref).
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).
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: Not completely established; 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). A minimum 3-month duration of alpha-1 blocker use has been proposed as a risk for IFIS (Ref).
Risk factors:
• Individual alpha-1 blocker (risk highest with tamsulosin) (Ref)
• Hypertension (Ref)
• Male sex (Ref)
• Older age (Ref)
• Decreased pre-operative dilated pupil diameter (Ref)
Tamsulosin is associated with orthostatic hypotension, which can manifest as dizziness and vertigo.
Mechanism: Dose-related; related to the pharmacologic action (ie, inhibition of vascular smooth muscle contraction and vasodilation) (Ref).
Onset: Rapid; “first dose” orthostatic hypotension may occur 4 to 8 hours after dose.
Risk factors:
• Individual alpha-1 blocker (risk lowest with tamsulosin) (Ref)
• First dose or redose after dose interruption (Ref)
• Rapid increase in dose
• Concurrent medications that cause orthostatic hypotension (eg, antihypertensives, nitrates, PDE-5 inhibitors) (Ref)
• Alcohol use (Ref)
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%, chronic use: 16% to 19%; symptomatic: <1%) (table 1)
Drug (Tamsulosin) |
Placebo |
Dose |
Number of Patients (Tamsulosin) |
Number of Patients (Placebo) |
Comments |
---|---|---|---|---|---|
19% |
11% |
0.8 mg |
491 |
493 |
Studies 1 & 2 |
16% |
11% |
0.4 mg |
502 |
493 |
Studies 1 & 2 |
7% |
3% |
0.4 mg |
498 |
253 |
Study 1: 4 hours after first dose |
6% |
4% |
0.4 mg |
498 |
250 |
Study 1: 8 hours after first dose |
0.4% |
0% |
0.8 mg |
492 |
493 |
Symptomatic; Studies 1 & 2 |
0.2% |
0% |
0.4 mg |
502 |
493 |
Symptomatic; Studies 1 & 2 |
Genitourinary: Ejaculation failure (8% to 18%)
Infection: Infection (9% to 11%)
Nervous system: Dizziness (15% to 17%) (table 2) , headache (19% to 21%)
Drug (Tamsulosin) |
Placebo |
Dose |
Number of Patients (Tamsulosin) |
Number of Patients (Placebo) |
---|---|---|---|---|
17% |
10% |
0.8 mg |
492 |
493 |
15% |
10% |
0.4 mg |
502 |
493 |
Respiratory: Rhinitis (13% to 18%)
1% to 10%:
Endocrine & metabolic: Decreased libido (2%)
Gastrointestinal: Diarrhea (6%), nausea (4%)
Nervous system: Asthenia (8% to 9%), drowsiness (3% to 4%), insomnia (1% to 2%), vertigo (1%) (table 3)
Drug (Tamsulosin) |
Placebo |
Dose |
Number of Patients (Tamsulosin) |
Number of Patients (Placebo) |
---|---|---|---|---|
1% |
0.6% |
0.8 mg |
492 |
493 |
0.6% |
0.6% |
0.4 mg |
502 |
493 |
Neuromuscular & skeletal: 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 (Ref), erythema multiforme (Ref), exfoliative dermatitis, fixed drug eruption (Ref), skin photosensitivity (Ref), Stevens-Johnson syndrome
Gastrointestinal: Constipation, vomiting, xerostomia
Genitourinary: Priapism (Ref)
Hypersensitivity: Angioedema
Ophthalmic: Choroidal detachment (Ref), intraoperative floppy iris syndrome (in patients undergoing cataract or glaucoma surgery) (Ref)
Respiratory: Dyspnea, epistaxis
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)
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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]).
Special populations:
• Patients undergoing cataract surgery: Intraoperative floppy iris syndrome has been observed in patients undergoing cataract surgery who were on or were previously treated with alpha-1 blockers; there appears to be no benefit in discontinuing alpha-blocker therapy prior to surgery. May require modifications to surgical technique; instruct patients to inform ophthalmologist of current or previous alpha-1 blocker use when considering eye surgery.
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.
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,indigo carmine)]
Generic: 0.4 mg
Yes
Capsules (Flomax Oral)
0.4 mg (per each): $11.67
Capsules (Tamsulosin HCl Oral)
0.4 mg (per each): $0.53 - $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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule Extended Release 24 Hour, Oral:
Generic: 0.4 mg
Tablet Extended Release 24 Hour, Oral:
Flomax CR: 0.4 mg [DSC]
Generic: 0.4 mg
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, pudding), water, or juice (Ref); however, if administered via this method, do not crush, chew, or dissolve the granules as this may lead to rapid release and increased risk of adverse effects (manufacturer data on file). Administration via nasogastric, gastric, jejunostomy, or other feeding tubes has not been adequately evaluated, and based on limited reports, the granules may adhere to the tube with resultant blockage (manufacturer data on file).
Oral: Administer capsules ~30 minutes after the same mealtime each day. Per the manufacturer’s labeling, 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 (Ref); however, if administered via this method, do not crush, chew, or dissolve the granules as this may lead to rapid release and increased risk of adverse effects (manufacturer data on file). Administration via nasogastric, gastric, jejunostomy, or other feeding tubes has not been adequately evaluated, and based on limited reports, the granules may adhere to the tube with resultant blockage (manufacturer data on file). The controlled-release tablet [Canadian product] should be administered at the same time each day with or without food, and should be swallowed whole.
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
Treatment of signs and symptoms of benign prostatic hyperplasia (BPH) (FDA approved in adults); has also been used for nephrolithiasis and for management of primary bladder neck dysfunction.
Flomax may be confused with Flonase, Flovent, Foltx, Fosamax
Tamsulosin may be confused with tacrolimus, tamoxifen, terazosin
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]
Substrate of CYP2D6 (major), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
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 therapeutic effect of Alpha-/Beta-Agonists. 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
Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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
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
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
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). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider therapy modification
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
Iloperidone: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Mavorixafor: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk X: Avoid combination
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
Phenylephrine (Systemic): Alpha1-Blockers may diminish the vasoconstricting effect of Phenylephrine (Systemic). 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
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.
Ejaculation failure, ejaculation disorder, retrograde ejaculation, and decreased ejaculation has been associated with use of tamsulosin.
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).
Blood pressure, urinary symptoms.
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.
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%)
Older adult: AUC is 40% higher in subjects 55 to 75 years of age compared with subjects 20 to 32 years of age.
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