Reduction of urinary obstruction and relief of associated manifestations (e.g., hesitancy, terminal dribbling of urine, interrupted or weak stream, impaired size and force of stream, sensation of incomplete bladder emptying or straining) in hypertensive or normotensive patients with symptomatic BPH.
Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.
May consider combined therapy with an α1-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement. Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression. Men at risk for BPH progression are most likely to benefit from combination therapy.
Other Uses
Manufacturer states that tamsulosin should not be used for the treatment of hypertension.
Dosage and Administration
Administration
Oral Administration
Administer orally once daily, 30 minutes after the same meal each day.
Swallow capsules intact; do not open, crush, or chew capsules.
Dosage
Available as tamsulosin hydrochloride; dosage expressed in terms of the salt.
Adults
BPH
Oral
Initially, 0.4 mg once daily. Allow 2–4 weeks to assess response at initial dosage. May increase dosage to 0.8 mg once daily, if necessary, to improve urinary flow rates and reduce symptoms.
If administration is interrupted for several days at either dosage (i.e., 0.4 or 0.8 mg daily), reinitiate therapy at dosage of 0.4 mg once daily.
Special Populations
Hepatic Impairment
Dosage adjustment not necessary in patients with moderate hepatic impairment.
Renal Impairment
Dosage adjustment not necessary in patients with mild to severe renal impairment (Clcr 10–70 mL/minute per 1.73 m2).
Not studied in patients with end-stage renal disease (Clcr <10 mL/minute per 1.73 m2).
Cautions
Contraindications
Known hypersensitivity to tamsulosin or any ingredient in the formulation.
Warnings/Precautions
Warnings
Postural Hypotension
Potential for postural hypotension, dizziness, or vertigo; syncope may occur.
Priapism
Priapism reported rarely; treat promptly.
Sensitivity Reactions
Allergic Reactions
Rash, pruritus, urticaria, and angioedema of the tongue, lips, and face reported; positive rechallenge in some patients.
Sulfonamide Sensitivity
Allergic reaction to tamsulosin reported rarely in patients with sulfonamide sensitivity. Use with caution in patients with serious or life-threatening sulfonamide sensitivity.
General Precautions
Prostate Cancer
Exclude possibility of prostate cancer prior to initiation of therapy.
Intraoperative Floppy Iris Syndrome (IFIS)
IFIS observed during phacoemulsificationcataract surgery in some patients receiving α1-blockers, including tamsulosin. Most cases were in patients who continued tamsulosin therapy at the time of cataract surgery.
Specifically question male patients being considered for cataract surgery to ascertain whether they have received tamsulosin or other α1-blockers. If patient has received tamsulosin, ophthalmologist should be prepared for possible modifications to his/her surgical technique (e.g., use of iris hooks, iris dilator rings, viscoelastic substances) to minimize complications of IFIS.
Benefit of discontinuing α1-blockers, including tamsulosin, prior to cataract surgery not established.
Specific Populations
Pregnancy
Category B. Not indicated for use in women.
Lactation
Not indicated for use in women.
Pediatric Use
Not indicated for use in children.
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.
Essentially completely absorbed following oral administration under fasting conditions; peak plasma concentrations attained within 4–5 hours.
Food
Food delays time to peak plasma concentration by about 2 hours. When administered under fasting conditions, bioavailability and peak plasma concentration are increased by 30 and 40–70%, respectively, compared with fed state.
Distribution
Extent
Appears to distribute into extracellular fluids in humans. In animals, distributed into kidney, prostate, liver, gallbladder, heart, aorta, and brown fat, with minimal distribution into brain, spinal cord, and testes.
Plasma Protein Binding
94–99% (mainly to α1-acid glycoprotein).
Special Populations
In patients with moderate hepatic impairment, protein binding is altered, resulting in changes in overall plasma concentrations; however, no substantial alterations in intrinsic clearance and concentrations of unbound drug.
In patients with renal impairment, protein binding is altered, resulting in changes in overall plasma concentrations; however, no substantial alterations in intrinsic clearance and concentrations of unbound drug.
Elimination
Metabolism
Extensively metabolized by CYP enzymes (specific isoenzyme[s] not identified) in the liver. Metabolites undergo further conjugation prior to excretion.
Elimination Route
Excreted in urine (76%) and feces (21%).
Half-life
Because of absorption rate-controlled pharmacokinetics of tamsulosin capsules, apparent half-life is about 9–13 hours in healthy individuals and 14–15 hours in patients with BPH.
Special Populations
In males 55–75 years of age, intrinsic clearance is decreased and elimination half-life is prolonged, resulting in a 40% increase in AUC compared with males 20–32 years of age.
Stability
Storage
Oral
Capsules
25°C (may be exposed to 15–30°C).
Actions
Binds to α1-adrenergic receptors on the prostate and the bladder trigone, resulting in decreased urinary outflow resistance in men.
Higher affinity for α1A-adrenergic receptors, which are located in nonvascular smooth muscle (e.g., prostate), than for α1B-adrenergic receptors located in vascular smooth muscle (e.g., internal iliac artery); may result in reduced incidence of cardiovascular effects (e.g., syncope, dizziness, hypotension).
Advice to Patients
Importance of providing patient a copy of manufacturer’s patient information and advising patient to read and follow instructions for use.
Risk of feeling faint or dizzy, particularly following initiation of therapy or dosage increase; avoid operating machinery or driving a motor vehicle for 12 hours following initial dose or dosage increase.
Importance of sitting or lying down when symptoms of lowered BP occur and of rising carefully from a sitting or lying position.
Importance of advising male patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior α1-blocker therapy.
Importance of men seeking medical treatment promptly if an erection is painful or persists for several hours.
Importance of taking tamsulosin 30 minutes after the same meal each day. Importance of swallowing the capsules whole and of not chewing, crushing, or opening the capsules.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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