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ASCEND LABORATO
SKU
67877045005

tamsulosin hcl 0.4 mg capsule (generic flomax)

Generic
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Uses

Benign Prostatic Hyperplasia

Tamsulosin is used to reduce urinary obstruction and relieve associated manifestations in hypertensive or normotensive patients with symptomatic benign prostatic hyperplasia (BPH, benign prostatic hypertrophy). Tamsulosin relieves mild to moderate obstructive 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) and improves urinary flow rates in a substantial proportion of patients and may be a useful alternative to surgery, particularly in those who are awaiting or are unwilling to undergo surgical correction of the hyperplasia (e.g., via transurethral resection of the prostate [TURP]) or who are not candidates for such surgery. Therapy with α1-adrenergic blocking agents appears to be less effective in relieving irritative (e.g., nocturia, daytime frequency, urgency, dysuria) than obstructive symptomatology, although tamsulosin also has been shown to be effective in relieving irritative symptoms. In addition, therapy with α1-adrenergic blocking agents generally can be expected to produce less subjective and objective improvement than prostatectomy, and periodic monitoring (e.g., performance of digital rectal examinations, serum creatinine determinations, serum prostate specific antigen [PSA] assays) is indicated in these patients to detect and manage other potential complications of or conditions associated with BPH (e.g., obstructive uropathy, prostatic carcinoma).

Results of several controlled studies indicate that tamsulosin is more effective than placebo and limited data suggest that the drug is at least as effective as other α1-adrenergic blocking agents (e.g., doxazosin, prazosin, terazosin) in the management of BPH. While symptomatic improvement has been maintained for up to at least 60 weeks of tamsulosin therapy in some patients, the long-term effects of α-blockers on the need for surgery and on the frequency of developing BPH-associated complications such as acute urinary obstruction remain to be established. Although tamsulosin appears to be associated with a decreased incidence of adverse cardiovascular effects including hypotension, dizziness, and syncope, patients should be warned of the possibility of tamsulosin-induced postural dizziness and measures to take if it develops (e.g., sitting, lying down). During initiation of tamsulosin therapy, patients should be cautioned to avoid situations where injury could result if syncope occurs. If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary.

Combination therapy with an α1-blocker and 5α-reductase inhibitor (e.g., finasteride) has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression; combined therapy also can reduce the risks of long-term acute urinary retention and the need for invasive therapy compared with α-blocker monotherapy.

For additional information on the use of α1-blockers in the management of BPH,

Allergic-type reactions, including skin rash, pruritus, urticaria, and angioedema of the tongue, lips, and face, have been reported in some patients with positive rechallenge of tamsulosin therapy.

The possibility of carcinoma of the prostate and other conditions associated with manifestations that mimic those of BPH should be excluded in any patient for whom tamsulosin therapy for presumed BPH is being considered.

The manufacturer states that tamsulosin should not be used in the management of hypertension.

Dosage and Administration

Administration

Tamsulosin is administered orally. Because food may decrease peak plasma concentrations of tamsulosin and lengthen the time to achievement of peak plasma concentrations and decrease oral bioavailability of the drug, the manufacturer recommends that tamsulosin be taken 30 minutes after a meal; it is recommended that the drug be taken after the same meal each day. Patients should be advised that the capsules must be swallowed intact and not be opened, chewed, or crushed.

Risk of Intraoperative Floppy Iris Syndrome

A condition termed intraoperative floppy iris syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients receiving α1-adrenergic blocking agents, including tamsulosin. 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 mydriatics, and potential prolapse of the iris toward the phacoemulsification incisions. Most reported cases of IFIS were in patients who continued α1-blocker therapy at the time of cataract surgery. A few cases also were reported in patients who had discontinued such therapy prior to surgery, generally 2-14 days prior to surgery but occasionally 5 weeks to 9 months prior to surgery. The manufacturer of tamsulosin recommends that male patients being considered for cataract surgery be specifically questioned to ascertain whether they have received tamsulosin or other α1-blockers. If a patient has received such agents, the ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, or viscoelastic substances) to minimize complications of IFIS. The benefit of discontinuing α1-blockers, including tamsulosin, prior to cataract surgery has not been established.

Dosage

The manufacturer states that safety and efficacy of tamsulosin in children younger than 18 years of age have not been established, and clinical experience in these patients is not available.

Benign Prostatic Hyperplasia

For the management of benign prostatic hyperplasia (BPH), the usual initial adult dosage of tamsulosin is 0.4 mg once daily. About 2-4 weeks may be needed to adequately assess the response at this dosage. To achieve the desired improvement in symptoms and/or urinary flow rates, subsequent dosage may be increased to 0.8 mg daily as needed. If tamsulosin is discontinued for several days at either dosage (i.e., 0.4 or 0.8 mg daily), therapy with the drug should be reinstituted at the lower daily dosage. Although the elimination half-life may be slightly prolonged and intrinsic clearance of tamsulosin may be decreased in patients 55 years of age and older, the manufacturer makes no specific recommendations for dosage adjustment in such patients.

The manufacturer states that tamsulosin should not be used concomitantly with other α-adrenergic blocking agents.

Dosage in Renal and Hepatic Impairment

Although protein binding of tamsulosin may be altered in patients with mild to moderate (i.e., creatinine clearance of 30-70 mL/minute per 1.73 m) or severe (i.e., creatinine clearance of 10 to less than 30 mL/minute per 1.73 m) renal impairment and in patients with moderate hepatic impairment resulting in changes of overall plasma concentrations of the drug, alterations in intrinsic clearance and concentrations of unbound tamsulosin do not appear to be substantial. Therefore, the manufacturer states that dosage adjustment in such patients is not necessary. However, tamsulosin has not been studied in patients with end-stage (i.e., creatinine clearance of less than 10 mL/minute per 1.73 m) renal disease.

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.

Sulfa Sensitivity

Allergic reaction to tamsulosin reported rarely in patients with sulfa sensitivity. Use with caution in patients with serious or life-threatening sulfa sensitivity.

General Precautions

Prostate Cancer

Exclude possibility of prostate cancer prior to initiation of therapy.

Intraoperative Floppy Iris Syndrome

Intraoperative floppy iris syndrome (IFIS) observed during phacoemulsification cataract surgery in some patients receiving α1-adrenergic blocking agents, including tamsulosin. Most reported cases were in patients who continued such therapy at the time of cataract surgery.

Manufacturer recommends that male patients being considered for cataract surgery be specifically questioned to ascertain whether they have received tamsulosin or other α1-blockers. If the patient has received α1-blockers, the ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, or viscoelastic substances) to minimize complications of IFIS.

Benefit of discontinuing α1-blockers 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.

Common Adverse Effects

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

Drug Interactions

α-Adrenergic blocking agents

Additive effects; concomitant use not recommended.

Atenolol

No change in blood pressure or pulse rate; dosage adjustment not necessary.

Cimetidine

Increased plasma tamsulosin concentrations. Use with caution, particularly with doses >0.4 mg.

Digoxin

Pharmacokinetic interaction unlikely.

Enalapril

No change in blood pressure or pulse rate; dosage adjustment not necessary.

Furosemide

Decreased plasma tamsulosin concentrations; not clinically important.

Nifedipine

No change in blood pressure or pulse rate; dosage adjustment not necessary.

Theophylline

Pharmacokinetic interaction unlikely.

Warfarin

Possible pharmacokinetic interaction. Available data inconclusive; use with caution.

Pharmacokinetics

Absorption

Bioavailability

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.

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