Can women take tamsulosin. What are the uses of tamsulosin for women. How is tamsulosin dosed for female patients. What side effects may women experience when taking tamsulosin. Are there any specific interactions or warnings for women using tamsulosin.

Understanding Tamsulosin: Mechanism of Action and Clinical Pharmacology

Tamsulosin is an alpha1 adrenoceptor blocking agent primarily used to treat benign prostatic hyperplasia (BPH) symptoms in men. However, its mechanism of action may have potential benefits for women with certain urological conditions.

How does tamsulosin work? The drug exhibits selectivity for alpha1 receptors in the prostate and bladder neck. By blocking these receptors, tamsulosin causes smooth muscles to relax, improving urine flow and reducing BPH symptoms. Approximately 70% of alpha1 receptors in the human prostate are of the alpha1A subtype, which tamsulosin targets specifically.

While the prostate is a male organ, the alpha1 receptors targeted by tamsulosin are also present in the female urinary tract. This has led researchers to investigate its potential use in women with certain urological disorders.

Pharmacokinetics of Tamsulosin

Understanding how tamsulosin is absorbed, distributed, and eliminated in the body is crucial for its proper use in both men and women:

• Absorption: Over 90% of tamsulosin is absorbed when taken orally under fasting conditions.
• Food effect: Taking tamsulosin with food increases the time to maximum concentration (Tmax) by 1-2 hours and decreases peak concentrations (Cmax) by 30-40%.
• Linear kinetics: Tamsulosin exhibits linear pharmacokinetics, meaning its concentration in the body increases proportionally with the dose.
• Steady-state: It takes about 5 days of once-daily dosing to reach steady-state concentrations in the body.

Potential Uses of Tamsulosin in Women

While tamsulosin is primarily prescribed for men with BPH, research has explored its potential benefits for women with certain urological conditions. What conditions might tamsulosin help treat in women?

• Overactive bladder (OAB)
• Lower urinary tract symptoms (LUTS)
• Urinary retention
• Kidney stones

Studies have shown that tamsulosin may help relax the smooth muscles in the female urinary tract, potentially improving symptoms associated with these conditions. However, it’s important to note that tamsulosin is not FDA-approved for use in women, and its use in female patients is considered off-label.

Overactive Bladder and LUTS in Women

Some research suggests that tamsulosin may help alleviate symptoms of overactive bladder and lower urinary tract symptoms in women. These conditions can cause frequent urination, urgency, and nocturia. By relaxing the smooth muscles in the bladder and urethra, tamsulosin may help reduce these symptoms.

Kidney Stone Expulsion

Tamsulosin has shown promise in aiding the passage of kidney stones in both men and women. How does it work for kidney stones? The drug helps relax the muscles in the ureter, potentially facilitating the passage of smaller stones and reducing pain during the process.

Dosage Considerations for Tamsulosin in Women

When prescribing tamsulosin for women, healthcare providers must consider appropriate dosing strategies. How is tamsulosin typically dosed for female patients?

While there is no standardized dosing regimen for women, most studies have used doses similar to those prescribed for men:

• Starting dose: Usually 0.4 mg once daily
• Maximum dose: Up to 0.8 mg once daily, if needed and tolerated

It’s crucial to note that dosing should be individualized based on the patient’s response and tolerability. Women may require lower doses than men due to differences in body weight and metabolism.

Timing of Tamsulosin Administration

The timing of tamsulosin administration can affect its absorption and efficacy. Should tamsulosin be taken with food or on an empty stomach?

Studies have shown that taking tamsulosin with food can significantly alter its pharmacokinetics:

• Fasted state: Higher peak concentrations and faster absorption
• Fed state: Lower peak concentrations and slower absorption, but potentially fewer side effects

For consistency, it’s generally recommended to take tamsulosin at the same time each day, either always with food or always on an empty stomach.

Potential Side Effects of Tamsulosin in Women

While tamsulosin is generally well-tolerated, women may experience certain side effects. What are the most common side effects of tamsulosin in female patients?

• Dizziness
• Headache
• Nasal congestion
• Fatigue
• Abnormal ejaculation (in men, but not applicable to women)

It’s important to note that most side effects are mild and tend to diminish over time as the body adjusts to the medication. However, if side effects persist or worsen, patients should consult their healthcare provider.

Orthostatic Hypotension

One potential concern with tamsulosin use is orthostatic hypotension, a sudden drop in blood pressure upon standing. This can lead to dizziness or fainting. Women, especially those with low blood pressure or taking other medications that affect blood pressure, should be cautious when starting tamsulosin.

Drug Interactions and Precautions for Women Taking Tamsulosin

When considering tamsulosin for women, it’s crucial to be aware of potential drug interactions and necessary precautions. What medications might interact with tamsulosin?

• Other alpha-blockers (e.g., prazosin, doxazosin)
• Certain antihypertensive medications
• PDE5 inhibitors (e.g., sildenafil, tadalafil)
• Strong CYP3A4 inhibitors (e.g., ketoconazole)

Women taking any of these medications should inform their healthcare provider before starting tamsulosin. Additionally, those with a history of allergic reactions to sulfa drugs should use tamsulosin cautiously, as cross-sensitivity may occur.

Precautions for Specific Populations

Certain groups of women may need extra monitoring or dose adjustments when taking tamsulosin:

• Elderly patients: May be more sensitive to the effects of tamsulosin
• Patients with liver or kidney impairment: May require lower doses
• Pregnant or breastfeeding women: Limited data available, should be used only if potential benefits outweigh risks

Monitoring and Follow-up for Women on Tamsulosin

Regular monitoring is essential for women taking tamsulosin to ensure its effectiveness and detect any potential issues. How should healthcare providers monitor women on tamsulosin therapy?

• Regular blood pressure checks, especially in the first few weeks of treatment
• Assessment of urinary symptoms and quality of life
• Monitoring for side effects and adjusting dosage if necessary
• Periodic evaluation of liver and kidney function

Patients should be encouraged to keep a symptom diary and report any significant changes or concerns to their healthcare provider promptly.

Long-term Use Considerations

While tamsulosin is generally considered safe for long-term use in men, data on extended use in women is limited. Healthcare providers should periodically reassess the need for continued therapy and consider the risk-benefit ratio for each patient.

Alternative Treatments and Complementary Approaches

For women with urological conditions who may not be suitable candidates for tamsulosin or prefer alternative approaches, several options are available. What are some alternatives to tamsulosin for treating urological symptoms in women?

• Lifestyle modifications (e.g., bladder training, pelvic floor exercises)
• Other medications (e.g., anticholinergics, beta-3 agonists)
• Botox injections for overactive bladder
• Neuromodulation therapies
• Surgical interventions for severe cases

Healthcare providers should discuss all available options with their patients to determine the most appropriate treatment plan based on individual needs and preferences.

Complementary Approaches

Some women may benefit from complementary approaches alongside or instead of pharmaceutical treatments. These may include:

• Acupuncture
• Herbal supplements (e.g., saw palmetto, pygeum)
• Mindfulness and relaxation techniques
• Dietary modifications

It’s important to note that the efficacy of these complementary approaches may vary, and patients should discuss their use with a healthcare provider to ensure safety and avoid potential interactions with other treatments.

Future Research and Developments

As interest in using tamsulosin for women’s urological conditions grows, ongoing research aims to better understand its efficacy and safety in female patients. What areas of research are currently being explored?

• Large-scale clinical trials specifically focused on women
• Long-term safety and efficacy studies
• Comparison of tamsulosin with other treatments for female urological conditions
• Development of targeted formulations for women
• Investigation of combination therapies

These research efforts may lead to more tailored treatment options for women with urological disorders and potentially FDA approval for specific indications in female patients.

Personalized Medicine Approaches

The future of tamsulosin use in women may involve more personalized approaches to treatment. This could include:

• Genetic testing to predict response and side effects
• Biomarker-guided therapy selection
• Customized dosing regimens based on individual patient characteristics

As our understanding of the genetic and physiological factors influencing drug response improves, treatments like tamsulosin may be more precisely tailored to individual patients, potentially improving outcomes and minimizing side effects.

Uses, Dosage, Side Effects, Interactions, Warning

CLINICAL PHARMACOLOGY

Mechanism Of Action

The symptoms associated with benign prostatic hyperplasia
(BPH) are related to bladder outlet obstruction, which is comprised of two
underlying components: static and dynamic. The static component is related to
an increase in prostate size caused, in part, by a proliferation of smooth
muscle cells in the prostatic stroma. However, the severity of BPH symptoms and
the degree of urethral obstruction do not correlate well with the size of the prostate.
The dynamic component is a function of an increase in smooth muscle tone in the
prostate and bladder neck leading to constriction of the bladder outlet. Smooth
muscle tone is mediated by the sympathetic nervous stimulation of alpha₁ adrenoceptors,
which are abundant in the prostate, prostatic capsule, prostatic urethra, and
bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the
bladder neck and prostate to relax, resulting in an improvement in urine flow
rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha₁ adrenoceptor blocking agent,
exhibits selectivity for alpha₁ receptors in the human prostate. At least three
discrete alpha₁ adrenoceptor subtypes have been identified: alpha_1A,
alpha_1B, and alpha_1D; their distribution differs between
human organs and tissue. Approximately 70% of the alpha₁ receptors in the human
prostate are of the alpha_1A subtype.

FLOMAX capsules are not intended for use as an
antihypertensive drug.

Pharmacodynamics

Urologic pharmacodynamic effects have been evaluated in
neurologically impaired pediatric patients and in adults with BPH [see Use In
Specific Populations and Clinical Studies].

Pharmacokinetics

The pharmacokinetics of tamsulosin hydrochloride have
been evaluated in adult healthy volunteers and patients with BPH after single
and/or multiple administration with doses ranging from 0.1 mg to 1 mg.

Absorption

Absorption of tamsulosin hydrochloride from FLOMAX
capsules 0.4 mg is essentially complete (>90%) following oral administration
under fasting conditions. Tamsulosin hydrochloride exhibits linear kinetics
following single and multiple dosing, with achievement of steady-state
concentrations by the fifth day of once-a-day dosing.

Effect Of Food

The time to maximum concentration (Tmax) is reached by 4
to 5 hours under fasting conditions and by 6 to 7 hours when FLOMAX capsules
are administered with food. Taking FLOMAX capsules under fasted conditions
results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in
peak concentrations (Cmax) compared to fed conditions (Figure 1).

Figure 1: Mean Plasma Tamsulosin Hydrochloride
Concentrations Following Single- Dose Administration of FLOMAX Capsules 0.4 mg
Under Fasted and Fed Conditions (n=8)

The effects of food on the pharmacokinetics of tamsulosin
hydrochloride are consistent regardless of whether a FLOMAX capsule is taken
with a light breakfast or a high-fat breakfast (Table 2).

Table 2: Mean (± S.D.) Pharmacokinetic Parameters
Following FLOMAX Capsules 0.4 mg Once Daily or 0.8 mg Once Daily with a Light
Breakfast, High-Fat Breakfast or Fasted

Pharmacokinetic Parameter	0.4 mg QD to healthy volunteers; n=23 (age range 18-32 years)		0.8 mg QD to healthy volunteers; n=22 (age range 55-75 years)
	Light Breakfast	Fasted	Light Breakfast	High-Fat Breakfast	Fasted
Cmin (ng/mL)	4. 0 ± 2.6	3.8 ± 2.5	12.3 ± 6.7	13.5 ± 7.6	13.3    ± 13.3
Cmax (ng/mL)	10.1 ± 4.8	17.1    ± 17.1	29.8 ± 10.3	29.1 ± 11.0	41.6    ± 15.6
Cmax/Cmin Ratio	3.1 ± 1.0	5.3 ± 2.2	2.7 ± 0.7	2.5 ± 0.8	3.6 ± 1.1
Tmax (hours)	6.0	4.0	7.0	6.6	5.0
T½ (hours)	–	–	–	–	14. 9 ± 3.9
AUCτ (ng•;hr/mL)	151 ± 81.5	199 ± 94.1	440 ± 195	449 ± 217	557 ± 257
Cmin = observed minimum concentration Cmax = observed maximum tamsulosin hydrochloride plasma concentration Tmax = median time-to-maximum concentration T½ = observed half-life AUCτ = area under the tamsulosin hydrochloride plasma time curve over the dosing interval

Distribution

The mean steady-state apparent volume of distribution of
tamsulosin hydrochloride after intravenous administration to 10 healthy male
adults was 16 L, which is suggestive of distribution into extracellular fluids
in the body.

Tamsulosin hydrochloride is extensively bound to human
plasma proteins (94% to 99%), primarily alpha₁ acid glycoprotein (AAG), with
linear binding over a wide concentration range (20 to 600 ng/mL). The results
of two-way in vitro studies indicate that the binding of tamsulosin
hydrochloride to human plasma proteins is not affected by amitriptyline, diclofenac,
glyburide, simvastatin plus simvastatin-hydroxy acid metabolite, warfarin, diazepam,
propranolol, trichlormethiazide, or chlormadinone. Likewise, tamsulosin
hydrochloride had no effect on the extent of binding of these drugs.

Metabolism

There is no enantiomeric bioconversion from tamsulosin
hydrochloride [R(-) isomer] to the S(+) isomer in humans. Tamsulosin
hydrochloride is extensively metabolized by cytochrome P450 enzymes in the
liver and less than 10% of the dose is excreted in urine unchanged. However,
the pharmacokinetic profile of the metabolites in humans has not been
established. Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6
as well as via some minor participation of other CYP isoenzymes. Inhibition of
hepatic drug-metabolizing enzymes may lead to increased exposure to tamsulosin [see
WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. The metabolites
of tamsulosin hydrochloride undergo extensive conjugation to glucuronide or
sulfate prior to renal excretion.

Incubations with human liver microsomes showed no
evidence of clinically significant metabolic interactions between tamsulosin
hydrochloride and amitriptyline, albuterol (beta agonist), glyburide
(glibenclamide) and finasteride (5-alpha-reductase inhibitor for treatment of
BPH). However, results of the in vitro testing of the tamsulosin hydrochloride interaction
with diclofenac and warfarin were equivocal.

Excretion

On administration of the radiolabeled dose of tamsulosin
hydrochloride to 4 healthy volunteers, 97% of the administered radioactivity
was recovered, with urine (76%) representing the primary route of excretion
compared to feces (21%) over 168 hours. Following intravenous or oral
administration of an immediate-release formulation, the elimination half-life
of tamsulosin hydrochloride in plasma ranged from 5 to 7 hours. Because of
absorption rate-controlled pharmacokinetics with FLOMAX capsules, the apparent
half-life of tamsulosin hydrochloride is approximately 9 to 13 hours in healthy
volunteers and 14 to 15 hours in the target population. Tamsulosin
hydrochloride undergoes restrictive clearance in humans, with a relatively low systemic
clearance (2.88 L/h).

Specific Populations

Pediatric use

FLOMAX capsules are not indicated for use in pediatric
populations [see Use In Specific Populations].

Geriatric (Age) Use

Cross-study comparison of FLOMAX capsules overall
exposure (AUC) and half-life indicates that the pharmacokinetic disposition of
tamsulosin hydrochloride may be slightly prolonged in geriatric males compared
to young, healthy male volunteers. Intrinsic clearance is independent of
tamsulosin hydrochloride binding to AAG, but diminishes with age, resulting in
a 40% overall higher exposure (AUC) in subjects of age 55 to 75 years compared
to subjects of age 20 to 32 years [see Use In Specific Populations].

Renal impairment

The pharmacokinetics of tamsulosin hydrochloride have
been compared in 6 subjects with mild-moderate (30≤ CLcr <70
mL/min/1.73 m²) or moderate-severe (10≤ CLcr

<30 mL/min/1.73 m²) renal impairment and 6 normal
subjects (CLcr >90 mL/min/1.73 m²). While a change in the overall plasma
concentration of tamsulosin hydrochloride was observed as the result of altered
binding to AAG, the unbound (active) concentration of tamsulosin hydrochloride,
as well as the intrinsic clearance, remained relatively constant. Therefore,
patients with renal impairment do not require an adjustment in FLOMAX capsules
dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73
m²) have not been studied [see Use In Specific Populations].

Hepatic impairment

The pharmacokinetics of tamsulosin hydrochloride have
been compared in 8 subjects with moderate hepatic impairment (Child-Pugh’s
classification: Grades A and B) and 8 normal subjects. While a change in the
overall plasma concentration of tamsulosin hydrochloride was observed as the
result of altered binding to AAG, the unbound (active) concentration of
tamsulosin hydrochloride does not change significantly, with only a modest
(32%) change in intrinsic clearance of unbound tamsulosin hydrochloride.
Therefore, patients with moderate hepatic impairment do not require an
adjustment in FLOMAX capsules dosage. FLOMAX has not been studied in patients
with severe hepatic impairment [see Use In Specific Populations].

Drug Interactions

Cytochrome P450 inhibition

Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6

The effects of ketoconazole (a strong inhibitor of
CYP3A4) at 400 mg once daily for 5 days on the pharmacokinetics of a single
FLOMAX capsule 0.4 mg dose was investigated in 24 healthy volunteers (age range
23 to 47 years). Concomitant treatment with ketoconazole resulted in an
increase in the Cmax and AUC of tamsulosin by a factor of 2. 2 and 2.8,
respectively [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g.,
erythromycin) on the pharmacokinetics of FLOMAX have not been evaluated [see WARNINGS
AND PRECAUTIONS and DRUG INTERACTIONS].

The effects of paroxetine (a strong inhibitor of CYP2D6)
at 20 mg once daily for 9 days on the pharmacokinetics of a single FLOMAX
capsule 0.4 mg dose was investigated in 24 healthy volunteers (age range 23 to
47 years). Concomitant treatment with paroxetine resulted in an increase in the
Cmax and AUC of tamsulosin by a factor of 1.3 and 1.6, respectively [see WARNINGS
AND PRECAUTIONS and DRUG INTERACTIONS]. A similar increase in
exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive
metabolizers (EM). A fraction of the population (about 7% of Caucasians and 2%
of African Americans) are CYP2D6 PMs. Since CYP2D6 PMs cannot be readily identified
and the potential for significant increase in tamsulosin exposure exists when FLOMAX
0.4 mg is co-administered with strong CYP3A4 inhibitors in CYP2D6 PMs, FLOMAX
0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4
(e.g., ketoconazole) [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

The effects of concomitant administration of a moderate
CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of FLOMAX have not
been evaluated [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

The effects of co-administration of both a CYP3A4 and a
CYP2D6 inhibitor with FLOMAX capsules have not been evaluated. However, there
is a potential for significant increase in tamsulosin exposure when FLOMAX 0.4
mg is co-administered with a combination of both CYP3A4 and CYP2D6 inhibitors [see
WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Cimetidine

The effects of cimetidine at the highest recommended dose
(400 mg every 6 hours for 6 days) on the pharmacokinetics of a single FLOMAX
capsule 0.4 mg dose was investigated in 10 healthy volunteers (age range 21 to
38 years). Treatment with cimetidine resulted in a significant decrease (26%)
in the clearance of tamsulosin hydrochloride, which resulted in a moderate
increase in tamsulosin hydrochloride AUC (44%) [see WARNINGS AND PRECAUTIONS
and DRUG INTERACTIONS].

Other Alpha Adrenergic Blocking Agents

The pharmacokinetic and pharmacodynamic interactions
between FLOMAX capsules and other alpha adrenergic blocking agents have not
been determined; however, interactions between FLOMAX capsules and other alpha
adrenergic blocking agents may be expected [see WARNINGS AND PRECAUTIONS
and DRUG INTERACTIONS].

PDE5 Inhibitors

Caution is advised when alpha adrenergic blocking agents,
including FLOMAX, are co-administered with PDE5 inhibitors. Alpha-adrenergic
blockers and PDE5 inhibitors are both vasodilators that can lower blood
pressure. Concomitant use of these two drug classes can potentially cause
symptomatic hypotension [see WARNINGS AND PRECAUTIONS and DRUG
INTERACTIONS].

Warfarin

A definitive drug-drug interaction study between
tamsulosin hydrochloride and warfarin was not conducted. Results from limited in
vitro and in vivo studies are inconclusive. Therefore, caution should be
exercised with concomitant administration of warfarin and FLOMAX capsules [see
WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Nifedipine, Atenolol, Enalapril

In three studies in hypertensive subjects (age range 47
to 79 years) whose blood pressure was controlled with stable doses of
nifedipine, atenolol, or enalapril for at least 3 months, FLOMAX capsules 0.4
mg for 7 days followed by FLOMAX capsules 0.8 mg for another 7 days (n=8 per
study) resulted in no clinically significant effects on blood pressure and pulse
rate compared to placebo (n=4 per study). Therefore, dosage adjustments are not
necessary when FLOMAX capsules are administered concomitantly with nifedipine, atenolol,
or enalapril [see DRUG INTERACTIONS].

Digoxin And Theophylline

In two studies in healthy volunteers (n=10 per study; age
range 19 to 39 years) receiving FLOMAX capsules 0.4 mg/day for 2 days, followed
by FLOMAX capsules 0.8 mg/day for 5 to 8 days, single intravenous doses of
digoxin 0.5 mg or theophylline 5 mg/kg resulted in no change in the
pharmacokinetics of digoxin or theophylline. Therefore, dosage adjustments are
not necessary when a FLOMAX capsule is administered concomitantly with digoxin
or theophylline [see DRUG INTERACTIONS].

Furosemide

The pharmacokinetic and pharmacodynamic interaction
between FLOMAX capsules 0.8 mg/day (steady-state) and furosemide 20 mg
intravenously (single dose) was evaluated in 10 healthy volunteers (age range
21 to 40 years). FLOMAX capsules had no effect on the pharmacodynamics
(excretion of electrolytes) of furosemide. While furosemide produced an 11% to
12% reduction in tamsulosin hydrochloride Cmax and AUC, these changes are
expected to be clinically insignificant and do not require adjustment of the FLOMAX
capsules dosage [see DRUG INTERACTIONS].

Clinical Studies

Four placebo-controlled clinical studies and one
active-controlled clinical study enrolled a total of 2296 patients (1003 received
FLOMAX capsules 0.4 mg once daily, 491 received FLOMAX capsules 0.8 mg once
daily, and 802 were control patients) in the U.S. and Europe.

In the two U.S. placebo-controlled, double-blind,
13-week, multicenter studies (Study 1 [US92-03A] and Study 2 [US93-01]), 1486
men with the signs and symptoms of BPH were enrolled. In both studies, patients
were randomized to either placebo, FLOMAX capsules 0.4 mg once daily, or FLOMAX
capsules 0.8 mg once daily. Patients in FLOMAX capsules 0.8 mg once-daily treatment
groups received a dose of 0. 4 mg once daily for one week before increasing to
the 0.8 mg once-daily dose. The primary efficacy assessments included: 1) total
American Urological Association (AUA) Symptom Score questionnaire, which
evaluated irritative (frequency, urgency, and nocturia), and obstructive
(hesitancy, incomplete emptying, intermittency, and weak stream) symptoms,
where a decrease in score is consistent with improvement in symptoms; and 2)
peak urine flow rate, where an increased peak urine flow rate value over
baseline is consistent with decreased urinary obstruction.

Mean changes from baseline to Week 13 in total AUA
Symptom Score were significantly greater for groups treated with FLOMAX
capsules 0.4 mg and 0.8 mg once daily compared to placebo in both U.S. studies
(Table 3, Figures 2A and 2B). The changes from baseline to Week 13 in peak
urine flow rate were also significantly greater for the FLOMAX capsules 0.4 mg
and 0.8 mg once-daily groups compared to placebo in Study 1, and for the FLOMAX
capsules 0. 8 mg once-daily group in Study 2 (Table 3, Figures 3A and 3B). Overall
there were no significant differences in improvement observed in total AUA Symptom
Scores or peak urine flow rates between the 0.4 mg and the 0.8 mg dose groups with
the exception that the 0.8 mg dose in Study 1 had a significantly greater
improvement in total AUA Symptom Score compared to the 0.4 mg dose.

Table 3: Mean (±S.D.) Changes from Baseline to Week 13
in Total AUA Symptom Score* and Peak Urine Flow Rate (mL/sec)

	Total AUA Symptom Score		Peak Urine Flow Rate
	Mean Baseline Value	Mean Change	Mean Baseline Value	Mean Change
Study 1†
FLOMAX capsules 0.8 mg once daily	19. 9 ± 4.9 n=247	-9.6‡ ± 6.7 n=237	9.57 ± 2.51 n=247	1.78‡ ± 3.35 n=247
FLOMAX capsules 0.4 mg once daily	19.8 ± 5.0 n=254	-8.3‡ ± 6.5 n=246	9.46 ± 2.49 n=254	1.75‡± 3.57 n=254
Placebo	19.6 ± 4.9 n=254	-5.5 ± 6.6 n=246	9.75 ± 2.54 n=254	0.52 ± 3.39 n=253
Study 2 §
FLOMAX capsules 0.8 mg once daily	18.2 ± 5.6 n=244	-5.8‡ ± 6.4 n=238	9. 96 ±3.16 n=244	1.79‡ ± 3.36 n=237
FLOMAX capsules 0.4 mg once daily	17.9 ± 5.8 n=248	-5.1‡ ± 6.4 n=244	9.94 ±3.14 n=248	1.52 ± 3.64 n=244
Placebo	19.2 ± 6.0 n=239	-3.6 ± 5.7 n=235	9.95 ±3.12 n=239	0.93 ± 3.28 n=235
Week 13: For patients not completing the 13-week study, the last observation was carried forward. *Total AUA Symptom Scores ranged from 0 to 35. †Peak urine flow rate measured 4 to 8 hours post dose at Week 13. ‡Statistically significant difference from placebo (p-value ≤0. 050; Bonferroni-Holm multiple test procedure). §Peak urine flow rate measured 24 to 27 hours post dose at Week 13.

Mean total AUA Symptom Scores for both FLOMAX capsules
0.4 mg and 0.8 mg once-daily groups showed a rapid decrease starting at 1 week
after dosing and remained decreased through 13 weeks in both studies (Figures
2A and 2B).

In Study 1, 400 patients (53% of the originally
randomized group) elected to continue in their originally assigned treatment
groups in a double-blind, placebo-controlled, 40-week extension trial (138
patients on 0.4 mg, 135 patients on 0.8 mg, and 127 patients on placebo). Three
hundred twenty-three patients (43% of the originally randomized group) completed
one year. Of these, 81% (97 patients) on 0.4 mg, 74% (75 patients) on 0.8 mg, and
56% (57 patients) on placebo had a response ≥25% above baseline in total
AUA Symptom Score at one year.

Figure 2A: Mean Change from Baseline in Total AUA
Symptom Score (0–35) Study 1

* indicates significant difference from placebo (p-value ≤0.050).

B = Baseline determined approximately one week prior to
the initial dose of double-blind medication at Week 0.

Subsequent values are observed cases.

LOCF = Last observation carried forward for patients not
completing the 13-week study.

Note: Patients in the 0.8 mg treatment group received 0.4
mg for the first week.

Note: Total AUA Symptom Scores range from 0 to 35.

Figure 2B: Mean Change from Baseline in Total AUA Symptom
Score (0–35) Study 2

* indicates significant difference from placebo (p-value ≤0.050).

Baseline measurement was taken Week 0. Subsequent values
are observed cases.

LOCF = Last observation carried forward for patients not
completing the 13-week study.

Note: Patients in the 0.8 mg treatment group received 0.4
mg for the first week.

Note: Total AUA Symptom Scores range from 0 to 35.

Figure 3A: Mean Increase in Peak Urine Flow Rate
(mL/Sec) Study 1

* indicates significant difference from placebo (p-value ≤0.050).

B = Baseline determined approximately one week prior to
the initial dose of double-blind medication at Week 0.

Subsequent values are observed cases.

LOCF = Last observation carried forward for patients not
completing the 13-week study.

Note: The uroflowmetry assessments at Week 0 were
recorded 4 to 8 hours after patients received the first dose of double-blind
medication.

Measurements at each visit were scheduled 4 to 8 hours
after dosing (approximate peak plasma tamsulosin concentration).

Note: Patients in the 0.8 mg treatment groups received
0.4 mg for the first week.

Figure 3B: Mean Increase in Peak Urine Flow Rate
(mL/Sec) Study 2

* indicates significant difference from placebo (p-value ≤0.050).

Baseline measurement was taken Week 0. Subsequent values
are observed cases.

LOCF = Last observation carried forward for patients not
completing the 13-week study.

Note: Patients in the 0.8 mg treatment group received 0.4
mg for the first week.

Note: Week 1 and Week 2 measurements were scheduled 4 to
8 hours after dosing (approximate peak plasma tamsulosin concentration).

All other visits were scheduled 24 to 27 hours after
dosing (approximate trough tamsulosin concentration).

Flomax (tamsulosin) dosing, indications, interactions, adverse effects, and more

Tamsulosin Dosage: What’s Right for Me?

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

Tamsulosin is available in generic form or as the brand name medication Flomax. It is prescribed for benign prostatic hyperplasia (BPH), more popularly—and infamously—known as an enlarged prostate.

Always follow your healthcare provider’s advice about taking tamsulosin. Below are the general recommendations regarding tamsulosin dosage.

• Tamsulosin (brand name Flomax) is a medication that’s FDA approved to treat benign prostatic hyperplasia (BPH), also known as an enlarged prostate.
• The recommended starting dose of tamsulosin is 0.4 mg daily.
• Your healthcare provider may increase your dosage after two to four weeks of consistent use.
• Never change your dosage of tamsulosin without consulting with your healthcare provider.

The recommended starting dose of tamsulosin (or tamsulosin hydrochloride) is 0.4 mg once a day. It should be taken 30 minutes after the same meal each day. Tamsulosin should be swallowed whole. Don’t crush, chew, or open tamsulosin capsules. If tamsulosin 0.4 mg doesn’t work for you after two to four weeks of consistent use, your healthcare provider might increase your dosage (DailyMed, 2020)

Suppose you need to discontinue tamsulosin for several days. In that case, your healthcare provider will likely restart you at the 0.4 mg dose, regardless of whether you had been taking a higher dose before stopping (DailyMed, 2020). You may experience significant low blood pressure (hypotension) when you begin retaking the medication, which is why it is usually restarted at the lowest dose.

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You should store tamsulosin at room temperature and not in areas with high heat or moisture (like the bathroom). In the event of a missed dose, take the medication as soon as possible, unless it’s almost time for your next dose. In that case, take the next dose as scheduled. Never take two doses of tamsulosin at once (MedlinePlus, 2018).

Most prescription plans cover tamsulosin. The cost of a 30-day supply ranges between $9 to $35 (GoodRx, n.d.).

Tamsulosin is used to treat the symptoms of benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate. BPH can cause urinary retention and other potentially uncomfortable symptoms.

Tamsulosin is part of a class of drugs known as alpha-blockers. It relaxes muscles in the prostate and bladder. This relaxation improves both the flow of urine and BPH symptoms.

Tamsulosin is also prescribed “off-label” for (UpToDate, n.d.):

• chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) 
• kidney stones in the urethra—by relaxing urethra muscles, tamsulosin can help dislodge those stones, allowing them to pass during urination

Tamsulosin (Flomax) warnings: be aware of these issues

5 minute read

As men age, the prostate naturally increases in size. For some men, this can put pressure on the urethra and bladder, partially obstructing the flow of urine and causing symptoms. 

Common symptoms of BPH include:

• Greater need to urinate
• Frequent nighttime urination
• Difficulty urinating 
• Straining while urinating
• Frequent starting and stopping of urination
• Weak urine stream
• Trouble starting urination

BPH is a common condition. Experts estimate that about half of all men between the ages of 51 and 60 are affected by BPH (AUA, 2020). In men older than 60, that number rises to above 70 percent and 90 percent in men over age 80 (Narayan, 2005; AUA, 2020). Since BPH and prostate cancer often exist together, talk to your healthcare provider about prostate cancer screening before starting treatment and at regular intervals afterward.

Urinary retention is the inability to empty your bladder fully; it’s often caused by BPH. Urinary retention can also be caused by prostatitis (inflammation of the prostate), urinary tract infections, urinary stones, and scars or tumors that block urine outflow (NIDDK, 2019).

Tamsulosin works by relaxing the smooth muscles in the prostate and bladder, making urination easier.

Tamsulosin (Flomax) interactions: what you need to know

4 minute read

Studies indicate that tamsulosin is generally safe and well-tolerated for long-term use (Narayan, 2005). However, like all medications, you might experience side effects while on tamsulosin, which can range from mild to severe. These side effects include (DailyMed, 2020):

• Orthostatic hypotension: low blood pressure and symptoms of dizziness/lightheadedness or fainting (syncope) when standing up after sitting. This is more likely to occur after taking your first dose or an increased dose.
• Headache
• Dizziness
• Abnormal ejaculation, including retrograde ejaculation 
• Runny nose or stuffy nose (rhinitis)
• Drowsiness
• Diarrhea
• Nausea
• Back pain
• Chest pain
• Intraoperative floppy iris syndrome (IFIS), a complication during cataract surgery or glaucoma surgery
• Priapism, a painful erection lasting four or more hours

Tell your healthcare provider about any other drugs you’re taking before starting tamsulosin, including prescription drugs, over-the-counter medications, and supplements. Potential drug interactions with tamsulosin include (DailyMed, 2020):

CYP3A4 and CYP2D6 are two enzymes that help the liver metabolize tamsulosin. Any drug that blocks or inhibits CYP3A4 and CYP2D6 can increase the concentration of tamsulosin in the body. Examples include cimetidine, ketoconazole, erythromycin, terbinafine, and paroxetine. If you’re taking those drugs, your healthcare provider may adjust your dose of tamsulosin to avoid potential adverse effects.

Phosphodiesterase-5 (PDE5) inhibitors are oral medications commonly used to treat erectile dysfunction (ED). They include sildenafil (brand name Viagra), tadalafil (brand name Cialis), vardenafil (brand name Levitra), and avanafil (brand name Stendra). Like tamsulosin, PDE5 inhibitors work by dilating blood vessels to improve blood flow into the penis. This also has the effect of lowering your blood pressure. Therefore, taking both tamsulosin and PDE5 inhibitors may cause your blood pressure to drop too low (hypotension). 

This is not a complete list. Talk to your healthcare provider or pharmacist for more information about potential drug interactions with tamsulosin.

People with certain medical conditions should be careful when using tamsulosin or even avoid it altogether. Tamsulosin is not approved for use in women. Consult with your healthcare provider for additional information. 

Since one of the side effects of tamsulosin is a drop in blood pressure, use tamsulosin with caution if you have low blood pressure or positional blood pressure changes, like orthostatic hypotension. Tamsulosin could potentially worsen already low pressures, especially after starting or increasing your dose.

Tamsulosin may affect your iris, leading to intraoperative floppy iris syndrome (IFIS) that may be noted during cataract surgery or glaucoma surgery. Avoid starting tamsulosin if you’re planning to have cataract or glaucoma surgery. Tell your healthcare provider if you’ve taken tamsulosin in the months preceding any scheduled surgery; IFIS has occurred even when tamsulosin was discontinued months before those eye procedures.

Tamsulosin may worsen existing heart failure.

Some people who are allergic to drugs in the sulfonamide (sulfa) class may also have an allergic reaction to tamsulosin (e.g., skin rash, swelling, trouble breathing, etc.). If you are allergic to sulfa drugs, make sure your healthcare provider knows about it, and use tamsulosin with caution. 

This list does not include all tamsulosin warnings. Seek medical advice from your healthcare provider or pharmacist for more drug information.

See more

Dutasteride and Tamsulosin | Memorial Sloan Kettering Cancer Center

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Jalyn

Brand Names: Canada

Jalyn

What is this drug used for?

• It is used to treat the signs of an enlarged prostate.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this drug.
• If you are female. This drug is not approved for use in females. This drug may cause harm to an unborn baby if it is taken during pregnancy. Talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

Children:

• If the patient is a child. This drug is not approved for use in children.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not donate blood while using this drug and for 6 months after stopping.
• In one trial of dutasteride for prostate cancer, a serious form of prostate cancer was seen more often in people taking dutasteride than in those who were not. Talk with your doctor.
• Pregnant females or females who may be pregnant must not touch the capsules. If one of these females touches a leaking capsule, the area must be washed right away with soap and water.
• If you are having cataract surgery or other eye procedure, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check your blood pressure as you have been told.
• Have a rectal exam (to check prostate gland) and blood work (PSA test). Talk with your doctor.
• If you have a sulfa (sulfonamide) allergy, talk with your doctor.
• This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
• Talk with your doctor before you drink alcohol.
• This drug may affect sperm. This may affect being able to father a child. Talk with the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Enlarged breasts.
• Low mood (depression).
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Runny nose.
• This drug may cause lowered interest in sex, ejaculation problems, or trouble getting or keeping an erection. This could go on after you stop this drug. Talk with your doctor if these effects go on or bother you.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
• Take 30 minutes after the same meal every day.
• Swallow whole. Do not chew, open, or crush.
• Do not take or touch the capsule if it is deformed, changes color, or is leaking.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, after a meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss taking this drug for a few days in a row, call your doctor before you start taking it again.

How do I store and/or throw out this drug?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2021-01-19

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Urinary Retention | Loma Linda University Health

Urinary Retention

WHAT IS URINARY RETENTION?

Urinary retention is the inability to completely empty the bladder when urinating.

From the moment you contact Loma Linda University Health, we do everything we can to make sure your treatment for urinary retention runs smoothly. Our goal is to make your experience as convenient, comfortable and stress-free as possible.

WHAT ARE THE SYMPTOMS OF URINARY RETENTION?

Some of the symptoms of urinary retention include:

• A poor or weak stream when urinating
• An intermittent flow when urinating
• Straining to urinate
• Feeling like you still have urine in your bladder even after you’ve urinated
• Needing to get up frequently at night to urinate
• Inability to urinate
• Lower abdominal pain
• Loss of bladder control

WHAT CAUSES URINARY RETENTION?

Urinary retention can be caused by a number of things, including:

• A weak bladder
• A  blockage in the urethra, caused by:
  • Constipation
  • Kidney stones
  • A cystocele
  • A tumor
• Nerve problems, caused by:
  • Diabetes
  • Stroke
  • Heavy metal poisoning
  • Spinal cord injuries
  • Parkinson’s disease

Researchers know that urinary retention is not just a “normal part of aging.” People who are experiencing symptoms should seek a medical evaluation.

HOW IS URINARY RETENTION DIAGNOSED?

Urinary retention is diagnosed in several different ways, including:

• A medical history and examination
• An ultrasound of the bladder
• A diagnosis of urinary retention after urinating
• A cystoscopy
• An MRI

HOW IS URINARY RETENTION TREATED?

For men, urinating in a sitting position may be helpful in reducing urinary retention. Additionally, there are a variety of medical interventions for treating urinary retention in both women and men.

Tamsulosin, finasteride, and dutasteride – When a mild case of benign prostatic hyperplasia (BPH, also known as prostate gland enlargement) is causing the urinary retention, some patients may be treated with these medications. Tamsulosin is designed to relax smooth muscles in the bladder neck, and finasteride and dutasteride are prescribed to decrease prostate enlargement.

Prostatic stents or suprapubic cystostomy – In acute urinary retention, placement of a prostatic stent or suprapubic cystostomy can relieve the retention.

Catheters – Acute urinary retention may be treated by placement of a urinary catheter (small thin flexible tube) into the bladder.

Alpha-blockers – Alpha-blockers may be used to provide relief of urinary retention following de-catheterization for both men and women.

Transurethral resection – In most patients with benign prostate hyperplasia (BPH), a procedure known as transurethral resection of the prostate (TURP) may be performed to relieve bladder obstruction.

Open Prostatectomy – This is the surgical removal of the prostate gland done under a general or spinal anesthetic.

WHAT ARE THE COMPLICATIONS OF URINARY RETENTION?

If left untreated, urinary retention could lead to:

• Stretching of the bladder
• Tearing of the bladder
• Constant dull pain
• Incontinence
• Nocturia (the need to make frequent nightly trips to the bathroom)
• Urine traveling into the kidneys
• Kidney failure
• Sepsis
• Acute urinary retention

Acute urinary retention is a medical emergency and must be treated immediately. If left untreated, it may lead to:

• Sweating
• Anxiety
• High blood pressure
• Pain, including chest pain
• Shock
• Kidney failure

WHO IS AT RISK FOR URINARY RETENTION?

Those at the greatest risk of suffering from urinary retention include:

• Men more than women
• Young, sexually active men
• People over the age of 50
• Those who suffer from shy bladder
• Men with benign prostatic hyperplasia (BPH)
• Men due to prostate issues
• Those who take NSAIDs or drugs with anticholinergic properties
• Those who suffer from substance abuse
• Those who have suffered certain muscle damage
• Those who have suffered neurological damage
• Those who go under general or spinal anesthesia
• Those who are being operated on for longer than 2 hours
• Those with Parkinson’s disease
• Those with cancer of any part of the urinary system

NEXT STEPS

• Stay aware. Both men and women in a wide age range are in the risk category for urinary retention. Stay aware of the symptoms of this condition and seek medical intervention immediately if you begin experiencing them.  
• Seek medical intervention. If left untreated, urinary retention can lead to more serious complications. To request an evaluation at Loma Linda University Health for urinary retention symptoms, contact your provider or schedule the appointment through MyChart.

People’s Pharmacy: Should a woman take a man’s prostate drug?

By Joe Graedon, M.S., and Teresa Graedon, Ph.D.

King Features Syndicate

Q. My family doctor has prescribed tamsulosin for frequent urination at night. I am a 75-year-old woman, and after reading about the side effects of this drug, I am concerned.

I can live with the frequent nightly nuisance, but it would be nice not to get up quite so often. What is your opinion on this?

A. Our first reaction was that tamsulosin (Flomax) is approved only for men with enlarged prostate glands and not for women. Upon searching, however, we found that tamsulosin has been studied and found helpful for reducing excessive nighttime urination in women (Urology Journal, May-June 2014).

The side effects of this medication vary in severity. Some, such as fatigue or drowsiness, might not be a problem since you are taking it at night. You will have to determine whether others, such as dizziness, sore throat, back pain and runny nose, pose a problem for you.

If you already have had cataract operations, one serious side effect won’t be relevant. But if you may need to have cataracts removed in the future, you might want to forgo the drug. It makes the iris floppy, complicating cataract procedures. This reaction appears to be irreversible.

Q. I recently filled a zolpidem prescription and was given a generic from an unfamiliar company. When I took it, I was unable to sleep. I felt agitated, and my restless legs syndrome was almost unbearable.

I don’t take zolpidem frequently, but I have used it occasionally over a number of years. This experience was jolting.

I would like to send these pills out for testing. Is there a lab that could analyze them?

A. Sadly, the cost of having your generic zolpidem pills analyzed would probably be exorbitant. The Food and Drug Administration rarely runs tests itself on generic drugs. Usually it relies on the manufacturer to submit such data.

We have heard from dozens of other readers who also have had trouble with some generic versions of zolpidem. This is just one example of similar complaints found on our website:

“I have been taking name-brand Ambien for 10 years. When I began, my copay was $50. Now it is $110, and my physician has to get prior approval for me to have the name brand.

“I have twice been given a generic by mistake and had a horrible experience. I could not sleep and had hallucinations and anxiety.

“Both times I called the pharmacy and found the prescription had been filled with generic even though I was charged for the name brand. I would NEVER knowingly take a generic again.”

Q. You’ve written about ketamine for hard-to-treat depression. Can ketamine be used for a few weeks while another, more standard, antidepressant is added? This would seem to offer the benefit of a quick-acting drug to prevent suicide until the other drug kicks in.

A. You offer an intriguing idea. Animal research suggests this may be a viable option, though it is not yet being offered in clinics (Translational Psychiatry, May 2015).

We have more information about ketamine, other antidepressants and nondrug approaches in our Guide to Dealing With Depression. Anyone who would like a copy, please send $3 in check or money order with a long (No. 10), stamped (68 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. E-7, P.O. Box 52027, Durham, NC 27717-2027. It also can be downloaded for $2 from our website: www.peoplespharmacy.com.

In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of this newspaper or email them via their Web site: www.PeoplesPharmacy.com. Their newest book is “Top Screwups Doctors Make and How to Avoid Them.”

Tamsulosin Sandoz SR – NPS MedicineWise

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Tamsulosin Sandoz SR.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet with the medicine.
You may need to read it again.

WHAT TAMSULOSIN SANDOZ SR IS USED FOR

Tamsulosin Sandoz SR is for use by men only.

This medicine is used for the relief of lower urinary tract symptoms (LUTS) associated with a condition called benign prostatic hyperplasia (BPH). BPH is NOT prostate cancer. BPH is a condition where your prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine. This can lead to symptoms such as:

• weak or interrupted stream of urine
• delay before you start to pass urine, and you have to strain to do so.
• feeling that you cannot empty your bladder completely
• may dribble at the end of passing urine.
• needing to pass urine often, especially at night
• feeling that you must pass urine right away.

BPH occurs only in men and is common over the age of 50 years. In some men, BPH can lead to serious problems, including urinary tract infections and the sudden inability to pass urine at all.

This medicine contains the active ingredient tamsulosin hydrochloride. Tamsulosin hydrochloride belongs to a group of medicines called alpha-blockers.

Tamsulosin Sandoz SR works by helping relax the smooth muscles in the prostate, in that way it improves the flow of urine, thus relieving the pain when passing urine.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

BEFORE YOU TAKE TAMSULOSIN SANDOZ SR

When you must not take it

Do not take this medicine if you have an allergy to:

• tamsulosin hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
• any other alpha-blockers

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take this medicine if you are a woman or a child. Tamsulosin Sandoz SR is for use in men only.

Do not take this medicine if you have or have had any of the following medical conditions:

• severe liver problems
• severe kidney problems
• feeling dizzy or light-headedness when you sit up or stand abruptly. This is a common symptom of a condition called orthostatic hypotension which is an excessive decrease in blood pressure that occurs when a person stands up, resulting in reduced blood flow to the brain and dizziness or fainting.
• are taking other medication which relaxes the smooth muscle of blood vessels (some of the tradenames are Minipress, Prasig and Hytrin.

Do not take this medicine if you are taking another alpha-blocker.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Use Tamsulosin Sandoz SR only if your doctor has prescribed it for you.

All medicines have benefits and risks. In deciding to prescribe Tamsulosin Sandoz SR for you, your doctor has weighed the risk of taking Tamsulosin Sandoz SR against the benefit it is expected to have for you.

Your doctor has prescribed Tamsulosin Sandoz SR for BPH. Tamsulosin Sandoz SR does not treat prostate cancer. BPH and prostate cancer may have similar symptoms. A man can have prostate cancer and BPH at the same time. You should be checked for prostate cancer before you start Tamsulosin Sandoz SR. It is recommended that men be checked for prostate cancer once a year, from 50 years of age onwards. These checks should continue while you are on Tamsulosin Sandoz SR.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• dizziness and lightheadedness (low blood pressure)
• heart attack or chest pain, feeling of tightness, pressure or heaviness in the chest (angina pectoris) during the last six months
• are allergic to Tamsulosin Sandoz SR (or any of the ingredients (see ‘Ingredients’)
• have high, or low blood pressure, or your blood pressure is controlled by medication
• have had ejaculation problems
• are suffering from any other illness
• have had allergies to sulfa or any other medications
• have had or planning to have cataract or glaucoma surgery
• you previously have taken any other similar medicine in the same class as Tamsulosin Sandoz SR.

If you have not told your doctor about any of the above, tell him/her before you start taking Tamsulosin Sandoz SR.

Your doctor will discuss the risks and benefits of using Tamsulosin Sandoz SR.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Tamsulosin Sandoz SR may interfere with each other. These include:

• cimetidine, a medicine generally used to treat stomach ulcers or reflux
• diuretic medicines used to treat high blood pressure such as frusemide
• h3 antagonists or h3 blockers, a class of medicines used to treat stomach ulcer, reflux or heartburn such as cimetidine.

These medicines may be affected by Tamsulosin Sandoz SR or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE TAMSULOSIN SANDOZ SR

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

The standard dose for this medicine is one tablet daily.

Patients with severe liver problems should not take these tablets.

Patients with severe kidney problems should not take these tablets.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.

Follow the instructions they give you.
If you take the wrong dose, Tamsulosin Sandoz SR may not work as well and your problem may not improve.

How to take it

Swallow the tablet whole with a full glass of water.

Do not break, chew, crunch or dissolve the tablets.
These tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines, where they can start to work. If you chew them, the coating is destroyed.

When to take Tamsulosin Sandoz SR

Take your medicine at about the same time each day.

Tamsulosin Sandoz SR can be taken on an empty stomach, or before, with or after food.

How long to take Tamsulosin Sandoz SR

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

If you miss a whole day, continue to take your normal daily dose the next day.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 088 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Tamsulosin Sandoz SR. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

Symptoms of an overdose may include vomiting, diarrhoea. Low blood pressure may also occur, leading to dizziness, lightheadedness and fainting. Medical attention should be sought immediately.

WHILE YOU ARE TAKING TAMSULOSIN SANDOZ SR

Things you must do

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Tamsulosin Sandoz SR.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think it is not working effectively and change your treatment unnecessarily.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.

If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken Tamsulosin Sandoz SR.

(See ‘Side Effects’)

Things you must not do

Do not take Tamsulosin Sandoz SR to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery while taking Tamsulosin Sandoz SR.
This medicine may cause dizziness in some people. If you feel dizzy do not drive, operate machinery or do anything else that could be dangerous.

If you feel dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tamsulosin Sandoz SR.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• changes or problems with ejaculation (retrograde ejaculation). Retrograde ejaculation is a condition described as abnormal ejaculation in which semen is ejaculated backward into the bladder rather than out through the penis. Retrograde ejaculation is painless.
• dizziness
• constipation, diarrhoea, nausea, vomiting, dry mouth
• insomnia
• headache
• fast heart beats
• unusual weakness
• blocked nose
• nose bleed
• skin rash, itchiness
• hives (pinkish, itchy swellings on the skin)
• fainting
• blurred vision or visual impairment
• inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals

Tamsulosin Sandoz SR can occasionally cause people to feel faint and dizzy. You should get up slowly from the sitting or lying position to reduce the risk of dizziness or lightheadedness. If you do feel faint on standing up, you should lie down for a short while. If the dizziness persists you should contact your doctor. You must not drive a car or operate machinery if you feel dizzy.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• persistent painful erection of the penis which occurs without sexual arousal
• skin rash, itchiness or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.

These are symptoms of an allergic reaction. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.

Tell your doctor if you notice any other effects or if the unwanted effects are particularly bothersome.

You should always tell your doctor about any problems you have whilst taking Tamsulosin Sandoz SR.

If you are having an operation on your eyes because of cataracts or glaucoma and are already taking or have taken Tamsulosin Sandoz SR, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This can be managed if your surgeon knows before carrying out the operation. If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken Tamsulosin Sandoz SR.

AFTER TAKING TAMSULOSIN SANDOZ SR

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Tamsulosin Sandoz SR or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Note the expiry date on the pack. Do not use after this expiry date.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Tamsulosin Sandoz SR 400mcg – brown, round, biconvex modified release tablets with debossing ‘0.4’ on one side and ‘SZ’ on the other side.

Available in blister packs of 10 and 30 tablets.

Ingredients

Active ingredients:

• Tamsulosin Sandoz SR 400mcg – 400mcg tamsulosin hydrochloride.

Inactive ingredients:

Excipients core:

• cellulose – microcrystalline
• hydroxypropyl cellulose
• polyethylene oxide
• butylated hydroxytoluene
• magnesium stearate
• silica – colloidal anhydrous.

Excipients coating:

• hypromellose
• hyprolose macrogol 400
• titanium dioxide
• purified talc
• quinoline yellow
• cochineal
• iron oxide black.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in April 2019.

Australian Register Number:

Tamsulosin Sandoz SR 400mcg modified release tablets: AUST R 196007 (blisters)

Published by MIMS June 2019

Tamsulosin in Combined Pharmacotherapy of Lower Urinary Tract Symptoms | V. V. Iremashvili

Preparations from the a1-blocker group are currently the most important component of the treatment of one of the most common diseases of elderly men – benign prostatic hyperplasia. The history of the development and introduction into clinical practice of these drugs is a good example of what factors determine the development of a particular scientific direction.

The first step towards studying a-blockers as a treatment for benign hyperplasia was an experimental study that showed that the smooth muscle elements of the prostate gland contract under the influence of norepinephrine, which mainly binds to a-adrenergic receptors [1]. These data became a prerequisite for the study of the clinical efficacy of the irreversible a-blocker phenoxybenzamine in the treatment of urinary disorders caused by benign prostatic hyperplasia.Although this drug improved urination, its use was accompanied by the development of a large number of side effects [2]. This, as well as data on the predominance of the activity of a1-adrenergic receptors in the prostate gland [3,4], forced researchers to look for safer and more selective drugs. The first of these drugs was prazosin, a selective short-acting a1-blocker. Despite the higher tolerance compared to phenoxybenzamine, this drug was short-acting, which greatly complicated its clinical use (patients had to take several doses of the drug per day) [5].Drugs of the next generation are characterized by significantly greater ease of use: long-acting a1-blockers – terazosin and doxazosin [6,7]. At the same time, these drugs are not ideal either. When prescribing them, it is necessary to titrate the dose in order to avoid the development of a dangerous side effect – orthostatic hypotension. This problem was solved with the advent of tamsulosin, a new drug from this group, which is characterized by selectivity for the alpha-subtype a1-adrenergic receptors, which explains the lower likelihood of developing hypotension during treatment and, as a consequence, no need for dose titration [8] …Tamsulosin is the only drug from this group that was developed specifically for the treatment of urinary disorders and has not been previously used in the pharmacotherapy of hypertension. It is to this drug that this literature review will be devoted.
Interestingly, after the appearance of another a1-adrenergic blocker, the use of which does not require titration – alfuzosin with sustained release [9], new drugs from this group did not appear on the market. Preliminary studies of other active substances have not demonstrated their higher efficacy compared to already existing a-blockers, and further development has been discontinued [10].
Tamsulosin is a competitive antagonist of a1A-adrenergic receptors. To date, the existence of three subtypes of a1-adrenergic receptors – A, B and D – has been confirmed, and in the prostate gland, subtype A receptors account for 70% of the total [11]. The bioavailability of tamsulosin is about 90%, and a stable concentration in the blood with daily intake is achieved in an average of 5 days. The main site of tamsulosin metabolism is the liver; enzymes from the cytochrome group play an important role in this process.Some of the most common side effects of tamsulosin include nasal congestion, headaches, and ejaculation problems.
The pharmacological characteristics of tamsulosin are of great clinical importance. This drug has selectivity for the most important receptor subtype in terms of action on the smooth muscle tissue of the urinary tract. This ensures its better tolerance and fewer side effects, which will be discussed below. In addition, the absence of a significant effect on the cardiovascular system avoids titration of the tamsulosin dose.Thus, the maximum clinical effect from its use is achieved rather quickly.
The optimal dosage regimen of tamsulosin was analyzed in a study that compared the effectiveness of this drug in doses of 0.2, 0.4 and 0.6 mg [12]. ¬After 1 month of treatment, it was found that improvements, assessed both clinically and according to uroflowmetry, were most pronounced among patients who received doses of 0.4 and 0.6 mg.
The clinical efficacy of tamsulosin in its standard dose (0.4 mg 1 time per day) has been thoroughly studied in several multicenter, randomized, placebo-controlled, double-blind studies conducted in Europe and North America and included a total of more than 1300 patients [8, 13-15].After 3 months of treatment with tamsulosin, all studies showed a decrease in the severity of urination disorders, assessed using different questionnaires, in the range from 39 to 48%, as well as an increase in the volumetric urinary flow rate by 1.4–2.2 ml / s. In all cases, these indicators were significantly higher than those among those who received placebo [8,13-15]. Patients taking tamsulosin did not differ significantly from those who received placebo in terms of the nature and frequency of side effects (with the exception of a higher incidence of ejaculation disorders among those taking tamsulosin).Of particular note is the fact that when taking tamsulosin, there was practically no dizziness, one of the most common side effects of other widely used drugs from the a1-blocker group – doxazosin and terazosin. In addition, the rate of refusal to continue treatment due to the development of side effects among those who received tamsulosin was significantly lower compared with similar indicators in studies of the clinical efficacy and tolerability of doxazosin and terazosin [16].Subsequently, an analysis of the effectiveness and tolerability of tamsulosin was carried out when it was taken for 1 year or more. In general, these studies confirmed the long-term nature of the efficacy and safety of tamsulosin as a drug for the pharmacotherapy of benign prostatic hyperplasia [16].
Classical manifestations of benign hyperplasia, along with urinary difficulties caused by bladder outlet obstruction, thinning of the urine stream and intermittent urination, are also increased frequency of urination (both day and night – nocturia) and urgent (irrepressible) urge to urinate, often reaching the degree of incontinence.These manifestations are considered a consequence of functional changes in the detrusor, the muscular component of the bladder. Traditionally, the development of such changes was usually explained by the hypertrophy of the bladder wall caused by the need to overcome the increased resistance to urine flow due to bladder obstruction. This concept, however, is not universal: in many elderly men, the severity of such disorders does not correlate with the severity of bladder obstruction; moreover, they often persist even after the latter is removed by surgery [17].
In addition, data gradually began to accumulate that urination disorders characteristic of benign prostatic hyperplasia are quite common in men who do not suffer from prostatic hyperplasia, as well as in women. In these groups, this disorder is called overactive bladder syndrome. Currently, this term is understood as a combination of clinical symptoms such as urge to urinate, urge incontinence and increased frequency of urination (more than 8 during the day, more than 1 during the night) [18].The main pathophysiological mechanism of the development of an overactive bladder is the increased excitability of the detrusor, manifested by involuntary contractions of the latter during the period of filling of the bladder. The incidence of overactive bladder is closely related to age, while it is approximately the same in similar age groups among men and women [19].
The existence of such disorders in the absence of bladder outlet obstruction, combined with the data that the elimination of the latter often does not have a significant effect on this complex of clinical manifestations, suggests that, at least in some men with benign prostatic hyperplasia, the symptoms of an overactive bladder are not associated with the presence of the latter [17].In other words, in some patients, enlargement of the prostate gland and increased urinary frequency only accompany each other and do not reveal any causal relationship between themselves. In addition, it can be assumed that in many patients with classical manifestations of benign prostatic hyperplasia, the symptoms of an overactive bladder, although they are a consequence of hypertrophy of the wall of the latter, caused by bladder obstruction, become so pronounced that a simple elimination of the disturbance of the urine flow is no longer enough to completely normalize urination. [twenty].Obviously, in such patients, in order to achieve the maximum clinical effect, it is necessary to influence not only the bladder outlet obstruction (using, for example, tamsulosin), but also the bladder itself. This can be achieved as a result of the use of drugs that suppress the activity of detrusor smooth muscle tissue. Among such agents, M-anticholinergics are currently most often used, which act on the bladder by preventing the contact of acetylcholine with its muscarinic-type receptors (for this effect, the effect on the 2nd and 3rd types of receptors is of greatest importance) located on the smooth muscle cells of the urinary bubble [21].
Many older men, along with lower urinary tract symptoms, also note problems with erectile function [22]. This relationship is so pronounced that it cannot be explained only by the fact that both of these disorders occur in similar age groups. Currently, the pathophysiological nature of the relationship between erectile dysfunction and lower urinary tract symptoms / benign prostatic hyperplasia has not been completely established, however, several theories are circulating, including impaired synthesis and / or decreased activity of nitric oxide NO, impaired function of the autonomic nervous system, as well as atherosclerosis. vessels of the small pelvis [23].From a clinical point of view, the existence of such a correlation leads to the fact that many patients with lower urinary tract symptoms also take drugs for the treatment of erectile dysfunction, phosphodiesterase type 5 inhibitors [24]. The mechanism of action of this group of drugs is associated with an increase in the effects of nitric oxide NO, which in the corpora cavernosa leads to increased blood flow and promotes the development of an erection. At the same time, it was noticed that taking these drugs also has a beneficial effect on urination, reducing the severity of symptoms of the lower urinary tract.Clinical studies have confirmed the existence of similar effects in all three currently available phosphodiesterase type 5 inhibitors: sildenafil, tadalafil, and vardenafil [25–27]. Interestingly, these drugs, while improving the clinical picture, do not affect the volumetric urinary flow rate, which may indicate the bladder as the object of their influence.
At the same time, it is known that a1-blockers can have a beneficial effect on erectile function [24]. In particular, drugs from this group were previously widely used as injections in the treatment of erectile dysfunction.Despite the fact that the effect of oral forms of a1-blockers on the corpora cavernosa is much less pronounced, it still exists [28].
All these data indicate that the combination of phosphodiesterase inhibitors and a1-blockers in patients with a combination of erectile dysfunction and lower urinary tract symptoms may increase the effectiveness of each of the components of treatment on the corresponding disorders, that is, be clinically justified. However, considering such a therapeutic tactic, one should not forget about the possibility of potentiating side effects, first of all, lowering blood pressure, which is a complication characteristic of drugs from both groups.This issue has been studied in several studies, which showed that the simultaneous administration of the phosphodiesterase 5 inhibitor tadalafil and various a1-blockers (doxazosin, tamsulosin and alfuzosin) was accompanied by a significant decrease in blood pressure only in the case of doxazosin [29]. These data are quite expected, in light of the above discussed safety of tamsulosin in relation to its action on the cardiovascular system, due to its pharmacological selectivity.
Unfortunately, there is currently no data on the effectiveness of the combined use of tamsulosin and drugs from the group of phosphodiesterase type 5 inhibitors.Nevertheless, in our opinion, the information presented above, as well as the results of the first studies of the effectiveness of a combination of type 5 phosphodiesterase inhibitors with other a1-blockers [30], allow us to expect that in the future such a combination may take an important place in the arsenal of treatment of patients with a combination of erectile dysfunction and urinary disorders.
Thus, tamsulosin (Taniz-K and others) is a highly effective a1-blocker for the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia.The high pharmacological selectivity of the action of tamsulosin determines the clinical safety of this drug and makes it convenient for practical use.

Literature
1. Caine M, Raz S, Zeigler M. Adrenergic and cholinergic receptors in the human prostate, prostatic capsule and bladder neck. Br J Urol 1975; 47: 193-202.
2. Caine M, Perlberg S, Meretyk S. A placebo – controlled double – blind study of the effect of phenoxybenzamine in benign prostatic obstruction.Br J Urol 1978; 50: 551-4.
3. Lepor H, Shapiro E. Characterization of alpha1 adrenergic receptors in human benign prostatic hyperplasia. J Urol 1984; 132: 1226-9.
4. Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha – 1 blockade in prostatic hyperplasia. Urology 1988; 32: 21-6.
5. Kirby RS, Coppinger SW, Corcoran MO, Chapple CR, Flannigan M, Milroy EJ. Prazosin in the treatment of prostatic obstruction. A placebo – controlled study.Br J Urol 1987; 60: 136–42.
6. Lepor H, Auerbach S, Puras-Baez A, et al. A randomized, placebo – controlled multicenter study of the efficacy and safety of terazosin in the treatment of benign prostatic hyperplasia. J Urol 1992; 148: 1467-74.
7. Fawzy A, Braun K, Lewis GP, Gaffney M, Ice K, Dias N. Doxazosin in the treatment of benign prostatic hyperplasia in normotensive patients: a multicenter study. J Urol 1995; 154: 105-9.
8. Lepor H. Phase III multicenter placebo – controlled study of tamsulosin in benign prostatic hyperplasia.Tamsulosin Investigator Group. Urology 1998; 51: 892-900.
9.van Kerrebroeck P, Jardin A, Laval KU, van Cangh P. Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia. ALFORTI Study Group. Eur Urol 2000; 37: 306-13.
10. Lepor H. The evolution of alpha – blockers for the treatment of benign prostatic hyperplasia. Rev Urol 2006; 8 Suppl 4: S3-9.
11. Roehrborn CG, Schwinn DA. Alpha1 – adrenergic receptors and their inhibitors in lower urinary tract symptoms and benign prostatic hyperplasia. J Urol 2004; 171: 1029-35.
12. Abrams P, Speakman M, Stott M, Arkell D, Pocock R. A dose – ranging study of the efficacy and safety of tamsulosin, the first prostate – selective alpha 1A – adrenoceptor antagonist, in patients with benign prostatic obstruction (symptomatic benign prostatic hyperplasia). Br J Urol 1997; 80: 587–96.
13.Abrams P, Schulman CC, Vaage S. Tamsulosin, a selective alpha 1c – adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic ‘obstruction’ (symptomatic BPH). The European Tamsulosin Study Group. Br J Urol 1995; 76: 325-36.
14. Chapple CR, Wyndaele JJ, Nordling J, Boeminghaus F, Ypma AF, Abrams P. Tamsulosin, the first prostate – selective alpha 1A – adrenoceptor antagonist. A meta – analysis of two randomized, placebo – controlled, multicenter studies in patients with benign prostatic obstruction (symptomatic BPH).European Tamsulosin Study Group. Eur Urol 1996; 29: 155–67.
15. Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93–01 Study Group. J Urol 1998; 160: 1701-6.
16. 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: 1-13.
17. Abdel-Aziz KF, Lemack GE. Overactive bladder in the male patient: bladder, outlet, or both? Curr Urol Rep 2002; 3: 445-51.
18. Abrams P, Cardozo L, Fall M, et al. The standardization of terminology in lower urinary tract function: report from the standardization sub – committee of the International Continence Society. Urology 2003; 61: 37-49.
19. Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology 2004; 64: 2-6.
20. Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol 2006; 49: 651-8.
21. Kay GG, Granville LJ. Antimuscarinic agents: implications and concerns in the management of overactive bladder in the elderly. Clin Ther 2005; 27: 127-38; quiz 39-40.
22. Rosen R, Altwein J, Boyle P, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM – 7).Eur Urol 2003; 44: 637-49.
23. McVary K. Lower urinary tract symptoms and sexual dysfunction: epidemiology and pathophysiology. BJU Int 2006; 97 Suppl 2: 23-8; discussion 44-5.
24. Lue TF, Giuliano F, Montorsi F, et al. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2004; 1: 6-23.
25. McVary KT, Monnig W, Camps JL, Jr., Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double – blind trial.J Urol 2007; 177: 1071-7.
26. McVary KT, Roehrborn CG, Kaminetsky JC, et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2007; 177: 1401-7.
27. Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomized, placebo – controlled study to assess the efficacy of twice – daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol 2008; 53: 1236–44.
28. Kirby RS, O’Leary MP, Carson C.Efficacy of extended – release doxazosin and doxazosin standard in patients with concomitant benign prostatic hyperplasia and sexual dysfunction. BJU Int 2005; 95: 103-9; discussion 9.
29. Kloner RA, Jackson G, Emmick JT, et al. Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy normotensive men. J Urol 2004; 172: 1935-40.
30. Kaplan SA, Gonzalez RR, Te AE. Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction.Eur Urol 2007; 51: 1717-23.

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Alpha blockers for ureteral stones in adult patients with symptoms of urolithiasis

Review Question

Can alpha-blocker drug treatment improve outcomes in patients with ureteral stones?

Relevance

Stones in the ureter (the tube that carries urine from the kidneys to the bladder) are often painful and cause medical attention.Depending on the section of the ureter in which the stone is located, and the size of the stone, most often it enters the bladder at some speed (over several weeks). If the stone does not come out on its own, medical procedures are required to remove it.

Alpha-blockers are medicines that relax the muscles of the urinary tract and help the stone pass into the bladder more quickly. However, they can cause unwanted effects. We have updated a Cochrane Review published in 2014 to look at the effects of alpha blockers.

Characteristics of research

Based on our most recent literature search in November 2017, we included 64 studies with 10,509 participants. In 15 of these, alpha blockers were compared with placebo in 5787 participants. A placebo is a pill that looks and tastes like the actual medication, so the participants don’t know what they are taking. The quality of these studies was higher and we trusted them more.

Key Outcomes

Based on higher quality studies using placebos, more people cleared stones with alpha blockers.However, these patients were more likely to have slightly more serious adverse effects of these drugs.

People who received alpha-blockers had stones that heal faster, had a lower need for diclofenac (one of the drugs used for pain), and were less likely to be hospitalized. At the same time, the need for stone surgery was similar.

After additional analyzes, we found that the effects of alpha blockers may differ between people with small (5 mm or less) and large (larger than 5 mm) stones.These medications appear to work better in people with larger stones. We found no differences in the effect of alpha-blockers depending on the location of the ureteral stone and the type of alpha-blocker used.

Authors’ conclusions

In patients with ureteral stones, alpha-blockers are likely to facilitate stone passage, but cause slightly more adverse effects. It turned out that alpha blockers work better in people with larger (more than 5 mm) stones than small (5 mm or less) stones.

Quality of evidence

The quality of the evidence for most of the outcomes was moderate or low; this means that our confidence in most of the results was moderate or low.

Focusin caps. with mod. vysv. 0.4mg No. 90 – instructions for use, description, contraindications, side effects, overdose, composition

Before starting therapy with Fokusin ^® , it is necessary to exclude the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia.Before starting treatment and regularly during therapy, an examination of the prostate gland (digital rectal examination, PSA determination) should be performed.

As with the use of other alpha ₁ -adrenergic blockers, during treatment with Fokusin ^® , in some cases, a decrease in blood pressure may be observed, which can lead to fainting. Fokusin ^® should be used with caution in patients with a predisposition to orthostatic hypotension.

At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.

There are reports of cases of the development of prolonged erection and priapism during therapy with alpha ₁ -adrenergic blockers. If an erection persists for more than 4 hours, you should immediately seek medical help. If priapism therapy is not carried out immediately, it can lead to damage to the tissues of the penis and irreversible loss of potency.

With the development of angioedema, as well as other immunological reactions, such as Stevens-Johnson syndrome, the drug should be discontinued immediately. The patient must be under the supervision of a physician until the elimination of this pathological condition; reappointment of tamsulosin is not allowed.

During cataract surgery, some patients who received tasmulosin hydrochloride at the time of surgery and in the past developed intraoperative iris instability syndrome (narrow pupil syndrome).The occurrence of the syndrome of intraoperative instability of the iris of the eye can lead to an increased risk of complications from the organ of vision during and after surgery.

Tamsulosin hydrochloride should not be used in combination with potent inhibitors of the CYP3A4 isoenzyme (eg, ketoconazole, voriconazole) in patients with the “slow metabolism” phenotype of the CYP2D6 isoenzyme.

Tamsulosin is not intended for use in women.

Influence on the ability to drive vehicles and mechanisms

Care should be taken when driving vehicles and activities that require increased concentration of attention and speed of psychomotor reactions.