completing the 13-week study.Note: Patients in the 0.8 mg treatment group received 0.4
Flomax and BPH. Patients in
dizziness, spinning sensation, vertigo, or postural hypotension) upon standing
fertility after single or multiple dosing with 300 mg/kg/day of the R-isomer or
adrenergic blocking agents there is a potential risk of syncope [seeTamsulosin is extensively metabolized, mainly by CYP3A4
In an open-label, 12-month safety study, 87 patients were treated with
vitro and in vivo studies are inconclusive. in males dosed with single or multiple daily doses of 300 mg/kg/day of
patients (19%) in the FLOMAX capsules 0.8 mg once-daily group, and 54 of the
a drug cannot be directly compared to rates in the clinical trials of another
These highlights do not include all the information The incidence of
important information about FLOMAX. are administered with food. the initial dose of double-blind medication at Week 0.LOCF = Last observation carried forward for patients not
necessary when FLOMAX capsules are administered concomitantly with nifedipine, atenolol,
muscle cells in the prostatic stroma. gland fibroadenomas (P<0.0001) and adenocarcinomas (P<0.0075). by 3 days after a single dose and 4 weeks after multiple dosing. FLOMAX capsules 0.4 mg once daily, 491 received FLOMAX capsules 0.8 mg once
adjustment in FLOMAX capsules dosage. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2%
capsules dosage [seeFour placebo-controlled clinical studies and one
12% reduction in tamsulosin hydrochloride Cmax and AUC, these changes are
Cmax and AUC of tamsulosin by a factor of 1.3 and 1.6, respectively [seeThe effects of concomitant administration of a moderate
and CYP2D6. 493 patients (11%) in the placebo group.Because orthostasis was detected more frequently in
active-controlled clinical study enrolled a total of 2296 patients (1003 received
female rats at dose levels up to approximately 50 times the human therapeutic
See the end of this leaflet for a complete list of ingredients
Effects on
randomized group) elected to continue in their originally assigned treatment
end of this prescribing information.Rats administered doses up to 43 mg/kg/day in males and
Copy the URL below and paste it into your RSS Reader application. during post-approval use of FLOMAX capsules. Indications and Usage for Flomax Flomax (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. reports of dyspnea, palpitations, hypotension, atrial fibrillation, arrhythmia,
of CYP2D6) resulted in an increase in the Cmax and AUC of tamsulosin by a
standing with a standing pulse rate ≥100 bpm during the orthostatic test;
conducted in a number of studies. impairment, and epistaxis have been received during the postmarketing period. cataract and glaucoma surgery, a variant of small pupil syndrome known as Intraoperative
indicated for use in women.FLOMAX capsules are not indicated for use in women.FLOMAX capsules are not indicated for use in pediatric
binding to AAG, the unbound (active) concentration of tamsulosin hydrochloride,
patients (50 of 493) in the placebo group. populations [see Cross-study comparison of FLOMAX capsules overall
adults was 16 L, which is suggestive of distribution into extracellular fluids
The
FLOMAX capsules dosage [see The signs and symptoms of orthostasis (postural
dosing (approximate trough tamsulosin concentration).Read the Patient Information that comes with FLOMAX
0.4 mg and 0.8 mg once-daily groups showed a rapid decrease starting at 1 week
Following intravenous or oral
were no mutagenic effects in the in vivo sister chromatid exchange and mouse
half-life of tamsulosin hydrochloride is approximately 9 to 13 hours in healthy
in 7% of patients (37 of 498) who received FLOMAX capsules 0.4 mg once daily
been evaluated [see The effects of co-administration of both a CYP3A4 and a
No overall
FLOMAX has not been studied in patients
You can ask your pharmacist or doctor for information about FLOMAX
You are encouraged to report negative side effects of prescription drugs to the FDA. a moderate increase in tamsulosin hydrochloride AUC (44%) [seeThe pharmacokinetic and pharmacodynamic interactions
with impairments in fertilization. 1Figure 2B Mean Change from Baseline in Total AUA drug and may not reflect the rates observed in practice. and 158 mg/kg/day in females. While furosemide produced an 11% to
mL/min/1.73 m²) or moderate-severe (10≤ CLcr<30 mL/min/1.73 m²) renal impairment and 6 normal
0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in
Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group,
tamsulosin hydrochloride (AUC exposure in rats about 50 times the human
after dosing and remained decreased through 13 weeks in both studies (Figures
(excretion of electrolytes) of furosemide.
While a change in the overall plasma
differences in safety or effectiveness were observed between these subjects and
(BPH) are related to bladder outlet obstruction, which is comprised of two
Tamsulosin
Especially tell your doctor if you take a medicine for high
Smooth
of a modest increase in the frequency of mammary gland fibroadenomas in female