whats the best time to take tamsulosin 0.4mg

What is Flomax and how is it used?

Flomax is a prescription medicine used to treat the symptoms of beneficial prostatic hyperplasia (enlarged prostate), bladder outlet obstruction and kidney stones. Flomax may be used alone or with other medications.

Flomax belongs to a grade of drugs called Alpha i Blockers.

What are side effects of Flomax?

Flomax may cause serious side effects including:

• lightheadedness and
• an erection that lasts over four or is painful

Get medical assist right abroad, if you have any of the symptoms listed above.

The nearly common side effects of Flomax include:

• abnormal ejaculation,
• decreased corporeality of semen,
• dizziness,
• drowsiness,
• weakness,
• runny olfactory organ,
• cough,
• back hurting,
• breast pain,
• nausea,
• diarrhea,
• tooth problems,
• blurred vision,
• sleep problems (insomnia), and
• decreased interest in sexual practice

Tell the doctor if you take any side effect that bothers you or that does not get abroad.

These are not all the possible side furnishings of Flomax. For more information, ask your doctor or pharmacist.

Call your md for medical advice about side effects. You may written report side furnishings to FDA at 1-800-FDA-1088.

Description

Tamsulosin hydrochloride is an adversary of alpha1A adrenoceptors in the prostate.

Tamsulosin hydrochloride is (-)-(R)-5-[two-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. Information technology is sparingly soluble in water and methanol, slightly soluble in glacial acetic acrid and ethanol, and practically insoluble in ether.

The empirical formula of tamsulosin hydrochloride is C_twentyH₂₈N_twoO₅S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:

Each FLOMAX sheathing for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the post-obit inactive ingredients: microcrystalline cellulose; methacrylic acrid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. two; titanium dioxide; propylene glycol; and shellac.

INDICATIONS

FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies]. FLOMAX capsules are not indicated for the handling of hypertension.

DOSAGE AND Assistants

FLOMAX capsules 0.4 mg in one case daily is recommended as the dose for the handling of the signs and symptoms of BPH. Information technology should exist administered approximately ane-half hour post-obit the aforementioned meal each day. FLOMAX capsules should not exist crushed, chewed or opened.

For those patients who fail to answer to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of FLOMAX capsules can exist increased to 0.8 mg once daily. FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.thou., ketoconazole) [meet WARNINGS AND PRECAUTIONS].

If FLOMAX capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should exist started again with the 0.four mg in one case-daily dose.

HOW SUPPLIED

Dosage Forms And Strengths

Sheathing: 0.4 mg, olive green and orangish hard gelatin, imprinted on one side with Flomax 0.4 mg and on the other side with BI 58

Storage And Handling

FLOMAX capsules 0.four mg are supplied in high density polyethylene bottles containing 100 hard gelatin capsules with olive dark-green opaque cap and orange opaque torso. The capsules are imprinted on one side with Flomax 0.4 mg and on the other side with BI 58.

FLOMAX capsules 0.4 mg, 100 capsules (NDC 0024-5837-01)

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

Keep FLOMAX capsules and all medicines out of reach of children.

Distributed by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI Company. Revised: Oct 2018

SLIDESHOW

Signs of Prostate Cancer: Symptoms, PSA Exam, Treatments Run into Slideshow

SIDE Furnishings

Clinical Trials Experience

Considering clinical trials are conducted nether widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may non reflect the rates observed in practice. The incidence of treatment-emergent agin events has been ascertained from six curt-term U.Southward. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg FLOMAX capsules were used. These studies evaluated safe in 1783 patients treated with FLOMAX capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either FLOMAX capsules 0.iv mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men.

Table 1: Treatment-Emergent* Adverse Events Occurring in ≥2% of FLOMAX Capsules or Placebo Patients in Two U.South. Short-Term Placebo-Controlled Clinical Studies

Trunk SYSTEM/ ADVERSE Result	FLOMAX CAPSULES GROUPS		PLACEBO
	0.four mg n=502	0.8 mg due north=492	n=493
BODY AS WHOLE
Headache	97 (xix.three%)	104 (21.1%)	99 (twenty.1%)
Infection†	45 (9.0%)	53 (10.8%)	37 (7.5%)
Asthenia	39 (7.8%)	42 (eight.5%)	27 (5.five%)
Dorsum pain	35 (7.0%)	41 (8.3%)	27 (5.5%)
Breast hurting	20 (4.0%)	20 (four.one%)	18 (three.7%)
NERVOUS SYSTEM
Dizziness	75 (14.9%)	84 (17.ane%)	l (10.1%)
Somnolence	15 (3.0%)	21 (four.3%)	8 (1.6%)
Insomnia	12 (2.4%)	7 (1.4%)	iii (0.6%)
Libido decreased	v (1.0%)	10 (two.0%)	half-dozen (1.2%)
RESPIRATORY Arrangement
Rhinitis‡	66 (13.1%)	88 (17.9%)	41 (eight.3%)
Pharyngitis	29 (5.eight%)	25 (5.1%)	23 (four.7%)
Cough increased	17 (3.4%)	22 (4.5%)	12 (2.iv%)
Sinusitis	11 (2.2%)	eighteen (3.7%)	8 (1.6%)
DIGESTIVE SYSTEM
Diarrhea	31 (6.ii%)	21 (4.3%)	22 (4.5%)
Nausea	13 (2.half dozen%)	19 (3.9%)	16 (3.2%)
Tooth disorder	six (1.two%)	10 (two.0%)	seven (ane.4%)
UROGENITAL Organization
Aberrant ejaculation	42 (8.4%)	89 (eighteen.i%)	1 (0.2%)
SPECIAL SENSES
Blurred vision	ane (0.two%)	10 (2.0%)	2 (0.four%)
*A treatment-emergent adverse outcome was divers as any upshot satisfying one of the following criteria: The adverse event occurred for the first time subsequently initial dosing with double-blind study medication. The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind handling; or The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and and so reappeared during double-blind treatment. †Coding preferred terms likewise include cold, common cold, head cold, flu, and flu-like symptoms. ‡Coding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever.

Signs And Symptoms Of Orthostasis

In the 2 U.S. studies, symptomatic postural hypotension was reported past 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg grouping, and by no patients in the placebo group. Syncope was reported by 0.two% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (two of 492) in the 0.8 mg group, and 0.six% of patients (3 of 493) in the placebo grouping. Dizziness was reported by 15% of patients (75 of 502) in the 0.four mg group, 17% of patients (84 of 492) in the 0.8 mg group, and ten% of patients (50 of 493) in the placebo grouping. Vertigo was reported by 0.6% of patients (3 of 502) in the 0.four mg group, 1% of patients (5 of 492) in the 0.8 mg group, and by 0.6% of patients (3 of 493) in the placebo grouping.

Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a examination was considered positive if it met 1 or more of the following criteria: (ane) a subtract in systolic blood pressure of ≥20 mmHg upon continuing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure ≥ten mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test; (3) an increase in pulse rate of ≥20 bpm upon standing with a standing pulse rate ≥100 bpm during the orthostatic exam; and (iv) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon continuing during the orthostatic exam.

Following the starting time dose of double-blind medication in Report i, a positive orthostatic test upshot at 4 hours mail-dose was observed in 7% of patients (37 of 498) who received FLOMAX capsules 0.four mg once daily and in 3% of the patients (viii of 253) who received placebo. At 8 hours postal service-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received FLOMAX capsules 0.4 mg once daily and 4% (ix of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the kickoff week of Study 1).

In Studies 1 and two, at least one positive orthostatic test issue was observed during the form of these studies for 81 of the 502 patients (sixteen%) in the FLOMAX capsules 0.4 mg once-daily group, 92 of the 491 patients (nineteen%) in the FLOMAX capsules 0.8 mg once-daily group, and 54 of the 493 patients (11%) in the placebo grouping.

Considering orthostasis was detected more frequently in FLOMAX sheathing-treated patients than in placebo recipients, there is a potential adventure of syncope [see WARNINGS AND PRECAUTIONS].

Abnormal Ejaculation

Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation subtract. As shown in Table 1, abnormal ejaculation was associated with FLOMAX capsules administration and was dose-related in the U.Due south. studies. Withdrawal from these clinical studies of FLOMAX capsules considering of aberrant ejaculation was also dose-dependent, with viii of 492 patients (1.6%) in the 0.viii mg grouping and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation.

Laboratory Tests

No laboratory test interactions with FLOMAX capsules are known. Treatment with FLOMAX capsules for upwards to 12 months had no meaning effect on prostate-specific antigen (PSA).

Postmarketing Experience

The post-obit adverse reactions have been identified during post-approval use of FLOMAX capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably guess their frequency or constitute a causal human relationship to drug exposure. Decisions to include these reactions in labeling are typically based on ane or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (three) strength of causal connection to FLOMAX capsules. Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema, and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of dyspnea, palpitations, hypotension, atrial fibrillation, arrhythmia, tachycardia, peel desquamation including reports of Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative, constipation, vomiting, dry mouth, visual impairment, and epistaxis have been received during the postmarketing period. During cataract and glaucoma surgery, a variant of small educatee syndrome known equally Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha_ane blocker therapy [run into WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

Cytochrome P450 Inhibition

Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6

Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.

Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in an increase in the Cmax and AUC of tamsulosin by a factor of 2.2 and two.8, respectively [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. The effects of concomitant assistants of a moderate CYP3A4 inhibitor (e.k., erythromycin) on the pharmacokinetics of FLOMAX take not been evaluated [meet WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Concomitant handling with paroxetine (a strong inhibitor of CYP2D6) resulted in an increment in the Cmax and AUC of tamsulosin by a cistron of 1.3 and 1.6, respectively [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. A like increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). 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 potent inhibitors of CYP3A4 (e.g., ketoconazole) [meet WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

The furnishings 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 CLINICAL PHARMACOLOGY].

The effects of co-assistants of both a CYP3A4 and a CYP2D6 inhibitor with FLOMAX capsules accept not been evaluated. However, there is a potential for meaning 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 CLINICAL PHARMACOLOGY].

Cimetidine

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 CLINICAL PHARMACOLOGY].

Other Alpha Adrenergic Blocking Agents

The pharmacokinetic and pharmacodynamic interactions betwixt FLOMAX capsules and other alpha adrenergic blocking agents take not been determined; notwithstanding, interactions between FLOMAX capsules and other blastoff adrenergic blocking agents may be expected [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

PDE5 Inhibitors

Circumspection 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 tin can lower blood pressure level. Concomitant use of these two drug classes can potentially crusade symptomatic hypotension [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Warfarin

A definitive drug-drug interaction study between tamsulosin hydrochloride and warfarin was non conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and FLOMAX capsules [run into WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Nifedipine, Atenolol, Enalapril

Dosage adjustments are non necessary when FLOMAX capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see CLINICAL PHARMACOLOGY].

Digoxin And Theophylline

Dosage adjustments are not necessary when a FLOMAX capsule is administered concomitantly with digoxin or theophylline [see CLINICAL PHARMACOLOGY].

Furosemide

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 exercise not crave adjustment of the FLOMAX capsules dosage [run across CLINICAL PHARMACOLOGY].

WARNINGS

Included as part of the PRECAUTIONS department.

PRECAUTIONS

Orthostasis

The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more ofttimes in FLOMAX capsule-treated patients than in placebo recipients. As with other blastoff adrenergic blocking agents there is a potential gamble of syncope [run across Adverse REACTIONS]. Patients beginning treatment with FLOMAX capsules should be cautioned to avert situations in which injury could result should syncope occur.

Drug Interactions

Tamsulosin is extensively metabolized, mainly past CYP3A4 and CYP2D6. FLOMAX capsules 0.iv mg should not be used in combination with potent inhibitors of CYP3A4 (due east.1000., ketoconazole) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. FLOMAX capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (due east.g., erythromycin), in combination with potent (e.chiliad., paroxetine) or moderate (e.yard., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

FLOMAX capsules should be used with caution in combination with cimetidine, specially at a dose higher than 0.4 mg (due east.g., 0.8 mg) [come across DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

FLOMAX capsules should not be used in combination with other alpha adrenergic blocking agents [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

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 tin lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Caution should be exercised with concomitant administration of warfarin and FLOMAX capsules [run into DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Priapism

Rarely (probably less than one in fifty,000 patients), tamsulosin, like other alpha₁ antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Considering this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.

Screening For Prostate Cancer

Prostate cancer and BPH often co-be; therefore, patients should be screened for the presence of prostate cancer prior to treatment with FLOMAX capsules and at regular intervals after.

Intraoperative Floppy Iris Syndrome

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients on or previously treated with alpha_one blockers, including FLOMAX capsules [come across ADVERSE REACTIONS].

Most reports were in patients taking the blastoff₁ blocker when IFIS occurred, but in some cases, the alpha_i blocker had been stopped prior to surgery. In about of these cases, the alpha₁ blocker had been stopped recently prior to surgery (2 to fourteen days), but in a few cases, IFIS was reported after the patient had been off the alpha₁ blocker for a longer flow (five weeks to 9 months). IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. The patient'south ophthalmologist should exist prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

IFIS may increase the chance of eye complications during and subsequently the operation. The benefit of stopping alpha₁ blocker therapy prior to cataract or glaucoma surgery has not been established. The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended.

Sulfa Allergy

In patients with sulfa allergy, allergic reaction to FLOMAX capsules has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering FLOMAX capsules.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).

Hypotension

Advise the patient about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking FLOMAX capsules, and they should be cautioned nigh driving, operating machinery, or performing chancy tasks [see WARNINGS AND PRECAUTIONS].

Drug Interactions

Propose the patient that FLOMAX should not be used in combination with strong inhibitors of CYP3A4 [meet WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Priapism

Advise the patient nigh the possibility of priapism as a result of treatment with FLOMAX capsules and other similar medications. Patients should exist informed that this reaction is extremely rare, only if not brought to immediate medical attention, tin can lead to permanent erectile dysfunction (impotence) [see WARNINGS AND PRECAUTIONS].

Screening For Prostate Cancer

Prostate cancer and BPH frequently co-exist; therefore, screen patients for the presence of prostate cancer prior to treatment with FLOMAX capsules and at regular intervals later [see WARNINGS AND PRECAUTIONS].

Intraoperative Floppy Iris Syndrome

Advise the patient when because cataract or glaucoma surgery to tell their ophthalmologist that they accept taken FLOMAX capsules [see WARNINGS AND PRECAUTIONS].

Administration

Suggest the patient that FLOMAX capsules should non exist crushed, chewed or opened [meet DOSAGE AND ADMINISTRATION].

FDA-approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the stop of this prescribing information.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Rats administered doses up to 43 mg/kg/day in males and 52 mg/kg/day in females had no increases in tumor incidence, with the exception of a small-scale increase in the frequency of mammary gland fibroadenomas in female rats receiving doses ≥5.4 mg/kg (P<0.015). The highest doses of tamsulosin hydrochloride evaluated in the rat carcinogenicity written report produced systemic exposures (AUC) in rats 3 times the exposures in men receiving the maximum therapeutic dose of 0.8 mg/day.

Mice were administered doses up to 127 mg/kg/twenty-four hours in males and 158 mg/kg/day in females. In that location were no significant tumor findings in male person mice. Female person mice treated for 2 years with the two highest doses of 45 and 158 mg/kg/mean solar day had statistically significant increases in the incidence of mammary gland fibroadenomas (P<0.0001) and adenocarcinomas (P<0.0075). The highest dose levels of tamsulosin hydrochloride evaluated in the mice carcinogenicity study produced systemic exposures (AUC) in mice eight times the exposures in men receiving the maximum therapeutic dose of 0.8 mg/solar day.

The increased incidences of mammary gland neoplasms in female rats and mice were considered secondary to tamsulosin hydrochloride-induced hyperprolactinemia. Information technology is not known if FLOMAX capsules elevate prolactin in humans. The relevance for human take chances of the findings of prolactin-mediated endocrine tumors in rodents is non known.

Tamsulosin hydrochloride produced no evidence of mutagenic potential in vitro in the Ames reverse mutation test, mouse lymphoma thymidine kinase assay, unscheduled Deoxyribonucleic acid repair synthesis assay, and chromosomal aberration assays in Chinese hamster ovary cells or homo lymphocytes. In that location were no mutagenic effects in the in vivo sister chromatid substitution and mouse micronucleus analysis.

Studies in rats revealed significantly reduced fertility in males dosed with single or multiple daily doses of 300 mg/kg/day of tamsulosin hydrochloride (AUC exposure in rats almost 50 times the homo exposure with the maximum therapeutic dose). The machinery of decreased fertility in male rats is considered to exist an effect of the compound on the vaginal plug formation possibly due to changes of semen content or impairment of ejaculation. The effects on fertility were reversible, showing improvement by iii days after a single dose and iv weeks later on multiple dosing. Furnishings on fertility in males were completely reversed within nine weeks of discontinuation of multiple dosing. Multiple doses of 10 and 100 mg/kg/day tamsulosin hydrochloride (i/five and xvi times the predictable human AUC exposure) did non significantly alter fertility in male rats. Furnishings of tamsulosin hydrochloride on sperm counts or sperm office accept non been evaluated.

Studies in female rats revealed pregnant reductions in fertility after unmarried or multiple dosing with 300 mg/kg/day of the R-isomer or racemic mixture of tamsulosin hydrochloride, respectively. In female person rats, the reductions in fertility afterwards single doses were considered to be associated with impairments in fertilization. Multiple dosing with ten or 100 mg/kg/day of the racemic mixture did not significantly alter fertility in female rats.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category B.

Administration of tamsulosin hydrochloride to pregnant female person rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no show of damage to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. FLOMAX capsules are not indicated for use in women.

Nursing Mothers

FLOMAX capsules are not indicated for employ in women.

Pediatric Employ

FLOMAX capsules are non indicated for use in pediatric populations.

Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients two years to xvi years of age with elevated detrusor leak betoken pressure (>40 cm Water) associated with known neurological disorder (e.g., spina bifida). Patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.two mg, or 0.iv mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm H2O. In a randomized, double-bullheaded, placebo-controlled, 14-calendar week, pharmacokinetic, safety and efficacy written report in 161 patients, no statistically pregnant departure in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. In an open up-label, 12-month safety report, 87 patients were treated with tamsulosin hydrochloride. The well-nigh frequently reported adverse events (≥5%) from the pooled information of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation.

Geriatric Use

Of the full number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed betwixt these subjects and younger subjects, and the other reported clinical experience has non identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [run across CLINICAL PHARMACOLOGY].

Renal Harm

Patients with renal impairment practise non require an adjustment in FLOMAX capsules dosing. Even so, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m²) have not been studied [run into CLINICAL PHARMACOLOGY].

Hepatic Impairment

Patients with moderate hepatic harm do not require an aligning in FLOMAX capsules dosage. FLOMAX has not been studied in patients with severe hepatic harm [meet CLINICAL PHARMACOLOGY].

Overdosage & Contraindications

OVERDOSE

Should overdosage of FLOMAX capsules lead to hypotension [meet WARNINGS AND PRECAUTIONS and Agin REACTIONS], support of the cardiovascular organization is of offset importance. Restoration of blood pressure level and normalization of heart rate may exist accomplished past keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should and so exist used and renal function should be monitored and supported as needed.  Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of do good.

CONTRAINDICATIONS

FLOMAX capsules are contraindicated in patients known to exist hypersensitive to tamsulosin hydrochloride or any component of FLOMAX capsules. Reactions take included peel rash, urticaria, pruritus, angioedema, and respiratory symptoms [come across Agin REACTIONS].

CLINICAL PHARMACOLOGY

Mechanism Of Activeness

The symptoms associated with beneficial prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of 2 underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, past a proliferation of polish musculus cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction practise not correlate well with the size of the prostate. The dynamic component is a function of an increment 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 arable in the prostate, prostatic capsule, prostatic urethra, and float neck. Blockade of these adrenoceptors tin can crusade polish muscles in the bladder neck and prostate to relax, resulting in an improvement in urine catamenia rate and a reduction in symptoms of BPH.

Tamsulosin, an blastoff_i adrenoceptor blocking agent, exhibits selectivity for blastoff₁ receptors in the homo prostate. At least three discrete blastoff₁ adrenoceptor subtypes accept been identified: alpha_1A, alpha_1B, and alpha_1D; their distribution differs between human organs and tissue. Approximately lxx% of the alpha₁ receptors in the human prostate are of the blastoff_1A subtype.

FLOMAX capsules are not intended for use every bit an antihypertensive drug.

Pharmacodynamics

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

Pharmacokinetics

The pharmacokinetics of tamsulosin hydrochloride have been evaluated in developed healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.one mg to 1 mg.

Absorption

Absorption of tamsulosin hydrochloride from FLOMAX capsules 0.iv mg is essentially complete (>90%) following oral administration under fasting conditions. Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with accomplishment of steady-land concentrations by the fifth twenty-four hour period of one time-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 seven hours when FLOMAX capsules are administered with food. Taking FLOMAX capsules under fasted weather condition results in a 30% increase in bioavailability (AUC) and twoscore% to 70% increase in peak concentrations (Cmax) compared to fed weather (Figure 1).

Effigy 1: Hateful Plasma Tamsulosin Hydrochloride Concentrations Following Unmarried- Dose Assistants of FLOMAX Capsules 0.iv mg Under Fasted and Fed Weather (northward=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 ii).

Table ii: Mean (± S.D.) Pharmacokinetic Parameters Following FLOMAX Capsules 0.iv mg Once Daily or 0.8 mg Once Daily with a Light Breakfast, Loftier-Fat Breakfast or Fasted

Pharmacokinetic Parameter	0.four mg QD to healthy volunteers; n=23 (age range 18-32 years)		0.eight mg QD to salubrious volunteers; north=22 (age range 55-75 years)
	Light Breakfast	Fasted	Light Breakfast	High-Fat Breakfast	Fasted
Cmin (ng/mL)	iv.0 ± 2.6	3.8 ± ii.v	12.iii ± vi.7	13.5 ± seven.vi	thirteen.3    ± 13.3
Cmax (ng/mL)	ten.1 ± 4.viii	17.1    ± 17.ane	29.viii ± 10.3	29.ane ± 11.0	41.vi    ± xv.half-dozen
Cmax/Cmin Ratio	3.ane ± ane.0	5.3 ± 2.ii	2.7 ± 0.7	ii.five ± 0.8	3.6 ± one.1
Tmax (hours)	vi.0	4.0	vii.0	half dozen.vi	5.0
T½ (hours)	-	-	-	-	14.9 ± 3.nine
AUCτ (ng•;hr/mL)	151 ± 81.v	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 one-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 afterwards intravenous assistants to 10 healthy male person adults was sixteen 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 blastoff_i acid glycoprotein (AAG), with linear binding over a wide concentration range (20 to 600 ng/mL). The results of ii-style in vitro studies indicate that the bounden of tamsulosin hydrochloride to human plasma proteins is not affected past amitriptyline, diclofenac, glyburide, simvastatin plus simvastatin-hydroxy acrid metabolite, warfarin, diazepam, propranolol, trichlormethiazide, or chlormadinone. Also, tamsulosin hydrochloride had no result on the extent of binding of these drugs.

Metabolism

There is no enantiomeric bioconversion from tamsulosin hydrochloride [R(-) isomer] to the South(+) 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 every bit well every bit 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 handling of BPH). Nevertheless, 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 four good for you volunteers, 97% of the administered radioactivity was recovered, with urine (76%) representing the primary road of excretion compared to feces (21%) over 168 hours. Following intravenous or oral administration of an immediate-release formulation, the elimination one-half-life of tamsulosin hydrochloride in plasma ranged from 5 to seven hours. Because of absorption charge per unit-controlled pharmacokinetics with FLOMAX capsules, the apparent one-half-life of tamsulosin hydrochloride is approximately 9 to thirteen hours in salubrious 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 employ

FLOMAX capsules are non indicated for use in pediatric populations [see Utilise In Specific Populations].

Geriatric (Age) Use

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

Renal harm

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

<thirty mL/min/1.73 m²) renal impairment and 6 normal subjects (CLcr >90 mL/min/ane.73 m²). While a modify in the overall plasma concentration of tamsulosin hydrochloride was observed as the event of altered binding to AAG, the unbound (active) concentration of tamsulosin hydrochloride, as well as the intrinsic clearance, remained relatively abiding. Therefore, patients with renal impairment do non require an aligning in FLOMAX capsules dosing. However, patients with end-stage renal disease (CLcr <x mL/min/1.73 1000²) have non been studied [run across Employ In Specific Populations].

Hepatic impairment

The pharmacokinetics of tamsulosin hydrochloride accept been compared in viii subjects with moderate hepatic impairment (Child-Pugh's nomenclature: Grades A and B) and 8 normal subjects. While a alter in the overall plasma concentration of tamsulosin hydrochloride was observed equally the result of altered bounden to AAG, the unbound (agile) 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 crave an adjustment in FLOMAX capsules dosage. FLOMAX has non been studied in patients with severe hepatic harm [see Use In Specific Populations].

Drug Interactions

Cytochrome P450 inhibition

Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6

The furnishings of ketoconazole (a strong inhibitor of CYP3A4) at 400 mg once daily for five 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 furnishings of concomitant administration of a moderate CYP3A4 inhibitor (east.m., 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 increment in the Cmax and AUC of tamsulosin past a gene of i.iii and 1.6, respectively [encounter 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 (well-nigh 7% of Caucasians and 2% of African Americans) are CYP2D6 PMs. Since CYP2D6 PMs cannot be readily identified and the potential for pregnant increment in tamsulosin exposure exists when FLOMAX 0.4 mg is co-administered with stiff CYP3A4 inhibitors in CYP2D6 PMs, FLOMAX 0.4 mg capsules should not exist used in combination with stiff inhibitors of CYP3A4 (e.g., ketoconazole) [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

The effects of concomitant administration of a moderate CYP2D6 inhibitor (due east.chiliad., terbinafine) on the pharmacokinetics of FLOMAX take non been evaluated [encounter WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

The effects of co-administration of both a CYP3A4 and a CYP2D6 inhibitor with FLOMAX capsules take not been evaluated. Still, in that location is a potential for meaning 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.iv mg dose was investigated in 10 salubrious 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 betwixt FLOMAX capsules and other alpha adrenergic blocking agents have not been determined; still, interactions betwixt FLOMAX capsules and other alpha adrenergic blocking agents may exist expected [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

PDE5 Inhibitors

Caution is brash when alpha adrenergic blocking agents, including FLOMAX, are co-administered with PDE5 inhibitors. Blastoff-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower claret force per unit area. Concomitant use of these two drug classes can potentially crusade symptomatic hypotension [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Warfarin

A definitive drug-drug interaction written report between tamsulosin hydrochloride and warfarin was non conducted. Results from express 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 (historic period range 47 to 79 years) whose blood pressure was controlled with stable doses of nifedipine, atenolol, or enalapril for at to the lowest degree 3 months, FLOMAX capsules 0.4 mg for 7 days followed by FLOMAX capsules 0.8 mg for another 7 days (north=8 per report) resulted in no clinically pregnant effects on blood pressure and pulse rate compared to placebo (n=4 per study). Therefore, dosage adjustments are non necessary when FLOMAX capsules are administered concomitantly with nifedipine, atenolol, or enalapril [run across DRUG INTERACTIONS].

Digoxin And Theophylline

In 2 studies in good for you volunteers (n=x per study; age range xix to 39 years) receiving FLOMAX capsules 0.4 mg/day for 2 days, followed by FLOMAX capsules 0.8 mg/solar day for five to 8 days, unmarried 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 [encounter DRUG INTERACTIONS].

Furosemide

The pharmacokinetic and pharmacodynamic interaction between FLOMAX capsules 0.viii mg/day (steady-land) and furosemide twenty mg intravenously (unmarried dose) was evaluated in x good for you volunteers (age range 21 to 40 years). FLOMAX capsules had no consequence 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 exercise not require adjustment of the FLOMAX capsules dosage [see DRUG INTERACTIONS].

Clinical Studies

Four placebo-controlled clinical studies and ane active-controlled clinical written report enrolled a total of 2296 patients (1003 received FLOMAX capsules 0.4 mg one time 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, thirteen-week, multicenter studies (Study i [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.four mg once daily, or FLOMAX capsules 0.8 mg once daily. Patients in FLOMAX capsules 0.8 mg in one case-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 principal efficacy assessments included: 1) full 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 menstruum rate, where an increased peak urine flow rate value over baseline is consequent 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.iv mg and 0.8 mg one time daily compared to placebo in both U.S. studies (Table three, Figures 2A and 2B). The changes from baseline to Calendar week xiii in peak urine menstruum rate were also significantly greater for the FLOMAX capsules 0.4 mg and 0.8 mg once-daily groups compared to placebo in Study i, and for the FLOMAX capsules 0.eight mg once-daily group in Study 2 (Table iii, Figures 3A and 3B). Overall in that location were no pregnant differences in improvement observed in full AUA Symptom Scores or peak urine menses rates betwixt the 0.4 mg and the 0.8 mg dose groups with the exception that the 0.eight mg dose in Study 1 had a significantly greater comeback in total AUA Symptom Score compared to the 0.4 mg dose.

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

	Full AUA Symptom Score		Peak Urine Flow Rate
	Mean Baseline Value	Mean Change	Mean Baseline Value	Mean Change
Report 1†
FLOMAX capsules 0.8 mg once daily	19.9 ± four.9 n=247	-9.6‡ ± half-dozen.vii n=237	9.57 ± 2.51 n=247	one.78‡ ± 3.35 northward=247
FLOMAX capsules 0.4 mg once daily	19.viii ± 5.0 northward=254	-8.iii‡ ± 6.5 n=246	nine.46 ± two.49 n=254	ane.75‡± 3.57 n=254
Placebo	19.half dozen ± 4.9 n=254	-5.5 ± half-dozen.6 due north=246	9.75 ± two.54 north=254	0.52 ± 3.39 n=253
Study 2 §
FLOMAX capsules 0.eight mg once daily	eighteen.2 ± five.vi northward=244	-v.8‡ ± half-dozen.4 northward=238	nine.96 ±iii.16 northward=244	one.79‡ ± three.36 n=237
FLOMAX capsules 0.4 mg once daily	17.9 ± 5.8 n=248	-5.i‡ ± half dozen.four n=244	9.94 ±3.fourteen n=248	one.52 ± 3.64 n=244
Placebo	xix.2 ± 6.0 northward=239	-iii.6 ± 5.7 northward=235	9.95 ±3.12 northward=239	0.93 ± 3.28 n=235
Calendar week 13: For patients not completing the 13-week report, the last ascertainment was carried forward. *Total AUA Symptom Scores ranged from 0 to 35. †Peak urine menses rate measured 4 to 8 hours post dose at Week thirteen. ‡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 in one case-daily groups showed a rapid subtract starting at 1 calendar week after dosing and remained decreased through 13 weeks in both studies (Figures 2A and 2B).

In Report 1, 400 patients (53% of the originally randomized grouping) elected to go along in their originally assigned handling groups in a double-blind, placebo-controlled, xl-week extension trial (138 patients on 0.iv mg, 135 patients on 0.8 mg, and 127 patients on placebo). Three hundred 20-iii patients (43% of the originally randomized group) completed one twelvemonth. Of these, 81% (97 patients) on 0.four 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 twelvemonth.

Figure 2A: Mean Modify from Baseline in Total AUA Symptom Score (0–35) Written report 1

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

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

Subsequent values are observed cases.

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

Note: Patients in the 0.viii mg treatment group received 0.4 mg for the start week.

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

Figure 2B: Hateful Change from Baseline in Total AUA Symptom Score (0–35) Written report 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 forrard for patients non completing the 13-calendar week study.

Note: Patients in the 0.8 mg treatment grouping received 0.iv mg for the first week.

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

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

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

B = Baseline adamant approximately i calendar week prior to the initial dose of double-blind medication at Week 0.

Subsequent values are observed cases.

LOCF = Terminal observation carried forward for patients not completing the 13-week report.

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

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

Notation: Patients in the 0.8 mg handling groups received 0.four mg for the start week.

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

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

Baseline measurement was taken Calendar week 0. Subsequent values are observed cases.

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

Note: Patients in the 0.8 mg treatment grouping received 0.4 mg for the get-go week.

Notation: Week i 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 (gauge trough tamsulosin concentration).

PATIENT INFORMATION

Flomax®
(Flo -max) (tamsulosin hydrochloride, USP) Capsules, 0.4 mg

Read the Patient Information that comes with FLOMAX capsules before you start taking information technology and each time you refill your prescription. The information may have inverse. This leaflet does non accept the identify of discussions with your doctor about your medical condition or your handling.

What is FLOMAX?

FLOMAX is a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a status your md may refer to as an enlarged prostate.

• FLOMAX is not for women.
• FLOMAX is not for children.

Who should not accept FLOMAX?

Do non take FLOMAX capsules if you are allergic to any of its ingredients. Encounter the end of this leaflet for a complete listing of ingredients in FLOMAX capsules.

What should I tell my doc before using FLOMAX?

Earlier taking FLOMAX capsules, tell your doc nigh all your medical atmospheric condition, including:

• any kidney or liver problems.
• whatsoever history of low blood pressure.
• whatsoever allergies to sulfa or whatever other medicines.
• if you are planning to have cataract or glaucoma surgery.

Tell your doctor most all the medicines you have, including:

• any prescription medicines, including blood force per unit area medicines.
• whatever not-prescription medicines, including vitamins and herbal supplements.

Some of your other medicines may affect the way FLOMAX capsules work. Especially tell your dr. if you lot take a medicine for high claret pressure. You should not take FLOMAX if you are already taking certain blood pressure medicines.

Know the medicines you lot take. Keep a list of them and evidence information technology to your physician and pharmacist when y'all go a new medicine.

How should I take FLOMAX?

• Take FLOMAX exactly as prescribed by your doctor.
• Do not crush, chew, or open FLOMAX capsules.
• Take FLOMAX ane time each day, about xxx minutes after the aforementioned repast each day. For example, you may take FLOMAX 30 minutes afterward dinner each 24-hour interval.
• If you miss a dose of FLOMAX, take information technology as before long as you remember. If you lot miss your dose for the whole 24-hour interval, continue with your next dose on your regular schedule. Do non take two doses at the same time.
• If you end or forget to take FLOMAX for several days, talk with your md earlier starting again.
• If you have more FLOMAX capsules than prescribed, call your md right away.

What are the possible side furnishings of FLOMAX capsules?

Possible side effects of FLOMAX may include:

• Decreased claret pressure when changing positions. FLOMAX capsules may cause a sudden drop in blood force per unit area upon continuing, especially afterward the first dose or when changing doses.
  Symptoms may include:
  • fainting
  • dizziness
  • lightheadedness
    Change positions slowly from lying downward to sitting up or from a sitting to a standing position until you learn how you lot react to FLOMAX capsules. If you brainstorm to experience featherbrained, sit down or lie down until you feel better. If the symptoms are severe or practice not improve, call your doctor.
• Allergic reactions. Make your doc aware of any allergic reactions yous may feel while taking FLOMAX.
  Allergic reactions may include:
  • rash
  • itching
  • hives
    Rare and more serious allergic reactions may also occur. Get medical help right away if y'all have whatsoever of the following reactions:
  • swelling of face up, tongue, or throat
  • difficulty breathing
  • blistering of the skin
• A painful erection that volition not go abroad. FLOMAX capsules can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, go medical assistance correct away. If priapism is not treated, you lot may not be able to become an erection in the hereafter.
• Centre problems during cataract or glaucoma surgery. During cataract or glaucoma surgery, a condition called intraoperative floppy iris syndrome (IFIS) tin can happen if you accept or have taken FLOMAX capsules. If you need to accept cataract or glaucoma surgery, be sure to tell your surgeon if yous accept or have taken FLOMAX capsules.

Mutual side effects of FLOMAX capsules may include:

• runny nose
• dizziness
• decreased semen

These are not all the possible side effects with FLOMAX capsules. Tell your doctor if you take whatever side effect that bothers you or that does not get abroad.

Call your medico for medical advice about side effects. You may report side effects to FDA at ane-800-FDA-1088, or past visiting www.fda.gov/medwatch.

What should I avert while taking FLOMAX capsules?

Avert driving, operating mechanism, or other dangerous activities, until y'all know how FLOMAX affects you. FLOMAX capsules may crusade a sudden driblet in blood pressure upon standing, especially subsequently the offset dose or when changing doses. See "What are the possible side effects of FLOMAX capsules?"

How practise I store FLOMAX capsules?

Store FLOMAX capsules at Room Temperature [77°F (25°C)]. Shortterm exposure to college or lower temperatures [from 59°F (fifteen°C) to 86°F (thirty°C)] is acceptable. Enquire your md or pharmacist if you have any questions about storing your capsules.

Keep FLOMAX capsules and all medicines out of the reach of children.

General data

This medicine was prescribed for you by your doctor for your condition. Exercise not employ it for another condition. Do not give FLOMAX to other people, even if they take the same symptoms that y'all take. It may harm them. While taking FLOMAX, you must have regular checkups. Follow your doctor's advice about when to have these checkups.

BPH can occur with other more serious conditions, including prostate cancer. Therefore, enquire your doc about screening for prostate cancer prior to treatment with FLOMAX capsules and at regular intervals afterwards.

This patient information leaflet summarizes the near important information about FLOMAX. If y'all would like more information, talk with your doctor. Yous can inquire your pharmacist or doctor for information about FLOMAX that is written for health professionals. For electric current prescribing data, access www.4flomax.com or call sanofi-aventis U.S. LLC at 1-800-633-1610.

What are the ingredients in FLOMAX capsules?

• Active Ingredient: tamsulosin hydrochloride, USP
• Inactive Ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; fe oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.

From

Report Problems to the Nutrient and Drug Administration

Y'all are encouraged to study negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or phone call 1-800-FDA-1088.

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