Clinical Information
Gen. Code and Des.
27546 tamsulosin HCl ORAL CAPSULE 0.4 MG
GCN and Des.
48191 tamsulosin HCl ORAL CAPSULE 0.4 MG
Strength
0.4MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
12160412 SELECTIVE ALPHA-1-ADRENERGIC BLOCK.AGENT
Active Ingredients
6116 tamsulosin HCl 106463176
Inactive Ingredients
10138 blue dye
2549 gelatin 9000708
FLOMAX- tamsulosin hydrochloride capsule
Boehringer Ingelheim Pharmaceuticals, Inc.
1? INDICATIONS AND USAGE
FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. FLOMAX capsules are not indicated for the treatment of hypertension.
2? DOSAGE AND ADMINISTRATION
FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. FLOMAX capsules should not be crushed, chewed or opened.
For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].
If FLOMAX capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.
3? DOSAGE FORMS AND STRENGTHS
Capsule: 0.4 mg, olive green and orange hard gelatin, imprinted on one side with FLOMAX 0.4 mg and on the other side with BI 58
4? CONTRAINDICATIONS
FLOMAX capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of FLOMAX capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)].
5? WARNINGS AND PRECAUTIONS
5.1? Orthostasis
The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in FLOMAX capsule-treated patients than in placebo recipients. As with other alpha adrenergic blocking agents there is a potential risk of syncope [see Adverse Reactions (6.1)]. Patients beginning treatment with FLOMAX capsules should be cautioned to avoid situations in which injury could result should syncope occur.
DESCRIPTION
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.
Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230�C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether.
The empirical formula of tamsulosin hydrochloride is C20 H28 N2 O5 S � HCl. The molecular weight of tamsulosin hydrochloride is 444.98.
Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.
12? CLINICAL PHARMACOLOGY
12.1? 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.
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 about driving, operating machinery, or performing hazardous tasks [see Warnings and Precautions (5.1)].
Drug Interactions
Advise the patient that FLOMAX should not be used in combination with strong inhibitors of CYP3A4 [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].
Priapism
Advise the patient about the possibility of priapism as a result of treatment with FLOMAX capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.3)].
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 afterwards [see Warnings and Precautions (5.4) ].
Intraoperative Floppy Iris Syndrome
Advise the patient when considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken FLOMAX capsules [see Warnings and Precautions (5.5)].
Administration
Advise the patient that FLOMAX capsules should not be crushed, chewed or opened [see Dosage and Administration (2) ].