DOXAZOSIN- doxazosin mesylate tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Tersedia dari:

Aidarex Pharmaceuticals LLC

INN (Nama Internasional):

DOXAZOSIN MESYLATE

Komposisi:

DOXAZOSIN 4 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Doxazosin tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin tablets may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin tablet monotherapy. Doxazosin tablets provide rapid improvement in symptoms and urinary flow rate in 66% to 71% of patients. Sustained improvements with doxazosin tablets were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. Doxazosin tablets are also indicated for the treatment of hypertension. Doxazosin tablets may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-

Ringkasan produk:

Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate, USP equivalent to 4 mg of doxazosin. The 4 mg are available as blue, round tablets debossed with M over D11 on one side of the tablet and scored on the other side. They are available as follows: NDC 33261-0658-30 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DOXAZOSIN- DOXAZOSIN MESYLATE TABLET
AIDAREX PHARMACEUTICALS LLC
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DOXAZOSIN MESYLATE 4MG TAB FOR MYLAN
DESCRIPTION
Doxazosin mesylate is a quinazoline compound that is a selective
inhibitor of the alpha subtype of
alpha adrenergic receptors. The chemical name of doxazosin mesylate is
1-(4-amino-6,7-dimethoxy-2-
quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine
methanesulfonate. The molecular formula
for doxazosin mesylate is C
H N O • CH O S and the molecular weight is 547.6. It has the
following structure:
Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in
dimethylformamide, slightly
soluble in methanol, ethanol, and water (0.8% at 25°C), and very
slightly soluble in acetone and
methylene chloride.
Doxazosin Tablets, USP for oral administration, contain 1 mg, 2 mg, 4
mg or 8 mg of doxazosin as
doxazosin mesylate, USP. In addition, each tablet also contains the
following inactive ingredients:
anhydrous lactose, colloidal silicon, magnesium stearate,
microcrystalline cellulose, sodium lauryl
sulfate and sodium starch glycolate. The 2 mg tablets also contain D&C
Red No. 30 Aluminum Lake, the
4 mg tablets contain FD&C Blue No. 2 Aluminum Lake, and the 8 mg
tablets contain D&C Red No. 30
Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia (BPH) is a common cause of urinary
outflow obstruction in aging males.
Severe BPH may lead to urinary retention and renal damage. A static
and a dynamic component
contribute to the symptoms and reduced urinary flow rate associated
with BPH. 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 of
BPH is associated with an
increase in smooth muscle tone in the prostate and bladder neck. The
degree of tone