DOXAZOSIN- doxazosin mesylate tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

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Download Ciri produk (SPC)
25-05-2010

Bahan aktif:

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

Boleh didapati daripada:

State of Florida DOH Central Pharmacy

INN (Nama Antarabangsa):

DOXAZOSIN MESYLATE

Komposisi:

DOXAZOSIN MESYLATE 4 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin monotherapy. Doxazosin provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin 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 may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors. Doxazosin

Ringkasan produk:

Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg of doxazosin. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Detach Patient Information Leaflet at each perforation and give leaflet to patient.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

                                DOXAZOSIN - DOXAZOSIN MESYLATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
DOXAZOSIN TABLETS, USP
1 MG, 2 MG, 4 MG AND 8 MG
RX ONLY
1
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. 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
1
(EACH TABLET CONTAINS DOXAZOSIN MESYLATE EQUIVALENT TO 1 MG , 2 MG , 4
MG OR 8 MG OF DOXAZOSIN)
1
23
25
5
5
4
3
correlate well with the size of the pr
                                
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