DOXAZOSIN mesylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN 4 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN - DOXAZOSIN MESYLATE TABLET
ST MARYS MEDICAL PARK PHARMACY
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DOXAZOSIN TABLETS USP
8120
8121
8122
8123
RX ONLY
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. It has the following
structure:
C
H N O •CH O S M.W. 547.6
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. Each doxazosin tablet USP, for oral
administration, contains 1 mg, 2 mg, 4 mg, or 8
mg of doxazosin as the free base.
The inactive ingredients for all tablets are: microcrystalline
cellulose, lactose monohydrate, sodium
starch glycolate, magnesium stearate, pregelatinized starch, and
sodium lauryl sulfate.
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
1
23
25
5
5
4
3
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 in this area is
mediated by the alpha adrenoceptor, which is present in high density
in the prostatic stroma, prostatic
capsule and bladder neck. Blockade of the alpha receptor decreases
urethral resistance and may
relieve the obstruction and BPH symptoms. In the human pros