DOXAZOSIN- 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:

Rebel Distributors Corp

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxazosin mesylate is 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 mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. Doxazosin mesylate is also indicated for the treatment of hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers, or angio

Product summary:

Doxazosin tablets USP, 2 mg (doxazosin as free base), are white to off-white, capsule-shaped, biconvex compressed tablet, debossed modified N over bisect 593 (N/593) on one side and 2 on the other side. They are supplied as follows: NDC 42254-075-30 bottles of 30’s Recommended Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. K 3/2010 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN- DOXAZOSIN MESYLATE TABLET
REBEL DISTRIBUTORS CORP
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DOXAZOSIN TABLETS USP
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
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
1
23
25
5
5
4
3
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 re