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:

Physicians Total Care, Inc.

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN MESYLATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 inhibito

Product summary:

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. 1 mg:  The 1 mg are available as white to off-white, round, biconvex tablets debossed with M over D9 on one side of the tablet and scored on the other side. They are available as follows: 2 mg:  The 2 mg are available as pink, round, biconvex tablets debossed with M over D10 on one side of the tablet and scored on the other side. They are available as follows: 4 mg:  The 4 mg are available as blue, round, biconvex tablets debossed with M over D11 on one side of the tablet and scored on the other side. They are available as follows: 8 mg:  The 8 mg are available as purple, round, biconvex tablets debossed with M over D12 on one side of the tablet and scored on the other side. They are available 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED AUGUST 2007 DXZN:R6p

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN - DOXAZOSIN MESYLATE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
1 MG, 2 MG, 4 MG AND 8 MG
RX ONLY (EACH TABLET CONTAINS DOXAZOSIN MESYLATE EQUIVALENT TO 1 MG, 2 MG, 4
MG OR 8 MG OF DOXAZOSIN)
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
PharmacodynamicsBenign 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