DOXAZOSIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxazosin Mesylate (UNII: 86P6PQK0MU) (Doxazosin - UNII:NW1291F1W8)

Available from:

Stat Rx USA

INN (International Name):

Doxazosin Mesylate

Composition:

Doxazosin Mesylate 4 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. 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: NDC 0378-4021-01 bottles of 100 tablets 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: NDC 0378-4022-01 bottles of 100 tablets NDC 0378-4022-05 bottles of 500 tablets 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: NDC 0378-4024-01 bottles of 100 tablets NDC 0378-4024-05 bottles of 500 tablets 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: NDC 0378-4028-01 bottles of 100 tablets 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 TABLET
STAT RX USA
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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.
CLINICAL PHARMACOLOGYPharmacodynamicsBenign 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
capsule and bladder neck. Blockade of the alpha receptor decreases
urethral resistance and may
relieve the obstruction and BPH symptoms. In the human prostate,
doxazosin antagonizes phenylephrine
(alpha agonist)-induced contractions,_in vitro_, and binds with high
affinity to the alpha
adrenoceptor.
The receptor subtype is thought to be the predominant functional type
in the prostate. Doxazosin acts
within 1 to 2 weeks to decrease the severity of BPH symptoms and
improve urinary f