DOXAZOSIN- doxazosin mesylate tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
25-05-2010

Aktīvā sastāvdaļa:

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

Pieejams no:

State of Florida DOH Central Pharmacy

SNN (starptautisko nepatentēto nosaukumu):

DOXAZOSIN MESYLATE

Kompozīcija:

DOXAZOSIN MESYLATE 4 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                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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