Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)
State of Florida DOH Central Pharmacy
DOXAZOSIN MESYLATE
DOXAZOSIN 4 mg
ORAL
PRESCRIPTION DRUG
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
Doxazosin mesylate tablets, 1 mg (doxazosin as free base), are white to off-white, round, biconvex compressed tablet, debossed modified N over bisect 590 (N)/590 on one side and 1 on the other side. Doxazosin mesylate tablets, 2 mg (doxazosin as free base), are white to off-white, capsule-shaped, biconvex compressed tablet, debossed modified N bisect 593 (N/593) on one side and 2 on the other side. Doxazosin mesylate tablets, 4 mg (doxazosin as free base), are white to off-white, modified diamond-shaped, biconvex compressed tablet, debossed modified N over bisect 596 (N)/596 on one side and 4 on the other side. Doxazosin mesylate tablets, 8 mg (doxazosin as free base), are white to off-white, round, biconvex compressed tablet, debossed modified N over bisect 598 (N)/598 on one side and 8 on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Recommended Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container. * Dalmane® is a registered trademark of Valeant Pharmaceuticals International.
Abbreviated New Drug Application
DOXAZOSIN MESYLATE - DOXAZOSIN MESYLATE TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- DOXAZOSIN MESYLATE TABLETS 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 mesylate tablet, 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 A. 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 capsule, and bladder neck. Blockade of the alpha receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms. In the human prostate, Przeczytaj cały dokument