DOXAZOSIN MESYLATE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dispensing Solutions, Inc.

INN (Tarptautinis Pavadinimas):

DOXAZOSIN MESYLATE

Sudėtis:

DOXAZOSIN 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

A. Benign Prostatic Hyperplasia (BPH). Doxazosin mesylate tablets 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 tablets 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 tablets monotherapy. Doxazosin mesylate tablets provides rapid improvement in symptoms and urinary flow rate in 66-71% of patients. Sustained improvements with doxazosin mesylate tablets were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. B. Hypertension . Doxazosin mesylate tablets is also indicated for the treatment of hypertension. Doxazosin mesylate tablets ma

Produkto santrauka:

Doxazosin mesylate is available as colored tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green) of the active constituent, doxazosin. Doxazosin Mesylate Tablets are available as 1 mg, white tablet, oval shape, partially bisected on one side, debossed with "1" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P16" on the other side; 2 mg, yellow tablet, oval shape, partially bisected on one side, debossed with "2" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P17" on the other side; 4 mg, orange tablet, oval shape, partially bisected on one side, debossed with "4" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P18" on the other side; and 8 mg, green tablet, oval shape, partially bisected on one side, debossed with "8" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P19" on the other side. Bottles of 90: 1 mg NDC 67253-380-09; 2 mg NDC 67253-381-09; 4 mg NDC 67253-382-09; 8 mg NDC 67253-383-09 Bottles of 100: 1 mg NDC 67253-380-10; 2 mg NDC 67253-381-10; 4 mg NDC 67253-382-10; 8 mg NDC 67253-383-10 Bottles of 150: 1 mg NDC 67253-380-15; 2 mg NDC 67253-381-15; 4 mg NDC 67253-382-15; 8 mg NDC 67253-383-15 Bottles of 500: 1 mg NDC 67253-380-50; 2 mg NDC 67253-381-50; 4 mg NDC 67253-382-50; 8 mg NDC 67253-383-50 Bottles of 1000: 1 mg NDC 67253-380-11; 2 mg NDC 67253-381-11; 4 mg NDC 67253-382-11; 8 mg NDC 67253-383-11 Bottles of 5000: 4 mg NDC 67253-382-51; 8 mg NDC 67253-383-51 Bottles of 5500: 1 mg NDC 67253-380-55; 2 mg NDC 67256-381-55 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.} Manufactured For: Dava Pharmaceuticals, Inc . Fort Lee, NJ 07024, USA By: Patheon Puerto Rico, Inc. Caguas, Puerto Rico 00725, USA And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DOXAZOSIN MESYLATE- DOXAZOSIN MESYLATE TABLET
DISPENSING SOLUTIONS, INC.
----------
DOXAZOSIN MESYLATE TABLETS, USP
RX ONLY
DESCRIPTION
Doxazosin mesylate is a quinazoline compound that is a selective
inhibitor of the alpha1 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 empirical 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 mesylate is available as colored tablets
for oral use and contains 1 mg
(white), 2 mg (yellow), 4 mg (orange) and 8 mg (green) of doxazosin as
the free base.
The inactive ingredients for all tablets are: microcrystalline
cellulose, NF; lactose, NF; sodium starch
glycolate, NF; magnesium stearate, NF and sodium lauryl sulfate, NF.
The 2 mg tablet contains D&C
yellow #10 Aluminum Lake and FD&C yellow #6 Aluminum Lake; the 4 mg
tablet contains FD&C
yellow #6 Aluminum Lake; the 8 mg tablet contains FD&C blue #2
Aluminum Lake and D&C yellow
#10 Aluminum Lake.
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 pr