ALPRAZOLAM- alprazolam tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)

Dostupné s:

Lake Erie Medical DBA Quality Care Products LLC

INN (Mezinárodní Name):

ALPRAZOLAM

Složení:

ALPRAZOLAM 1 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Anxiety Disorders Alprazolam tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or col

Přehled produktů:

Alprazolam tablets are available as follows: 0.25 mg (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’). 0.5 mg (Orange colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.5’) 1 mg (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’) 55700-491-30 55700-491-60 55700-491-90 2 mg (White to off white, oblong shaped, multi scored debossed ‘2’ on one side and plain on other side.) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ALPRAZOLAM- ALPRAZOLAM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
RX ONLY
CIV
DESCRIPTION
Alprazolam tablets contain alprazolam which is a triazolo analog of
the 1,4 benzodiazepine class of
central nervous system-active compounds.
The chemical name of alprazolam is
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4]
benzodiazepine.
The structural formula is represented below:
Alprazolam is a white crystalline powder, which is soluble in methanol
or ethanol but which has no
appreciable solubility in water at physiological pH.
Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1
or 2 mg of alprazolam.
Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown
below:
Inactive ingredients: Colloidal silicon dioxide, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose and povidone K-30. In addition, the 0.5 mg
tablet contains FD&C Yellow #6
aluminum lake and the 1 mg tablet contains FD&C Blue # 2 aluminum
lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
CNS agents of the 1,4 benzodiazepine class presumably exert their
effects by binding at stereo specific
receptors at several sites within the central nervous system. Their
exact mechanism of action is
unknown. Clinically, all benzodiazepines cause a dose-related central
nervous system depressant
activity varying from mild impairment of task performance to hypnosis.
PHARMACOKINETICS
Absorption
Following oral administration, alprazolam is readily absorbed. Peak
concentrations in the plasma occur
in 1 to 2 hours following administration. Plasma levels are
proportionate to the dose given; over the
dose range of 0.5 to 3.0 mg, peak levels of 8.0 to 37 ng/mL were
observed. Using a specific assay
methodology, the mean plasma elimination half-life of alprazolam has
been found to be about 11.2 hours
(range: 6.3–26.9 hours) in healthy adults.
Distribution
_In vitro_, alprazolam is bound (80 percent) to human serum protein.
Serum albumin accounts for the
majority of the binding.
Metabolism/Elimination
Alprazol