ALPRAZOLAM ER- alprazolam tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

STAT RX USA LLC

INN (Alþjóðlegt nafn):

ALPRAZOLAM

Samsetning:

ALPRAZOLAM 2 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (

Vörulýsing:

Alprazolam extended-release tablets 0.5 mg are white, round compressed tablets debossed cor over 187 on one side and other side is plain. They are supplied as follows:            Bottles of 60                    (NDC 64980-140-06)            Bottles of 100                  (NDC 64980-140-01)            Bottles of 1000                (NDC 64980-140-10) Alprazolam extended-release tablets 1 mg are yellow, round compressed tablets debossed cor over 188 on one side and other side is plain. They are supplied as follows:            Bottles of 60                    (NDC 64980-141-06)            Bottles of 100                  (NDC 64980-141-01)            Bottles of 1000                (NDC 64980-141-10) Alprazolam extended-release tablets 2 mg are blue, round compressed tablets debossed cor over 189 on one side and other side is plain. They are supplied as follows:            Bottles of 60                    (NDC 64980-142-06)            Bottles of 100                  (NDC 64980-142-01)            Bottles of 1000                (NDC 64980-142-10) Alprazolam extended-release tablets 3 mg are green, round compressed tablets debossed cor over 190 on one side and other side is plain. They are supplied as follows:            Bottles of 60                    (NDC 64980-143-06)            Bottles of 100                  (NDC 64980-143-01)            Bottles of 1000                (NDC 64980-143-10) Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Dispense in a tight light-resistant container as defined in the USP. Keep container tightly closed. Keep this and all drugs out of the reach of children.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ALPRAZOLAM ER- ALPRAZOLAM TABLET, EXTENDED RELEASE
STAT RX USA LLC
----------
ALPRAZOLAM EXTENDED-RELEASE TABLETS CIV
0.5 MG, 1 MG, 2 MG AND 3 MG
RX ONLY
DESCRIPTION
Alprazolam extended-release tablets contain alprazolam, USP 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-4
_H-s_-triazolo [4,3-α] [1,4]
benzodiazepine. The molecular formula is C
H ClN which corresponds to a molecular weight of
308.76.
The structural formula is:
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 extended-release tablet, for oral administration,
contains 0.5 mg, 1 mg, 2 mg, or 3 mg
of alprazolam, USP. The inactive ingredients are colloidal silicon
dioxide, hypromellose, lactose
monohydrate, and magnesium stearate. In addition, the 1 mg and 3 mg
tablets contain D & C yellow No.
10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
CNS agents of the 1,4 benzodiazepine class presumably exert their
effects by binding at stereospecific
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.
17
13
4
PHARMACOKINETICS
Absorption
Following oral administration of alprazolam (immediate-release)
tablets, alprazolam is readily absorbed.
Peak concentrations in the plasma occur in one to two hours following
administration. Plasma levels are
proportional 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.
The mean absolute bioavailability of alprazolam fr