ALPRAZOLAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Rising Pharmaceuticals, Inc.

INN（国际名称）:

ALPRAZOLAM

组成:

ALPRAZOLAM 0.25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Alprazolam tablets, USP 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 cold clammy hands; dry mouth; dizz

產品總結:

Alprazolam Tablets USP, 0.25 mg are white, oval shaped, uncoated tablets with breakline on one side debossed with ‘1’ and ‘8’ on either sides of the breakline and ‘Y’ on the other side.                   Bottles of 100                           NDC 64980-396-01                   Bottles of 500                           NDC 64980-396-50                   Bottles of 1,000                        NDC 64980-396-10 Alprazolam Tablets USP, 0.5 mg are peach colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘1’ and ‘9’ on either sides of the breakline and ‘Y’ on the other side.                    Bottles of 100                           NDC 64980-397-01                   Bottles of 500                           NDC 64980-397-50                   Bottles of 1,000                        NDC 64980-397-10 Alprazolam Tablets USP, 1 mg are blue colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘2’ and ‘0’ on either sides of the breakline and ‘Y’ on the other side.                   Bottles of 100                           NDC 64980-398-01                   Bottles of 500                           NDC 64980-398-50                   Bottles of 1,000                        NDC 64980-398-10 Alprazolam Tablets USP, 2 mg are white, oblong, uncoated tablets with three breaklines on both sides debossed with ‘2’ and ‘1’ on either sides of the center breakline and ‘Y’ on the other side.                    Bottles of 100                           NDC 64980-399-01                   Bottles of 500                           NDC 64980-399-50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

授权状态:

Abbreviated New Drug Application

资料单张

ALPRAZOLAM - ALPRAZOLAM TABLET
Rising Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Alprazolam Tablets, USP CIV
(al pra' zoe lam)
What is the most important information I should know about alprazolam
tablets?
•
Alprazolam tablets are a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death.
•
Alprazolam tablets can make you sleepy or dizzy, and can slow your
thinking and motor skills.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
alprazolam tablets affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
alprazolam tablets without first talking to your healthcare provider.
When taken with alcohol
or drugs that cause sleepiness or dizziness, alprazolam tablets may
make your sleepiness or
dizziness much worse.
•
Do not take more alprazolam tablets than prescribed.
What are alprazolam tablets?
•
Alprazolam tablets are a prescription medicine used:
•
to treat anxiety disorders
•
for the short-term relief of the symptoms of anxiety
•
to treat panic disorder with or without a fear of places and
situations that mightcause panic,
helplessness, or embarrassment (agoraphobia)
•
Alprazolam are a federal controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep alprazolam tablets in a safe place to prevent misuse and abuse.
Selling or giving away
alprazolam tablets may harm others, and is against the law. Tell your
healthcare provider if you have
abused or been dependent on alcohol, prescription medicines or street
drugs.
•
It is not known if alprazolam tablets are safe and effective in
children.
•
Elderly patients are especially susceptible to dose related adverse
effects when taking alprazolam
tablets.
•
It is not known if alprazolam tablets are safe and effective when used
to treat anxiety disorder

产品特点

ALPRAZOLAM - ALPRAZOLAM TABLET
RISING PHARMACEUTICALS, INC.
----------
ALPRAZOLAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death _[see Warnings, Drug
Interactions]._
Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
DESCRIPTION
Alprazolam tablets, USP 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:
Alprazolam USP is a white to off-white, crystalline powder, which is
soluble in methanol
or ethanol but which has no appreciable solubility in water at
physiological pH.
Each alprazolam tablet USP, for oral administration, contains 0.25 mg,
0.5 mg, 1 mg or
2 mg of alprazolam USP.
Alprazolam tablets USP, 2 mg, are multi-scored and may be divided as
shown below:
Inactive ingredients: colloidal silicon dioxide, corn starch, docusate
sodium 85% with
sodium benzoate 15%, lactose monohydrate, magnesium stearate, and
microcrystalline
cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6
aluminum lake and the
1 mg tablet contains FD&C Blue No. 2 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 t