ALPRAZOLAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

NuCare Pharmaceuticals,Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Alprazolam Tablets, USP (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

Ringkasan produk:

Alprazolam Tablets,USP are available as follows: 0.5 mg (Light orange to orange, oval, biconvex tablets with break line on one side and debossed B705 on the other side.) NDC 68071-5113-5 BOTTLES OF 15 NDC 68071-5113-3 BOTTLES OF 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light. Dispense in tight (USP), light-resistant, child-resistant containers. Rx only

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Alprazolam Tablets USP C-IV
(al pra' zoe lam)
What is the most important information I should know about alprazolam
tablets?
•
Alprazolam Tablets is 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 might cause
panic, helplessness, or embarrassment (agoraphobia)
•
Alprazolam is 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 for
longer than 4 months.
•
It i

Ciri produk

ALPRAZOLAM- ALPRAZOLAM TABLET
NUCARE PHARMACEUTICALS,INC.
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ALPRAZOLAM TABLETS, USP
CIV
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 represented to the right:
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, USP, for oral administration, contains 0.25,
0.5, 1 or 2 mg of
alprazolam
Alprazolam Tablets USP, 2 mg, are multi-scored and may be divided as
shown below:
Complete 2 mg
Tablet
Two 1 mg
segments
Four 0.5 mg
segments
Inactive ingredients: Lactose monohydrate, microcrystalline cellulose,
sodium starch
glycolate, hydroxy propyl cellulose, sodium lauryl sulfate and
magnesium stearate. In
addition, the 0.5 mg tablet contains FD & C Yellow 6 lake and the 1 mg
and 2 mg tablet
contains FD & C Blue 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 abso