ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 six 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 m

Product summary:

Alprazolam Tablets, USP are available as follows: 0.5 mg (yellow, oval, scored on one side; S left of bisect 901 to right) Bottles of 20 - 68788-9997-2 Bottles of 30 - 68788-9997-3 Bottles of 60 - 68788-9997-6 Bottles of 90 - 68788-9997-9 Bottles of 120 - 68788-9997-8 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx only

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Alprazolam Tablets (al pra' zoe lam), C-IV
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 is alprazolam tablets?
•
Alprazolam tablets is 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 tablets 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 is 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 is safe and effective when used
to treat anxiety disorder for
longer than 4 months.
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Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
PREFERRED PHARMACEUTICALS, INC.
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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_).
•
•
•
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.
Inactive ingredients: crospovidone, docusate sodium, lactose,
magnesium stearate,
microcrystalline cellulose, silicon dioxide, sodium benzoate and
starch 1500. In addition,
the 0.5 mg tablet contains D&C Yellow No. 10 and the 1 mg and 2 mg
tablet contains
Green Lake Blend.
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.
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 g