ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam Tablets 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; dizziness or l

Product summary:

Alprazolam tablets are available as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
ALPRAZOLAM TABLETS, C-IV
What is the most important information I should know about alprazolam?
•
Alprazolam 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 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 affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
alprazolam without first talking to your healthcare provider. When
taken with alcohol or
drugs that cause sleepiness or dizziness, alprazolam may make your
sleepiness or
dizziness much worse.
•
Do not take more alprazolam than prescribed.
What is alprazolam?
•
Alprazolam 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 is a federal controlled substance (C-IV) because it can be
abused or lead to
dependence. Keep alprazolam in a safe place to prevent misuse and
abuse. Selling or giving away
alprazolam 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 is safe and effective in children.
•
Elderly patients are especially susceptible to dose related adverse
effects when taking alprazolam.
•
It is not known if alprazolam is safe and effective when used to treat
anxiety disorder for longer
than 4 months.
•
It is not known if alprazolam is safe and effective when used to treat
panic disorder for longer
than 10 weeks.
Do not take alp

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 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, 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: Cellulose, corn starch, docusate sodium,
lactose, magnesium stearate, silicon
dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains
FD&C Yellow No. 6 and the 1 mg
tablet contains FD&C Blue No. 2.
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
proportio