ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

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 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

Product summary:

Alprazolam Tablets,USP are available as follows: 0.25 mg (White to off white, oval, biconvex tablets with break line on one side and debossed "B704" on the other side.) 0.5 mg (Light orange to orange, oval, biconvex tablets with break line on one side and debossed "B705" on the other side.) 1 mg (Light blue to blue, oval, biconvex tablets with break line on one side and debossed "B706" on the other side.) 2 mg (Light blue to blue, rectangle tablets with three breaklines on one side and two notches in between two breaklines, debossed 'B707' on other side.) 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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RedPharm Drug, Inc.
----------
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 is not kn

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
REDPHARM DRUG, INC.
----------
ALPRAZOLAM 0.25MG TAB
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 absorbed. Peak
con