ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.25 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: 0.25 mg (white, oval, scored on one side: S left of bisect 900 to right) Bottles of 90             NDC 67253-900-09 Bottles of 100           NDC 67253-900-10 Bottles of 500           NDC 67253-900-50 Bottles of 1000         NDC 67253-900-11 0.5 mg (yellow, oval, scored on one side; S left of bisect 901 to right) Bottles of 100           NDC 67253-901-10 Bottles of 500           NDC 67253-901-50 Bottles of 1000         NDC 67253-901-11 1 mg (green, oval, scored on one side; S left of bisect 902 to right) Bottles of 100            NDC 67253-902-10 Bottles of 500            NDC 67253-902-50 Bottles of 1000          NDC 67253-902-11 2 mg (green, elongated, rectangular-shaped, multi-scored; S left of bisect, 90 center and 3 to right) Bottles of 100             NDC 67253-903-10 Bottles of 500             NDC 67253-903-50 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

Par Pharmaceutical
----------
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.
•
It is not k

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
PAR PHARMACEUTICAL
----------
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 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.
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 given; over the
dose range