ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE Anxiety Disorders Alprazolam tablets, USP 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 c

Product summary:

Alprazolam tablets, USP are supplied as follows: 1 mg — Each blue, round tablet imprinted with [1] on one side and 031 and bisect on the other side contains 1 mg of alprazolam, USP. Tablets are supplied in bottles of: Dispense in tight, light-resistant containers as defined in the USP. Keep container tightly closed. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALPRAZOLAM- ALPRAZOLAM TABLET
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
MEDICATION GUIDE
Alprazolam (al pra' zoe lam) Tablets, USP C-IV
What is the most important information I should know about alprazolam
tablets?
Alprazolam tablets are 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 affect 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 tablets are a federal controlled substance (C-IV) because
they 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 lon

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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ALPRAZOLAM 1MG TABLET
BOXED WARNING
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND
DEPENDENCE AND WITHDRAWAL REACTIONS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death. Reserve concomitant
prescribing of
these drugs for 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 [see Warnings and
Precautions
(5.1), Drug Interactions (7.1)].
The use of benzodiazepines, including alprazolam, exposes users to
risks of abuse,
misuse, and addiction, which can lead to overdose or death. Abuse and
misuse of
benzodiazepines commonly involve concomitant use of other medications,
alcohol,
and/or illicit substances, which is associated with an increased
frequency of serious
adverse outcomes. Before prescribing alprazolam and throughout
treatment,
assess each patient’s risk for abuse, misuse, and addiction [see
Warnings and
Precautions (5.2)].
The continued use of benzodiazepines, including alprazolam, may lead
to clinically
significant physical dependence. The risks of dependence and
withdrawal increase
with longer treatment duration and higher daily dose. Abrupt
discontinuation or
rapid dosage reduction of alprazolam after continued use may
precipitate acute
withdrawal reactions, which can be life-threatening. To reduce the
risk of
withdrawal reactions, use a gradual taper to discontinue alprazolam or
reduce the
dosage [see Dosage and Administration (2.2), Warnings and Precautions
(5.3)].
INDICATIONS AND USAGE SECTION
INDICATIONS AND USAGE
Anxiety Disorders
Alprazolam tablets, USP 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 sympt