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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 cold clammy hands; dr

Product summary:

Alprazolam tablets, USP are supplied as follows: 0.25 mg — Each white, round tablet imprinted with on one side and 027 and bisect on the other contains 0.25 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2027-10), 500 (NDC 0228-2027-50), and 1000 (NDC 0228-2027-96). 0.5 mg — Each peach, round tablet imprinted with on one side and 029 and bisect on the other contains 0.5 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2029-10), 500 (NDC 0228-2029-50), and 1000 (NDC 0228-2029-96). 1 mg — Each blue, round tablet imprinted with on one side and 031 and bisect on the other contains 1 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2031-10), 500 (NDC 0228-2031-50), and 1000 (NDC 0228-2031-96). 2 mg — Each yellow, rectangle shaped, flat faced, beveled edge tablet imprinted with and 039 on one side and multi-scored on both sides contains 2 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2039-10). 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]. ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9170 Revised — July 2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALPRAZOLAM- ALPRAZOLAM TABLET
Aphena Pharma Solutions - Tennessee, LLC
----------
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 t

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ALPRAZOLAM TABLETS, USP
C-IV
Revised — July 2017
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, USP which is a triazolo
analog of the 1,4 benzodiazepine
class of central nervous system-active compounds.
The chemical name of alprazolam, USP is
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4]
benzodiazepine and its structural formula is:
Alprazolam, USP is a white to off-white crystalline powder, which is
soluble in methanol or ethanol but
which has no appreciable solubility in water at physiological pH.
Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg,
and 2 mg of alprazolam, USP. The 2
mg tablets are multi-scored and may be divided in half to provide two
1 mg segments, or quarters to
provide four 0.5 mg segments.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, corn
starch, docusate sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and
sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6
aluminum lake (sunset yellow lake).
The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg
tablet also contains D&C yellow
#10 aluminum 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