ALPRAZOLAM EXTENDED RELEASE- alprazolam tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam extended-release tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL EFFICACY TRIALS). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dyi

Product summary:

Alprazolam extended-release tablets, USP are available as follows: 1 mg — Each yellow, round tablet imprinted with on one side and 84 on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3084-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the 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 40-9181 Revised – May 2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Alprazolam (al pra' zoe lam)
Extended-Release Tablets, USP C-IV
What is the most important information I should know about alprazolam
extended-release tablets?
•
Alprazolam extended-release 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 extended-release 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 extended-release tablets affect you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
alprazolam extended-release tablets without first talking to your
healthcare provider. When
taken with alcohol or drugs that cause sleepiness or dizziness,
alprazolam extended-release
tablets may make your sleepiness or dizziness much worse.
•
Do not take more alprazolam extended-release tablets than prescribed.
What are alprazolam extended-release tablets?
•
Alprazolam extended-release tablets are a prescription medicine used
to treat panic disorder, with or
without a fear of places and situations that might cause panic,
helplessness, or embarrassment
(agoraphobia)
•
Alprazolam extended-release tablets are a federal controlled substance
(C-IV) because it can be
abused or lead to dependence. Keep alprazolam extended-release tablets
in a safe place to prevent
misuse and abuse. Selling or giving away alprazolam extended-release
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 extended-release tablets are safe and
effective in children.
•
Elderly patients are especially susceptible to dose related adverse
effects when ta

Summary of Product characteristics

ALPRAZOLAM EXTENDED RELEASE- ALPRAZOLAM TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
ALPRAZOLAM EXTENDED-RELEASE TABLETS, USP
C-IV
40-9181
Revised – May 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]_.
•
•
•
DESCRIPTION
Alprazolam extended-release 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-4_H_-_s_-triazolo [4,3-α]
[1,4] benzodiazepine. The molecular formula is C
H
ClN which corresponds to a
molecular weight of 308.76.
The structural formula is represented below:
Alprazolam, USP is a white crystalline powder, which is soluble in
methanol or ethanol 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.
17
13
4
but which has no appreciable solubility in water at physiological pH.
Each alprazolam extended-release tablet, for oral administration,
contains 0.5 mg, 1 mg,
2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose
monohydrate,
hypromellose, and magnesium stearate. In addition, the 1 mg tablets
also contain D&C
yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6
aluminum lake,
and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and
FD&C Blue #2
aluminum lake.
Product meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
CNS agents of the 1,4 benzodiazepine class presumably exert their
effects by binding at
stereospecific 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 depre