ALPRAZOLAM- alprazolam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam tablets 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; dry mouth; dizziness or l

Product summary:

Alprazolam Tablets, USP are available containing 0.25 mg, 0.5 mg or 1 mg of alprazolam, USP. The 0.25 mg tablets are white, round, scored tablets debossed with MYLAN over A on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-788-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 0.5 mg tablets are peach, round, scored tablets debossed with MYLAN over A3 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-789-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1 mg tablets are blue, round, scored tablets debossed with MYLAN over A1 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-790-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALPRAZOLAM- ALPRAZOLAM TABLET
Mylan Institutional Inc.
----------
MEDICATION GUIDE
Alprazolam Tablets, USP
(al pra' zoe lam)
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

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
MYLAN INSTITUTIONAL INC.
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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 and PRECAUTIONS: 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 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 structural formula is represented below:
Alprazolam, USP 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, for oral administration, contains 0.25 mg, 0.5
mg, 1 mg or 2 mg of alprazolam,
USP.
Inactive ingredients: colloidal silicon dioxide, croscarmellose
sodium, docusate sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, sodium
benzoate and sodium lauryl
sulfate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6
Aluminum Lake and the 1 mg tablet
contains FD&C Blue No. 2 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 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
pr