ALPRAZOLAM tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

St. Marys Medical Park Pharmacy

INN (International Name):

ALPRAZOLAM

Sammensætning:

ALPRAZOLAM 1 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 r

Produkt oversigt:

1 mg: Oval, blue tablets debossed GG 258 on one side and scored on the reverse side and supplied as: NDC: 60760-0813-30 bottles of 30 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ALPRAZOLAM- ALPRAZOLAM TABLET
St. Marys Medical Park Pharmacy
----------
ALPRAZOLAM- alprazolam tablet
Sandoz Inc
Reference Label Set Id: 210bf21f-340b-4fa1-9062-c67465ee051f
----------
MEDICATION GUIDE
Alprazolam Tablets, USP CIV
(al PRAY 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
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 are safe and effective in
children.
•
Elderly patients are especially susceptible to dose related adverse
effects when takin

Produktets egenskaber

ALPRAZOLAM- ALPRAZOLAM TABLET
ST. MARYS MEDICAL PARK PHARMACY
----------
ALPRAZOLAM TABLETS, USP
DESCRIPTION
Alprazolam 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:
Alprazolam is a white to off-white crystalline powder, which is
soluble in alcohol but which has no
appreciable solubility in water at physiological pH.
Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1
or 2 mg of alprazolam.
Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown
below:
Inactive ingredients: docusate sodium, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch, and sodium benzoate. Additionally,
the 0.5 MG also contains FD & C
Yellow #6 Aluminum Lake, and the 1 MG also contains FD & C Blue #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 one to two hours following administration. Plasma levels are
proportionate to the dose given; over
the dose range of 0.5 to 3 mg, peak levels of 8 to 37 ng/mL were
observed. Using a specific assay
methodology, the mean plasma elimination half-life of alprazolam has
been found to be about 11.2 hours
(range: 6.3 to 26.9 hours) in healthy adults.
Distribution
_In vitro_, alprazolam is bound (80 percent) to human serum protein.
Serum albumin accounts for the
majority of the binding.
Metabolism/Elimination
Alprazolam is extensively metabolized