ALPRAZOLAM tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Direct_Rx

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Alprazolam extended-release tablets 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)

Prehľad produktov:

Alprazolam Extended-Release Tablets USP, 0.5 mg are white to off-white, round, biconvex tablets with beveled edge debossed with ‘X’ on one side and ‘70’ on the other side. Bottles of 60 Bottles of 1,000 Bottles of 7,000 Alprazolam Extended-Release Tablets USP, 1 mg are yellow colored, round, biconvex tablets with beveled edge debossed with ‘X’ on one side and ‘73’ on the other side. The tablets may be mottled. Bottles of 60 Bottles of 1,000 Bottles of 7,000 Alprazolam Extended-Release Tablets USP, 2 mg are blue colored, round, biconvex tablets with beveled edge debossed with ‘X’ on one side and ‘74’ on the other side. The tablets may be mottled. Bottles of 60 Bottles of 1,000 Bottles of 7,000 Alprazolam Extended-Release Tablets USP, 3 mg are green colored, round, biconvex tablets with beveled edge debossed with ‘X’ on one side and ‘75’ on the other side. The tablets may be mottled. Bottles of 60 Bottles of 1,000 Bottles of 7,000 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

ALPRAZOLAM- ALPRAZOLAM TABLET, EXTENDED RELEASE
Direct_Rx
----------
Alprazolam Extended-Release Tablets, USP
(al pra' zoe lam) CIV
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 affects 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 taking alprazolam
extended-r

Súhrn charakteristických

ALPRAZOLAM- ALPRAZOLAM TABLET, EXTENDED RELEASE
DIRECT_RX
----------
ALPRAZOLAM
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.
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-4H-s-triazolo [4,3-α] [1,4]
benzodiazepine. The molecular formula is C17H13ClN4 which corresponds
to a molecular weight of
308.76.
The structural formula is represented below:
[Chemical Structure]
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 alprazolam extended-release tablet USP, for oral administration,
contains 0.5 mg, 1 mg, 2 mg, or 3
mg of alprazolam. The inactive ingredients are colloidal silicon
dioxide, hypromellose, lactose
monohydrate, and magnesium stearate. In addition, the 1 mg and 3 mg
tablets contain D&C Yellow No.
10 aluminum lake and the 2 mg and 3 mg tablets contain FD&C Blue No. 2
lake.
Meets USP Dissolution Test 4.
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 depressant
activity varying from mild impairment of task performance to hypnosis.
Pharmacokinetics
Absorption
Following oral administration of alprazolam (immediate-release)
tablets, alprazolam is readily absor