ALPRAZOLAM tablet, orally disintegrating

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Par Pharmaceutical, Inc.

INN (الاسم الدولي):

ALPRAZOLAM

تركيب:

ALPRAZOLAM 0.25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials [see Clinical Studies (14.1)] . Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials [see Clinical Studies (14.2)] . Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient. Alprazolam orally disintegrating tablets a

ملخص المنتج:

Alprazolam orally disintegrating tablets, USP 0.25 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘110’ on the scored side and plain on the other. They are supplied as follows: Blisters of 10 x 10                                  NDC 49884-110-74 Alprazolam orally disintegrating tablets, USP 0.5 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘111’ on the scored side and plain on the other. They are supplied as follows: Blisters of 10 x 10                                  NDC 49884-111-74 Alprazolam orally disintegrating tablets, USP 1 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘213’ on the scored side and plain on the other. They are supplied as follows: Blisters of 10 x 10                                  NDC 49884-213-74 Alprazolam orally disintegrating tablets, USP 2 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘214’ on the scored side and plain on the other.  They are supplied as follows: Blisters of 10 x 10                                  NDC 49884-214-74   Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant containers as defined in the USP. Keep container tightly closed.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

ALPRAZOLAM- ALPRAZOLAM TABLET, ORALLY DISINTEGRATING
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Alprazolam (al pra′ zoe lam)
Orally Disintegrating Tablet (ODT), C-IV
•
What is the most important information I should know about alprazolam
ODT?
Alprazolam ODT is a benzodiazepine medicine. Taking benzodiazepines
with opioid medicines, alcohol,
or other central nervous system (CNS) depressants (including street
drugs) can cause severe drowsiness,
breathing problems (respiratory depression), coma and death. Get
emergency help right away if any of the
following happens:
Do not drive or operate heavy machinery until you know how taking
alprazolam ODT with
opioids affects you.
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including alprazolam ODT which can lead to overdose
and serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including Alprazolam ODT. These serious
side effects may
also include delirium, paranoia, suicidal thoughts or actions,
seizures, and difficulty
breathing. Call your healthcare provider or go to the nearest hospital
emergency room right
away if you get any of these serious side effects.
•
You can develop an addiction even if you take Alprazolam ODT exactly
as prescribed by
your healthcare provider.
•
Take Alprazolam ODT exactly as your healthcare provider prescribed.
•
Do not share your Alprazolam ODT with other people.
•
Keep Alprazolam ODT in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Alprazolam ODT can cause
physical dependence
and withdrawal reactions, especially if you continue to take
Alprazolam ODT for several days to
several weeks.
•
Do not suddenly stop taking Alprazolam ODT. Stopping Alprazolam ODT
suddenly can cause
ser

خصائص المنتج

ALPRAZOLAM- ALPRAZOLAM TABLET, ORALLY DISINTEGRATING
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPRAZOLAM ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ALPRAZOLAM ORALLY DISINTEGRATING TABLETS.
ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, C-IV
INITIAL U.S. APPROVAL: 2005
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND
WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE USE OF BENZODIAZEPINES, INCLUDING ALPRAZOLAM ORALLY DISINTEGRATING
TABLETS,
EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION. CONCOMITANT
USE OF
BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH_. _RESERVE CONCOMITANT PRESCRIBING OF
THESE DRUGS 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 (5.1, 7.1).
THE USE OF BENZODIAZEPINES, INCLUDING ALPRAZOLAM ORALLY DISINTEGRATING
TABLETS,
EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD
TO OVERDOSE
OR DEATH. BEFORE PRESCRIBING ALPRAZOLAM ORALLY DISINTEGRATING TABLETS
AND THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION (5.2).
_ _ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM
ORALLY
DISINTEGRATING TABLETS AFTER CONTINUED USE MAY PRECIPITATE ACUTE
WITHDRAWAL
REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF
WITHDRAWAL REACTIONS,
USE A GRADUAL TAPER TO DISCONTINUE ALPRAZOLAM ORALLY DISINTEGRATING
TABLETS OR
REDUCE THE DOSAGE (2.3, 5.3).
RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 08/2022
INDICATIONS AND USAGE
Alprazolam orally disintegrating tablets are a benzodiazepine
indicated for:
The treatment of generalized anxiety disorder (1.1). The efficacy of
alprazolam was demonstrated in 5
short