LORAZEPAM tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)

Verfügbar ab:

Preferred Pharmaceuticals, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Lorazepam is contraindicated in patients with: Controlled Substance Lorazepam tablets contain lorazepam, a Schedule IV controlled substance. Abuse Lorazepam tablets are a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healt

Produktbesonderheiten:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 2/2021 Repackaged By: Preferred Pharmaceuticals Inc.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Lorazepam (lor azʹ e pam)
Tablets C-IV
What is the most important information I should know about lorazepam
tablets?
•
Lorazepam is 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. Get
emergency help right away if any of
the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
lorazepam tablets with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including lorazepam tablets 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 lorazepam tablets. 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 lorazepam tablets
exactly as prescribed by your
healthcare provider.
•
Take lorazepam tablets exactly as your healthcare provider prescribed.
•
Do not share your lorazepam tablets with other people.
•
Keep lorazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Lorazepam tablets can
cause physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking lorazepam tablets. Stopping lorazepam
tablets suddenly can cause serious
and life-threatening side effects, including, unusual movements,
responses or expressions, seizures,
sudden and severe mental or nervous

Fachinformation

LORAZEPAM- LORAZEPAM TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
LORAZEPAM TABLETS, USP C-IV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Lorazepam, USP, an antianxiety agent, has the chemical formula,
7-chloro-5-(_o_-
chlorophenyl)-1,3-dihydro-3-hydroxy-2_H_-1,4-benzodiazepin-2-one:
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM TABLETS, EXPOSES
USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING LORAZEPAM TABLETS
AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM TABLETS
MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF LORAZEPAM 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 LORAZEPAM TABLETS OR REDUCE THE DOSAGE (DOSAGE AND
ADMINISTRATION AND WARNINGS).
C
H CL
N O M.W. 321.16
It is a nearly white powder almost insoluble in water. Each lorazepam
tablet, to be taken
orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive
ingredients
present are