LORAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

LORAZEPAM

Composition:

LORAZEPAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma. 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 i

Product summary:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg: white to off-white, round flat-faced, beveled edge tablet, scored on one side debossed with 240 above bisect and 0.5 below bisect and debossed WATSON on the other side, supplied in bottles of 30 (NDC 55289-402-30), and 90 (NDC 55289-402-90). 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
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 sy

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
PD-RX 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
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).
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:
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 lactose mono