LORAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

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 tablets, 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. Lorazepam contains lorazepam, a Schedule IV controlled substance. Lorazepam is 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 pu

Product summary:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg white, round, flat face, beveled edge tablets, debossed “IP” on one side and “15” on the other side. They are available as follows: Bottles of 100:            NDC 65162-015-10 Bottles of 500:            NDC 65162-015-50 Bottles of 1000:          NDC 65162-015-11 1 mg white, round, flat face, beveled edge tablets, debossed “IP” scored “16” on one side and plain on the other side. They are available as follows: Bottles of 100:            NDC 65162-018-10 Bottles of 500:            NDC 65162-018-50 Bottles of 1000:          NDC 65162-018-11 2 mg white, round, flat face, beveled edge tablets, debossed “IP” scored “17” on one side and plain on the other side. They are available as follows: Bottles of 100:            NDC 65162-017-10 Bottles of 500:            NDC 65162-017-50 Bottles of 1000:          NDC 65162-017-11 Keep bottles tightly closed. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Amneal Pharmaceuticals of NY, LLC Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 03-2021-01

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Lorazepam ( lor az’ e pam) Tablets, USP CIV
What is the most important information I should know about lorazepam
tablets?
•
Lorazepam 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. 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 o

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
AMNEAL PHARMACEUTICALS LLC
----------
LORAZEPAM TABLETS USP, CIV
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, 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 AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM 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 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 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
C N O M.W. 321.16
It is a nearly white powder almost insoluble in water. Each lorazepam
tablet, USP to be
taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The
inactive ingredients
present are lactose monohydrate, magnesium stearate, microcrystalli