LORAZEPAM tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Preferred Pharmaceuticals Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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: Lorazepam tablets 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 purposes, of a drug by an individual in a way other than prescribed by a healthcare

Toote kokkuvõte:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U32’ on one side and plain on the other side.       Bottles of 30             NDC 68788-7355-3       Bottles of 60             NDC 68788-7355-6       Bottles of 90             NDC 68788-7355-9       Bottles of 100           NDC 68788-7355-1 Keep bottles tightly closed.   Keep out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 06/2023 Repackaged By: Preferred Pharmaceuticals Inc. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Lorazepam Tablets, USP CIV
(lor-A-ze-pam)
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

Toote omadused

LORAZEPAM- LORAZEPAM TABLET
PREFERRED PHARMACEUTICALS INC.
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LORAZEPAM TABLETS, USP CIV
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, 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).
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 anhydrous lactose, magnesium stearate, microcrystalline
c