ATIVAN- lorazepam tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

lorazepam (UNII: O26FZP769L) (lorazepam - UNII:O26FZP769L)

Διαθέσιμο από:

Bausch Health US LLC

INN (Διεθνής Όνομα):

lorazepam

Σύνθεση:

lorazepam 0.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ativan (lorazepam) is 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 Ativan (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. Ativan (lorazepam) is contraindicated in patients with: Controlled Substance Ativan contains lorazepam, a Schedule IV controlled substance. Abuse Ativan 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 healt

Περίληψη προϊόντος:

Ativan® (lorazepam) Tablets are available in the following dosage strengths: 0.5 mg, white, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "63" impressed on reverse side. NDC 0187-0063-01 - Bottles of 100 tablets. 1 mg, white, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "64" impressed on scored reverse side. NDC 0187-0064-01 - Bottles of 100 tablets. NDC 0187-0064-10 - Bottles of 1,000 tablets. 2 mg, white, five-sided (regular pentagon) tablet with a raised "A" and impressed "2" on one side and "BPI" and "65" impressed on scored reverse side. NDC 0187-0065-01 - Bottles of 100 tablets. Keep bottles tightly closed. Keep out of reach of children. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada Ativan is a trademark of Bausch Health Companies Inc. or its affiliates. © 2023 Bausch Health Companies Inc. or its affiliates 9644303 Rev. 01/2023

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

Bausch Health US LLC
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MEDICATION GUIDE
MEDICATION GUIDE
ATIVAN (AT-ivan)
(lorazepam) Tablets
What is the most important information I should know about ATIVAN?
•
ATIVAN 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
ATIVAN with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including ATIVAN 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 ATIVAN. 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 ATIVAN exactly as
prescribed by your
healthcare provider.
•
Take ATIVAN exactly as your healthcare provider prescribed.
•
Do not share your ATIVAN with other people.
•
Keep ATIVAN in a safe place and away from children.
•
Physical dependence and withdrawal reactions. ATIVAN can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking ATIVAN. Stopping ATIVAN suddenly can cause
serious and life-
threatening side effects, including, unusual movements, responses or
expressions, seizures,
sudden and severe mental or nervous system changes, depression, seeing
or hearing things that
others do not see or hear, an extreme increase in activity or

Αρχείο Π.Χ.Π.

ATIVAN- LORAZEPAM TABLET
BAUSCH HEALTH US LLC
----------
ATIVAN
(LORAZEPAM)
TABLETS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Ativan (lorazepam), an antianxiety agent, has the chemical formula,
7-chloro-5-(_o_-
®
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 ATIVAN, 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 ATIVAN AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING ATIVAN, 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
ATIVAN 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 ATIVAN OR
REDUCE THE DOSAGE (DOSAGE AND ADMINISTRATION AND
WARNINGS).
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 Ativan
(lorazepam) tablet, to
be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The
inactive ingredients
present are lactose monohydrate, magnesium stearate, microcrystalline
cellulo