LORAZEPAM tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Aphena Pharma Solutions - Tennessee, LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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

Produktbesonderheiten:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg white, round, flat face, beveled edge tablets, debossed “EP 904” on one side and plain on the other side. They are available as follows: Bottles of 100 Tablets NDC# 0904-6007-60 Bottles of 500 Tablets NDC# 0904-6007-40 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6007-61 1 mg white, round, flat face, beveled edge tablets, debossed “EP 905” and scored on one side and "1" on the other side. They are available as follows: Bottles of 100 Tablets NDC# 0904-6008-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6008-61 2 mg white, round, flat face, beveled edge tablets, debossed “EP 906” and scored on one side and "2" on the other side. They are available as follows: Bottles of 100 Tablets NDC# 0904-6009-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6009-61 BOTTLES: Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. Keep this and all Medications out of the reach of children. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
LORAZEPAM TABLETS, C-IV
(LOR AZ' E PAM)
What is the most important information I should know about Lorazepam?
•
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.
•
Lorazepam can make you sleepy or dizzy, and can slow your thinking and
motor skills.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
Lorazepam affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
Lorazepam without first talking to your healthcare provider. When
taken with alcohol or
drugs that cause sleepiness or dizziness, Lorazepam may make your
sleepiness or dizziness
much worse.
•
Do not take more Lorazepam than prescribed.
What is Lorazepam?
•
Lorazepam is a prescription medicine used:
•
to treat anxiety disorders
•
for the short-term relief of the symptoms of anxiety or anxiety that
can happen with symptoms
of depression
•
Lorazepam is a federal controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep Lorazepam in a safe place to prevent misuse and abuse. Selling or
giving away Lorazepam
may harm others, and is against the law. Tell your healthcare provider
if you have abused or been
dependent on alcohol, prescription medicines or street drugs.
•
It is not known if Lorazepam is safe and effective in children less
than 12 years of age.
•
It is not known if Lorazepam is safe and effective for use for longer
than 4 months.
Do not take Lorazepam if you:
•
are allergic to lorazepam, other benzodiazepines, or any of the
ingredients in Lorazepam . See the
end of this Medication Guide for a complete list of ingredients in
Lorazepam
Before you take Lorazepam , tell your healthcare provider about all of
your medical conditions, including
if you:
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Fachinformation

LORAZEPAM- LORAZEPAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
LORAZEPAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (SEE WARNINGS; PRECAUTIONS, CLINICALLY
SIGNIFICANT DRUG
INTERACTIONS ).
•
•
•
DESCRIPTION
Lorazepam, an antianxiety agent, has the chemical formula,
7-chloro-5-(_o_-chlorophenyl)-1,3-dihydro-3-
hydroxy-2_H_-1,4-benzodiazepin-2-one:
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. The inactive ingredients present
are lactose anhydrous,
microcrystalline cellulose, polacrilin potassium and magnesium
stearate.
Reserve concomitant prescribing of these drugs for use in 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.
CLINICAL PHARMACOLOGY
Studies in healthy volunteers show that in single high doses lorazepam
has a tranquilizing action on the
central nervous system with no appreciable effect on the respiratory
or cardiovascular systems.
Lorazepam is readily absorbed with an absolute bioavailability of 90
percent. Peak concentrations in
plasma occur approximately 2 hours following administration. The peak
plasma level of lorazepam from
a 2 mg dose is approximately 20 ng/mL.
The mean half-life of unconjugated lorazepam in human plasma is about
12 hours and for its major
metabolite, lorazepam glucuronide, about 18 hours. At clinically
relevant concentrations, lorazepam is
approximately 85% bound to plasma proteins. Lorazepam is rapidly
conjugated at its 3-hydroxy group
into lorazepam glucuronide which is then excreted in the urine.
Lorazepam glucuronide has no
demonstrable CNS activity in animals.
The plasma levels of lorazepam are proportional to the dose given.
There is no evidence of
accumulation of