LORAZEPAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

PharmPak, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

1 mg White color, round, bisected flat face beveled edge compressed tablets, debossed "EP" above bisect and "905" below bisect on one side, and "1" on the other side. NDC# 54348-049-01 Bottles of 1 Tablets. 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].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

LORAZEPAM- LORAZEPAM TABLET
PharmPak, Inc.
----------
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:

Ficha técnica

LORAZEPAM- LORAZEPAM TABLET
PHARMPAK, INC.
----------
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).
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.
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.
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 lorazepam on administration up to s