LORAZEPAM- lorazepam tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Proficient Rx LP

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 tablets are contraindicated in patients with

Огляд продуктів:

Lorazepam Tablets, USP are available containing 0.5 mg, USP. The 0.5 mg tablet is a white to off-white round tablet debossed with M on one side of the tablet and 321 on the other side. They are available as follows: The 1 mg tablet is a white to off-white round tablet debossed with MYLAN above the score and 457 below the score on one side of the tablet and blank on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED APRIL 2010 LORZ:R3 Repackaged by: Proficient Rx LP Westlake Village, CA, 91362

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Proficient Rx LP
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MEDICATION GUIDE
Lorazepam Tablets, USP CIV
(lor az' e 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.
•
Lorazepam tablets can make you sleepy or dizzy, and can slow your
thinking and motor skills.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
lorazepam tablets affect you.
o
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking lorazepam
tablets without first talking to your healthcare provider. When taken
with alcohol or drugs that
cause sleepiness or dizziness, lorazepam tablets may make your
sleepiness or dizziness much
worse.
•
Do not take more lorazepam tablets than prescribed.
What are lorazepam tablets?
•
Lorazepam tablets are a prescription medicine used:
o
to treat anxiety disorders
o
for the short-term relief of the symptoms of anxiety or anxiety that
can happen with symptoms of
depression
•
Lorazepam tablets are a federal controlled substance (C-IV) because it
can be abused or lead to
dependence. Keep lorazepam tablets in a safe place to prevent misuse
or abuse. Selling or giving
away lorazepam tablets 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 tablets are safe and effective in
children less than 12 years of age.
•
It is not known if lorazepam tablets are safe and effective for use
for longer than 4 months.
Do not take lorazepam tablets if you:
•
are allergic to lorazepam, other benzodiazepines, or any of the
ingredients in lorazepam tablets. See
the end of this Medication Guide for a complete list of ingredients in
lorazepam tablets.
Befor

Характеристики продукта

LORAZEPAM- LORAZEPAM TABLET
PROFICIENT RX LP
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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:
C15H10CL2N2O2 MW: 321.16
C15H10Cl2N2O2 MW: 321.16
C15H10Cl2N2O2 MW: 321.16
Lorazepam, USP is a white or almost white crystalline powder almost
insoluble in water. Each
lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg
of lorazepam, USP. The inactive
ingredients present are lactose monohydrate, microcrystalline
cellulose, polacrilin potassium and
sodium stearyl fumarate.
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%.
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 6 months.
Studies comparing young and elderly subjects have shown that advancing
age does not have a significant
effect on the pharmacokinetics of lorazepam.
INDICATIONS AND USAGE
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