LORAZEPAM- lorazepam tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Lorazepam Tablets USP are available in the following dosage strengths: 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. 55700-249-30 55700-249-60 1 mg: white, scored, round flat faced beveled edge, debossed with 241 over 1 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. 2 mg: white, scored, round flat faced beveled edge, debossed with 242 over 2 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2008 0608B 173019

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

LORAZEPAM- LORAZEPAM TABLET
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Lorazepam (lor azʹ e pam)
Tablets, USP C-IV
What is the most important information I should know about lorazepam
tablets?
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 tablets 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 tablets
affect you.
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: to treat anxiety
disorders
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
they can be abused or lead to
dependence. Keep lorazepam tablets in a safe place to prevent misuse
and 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

Produktets egenskaber

LORAZEPAM- LORAZEPAM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
LORAZEPAM TABLETS USP
REVISED: JUNE 2008
RX ONLY
CIV
173019
RX ONLY
DESCRIPTION
Lorazepam, an antianxiety agent, has the chemical formula,
7-chloro-5-(_o_-chlorophenyl)-1,3-dihydro-3-
hydroxy-2H-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, magnesium stearate,
microcrystalline cellulose and polacrilin potassium.
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 six months.
Studies comparing young and elderly subjects have shown that advancing
age does not have a significant
effect on the pharmacokinetics of lorazepam. However, in one study
involving single intravenous doses
of 1.5 to 3 mg of lorazepam injection, mean total body clearance of
lorazepam decreased by 20% in 15
elderly subjects of 60 to 84 years of age compared to that in 15
younger subjects of 19 to 38 years of
age.
INDICATIONS AND USA