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

Produkt oversigt:

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: 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: 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: 55700-614-30 BOTTLES: Keep tightly closed Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

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 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

Produktets egenskaber

LORAZEPAM- LORAZEPAM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
LORAZEPAM TABLETS, USP CIV
RX ONLY
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 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, 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 19 to 38 years of age.
INDICATIONS AND USAGE
Lorazepam is indicated for the