LORAZEPAM- lorazepam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

LORAZEPAM

Composition:

LORAZEPAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Lorazepam Tablets, USP are available as: 0.5 mg: White to off-white, round tablet, debossed SZ on one side and 197 on the reverse side, supplied as: Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
LORAZEPAM TABLETS, CIV
(LORE-AZ-EH-PAM)
What is the most important information I should know about lorazepam
tablets?
•
Lorazepam tablets 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 affects 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 is lorazepam tablets?
•
Lorazepam tablets 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 tablets is 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
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 is safe and effective in children
less than 12 years of age.
•
It is not known if lorazepam tablets is 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

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
PREFERRED PHARMACEUTICALS INC.
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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:
C H C N O MW: 321.16
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 following inactive ingredients are contained in these products:
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, 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
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.
15
10
L2
2
2
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 t