LORAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

LORAZEPAM

Composition:

LORAZEPAM 1 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: NDC 0781-5371-01 bottles of 100 NDC 0781-5371-05 bottles of 500 1 mg: White to off-white, round tablet, scored on one side and debossed SZ 198 on the reverse side, supplied as: NDC 0781-5377-01 bottles of 100 NDC 0781-5377-05 bottles of 500 2 mg: White to off-white, round tablet, scored on one side and debossed SZ 199 on the reverse side, supplied as: NDC 0781-5379-01 bottles of 100 NDC 0781-5379-05 bottles of 500 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). 10-2013M 7446 Sandoz Inc. Princeton, NJ 08540

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LORAZEPAM- LORAZEPAM TABLET
RedPharm Drug, Inc.
----------
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 ingredie

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
REDPHARM DRUG, INC.
----------
LORAZEPAM 1MG
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:
[Lorazepam Chemical Structure]
C15H10Cl2N2O2 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
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.
INDIC