LORAZEPAM- lorazepam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

LORAZEPAM

Composition:

LORAZEPAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma.

Product summary:

Lorazepam Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of lorazepam, USP. The 0.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 321 on the other side. They are available as follows: NDC 51079-417-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1 mg tablets are white to off-white, round, scored tablets 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: NDC 51079-386-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 2 mg tablets are white to off-white, round, scored tablets debossed with MYLAN above the score and 777 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-387-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LORAZEPAM- LORAZEPAM TABLET
Mylan Institutional 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.
•
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 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 lis

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
MYLAN INSTITUTIONAL INC.
----------
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
Interactions).
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.
DESCRIPTION
Lorazepam tablets, USP, 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 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
tablets have a tranquilizing
action on the central nervous system with no appreciable effect on the
respiratory or cardiovascular
systems.
Lorazepam tablets are 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 tablets are
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
accu