LORAZEPAM tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

NuCare Pharmaceuticals,Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

1 mg: white, scored, round flat faced beveled edge, debossed with 241 over 1 on one side and WATSON on the other side. NDC 68071-5048-3 BOTTLES OF 30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: May 2017 220239-2

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

LORAZEPAM- LORAZEPAM TABLET
NuCare Pharmaceuticals,Inc.
----------
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

Ürün özellikleri

LORAZEPAM- LORAZEPAM TABLET
NUCARE PHARMACEUTICALS,INC.
----------
LORAZEPAM TABLETS, USP
REVISED: MAY 2017
RX ONLY
C-IV
220239-2
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).
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, 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 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 accumul