LORAZEPAM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Proficient Rx LP

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Lorazepam Tablets, USP are available as: 1 mg: White to off-white, round tablet, scored on one side and debossed SZ 198 on the reverse side, supplied as: NDC 63187-536-06 bottles of 06 NDC 63187-536-15 bottles of 15 NDC 63187-536-15 bottles of 20 NDC 63187-536-30 bottles of 30 NDC 63187-536-60 bottles of 60 NDC 63187-536-90 bottles of 90 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 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Proficient Rx LP
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MEDICATION GUIDE
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 tablets.
Before you take lorazepam tablets, tell your

Prekės savybės

LORAZEPAM- LORAZEPAM TABLET
PROFICIENT RX LP
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LORAZEPAM TABLETS, USP
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:
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.
INDICATIONS AND USAGE
Loraze