LORAZEPAM- lorazepam tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

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 66267-427-30 bottles of 30 NDC 66267-427-60 bottles of 60 NDC 66267-427-90 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

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

NuCare Pharmaceuticals, Inc.
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The benzodiazepines, including lorazepam, produce increased
CNS-depressant effects when administered
with other CNS depressants such as alcohol, barbiturates,
antipsychotics, sedative/hypnotics, anxiolytics,
antidepressants, narcotic analgesics, sedative antihistamines,
anticonvulsants, and anesthetics.
Concomitant use of clozapine and lorazepam may produce marked
sedation, excessive salivation,
hypotension, ataxia, delirium, and respiratory arrest.
Concurrent administration of lorazepam with valproate results in
increased plasma concentrations and
reduced clearance of lorazepam. Lorazepam dosage should be reduced to
approximately 50% when
coadministered with valproate.
Concurrent administration of lorazepam with probenecid may result in a
more rapid onset or prolonged
effect of lorazepam due to increased half-life and decreased total
clearance. Lorazepam dosage needs to
be reduced by approximately 50% when coadministered with probenecid.
The effects of probenecid and valproate on lorazepam may be due to
inhibition of glucuronidation.
Administration of theophylline or aminophylline may reduce the
sedative effects of benzodiazepines,
including lorazepam.
Revised: 12/2018
Document Id: 7c37fa20-ef33-01aa-e053-2a91aa0a7f23
34391-3
Set id: 415b7866-a5da-58fb-e054-00144ff8d46c
Version: 2
Effective Time: 20181204
NuCare Pharmaceuticals, Inc.

Produktets egenskaber

LORAZEPAM- LORAZEPAM TABLET
NUCARE PHARMACEUTICALS, INC.
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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:
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
Lorazepam is indica