LORAZEPAM- lorazepam tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Preferred Pharmaceuticals, Inc

INN (Nama Antarabangsa):

LORAZEPAM

Komposisi:

LORAZEPAM 0.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Lorazepam tablets, USP 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 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.

Ringkasan produk:

Lorazepam tablets, USP 0.5 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX7” on one side and plain on the other side. They are supplied as follows: Bottle of 30 – 68788-9840-3 Bottle of 60 – 68788-9840-6 Bottle of 90 – 68788-9840-9 Bottle of 100 – 68788-9840-1 Bottle of 120 – 68788-9840-8 Lorazepam tablets, USP 1 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX” above the bisect and “773” below the bisect on one side and plain on the other side. They are supplied as follows: Bottle of 30 – 68788-9839-3 Bottle of 60 – 68788-9839-6 Bottle of 90 – 68788-9839-9 Bottle of 100 – 68788-9839-1 Bottle of 120 – 68788-9839-8 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tightly closed. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA February 2013 Repackaged by Preferred Pharmaceuticals, Inc.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

LORAZEPAM- LORAZEPAM TABLET
PREFERRED PHARMACEUTICALS, INC
----------
LORAZEPAM TABLETS, USP C-IV
RX ONLY
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. Its molecular formula is C
H Cl
N O and its structural
formula is:
MW: 321.16
It is a white to practically white, practically odorless powder. It is
insoluble in water, sparingly soluble
in alcohol, and slightly soluble in chloroform. Each tablet, to be
taken orally, contains 0.5 mg, 1 mg, or
2 mg of lorazepam, USP.
The inactive ingredients present are lactose monohydrate, 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.
15
10
2
2
2
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
loraz