LORAZEPAM tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Excellium Pharmaceutical Inc.

DCI (Dénomination commune internationale):

LORAZEPAM

Composition:

LORAZEPAM 0.5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg white, round, flat face, beveled edge tablets, debossed “EP 904” on one side and plain on the other side. They are available as follows: Bottles of 100: NDC 64125-904-01 Bottles of 500: NDC 64125-904-05 Bottles of 1000: NDC 64125-904-10 1 mg white, round, flat face, beveled edge tablets, debossed “EP 905” and scored on one side and "1" on the other side. They are available as follows: Bottles of 100: NDC 64125-905-01 Bottles of 500: NDC 64125-905-05 Bottles of 1000: NDC 64125-905-10 2 mg white, round, flat face, beveled edge tablets, debossed “EP 906” and scored on one side and "2" on the other side. They are available as follows: Bottles of 100: NDC 64125-906-01 Bottles of 500: NDC 64125-906-05 Bottles of 1000: NDC 64125-906-10 BOTTLES: Keep tightly closed Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

LORAZEPAM - LORAZEPAM TABLET
EXCELLIUM PHARMACEUTICAL INC.
----------
LORAZEPAM TABLETS, USP CIV
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:
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 Anhydrous,
Microcrystalline Cellulose, Polacrilin Potassium and Magnesium
Stearate.
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, 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 19 to 38 years of age.
INDICATIONS AND USAGE
Lorazepam is indicated for the management of an