Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)
NCS HealthCare of KY, Inc dba Vangard Labs
LORAZEPAM
LORAZEPAM 0.5 mg
ORAL
PRESCRIPTION DRUG
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.
Lorazepam Tablets, USP 0.5 mg are white, round, flat-faced beveled edge tablets, debossed “4007” on one side, and debossed “V” on the reverse side, and supplied as follows: Lorazepam Tablets, USP 1 mg are white, round, scored, flat-faced beveled edge tablets, debossed “4008” on one side, and debossed “V” on the reverse side, and supplied as follows: Lorazepam Tablets, USP 2 mg are white, round, scored, flat-faced beveled edge tablets, debossed “4009” on one side, and debossed “V” on the reverse side, and supplied as follows: Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
LORAZEPAM- LORAZEPAM TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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-2H-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 monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 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 Baca dokumen lengkap