displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5 (2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is:Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains 2.0 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as preservative.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Lorazepam interacts with the γ-aminobutyric acid (GABA)-benzodiazepine receptor complex, which is widespread in the brain of humans as well as other species. This interaction is presumed to be responsible for lorazepam’s mechanism of action. Lorazepam exhibits relatively high and specific affinity for its recognition site but does not displace GABA. Attachment to the specific binding site enhances the affinity of GABA for its receptor site on the same receptor complex. The pharmacodynamic consequences of benzodiazepine agonist actions include antianxiety effects, sedation, and reduction of seizure activity. The intensity of action is directly related to the degree of benzodiazepine receptor occupancy.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Status EpilepticusLorazepam injection is indicated for the treatment of status epilepticus.PreanestheticLorazepam injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (seePRECAUTIONS, Information for Patients).
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lorazepam injection is contraindicated in patients with a known sensitivity to benzodiazepines or its vehicle (polyethylene glycol, propylene glycol, and benzyl alcohol), in patients with acute narrow-angle glaucoma, or in patients with sleep apnea syndrome. It is also contraindicated in patients with severe respiratory insufficiency, except in those patients requiring relief of anxiety and/or diminished recall of events while being mechanically ventilated. The use of lorazepam injection intra-arterially is contraindicated because, as with other injectable benzodiazepines, inadvertent intra-arterial injection may produce arteriospasm resulting in gangrene which may require amputation (seeWARNINGS).
DRUG ABUSE AND DEPENDENCE
displayName: DRUG ABUSE & DEPENDENCE SECTION
FDA Article Code: 42227-9
Controlled Substance ClassLorazepam is a controlled substance in Schedule IV.Abuse and Physical and Psychological DependenceAs with other benzodiazepines, lorazepam injection has a potential for abuse and may lead to dependence. Physicians should be aware that repeated doses over a prolonged period of time may result in physical and psychological dependence and withdrawal symptoms, following abrupt discontinuance, similar in character to those noted with barbiturates and alcohol.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
SymptomsOverdosage of benzodiazepines is usually manifested by varying degrees of central-nervous-system depression, ranging from drowsiness to coma. In mild cases symptoms include drowsiness, mental confusion and lethargy. In more serious examples, symptoms may include ataxia, hypotonia, hypotension, hypnosis, stages one (1) to three (3) coma, and, very rarely, death.TreatmentTreatment of overdosage is mainly supportive until the drug is eliminated from the body. Vital signs and fluid balance should be carefully monitored in conjunction with close observation of the patient. An adequate airway should be maintained and assisted respiration used as needed. With normally functioning kidneys, forced diuresis with intravenous fluids and electrolytes may accelerate elimination of benzodiazepines from the body. In addition, osmotic diuretics, such as mannitol, may be effective as adjunctive measures. In more critical situations, renal dialysis and exchange blood transfusions may be indicated. Lorazepam does not appear to be removed in significant quantities by dialysis, although lorazepam glucuronide may be highly dialyzable. The value of dialysis has not been adequately determined for lorazepam.The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert includingCONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be consulted prior to use.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Lorazepam must never be used without individualization of dosage particularly when used with other medications capable of producing central-nervous-system depression.EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY SHOULD BE IMMEDIATELY AVAILABLE PRIOR TO INTRAVENOUS ADMINISTRATION OF LORAZEPAM (seeWARNINGS).
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lorazepam Injection USP, 2 mg/mL is available in 1 mL single dose vials in cartons of 10 or 10 mL multiple dose vials in cartons of 10.For IM or IV injection.
Store in a refrigerator.
Protect from light.
Use carton to protect contents from light.Literature revised: April 2004
Product Nos.: 1013-01, 1013-10Watson Laboratories, Inc.
Corona, CA 92880 USA