LORAZEPAM, Injection, USP, CIV

/LORAZEPAM, Injection, USP, CIV
LORAZEPAM, Injection, USP, CIV2018-09-06T09:12:40+00:00

Prescription Drug Name:

LORAZEPAM, Injection, USP, CIV

ID:

c25fa90a-989d-4fac-967d-c1946866d9d8

Code:

34391-3

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS


id: c9afcaaf-fa3f-489c-ae22-552aaa4028d6
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation (see WARNINGS and PRECAUTIONS, Drug Interactions).

DESCRIPTION


id: d8a49e62-58e6-4d29-be17-05f407be5728
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.

CLINICAL PHARMACOLOGY


id: 947782b1-6568-4b53-9e18-6391194338e8
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.

CONTRAINDICATIONS


id: fcd60fe1-069f-4cab-b3d1-ac4e150175cb
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 (see WARNINGS). Lorazepam injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS – Pediatric Use).

DOSAGE AND ADMINISTRATION


id: 93ab9eba-ac2a-456c-9fd3-30d2fcd70ac1
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS – Pediatric Use) 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 (see WARNINGS).

HOW SUPPLIED


id: 0c921814-049d-4386-a793-bdb2b3bc3cc0
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lorazepam 2 mg/mL Injection, USP is supplied as follows: 1 mL fill in 2 mL size – 10 vials/box. NDC 0409-6778-05

ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY


id: 0d1e44bc-901a-4e43-878d-5672d2af4058
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans. In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data (See WARNINGS, Pediatric Neurotoxicity; PRECAUTIONS; Pregnancy, Pediatric Use).

PRINCIPAL DISPLAY PANEL – 2 mg/mL Vial Label


id: 54b77a42-1259-4c2b-bb5d-ed5283285098
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

1 mL

NDC 0409-6778-15 LORAZEPAM CIV

Inj., USP
2 mg/mL For IM use.
For IV route, see directions.
Rx only
Hospira, Inc.
Lake Forest, IL 60045 USA
RL-6849

PRINCIPAL DISPLAY PANEL – 2 mg/mL Vial Carton


id: bd322411-a9f2-4f74-8420-3e583f6c9142
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

10 – 1 mL Vials NDC 0409-6778-05 LORAZEPAM
Injection, USP
2 mg/mL For IM use.
For IV route, see directions.
Rx only
PREMIERProRx® CIV