Lorazepam (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Lorazepam (injection) is a general anesthetic that is FDA approved for the {{{indicationType}}} of anxiety, insomnia, due to anxiety or situational stress, premedication for anesthetic procedure, status epilepticus. Common adverse reactions include neurologic: asthenia (4.2% ), dizziness (6.9% ), sedated (15.9% ), unsteadiness present (3.4%), psychiatric: depression.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Alcohol withdrawal syndrome: 2 mg ORALLY every 6 hr for 4 doses, then 1 mg every 6 hr for 8 doses.
- Anxiety: initial, 2 to 3 mg/day ORALLY divided into 2 to 3 daily doses.
- Anxiety: maintenance, 2 to 6 mg/day ORALLY divided into 2 to 3 daily doses; dose may vary from 1 to 10 mg/day.
- Chemotherapy-induced nausea and vomiting; Prophylaxis: a single dose of 0.025 to 0.05 mg/kg (MAX 4 mg) IM OR IV given slowly (2 mg/min) 30 to 35 min prior to receiving chemotherapy; this dose may be supplemented with oral lorazepam 1 to 2 mg/hr as needed.
- Insomnia, due to anxiety or situational stress: 2 to 4 mg ORALLY at bedtime.
- Premedication for anesthetic procedure: 0.05 mg/kg IM (MAX 4 mg) 2 hours before procedure.
- Premedication for anesthetic procedure: 0.044 mg/kg IV OR 2 mg (whichever is less); MAX dose 0.05 mg/kg IV OR 4 mg (whichever is less) 15 to 20 minutes before the surgical procedure.
- Sedation: (intermittent) 0.02 to 0.06 mg/kg IV every 2 to 6 hours.
- Sedation: (continuous infusion) 0.01 to 0.1 mg/kg/hr IV.
- Status epilepticus: 4 mg IV given slowly at 2 mg/min, may repeat dose in 10 to 15 min if needed; IM dosing may be used, but IV dosing is preferred.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- Anxiety
- Insomnia, due to anxiety or situational stress
- Premedication for anesthetic procedure.
- Status epilepticus.
Non–Guideline-Supported Use
- Agitation - Psychotic disorder
- Alcohol withdrawal syndrome
- Chemotherapy-induced nausea and vomiting; Prophylaxis
- Sedation
- Seizure
- Seizure, drug-induced; Prophylaxis
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lorazepam (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Lorazepam in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Lorazepam in pediatric patients.
Contraindications
ATIVAN 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 ATIVAN 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)
Warnings
Use in Status Epilepticus
Management of Status Epilepticus
Status epilepticus is a potentially life-threatening condition associated with a high risk of permanent neurological impairment, if inadequately treated. The treatment of status, however, requires far more than the administration of an anticonvulsant agent. It involves observation and management of all parameters critical to maintaining vital function and the capacity to provide support of those functions as required. Ventilatory support must be readily available. The use of benzodiazepines, like ATIVAN Injection, is ordinarily only one step of a complex and sustained intervention which may require additional interventions (e.g., concomitant intravenous administration of phenytoin). Because status epilepticus may result from a correctable acute cause such as hypoglycemia, hyponatremia, or other metabolic or toxic derangement, such an abnormality must be immediately sought and corrected. Furthermore, patients who are susceptible to further seizure episodes should receive adequate maintenance antiepileptic therapy.
Any health care professional who intends to treat a patient with status epilepticus should be familiar with this package insert and the pertinent medical literature concerning current concepts for the treatment of status epilepticus. A comprehensive review of the considerations critical to the informed and prudent management of status epilepticus cannot be provided in drug product labeling. The archival medical literature contains many informative references on the management of status epilepticus, among them the report of the working group on status epilepticus of the Epilepsy Foundation of America “Treatment of Convulsive Status Epilepticus” (JAMA 1993; 270:854-859). As noted in the report just cited, it may be useful to consult with a neurologist if a patient fails to respond (e.g., fails to regain consciousness).
For the treatment of status epilepticus, the usual recommended dose of ATIVAN Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional ATIVAN Injection is required. If seizures continue or recur after a 10- to 15- minute observation period, an additional 4 mg intravenous dose may be slowly administered. Experience with further doses of ATIVAN is very limited. The usual precautions in treating status epilepticus should be employed. An intravenous infusion should be started, vital signs should be monitored, an unobstructed airway should be maintained, and artificial ventilation equipment should be available.
Respiratory Depression
The most important risk associated with the use of ATIVAN Injection in status epilepticus is respiratory depression. Accordingly, airway patency must be assured and respiration monitored closely. Ventilatory support should be given as required.
Excessive Sedation
Because of its prolonged duration of action, the prescriber should be alert to the possibility, especially when multiple doses have been given, that the sedative effects of lorazepam may add to the impairment of consciousness seen in the post-ictal state.
Preanesthetic Use
AIRWAY OBSTRUCTION MAY OCCUR IN HEAVILY SEDATED PATIENTS. INTRAVENOUS LORAZEPAM AT ANY DOSE, WHEN GIVEN EITHER ALONE OR IN COMBINATION WITH OTHER DRUGS ADMINISTERED DURING ANESTHESIA, MAY PRODUCE HEAVY SEDATION; THEREFORE, EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY AND TO SUPPORT RESPIRATION/VENTILATION SHOULD BE AVAILABLE.
As is true of similar CNS-acting drugs, the decision as to when patients who have received injectable lorazepam, particularly on an outpatient basis, may again operate machinery, drive a motor vehicle, or engage in hazardous or other activities requiring attention and coordination must be individualized. It is recommended that no patient engage in such activities for a period of 24 to 48 hours or until the effects of the drug, such as drowsiness, have subsided, whichever is longer. Impairment of performance may persist for greater intervals because of extremes of age, concomitant use of other drugs, stress of surgery, or the general condition of the patient.
Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged sedation with intravenous lorazepam (see also DOSAGE AND ADMINISTRATION, Preanesthetic).
As with all central-nervous-system-depressant drugs, care should be exercised in patients given injectable lorazepam as premature ambulation may result in injury from falling.
There is no added beneficial effect from the addition of scopolamine to injectable lorazepam, and their combined effect may result in an increased incidence of sedation, hallucination and irrational behavior.
General (All Uses)
PRIOR TO INTRAVENOUS USE, ATIVAN INJECTION MUST BE DILUTED WITH AN EQUAL AMOUNT OF COMPATIBLE DILUENT (see DOSAGE AND ADMINISTRATION). INTRAVENOUS INJECTION SHOULD BE MADE SLOWLY AND WITH REPEATED ASPIRATION. CARE SHOULD BE TAKEN TO DETERMINE THAT ANY INJECTION WILL NOT BE INTRA-ARTERIAL AND THAT PERIVASCULAR EXTRAVASATION WILL NOT TAKE PLACE. IN THE EVENT THAT A PATIENT COMPLAINS OF PAIN DURING INTENDED INTRAVENOUS INJECTION OF ATIVAN INJECTION, THE INJECTION SHOULD BE STOPPED IMMEDIATELY TO DETERMINE IF INTRA-ARTERIAL INJECTION OR PERIVASCULAR EXTRAVASATION HAS TAKEN PLACE.
Since the liver is the most likely site of conjugation of lorazepam and since excretion of conjugated lorazepam (glucuronide) is a renal function, this drug is not recommended for use in patients with hepatic and/or renal failure. ATIVAN should be used with caution in patients with mild-to-moderate hepatic or renal disease (see DOSAGE AND ADMINISTRATION).
Pregnancy
ATIVAN MAY CAUSE FETAL DAMAGE WHEN ADMINISTERED TO PREGNANT WOMEN. Ordinarily, ATIVAN Injection should not be used during pregnancy except in serious or life-threatening conditions where safer drugs cannot be used or are ineffective. Status epilepticus may represent such a serious and life-threatening condition.
An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. In humans, blood levels obtained from umbilical cord blood indicate placental transfer of lorazepam and lorazepam glucuronide.
Reproductive studies in animals were performed in mice, rats, and two strains of rabbits. Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to dosage. Although all of these anomalies were not present in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg orally or 4 mg/kg intravenously and higher, there was evidence of fetal resorption and increased fetal loss in rabbits which was not seen at lower doses.
The possibility that a woman of childbearing potential may be pregnant at the time of therapy should be considered.
There are insufficient data regarding obstetrical safety of parenteral lorazepam, including use in cesarean section. Such use, therefore, is not recommended.
Endoscopic Procedures
There are insufficient data to support the use of ATIVAN Injection for outpatient endoscopic procedures. Inpatient endoscopic procedures require adequate recovery room observation time.
When ATIVAN Injection is used for peroral endoscopic procedures; adequate topical or regional anesthesia is recommended to minimize reflex activity associated with such procedures.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lorazepam (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lorazepam (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lorazepam (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lorazepam (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lorazepam (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lorazepam (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lorazepam (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lorazepam (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lorazepam (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Lorazepam (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lorazepam (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lorazepam (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lorazepam (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lorazepam (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lorazepam (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lorazepam (injection) Administration in the drug label.
Monitoring
There is limited information regarding Lorazepam (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lorazepam (injection) and IV administrations.
Overdosage
There is limited information regarding Lorazepam (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lorazepam (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lorazepam (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Lorazepam (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lorazepam (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lorazepam (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lorazepam (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lorazepam (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lorazepam (injection) How Supplied in the drug label.
Storage
There is limited information regarding Lorazepam (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lorazepam (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lorazepam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lorazepam (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lorazepam (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Synonyms / Brand Names:Almazine, Alzapam, Anxiedin, Aplacassee, Ativan, Bonatranquan, Delormetazepam, Emotival, Idalprem, Lorabenz, Lorax, Loraz, Lorazepam Intensol, Lorsilan, Pro Dorm, Psicopax, Punktyl, Quait, Securit, Sedatival, Sedazin, Somagerol, Tavor, Temesta, Wypax