Lorazepam
Tablet · Oral, Intramuscular, Intravenous
Current shortage
Lorazepam, Injection, 4 mg/1 mL (NDC 0641-6045-25) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Estimated recovery: TBD
Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6046-10) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Estimated recovery: TBD
Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6044-25) – Limited Availability (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Estimated recovery: TBD
Lorazepam, Injection, 4 mg/1 mL (NDC 0641-6047-10) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Estimated recovery: TBD
Lorazepam, Injection, 2 mg/1 mL Syringes (NDC 0409-1985-30) – Limited Availability (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Limited Supply Available. Next Delivery: July 2027; Estimated Recovery: September 2027
Lorazepam, Injection, 2 mg/1 mL (NDC 65219-368-02) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release September 2026. Check wholesalers for inventory.
Lorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1) – Available (Amphastar Pharmaceuticals, Inc., updated Sep 16, 2026)
Uses
Status Epilepticus Lorazepam Injection is indicated for the treatment of status epilepticus. Preanesthetic Lorazepam 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 (see PRECAUTIONS, Information for Patients ).
Dosage and administration
DOSAGE AND ADMINISTRATION 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 ). Status Epilepticus GENERAL ADVICE 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 Lorazepam Injection, is ordinarily only an initial 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 healthcare 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). INTRAVENOUS INJECTION For the treatment of status epilepticus, the usual recommended dose of Lorazepam Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional Lorazepam 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 lorazepam 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. INTRAMUSCULAR INJECTION IM lorazepam is not preferred in the treatment of status epilepticus because therapeutic lorazepam levels may not be reached as quickly as with IV administration. However, when an intravenous port is not available, the IM route may prove useful (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). PEDIATRIC The safety of lorazepam in pediatric patients has not been established. Preanesthetic INTRAMUSCULAR INJECTION For the designated indications as a premedicant, the usual recommended dose of lorazepam for intramuscular injection is 0.05 mg/kg up to a maximum of 4 mg. As with all premedicant drugs, the dose should be individualized (see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ). Doses of other central-nervous-system-depressant drugs ordinarily should be reduced (see PRECAUTIONS ). For optimum effect, measured as lack of recall, intramuscular lorazepam should be administered at least 2 hours before the anticipated operative procedure. Narcotic analgesics should be administered at their usual preoperative time. There are insufficient data to support efficacy or make dosage recommendations for intramuscular lorazepam in patients less than 18 years of age; therefore, such use is not recommended. INTRAVENOUS INJECTION For the primary purpose of sedation and relief of anxiety, the usual recommended initial dose of lorazepam for intravenous injection is 2 mg total, or 0.02 mg/lb (0.044 mg/kg), whichever is smaller. This dose will suffice for sedating most adult patients and ordinarily should not be exceeded in patients over 50 years of age. In those patients in whom a greater likelihood of lack of recall for perioperative events would be beneficial, larger doses as high as 0.05 mg/kg up to a total of 4 mg may be administered (see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ). Doses of other injectable central-nervous-system-depressant drugs ordinarily should be reduced (see PRECAUTIONS ). For optimum effect, measured as lack of recall, intravenous lorazepam should be administered 15 to 20 minutes before the anticipated operative procedure. There are insufficient data to support efficacy or make dosage recommendations for intravenous lorazepam in patients less than 18 years of age; therefore, such use is not recommended. Dose Administration in Special Populations ELDERLY PATIENTS AND PATIENTS WITH HEPATIC DISEASE No dosage adjustments are needed in elderly patients and in patients with hepatic disease. PATIENTS WITH RENAL DISEASE For acute dose administration, adjustment is not needed for patients with renal disease. However, in patients with renal disease, caution should be exercised if frequent doses are given over relatively short periods of time (see CLINICAL PHARMACOLOGY ).
Contraindications
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 ).
Warnings
Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Lorazepam Injection, and opioids may result in profound sedation, respiratory depression, coma, and death. If a decision is made to use Lorazepam Injection concomitantly with opioids, monitor patients closely for respiratory depression and sedation (see PRECAUTIONS, Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including Lorazepam Injection, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE, Abuse ). Before prescribing Lorazepam Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. Use of Lorazepam Injection, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Lorazepam Injection along with monitoring for signs and symptoms of abuse, misuse, and addiction. Do not exceed the recommended dosing frequency; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions After Use of Lorazepam Injection More Frequently Than Recommended For patients using Lorazepam Injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Lorazepam Injection (a patient-specific plan should be used to taper the dose). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. ACUTE WITHDRAWAL REACTIONS The continued use of benzodiazepines may lead to clinically significant physical dependence. Although Lorazepam Injection is indicated only for intermittent use (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Lorazepam Injection, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE, Dependence ). PROTRACTED WITHDRAWAL SYNDROME In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE, Dependence ). 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 Lorazepam 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 healthcare 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 Lorazepam Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional Lorazepam 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 lorazepam 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 Lorazepam Injection in status epilepticus is respiratory depression. Accordingly, airway patency must be assured and respiration monitored closely. Ventilatory support should be given as required.
Precautions
General The additive central-nervous-system effects of other drugs, such as phenothiazines, narcotic analgesics, barbiturates, antidepressants, scopolamine, and monoamine-oxidase inhibitors, should be borne in mind when these other drugs are used concomitantly with or during the period of recovery from Lorazepam Injection (see CLINICAL PHARMACOLOGY and WARNINGS ). Extreme caution must be used when administering Lorazepam Injection to elderly patients, very ill patients, or to patients with limited pulmonary reserve because of the possibility that hypoventilation and/or hypoxic cardiac arrest may occur. Resuscitative equipment for ventilatory support should be readily available (see WARNINGS and DOSAGE AND ADMINISTRATION ). When lorazepam injection is used IV as the premedicant prior to regional or local anesthesia, the possibility of excessive sleepiness or drowsiness may interfere with patient cooperation in determining levels of anesthesia. This is most likely to occur when greater than 0.05 mg/kg is given and when narcotic analgesics are used concomitantly with the recommended dose (see ADVERSE REACTIONS ). As with all benzodiazepines, paradoxical reactions may occur in rare instances and in an unpredictable fashion (see ADVERSE REACTIONS ). In these instances, further use of the drug in these patients should be considered with caution. There have been reports of possible propylene glycol toxicity (e.g., lactic acidosis, hyperosmolality, hypotension) and possible polyethylene glycol toxicity (e.g., acute tubular necrosis) during administration of Lorazepam Injection at higher than recommended doses. Symptoms may be more likely to develop in patients with renal impairment. Information for Patients RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines, including Lorazepam Injection, and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS, Drug Interactions ). ABUSE, MISUSE, AND ADDICTION Inform patients that the use of Lorazepam Injection more frequently than recommended, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). WITHDRAWAL REACTIONS Inform patients that use of Lorazepam Injection more frequently than recommended may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Lorazepam Injection may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). EXCESSIVE SEDATION Patients should be informed of the pharmacological effects of the drug, including sedation, relief of anxiety, and lack of recall, the duration of these effects (about 8 hours), and be apprised of the risks as well as the benefits of therapy. Patients who receive Lorazepam Injection as a premedicant should be cautioned that driving a motor vehicle, operating machinery, or engaging in hazardous or other activities requiring attention and coordination, should be delayed for 24 to 48 hours following the injection or until the effects of the drug, such as drowsiness, have subsided, whichever is longer. Sedatives, tranquilizers and narcotic analgesics may produce a more prolonged and profound effect when administered along with injectable lorazepam. This effect may take the form of excessive sleepiness or drowsiness and, on rare occasions, interfere with recall and recognition of events of the day of surgery and the day after. Patients should be advised that getting out of bed unassisted may result in falling and injury if undertaken within 8 hours of receiving Lorazepam Injection. Since tolerance for CNS depressants will be diminished in the presence of Lorazepam Injection, these substances should either be avoided or taken in reduced dosage. Alcoholic beverages should not be consumed for at least 24 to 48 hours after receiving lorazepam injectable due to the additive effects on central-nervous-system depression seen with benzodiazepines in general. Elderly patients should be told that Lorazepam Injection may make them very sleepy for a period longer than 6 to 8 hours following surgery. EFFECT OF ANESTHETIC AND SEDATION DRUGS ON EARLY BRAIN DEVELOPMENT Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs (see WARNINGS , Pediatric Neurotoxicity ). Laboratory Tests In clinical trials, no laboratory test abnormalities were identified with either single or multiple doses of Lorazepam Injection. These tests included: CBC, urinalysis, SGOT, SGPT, bilirubin, alkaline phosphatase, LDH, cholesterol, uric acid, BUN, glucose, calcium, phosphorus, and total proteins. Drug Interactions INTERACTION WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors.
Side effects
Status Epilepticus The most important adverse clinical event caused by the use of Lorazepam Injection is respiratory depression (see WARNINGS ). The adverse clinical events most commonly observed with the use of Lorazepam Injection in clinical trials evaluating its use in status epilepticus were hypotension, somnolence, and respiratory failure. INCIDENCE IN CONTROLLED CLINICAL TRIALS All adverse events were recorded during the trials by the clinical investigators using terminology of their own choosing. Similar types of events were grouped into standardized categories using modified COSTART dictionary terminology. These categories are used in the table and listings below with the frequencies representing the proportion of individuals exposed to Lorazepam Injection or to comparative therapy. The prescriber should be aware that these figures cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigators involving different treatment, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied. COMMONLY OBSERVED ADVERSE EVENTS IN A CONTROLLED DOSE-COMPARISON CLINICAL TRIAL Table 1 lists the treatment-emergent adverse events that occurred in the patients treated with Lorazepam Injection in a dose-comparison trial of lorazepam 1 mg, 2 mg, and 4 mg. TABLE 1. NUMBER (%) OF STUDY EVENTS IN A DOSE COMPARISON CLINICAL TRIAL Body System Event Lorazepam Injection (n=130) One hundred and thirty (130) patients received Lorazepam Injection. Any Study Event (1 or more) Totals are not necessarily the sum of the individual study events because a patient may report two or more different study events in the same body system. 16 (12.3%) Body as a whole Infection 1 ( <1%) Cardiovascular system Hypotension 2 (1.5%) Digestive system Liver function tests abnormal 1 ( <1%) Nausea 1 ( <1%) Vomiting 1 ( <1%) Metabolic and Nutritional Acidosis 1 ( <1%) Nervous system Brain edema 1 ( <1%) Coma 1 ( <1%) Convulsion 1 ( <1%) Somnolence 2 (1.5%) Thinking abnormal 1 ( <1%) Respiratory system Hyperventilation 1 ( <1%) Hypoventilation 1 ( <1%) Respiratory failure 2 (1.5%) Terms not classifiable Injection site reaction 1 ( <1%) Urogenital system Cystitis 1 ( <1%) COMMONLY OBSERVED ADVERSE EVENTS IN ACTIVE-CONTROLLED CLINICAL TRIALS In two studies, patients who completed the course of treatment for status epilepticus were permitted to be reenrolled and to receive treatment for a second status episode, given that there was a sufficient interval between the two episodes. Safety was determined from all treatment episodes for all intent-to-treat patients, i.e., from all “patient-episodes.” Table 2 lists the treatment-emergent adverse events that occurred in at least 1% of the patient-episodes in which Lorazepam Injection or diazepam was given. The table represents the pooling of results from the two controlled trials. TABLE 2. NUMBER (%) OF STUDY EVENTS IN ACTIVE CONTROLLED CLINICAL TRIAL Body System Event Lorazepam Injection (n=85) The number indicates the number of “patient-episodes.” Patient-episodes were used rather than “patients” because a total of 7 patients were reenrolled for the treatment of a second episode of status: 5 patients received Lorazepam Injection on two occasions that were far enough apart to establish the diagnosis of status epilepticus for each episode, and, using the same time criterion, 2 patients received diazepam on two occasions. Diazepam (n=80) Any Study Event (1 or more) Totals are not necessarily the sum of the individual study events because a patient may report two or more different study events in the same body system. 14 (16.5%) 11 (13.8%) Body as a whole Headache 1 ( 1.2%) 1 (1.3%) Cardiovascular system Hypotension 2 (2.4%) 0 Hemic and lymphatic system Hypochromic anemia 0 1 (1.3%) Leukocytosis 0 1 (1.3%) Thrombocythemia 0 1 (1.3%) Nervous system Coma 1 (1.2 %) 1 (1.3%) Somnolence 3 (3.5%) 3 (3.8%) Stupor 1 (1.2%) 0 Respiratory system Hypoventilation 1 (1.2%) 2 (2.5%) Apnea 1 (1.2%) 1 (1.3%) Respiratory failure 2 (2.4%) 1 (1.3%) Respiratory disorder 1 (1.2%) 0 These trials were not designed or intended to demonstrate the comparative safety of the two treatments. The overall adverse experience profile for lorazepam was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse events by race. Generally, age greater than 65 years may be associated with a greater incidence of central-nervous-system depression and more respiratory depression. OTHER EVENTS OBSERVED DURING THE PRE-MARKETING EVALUATION OF LORAZEPAM INJECTION FOR THE TREATMENT OF STATUS EPILEPTICUS Lorazepam Injection, active comparators, and Lorazepam Injection in combination with a comparator were administered to 488 individuals during controlled and open-label clinical trials. Because of reenrollments, these 488 patients participated in a total of 521 patient-episodes. Lorazepam Injection alone was given in 69% of these patient-episodes (n=360). The safety information below is based on data available from 326 of these patient-episodes in which Lorazepam Injection was given alone. All adverse events that were seen once are listed, except those already included in previous listings (Table 1 and Table 2). Study events were classified by body system in descending frequency by using the following definitions: frequent adverse events were those that occurred in at least 1/100 individuals; infrequent study events were those that occurred in 1/100 to 1/1000 individuals.
Drug interactions
Drug Interactions INTERACTION WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Monitor patients closely for respiratory depression and sedation. Lorazepam Injection, like other injectable benzodiazepines, produces additive depression of the central nervous system when administered with other CNS depressants such as ethyl alcohol, phenothiazines, barbiturates, MAO inhibitors, and other antidepressants. When scopolamine is used concomitantly with injectable lorazepam, an increased incidence of sedation, hallucinations and irrational behavior has been observed. There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam. Marked sedation, excessive salivation, ataxia, and, rarely, death have been reported with the concomitant use of clozapine and lorazepam. Apnea, coma, bradycardia, arrhythmia, heart arrest, and death have been reported with the concomitant use of haloperidol and lorazepam. The risk of using lorazepam in combination with scopolamine, loxapine, clozapine, haloperidol, or other CNS-depressant drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of lorazepam and these drugs is required. Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. No change in lorazepam dosage is necessary when concomitantly given with any of these drugs. LORAZEPAM-VALPROATE INTERACTION Concurrent administration of lorazepam (2 mg intravenously) with valproate (250 mg twice daily orally for 3 days) to 6 healthy male subjects resulted in decreased total clearance of lorazepam by 40% and decreased formation rate of lorazepam glucuronide by 55%, as compared with lorazepam administered alone. Accordingly, lorazepam plasma concentrations were about two-fold higher for at least 12 hours post-dose administration during valproate treatment. Lorazepam dosage should be reduced to 50% of the normal adult dose when this drug combination is prescribed in patients (see DOSAGE AND ADMINISTRATION ). LORAZEPAM-ORAL CONTRACEPTIVE STEROIDS INTERACTION Coadministration of lorazepam (2 mg intravenously) with oral contraceptive steroids (norethindrone acetate, 1 mg, and ethinyl estradiol, 50 μg, for at least 6 months) to healthy females (n=7) was associated with a 55% decrease in half-life, a 50% increase in the volume of distribution, thereby resulting in an almost 3.7-fold increase in total clearance of lorazepam as compared with control healthy females (n=8). It may be necessary to increase the dose of lorazepam in female patients who are concomitantly taking oral contraceptives (see DOSAGE AND ADMINISTRATION ). LORAZEPAM-PROBENECID INTERACTION Concurrent administration of lorazepam (2 mg intravenously) with probenecid (500 mg orally every 6 hours) to 9 healthy volunteers resulted in a prolongation of lorazepam half-life by 130% and a decrease in its total clearance by 45%. No change in volume of distribution was noted during probenecid co-treatment. Lorazepam dosage needs to be reduced by 50% when coadministered with probenecid (see DOSAGE AND ADMINISTRATION ).
Pregnancy
Pregnancy Teratogenic Effects (see WARNINGS ). Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. In a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits (see WARNINGS, Pediatric Neurotoxicity , Pediatric Use , and ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ).
Pediatric use
Pediatric Use STATUS EPILEPTICUS The safety and effectiveness of lorazepam for status epilepticus have not been established in pediatric patients. A randomized, double-blind, superiority-design clinical trial of lorazepam versus intravenous diazepam in 273 pediatric patients ages 3 months to 17 years failed to establish the efficacy of lorazepam for the treatment of status epilepticus. In that trial, assisted ventilation was required in 18% of patients treated with lorazepam versus 16% of patients treated with diazepam. Patients treated with lorazepam were also more likely to be reported as sedated (67% for lorazepam vs. 50% for diazepam), and the time for return to baseline mental status was, on average, 2 hours longer for lorazepam than for diazepam. Open-label studies described in the medical literature included 273 pediatric patients; the age range was from a few hours old to 18 years of age. Paradoxical excitation was observed in 10% to 30% of the pediatric patients under 8 years of age and was characterized by tremors, agitation, euphoria, logorrhea, and brief episodes of visual hallucinations. Paradoxical excitation in pediatric patients also has been reported with other benzodiazepines when used for status epilepticus, as an anesthesia, or for pre-chemotherapy treatment. Pediatric patients (as well as adults) with atypical petit mal status epilepticus have developed brief tonic-clonic seizures shortly after lorazepam was given. This “paradoxical” effect was also reported for diazepam and clonazepam. Nevertheless, the development of seizures after treatment with benzodiazepines is probably rare, based on the incidence in the uncontrolled treatment series reported (i.e., seizures were not observed for 112 pediatric patients and 18 adults or during approximately 400 doses). Lorazepam Injection contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome”, (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. PREANESTHETIC There are insufficient data to support the efficacy of injectable lorazepam as a preanesthetic agent in patients less than 18 years of age. GENERAL Seizure activity and myoclonus have been reported to occur following administration of Lorazepam Injection, especially in very low birth weight neonates. Pediatric patients may exhibit a sensitivity to benzyl alcohol, polyethylene glycol and propylene glycol, components of Lorazepam Injection (see CONTRAINDICATIONS ). The “gasping syndrome”, characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine, has been associated with the administration of intravenous solutions containing the preservative benzyl alcohol in neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Central nervous system toxicity, including seizures and intraventricular hemorrhage, as well as unresponsiveness, tachypnea, tachycardia, and diaphoresis have been associated with propylene glycol toxicity. Although normal therapeutic doses of Lorazepam Injection contain very small amounts of these compounds, premature and low-birth-weight infants as well as pediatric patients receiving high doses may be more susceptible to their effects. Published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as lorazepam that either block NMDA receptors or potentiate the activity of GABA 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 of gestation 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 ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. Data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory.
Geriatric use
Geriatric Use Clinical studies of lorazepam generally were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects; however, age over 65 may be associated with a greater incidence of central nervous system depression and more respiratory depression (see WARNINGS, Preanesthetic Use , PRECAUTIONS, General and ADVERSE REACTIONS, Preanesthetic ). Age does not appear to have a clinically significant effect on lorazepam kinetics (see CLINICAL PHARMACOLOGY ). Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (see DOSAGE AND ADMINISTRATION ).
Overdosage
Symptoms Overdosage 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. Treatment Treatment 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 including CONTRAINDICATIONS , WARNINGS and PRECAUTIONS should be consulted prior to use.
Description
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-2 H -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 either 2.0 or 4.0 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as preservative. structural formula
How supplied
Lorazepam Injection, USP is available in the following dosage strengths in single-dose and multiple-dose vials: 2 mg per mL, NDC 0641-6048-25, 25 x 1 mL vial NDC 0641-6050-10, 10 x 10 mL vial 4 mg per mL, NDC 0641-6049-25, 25 x 1 mL vial NDC 0641-6051-10, 10 x 10 mL vial For IM or IV injection. Store in a refrigerator. PROTECT FROM LIGHT. Use carton to protect contents from light.
Patient information
Information for Patients RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines, including Lorazepam Injection, and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS, Drug Interactions ). ABUSE, MISUSE, AND ADDICTION Inform patients that the use of Lorazepam Injection more frequently than recommended, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). WITHDRAWAL REACTIONS Inform patients that use of Lorazepam Injection more frequently than recommended may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Lorazepam Injection may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). EXCESSIVE SEDATION Patients should be informed of the pharmacological effects of the drug, including sedation, relief of anxiety, and lack of recall, the duration of these effects (about 8 hours), and be apprised of the risks as well as the benefits of therapy. Patients who receive Lorazepam Injection as a premedicant should be cautioned that driving a motor vehicle, operating machinery, or engaging in hazardous or other activities requiring attention and coordination, should be delayed for 24 to 48 hours following the injection or until the effects of the drug, such as drowsiness, have subsided, whichever is longer. Sedatives, tranquilizers and narcotic analgesics may produce a more prolonged and profound effect when administered along with injectable lorazepam. This effect may take the form of excessive sleepiness or drowsiness and, on rare occasions, interfere with recall and recognition of events of the day of surgery and the day after. Patients should be advised that getting out of bed unassisted may result in falling and injury if undertaken within 8 hours of receiving Lorazepam Injection. Since tolerance for CNS depressants will be diminished in the presence of Lorazepam Injection, these substances should either be avoided or taken in reduced dosage. Alcoholic beverages should not be consumed for at least 24 to 48 hours after receiving lorazepam injectable due to the additive effects on central-nervous-system depression seen with benzodiazepines in general. Elderly patients should be told that Lorazepam Injection may make them very sleepy for a period longer than 6 to 8 hours following surgery. EFFECT OF ANESTHETIC AND SEDATION DRUGS ON EARLY BRAIN DEVELOPMENT Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs (see WARNINGS , Pediatric Neurotoxicity ).
Label text from the FDA structured product label by Hikma Pharmaceuticals USA Inc. (revised Apr 10, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lorazepam in 134 products
Lorazepam NDC products (134)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5563 | Lorazepam 1 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-5562 | Lorazepam 1 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-5509 | Lorazepam 1 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-5508 | Lorazepam 1 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 80425-0465 | Lorazepam 1 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 68000-108 | Lorazepam 2 mg/mL Liquid | American Health Packaging | ANDA · DEA CIV |
| 68000-107 | Lorazepam 2 mg/mL Liquid | American Health Packaging | ANDA · DEA CIV |
| 60687-842 | Lorazepam 2 mg/1 Tablet | American Health Packaging | ANDA · DEA CIV |
| 60687-831 | Lorazepam 1 mg/1 Tablet | American Health Packaging | ANDA · DEA CIV |
| 60687-820 | Lorazepam .5 mg/1 Tablet | American Health Packaging | ANDA · DEA CIV |
| 65162-687 | Lorazepam 2 mg/mL Concentrate | Amneal Pharmaceuticals LLC | ANDA · DEA CIV |
| 62559-195 | Lorazepam .5 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 62559-196 | Lorazepam 1 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 62559-197 | Lorazepam 2 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 71610-654 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-655 | Lorazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-255 | Lorazepam 1 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-229 | Lorazepam 1 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-225 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-199 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-178 | Lorazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-674 | Lorazepam 1 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-122 | Lorazepam 1 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-008 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-842 | Lorazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-828 | Lorazepam 1 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-827 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-768 | Lorazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-600 | Lorazepam 2 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-764 | Lorazepam .5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 76420-874 | Lorazepam 2 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-647 | Lorazepam .5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-872 | Lorazepam .5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-873 | Lorazepam 1 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 13107-083 | Lorazepam .5 mg/1 Tablet | Aurolife Pharma LLC | ANDA · DEA CIV |
| 13107-085 | Lorazepam 2 mg/1 Tablet | Aurolife Pharma LLC | ANDA · DEA CIV |
| 13107-084 | Lorazepam 1 mg/1 Tablet | Aurolife Pharma LLC | ANDA · DEA CIV |
| 71335-1694 | Lorazepam 1 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1467 | Lorazepam 1 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1455 | Lorazepam .5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1138 | Lorazepam 2 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0655 | Lorazepam 2 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0329 | Lorazepam .5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 62135-862 | Lorazepam 1 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-863 | Lorazepam 2 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-549 | Lorazepam 2 mg/mL Concentrate | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-861 | Lorazepam .5 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 58118-1096 | Lorazepam 2 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-1095 | Lorazepam 1 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-0904 | Lorazepam .5 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-0774 | Lorazepam 2 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 58118-0773 | Lorazepam 1 mg/1 Tablet | Clinical Solutions Wholesale, LLC | ANDA · DEA CIV |
| 67046-0230 | Lorazepam 1 mg/1 Tablet | Coupler LLC | ANDA · DEA CIV |
| 67046-0786 | Lorazepam .5 mg/1 Tablet | Coupler LLC | ANDA · DEA CIV |
| 67046-0936 | Lorazepam 2 mg/1 Tablet | Coupler LLC | ANDA · DEA CIV |
| 61919-062 | Lorazepam .5 mg/1 Tablet | DIRECT RX | ANDA · DEA CIV |
| 72189-351 | Lorazepam .5 mg/1 Tablet | DirectRx | ANDA · DEA CIV |
| 65219-368 | Lorazepam 2 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 51407-996 | Lorazepam .5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 51407-997 | Lorazepam 1 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 51407-998 | Lorazepam 2 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 0054-3532 | Lorazepam 2 mg/mL Solution, Concentrate | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0409-1985 | Lorazepam 2 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 76329-8261 | Lorazepam 2 mg/mL Injection | International Medication Systems, Limited | ANDA · DEA CIV |
| 69315-906 | Lorazepam 2 mg/1 Tablet | Leading Pharma, LLC | ANDA · DEA CIV |
| 69315-905 | Lorazepam 1 mg/1 Tablet | Leading Pharma, LLC | ANDA · DEA CIV |
| 69315-904 | Lorazepam .5 mg/1 Tablet | Leading Pharma, LLC | ANDA · DEA CIV |
| 68071-3010 | Lorazepam 2 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-3096 | Lorazepam .5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-3121 | Lorazepam .5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-3227 | Lorazepam 1 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-3242 | Lorazepam 1 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-3751 | Lorazepam .5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-5068 | Lorazepam .5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4916 | Lorazepam .5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4918 | Lorazepam 1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-5022 | Lorazepam 1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-5250 | Lorazepam 1 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 72789-226 | Lorazepam 1 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-197 | Lorazepam 2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-236 | Lorazepam .5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-376 | Lorazepam 2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-357 | Lorazepam 2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-356 | Lorazepam 1 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-355 | Lorazepam .5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-339 | Lorazepam 2 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 0121-0770 | Lorazepam 2 mg/mL Liquid | Pharmaceutical Associates, Inc. | ANDA · DEA CIV |
| 54348-049 | Lorazepam 1 mg/1 Tablet | PharmPak, Inc. | ANDA · DEA CIV |
| 68788-7355 | Lorazepam .5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-4180 | Lorazepam 1 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-7533 | Lorazepam 2 mg/1 Tablet | Preferred Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-7428 | Lorazepam 1 mg/1 Tablet | Preferred Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 71205-166 | Lorazepam .5 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 71205-228 | Lorazepam .5 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 71205-235 | Lorazepam 1 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 71205-756 | Lorazepam .5 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 67296-2238 | Lorazepam 1 mg/1 Tablet | Redpharm Drug | ANDA · DEA CIV |
| 67296-1478 | Lorazepam .5 mg/1 Tablet | Redpharm Drug | ANDA · DEA CIV |
| 67296-1629 | Lorazepam .5 mg/1 Tablet | RedPharm Drug, Inc. | ANDA · DEA CIV |
| 70518-0445 | Lorazepam 2 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3806 | Lorazepam .5 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-2442 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-1679 | Lorazepam 2 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-1520 | Lorazepam .5 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-0486 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-0275 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3188 | Lorazepam 2 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3423 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-4276 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3870 | Lorazepam 1 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3766 | Lorazepam 2 mg/mL Injection, Solution | REMEDYREPACK INC. | ANDA · DEA CIV |
| 64980-627 | Lorazepam .5 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA · DEA CIV |
| 64980-628 | Lorazepam 1 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA · DEA CIV |
| 64980-629 | Lorazepam 2 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA · DEA CIV |
| 60760-948 | Lorazepam 1 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 60760-947 | Lorazepam .5 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 63304-773 | Lorazepam 1 mg/1 Tablet | SUN PHARMACEUTICAL INDUSTRIES INC | ANDA · DEA CIV |
| 63304-772 | Lorazepam .5 mg/1 Tablet | SUN PHARMACEUTICAL INDUSTRIES INC | ANDA · DEA CIV |
| 63304-774 | Lorazepam 2 mg/1 Tablet | SUN PHARMACEUTICAL INDUSTRIES INC | ANDA · DEA CIV |
| 0093-3425 | Lorazepam .5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0093-3427 | Lorazepam 2 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0093-3426 | Lorazepam 1 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 87441-050 | Lorazepam .5 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA · DEA CIV |
| 87441-051 | Lorazepam 2 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA · DEA CIV |
| 72572-380 | Lorazepam 2 mg/mL Injection | Civica, Inc. | NDA · DEA CIV |
| 0641-6207 | Lorazepam 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6051 | Lorazepam 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6050 | Lorazepam 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6049 | Lorazepam 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6048 | Lorazepam 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6047 | Lorazepam 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6046 | Lorazepam 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6045 | Lorazepam 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
| 0641-6044 | Lorazepam 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA · DEA CIV |
Lorazepam recalls
- D-0551-2025 Aug 6, 2025 · Class II · Ongoing
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds - D-0574-2023 May 24, 2023 · Class II · Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. - D-1307-2022 Aug 17, 2022 · Class II · Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - D-1309-2022 Aug 17, 2022 · Class II · Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - D-1310-2022 Aug 17, 2022 · Class II · Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. - D-0120-2018 Dec 27, 2017 · Class I · Terminated
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. - D-0085-2018 Nov 29, 2017 · Class II · Terminated
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Frequently asked questions
What is Lorazepam used for?
Status Epilepticus Lorazepam Injection is indicated for the treatment of status epilepticus. Preanesthetic Lorazepam 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…
What are the side effects of Lorazepam?
Status Epilepticus The most important adverse clinical event caused by the use of Lorazepam Injection is respiratory depression (see WARNINGS ). The adverse clinical events most commonly observed with the use of Lorazepam Injection in clinical trials evaluating its use in status epilepticus were hypotension, somnolence, and respiratory failure. INCIDENCE IN CONTROLLED CLINICAL TRIALS All adverse… See the full label for the complete list.
Who makes Lorazepam?
Lorazepam is listed by 37 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, American Health Packaging, Amneal Pharmaceuticals LLC.
Has Lorazepam been recalled?
The FDA enforcement database lists 7 recalls for Lorazepam, most recently D-0551-2025 (class ii): Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds