Indicated for:

Status Epilepticus:

•  ATIVAN Injection is indicated for the treatment of status epilepticus.

Preanesthetic:

• ATIVAN 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.

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.

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.

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.

Prior to intravenous use, ativan injection must be diluted with an equal amount of compatible diluent. 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.

Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged sedation with intravenous lorazepam.

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.

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.

Extreme caution must be used when administering ATIVAN 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.

The use of benzodiazepines, including ATIVAN Injection, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing ATIVAN Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

The continued use of benzodiazepines for several days to weeks may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although ATIVAN Injection is indicated only for intermittent use if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of ATIVAN Injection may precipitate acute withdrawal reactions, which can be life-threatening. For patients using ATIVAN Injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue ATIVAN Injection.

In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.

ATIVAN Injection is contraindicated in patients with:

• acute narrow-angle glaucoma
• sleep apnea syndrome
• severe respiratory insufficiency, except in those patients requiring relief of anxiety and/or diminished recall of events while being mechanically ventilated 
• 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

ATIVAN Injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol.

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.

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 ATIVAN Injection at higher than recommended doses. Symptoms may be more likely to develop in patients with renal impairment.

ATIVAN 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.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is not clear. However, based on the available data, 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 three years of age in humans.

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.

The dose of ATIVAN should be reduced by 50% when coadministered with probenecid or valproate.

It may be necessary to increase the dose of ATIVAN in female patients who are concomitantly taking oral contraceptives.

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.

Lorazepam has been detected in human breast milk. Therefore, lorazepam should not be administered to nursing mothers because, like other benzodiazepines, the possibility exists that lorazepam may sedate or otherwise adversely affect the infant.

GoToSource

• Use in patients under the age of 18. GoToSource

• Psychotic symptoms. GoToSource

• Catatonia in mood disorder. GoToSource

• Palatal tremor. GoToSource

• Delirious mania. GoToSource

• Pain management in patients with rheumatoid arthritis. GoToSource

• Aggression. GoToSource

• Alcohol withdrawal. GoToSource 

• Panic disorder. GoToSource 

• Frontotemporal dementia. GoToSource

• Huntington’s disease. GoToSource

• Reduce liver motion in patients receiving upper abdominal radiation therapy. GoToSource

• Outpatient endoscopic procedures. GoToSource

Increased risk of and mortality from community-acquired pneumonia. GoToSource

Immune hemolytic anemia. GoToSource

Kidney injury, hyperosmolality and metabolic acidosis. GoToSource

Respiratory failure. GoToSource

Suicidal ideation and behavior. GoToSource

Addiction and withdrawal syndrome. GoToSource 

Birth defects. GoToSource

Increased risk of fall-related injuries in elderly patients. GoToSource

Diplopia (seeing double), impaired concentration and memory and increased intraocular pressure. GoToSource

Cognitive impairment. GoToSource

Lawsuits filed for addiction, withdrawal syndrome and respiratory failure.