Indicated for:

• The management of anxiety disorders or for the short-term relief of the symptoms of anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.

In general, benzodiazepines should be prescribed for short periods only (e.g., 2 to 4 weeks). Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Continuous long-term use of product is not recommended. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.

Ativan (lorazepam) is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma.

Lorazepam should be used with caution in patients with compromised respiratory function (e.g., COPD, sleep apnea syndrome).

Elderly or debilitated patients may be more susceptible to the sedative effects of lorazepam. Therefore, these patients should be monitored frequently and have their dosage adjusted carefully according to patient response; the initial dosage should not exceed 2 mg.

As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy; therefore, lorazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy.

Some patients on lorazepam tablets have developed leukopenia, and some have had elevations of LDH. As with other benzodiazepines, periodic blood counts and liver function tests are recommended for patients on long-term therapy.

Advise both patients and caregivers about the risks of respiratory depression and sedation when lorazepam tablets are used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders.

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Ativan (lorazepam) is not recommended for use in patients with a primary depressive disorder or psychosis. In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy.

Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam.

Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use 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.

The benzodiazepines, including lorazepam tablets, produce increased CNS- depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.

Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when co-administered with probenecid.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

Some patients on lorazepam have developed leukopenia, and some have had elevations of LDH. As with other benzodiazepines, periodic blood counts and liver function tests are recommended for patients on long-term therapy.

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. Because the use of these drugs is rarely a matter of urgency, the use of lorazepam during this period should be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.

Lorazepam has been detected in human breast milk; therefore, it should not be administered to breastfeeding women, unless the expected benefit to the woman outweighs the potential risk to the infant.

GoToSource

• Use in patients under the age of 12. 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 

• Acute convulsions and status epilepticus. GoToSource 

• Frontotemporal dementia. GoToSource 

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

Community-acquired pneumonia. GoToSource

Immune hemolytic anemia (immune system makes antibodies that attack red blood cells). GoToSource

Acute kidney injury, hyperosmolality and metabolic acidosis (body produces too much acid or when the kidneys are not removing enough acid from the body). 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 

Impairment of color perception and contrast discrimination. GoToSource 

Cognitive impairment. GoToSource

Liver injury. GoToSource

Anaphylaxis (potentially life-threatening allergic reaction). GoToSource

Tachycardia (fast heart rate), hypotension ( low blood pressure), syncope (temporary loss of consciousness), blood dyscrasias (blood disease or disorder), jaundice, paradoxical reaction (hyperactive and aggressive behavior), incontinence and urinary retention. GoToSource

Interaction with herbal products valerian and passionflower. GoToSource

Lawsuits filed for addiction, withdrawal syndrome and respiratory failure.