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).
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.