Ativan .5 mg/1
lorazepam · TABLET · Bausch Health US LLC
Ativan is a tablet containing lorazepam at .5 mg/1, taken oral. Manufactured by Bausch Health US LLC.
Key Facts
- Brand Name
- Ativan
- Generic Name
- lorazepam
- NDC Code (Product)
0187-0063- Manufacturer
- Bausch Health US LLC
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA017794
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 05/01/2013
Recall History
Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 (see PRECAUTIONS, Information for Patients ).
Dosage & Administration
DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS, Pediatric Use ). ATIVAN 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 ATIVAN 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 correct…
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including ATIVAN Injection, and opioids may result in profound sedation, respiratory depression, coma, and death. If a decision is made to use ATIVAN 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 ATIVAN 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 ATIVAN Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. Use of ATIVAN Injection, particularly in patients at elevated risk, necessitates counseling about the risks and proper use o…
Contraindications
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 ). ATIVAN Injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS, Pediatric Use ).
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. 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. 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 bee…
Adverse Reactions
ADVERSE REACTIONS Status Epilepticus The most important adverse clinical event caused by the use of ATIVAN Injection is respiratory depression (see WARNINGS ). The adverse clinical events most commonly observed with the use of ATIVAN 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 ATIVAN 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 differen…
Frequently Asked Questions
What is Ativan used for?
Ativan contains lorazepam. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ativan a controlled substance?
Yes, Ativan is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Ativan?
The generic name for Ativan is lorazepam. There are 11 other brand versions of lorazepam.
What is the NDC code for Ativan .5 mg/1?
The NDC (National Drug Code) for Ativan .5 mg/1 is 0187-0063, listed by Bausch Health US LLC.