Ativan

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ativan Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Lorazepam 0.5mg, 1mg+, 2mg+; tabs; +scored.

    Pharmacological Class

    Benzodiazepine.

    How Supplied

    Tabs 0.5mg, 2mg—100; 1mg—100, 1000

    How Supplied

    Ativan 0.5 mg Tablets:

    • White, five-sided (shield shape) tablet with a raised “A” on one side and “BPI” and “63” impressed on reverse side. 

    • Supplied in bottles of 100 tablets.

    Ativan 1 mg Tablets:

    • White, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "64" impressed on scored reverse side.

    • Supplied in bottles of 100 and 1000 tablets.

    Ativan 2 mg Tablets:

    • White, five-sided (regular pentagon) tablet with a raised "A" and impressed "2" on one side and "BPI" and "65" impressed on scored reverse side.  

    • Supplied in bottles of 100 tablets.

    Storage

    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 

    Manufacturer

    Bausch Health Companies Inc.

    Generic Availability

    YES

    Mechanism of Action

    Lorazepam has a tranquilizing action on the central nervous system (CNS) with no appreciable effect on the respiratory or cardiovascular systems.

    Ativan Indications

    Indications

    Anxiety.

    Indications

    • Indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.

    • The efficacy for the long-term use of Ativan for more than 4 months has not been evaluated in clinical studies. Periodically reassess the usefulness of Ativan in patients.

    Ativan Dosage and Administration

    Adult

    Give in 2 or 3 divided doses, with largest dose taken at bedtime. Individualize. Initially 2–3mg daily; range: 1–10mg daily. Elderly or debilitated: initially 1–2mg daily; adjust gradually if needed.

    Children

    <12yrs: not established.

    Ativan Contraindications

    Contraindications

    Acute narrow-angle glaucoma.

    Ativan Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Boxed Warning

    Risks from Concomitant Use with Opioids

    • Risk of profound sedation, respiratory depression, coma and death with opioids.

    • Reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required. Monitor for signs and symptoms of respiratory depression and sedation. 

    Abuse, Misuse, and Addiction

    • Risk of abuse, misuse, and addiction, that can potentially lead to overdose and death. Prior to initiating treatment, evaluate the risk for each patient and monitor regularly during treatment for the development of any addiction, abuse, and misuse.

    Dependence and Withdrawal Reactions

    • Continued use may lead to clinically significant physical dependence.

    • Increased risk for dependence and withdrawal with longer treatment duration and higher daily dose.

    • Abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions. 

    • Gradually taper to discontinue Ativan or reduce dose to reduce the risk for withdrawal reactions.

    Ativan Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Therapy for >4 months. Discontinue if paradoxical reactions occur. Primary depressive disorder or psychosis: not recommended. Suicidal tendencies (monitor). Renal or hepatic impairment. Compromised respiratory function. Seizure disorder. Reevaluate periodically. Monitor blood counts, liver function with long-term use. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Change dose gradually. Drug or alcohol abuse. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

    Warnings/Precautions

    Risks from Concomitant Use with Opioids

    • Increased sedation, respiratory depression, coma, and death with concomitant opioids. Because of these risks, reserve use in those for whom alternative treatment options are inadequate. 

    • If concomitant use with opioids is needed, limit dosages/durations to minimum and monitor patients closely for signs and symptoms of respiratory depression and sedation. 

    • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined.

    Abuse, Misuse, and Addiction

    • Risks for abuse, misuse, and addiction that can potentially lead to overdose or death.

    • Assess patient's risk for abuse, misuse, addiction prior to and during therapy. 

    • Prescribe the lowest effective dosage. Avoid or minimize concomitant use of CNS depressants and other substances associated with these risks.

    • Evaluate and institute early treatment if substance use disorder is suspected.

    Dependence and Withdrawal Reactions

    • Gradually taper to discontinue Ativan or reduce dose. Increased risk for withdrawal adverse reactions in patients who take higher doses and those with longer durations of use.

    • Acute Withdrawal Reactions: Abrupt discontinuation or rapid dose reduction after continued use, or administration of flumazenil may cause acute withdrawal reactions.

    • Protracted Withdrawal Syndrome: In some cases, this syndrome has lasted weeks to more than 12 months. Pre-existing depression may emerge or worsen during treatment. Do not use Ativan in patients with a primary depressive disorder or psychosis. 

    Neonatal Sedation and Withdrawal Syndrome

    • Use late in pregnancy can cause sedation and/or withdrawal symptoms in the neonate. Monitor neonates exposed during pregnancy or labor for signs of sedation and monitor for signs of withdrawal.

    General

    • Caution in patients with depression due to the risk for suicide. Do not use in these patients without adequate antidepressant therapy. 

    • Caution in patients with compromised respiratory function (eg, COPD, sleep apnea syndrome).

    • Increased risk for sedative effects in elderly or debilitated patients. Monitor frequently and adjust dose carefully (the initial dose should not exceed 2 mg).

    • Paradoxical reactions may occur, especially in children and elderly.

    • Caution in patients with renal or hepatic impairment. Caution in patients with severe hepatic insufficiency and/or encephalopathy.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including Ativan, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. 

    Risk Summary

    • Neonates born to mothers using benzodiazepines late in pregnancy have reported to experience symptoms of sedation and/or neonatal withdrawal. 

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Ativan during pregnancy or labor for sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Ativan during pregnancy for signs of withdrawal.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ativan and any potential adverse effects on the breastfed infant from Ativan or from the underlying maternal condition.  

    Clinical Considerations 

    • Monitor infants exposed to Ativan for sedation, poor feeding and poor weight gain.

    Pediatric Considerations

    Safety and efficacy of Ativan in pediatric patients less than 12 years of age has not been established.

    Geriatric Considerations

    In general, use caution when selecting dosage for an elderly patient.

     

    Ativan Pharmacokinetics

    Absorption

    Absolute bioavailability: 90%. Peak concentrations in plasma occur in ~2 hours. Peak plasma level (from a 2mg dose): ~20 ng/mL.

    Distribution

    Plasma protein bound: ~85%.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: ~12 hours.

    Ativan Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants (eg, barbiturates, antipsychotics, sedatives/hypnotics, anxiolytics, others). Caution with clozapine. May be potentiated by probenecid or valproate (reduce lorazepam dose by 50%). May be antagonized by theophylline, aminophylline.

    Ativan Adverse Reactions

    Adverse Reactions

    CNS depression (esp. sedation), dizziness, weakness, unsteadiness, transient memory impairment, confusion, disorientation, nausea, change in appetite, headache, sleep apnea; withdrawal reactions.

    Ativan Clinical Trials

    See Literature

    Ativan Note

    Not Applicable

    Ativan Patient Counseling

    Patient Counseling

    Risks from Concomitant Use with Opioids

    • Increased sedation, respiratory depression, coma, and death with concomitant opioids. Because of these risks, reserve use in those for whom alternative treatment options are inadequate. 

    • If concomitant use with opioids is needed, limit dosages/durations to minimum and monitor patients closely for signs and symptoms of respiratory depression and sedation. 

    • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined.

    Abuse, Misuse, and Addiction

    • Risks for abuse, misuse, and addiction that can potentially lead to overdose or death.

    • Assess patient's risk for abuse, misuse, addiction prior to and during therapy. 

    • Prescribe the lowest effective dosage. Avoid or minimize concomitant use of CNS depressants and other substances associated with these risks.

    • Evaluate and institute early treatment if substance use disorder is suspected.

    Dependence and Withdrawal Reactions

    • Gradually taper to discontinue Ativan or reduce dose. Increased risk for withdrawal adverse reactions in patients who take higher doses and those with longer durations of use.

    • Acute Withdrawal Reactions: Abrupt discontinuation or rapid dose reduction after continued use, or administration of flumazenil may cause acute withdrawal reactions.

    • Protracted Withdrawal Syndrome: In some cases, this syndrome has lasted weeks to more than 12 months. Pre-existing depression may emerge or worsen during treatment. Do not use Ativan in patients with a primary depressive disorder or psychosis. 

    Pregnancy

    • The use of Ativan late in pregnancy can cause sedation and/or withdrawal symptoms in newborns. Advise patients that there is a pregnancy exposure registry.

    Nursing

    • Notify your healthcare provider if you are breastfeeding or intend to breastfeed.

    • Advise breastfeeding patients taking Ativan to monitor infants for excessive sedation, poor feeding and poor weight gain.

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