Lorazepam

Generic Name: lorazepam

Benzodiazepine [EPC]Over-the-Counter (OTC)

Brand Names:

Lorazepam

DESCRIPTION Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-( o -chlorophenyl)-1,3­-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. Chemical Structure

Overview

DESCRIPTION Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-( o -chlorophenyl)-1,3­-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. Chemical Structure

Uses

INDICATIONS AND USAGE Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.

Dosage

DOSAGE AND ADMINISTRATION Lorazepam tablets are administeredorally. For optimalresults,dose,frequency of administration,andduration of therapyshould be individualizedaccording to patientresponse. To facilitatethis,0.5mg, 1 mg,and 2 mgtabletsareavailable. The usualrange is 2 to 6 mg/daygivenindivideddoses, the largestdosebeingtakenbeforebedtime, but the dailydosagemayvaryfrom 1 to 10 mg/day. For anxiety,mostpatientsrequireaninitialdose of 2 to 3 mg/daygiventwotimes a day or threetimes a day. For insomnia due to anxiety or transientsituationalstress, a singledailydose of 2 to 4 mgmay be given,usuallyatbedtime. For elderly or debilitatedpatients,aninitialdosage of 1 to 2 mg/day in divideddoses is recommended, to be adjustedasneededandtolerated.

Side Effects

ADVERSE REACTIONS Mostadversereactions to benzodiazepines,includingCNSeffectsandrespiratorydepression,aredose dependent,withmoresevereeffectsoccurringwithhighdoses. In a sample of about3500patientstreated for anxiety, the mostfrequentadversereaction to lorazepam wassedation(15.9%),followedbydizziness(6.9%),weakness(4.2%),andunsteadiness(3.4%). The incidence of sedationandunsteadinessincreasedwithage.

Interactions

Drug Interactions 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. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

Warnings

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. WARNINGS Risks from Concomitant Use with Opioids Concomitantuse of benzodiazepines, including lorazepam,andopioidsmayresult in profoundsedation,respiratorydepression,coma,anddeath.Because of theserisks,reserveconcomitantprescribing of these drugs in patients for whomalternativetreatmentoptionsareinadequate. Observationalstudieshavedemonstratedthatconcomitantuse of opioid analgesicsandbenzodiazepinesincreases the risk of drug-relatedmortalitycompared to use of opioidsalone. If a decision is made to prescribelorazepam concomitantlywithopioids,prescribe the lowesteffectivedosagesandminimumdurations of concomitantuse,andfollowpatientsclosely for signsandsymptoms of respiratorydepression andsedation. CONTRAINDICATIONS Lorazepam is contraindicated in patientswith: hypersensitivity to benzodiazepines or to anycomponents of the formulation acutenarrow-angleglaucoma.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including lorazepam, 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/.

Storage

HOW SUPPLIED Lorazepam Tablets, USP are available in the following dosage strengths: 2 mg, white to off-white, round, flat-faced beveled edge tablets debossed with a bisect separating “U” and “34” on one side and “2” on other side. Bottles of 30 tablets NDC 72789-339-30 Keep bottles tightly closed. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F).

Frequently Asked Questions

What is Lorazepam used for?

INDICATIONS AND USAGE Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.

What are the side effects of Lorazepam?

ADVERSE REACTIONS Mostadversereactions to benzodiazepines,includingCNSeffectsandrespiratorydepression,aredose dependent,withmoresevereeffectsoccurringwithhighdoses. In a sample of about3500patientstreated for anxiety, the mostfrequentadversereaction to lorazepam wassedation(15.9%),followedbydizziness(6.9%),weakness(4.2%),andunsteadiness(3.4%). The incidence of sedationandunsteadinessincreasedwithage.

Can I take Lorazepam during pregnancy?

Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including lorazepam, 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/.

What are the important warnings for Lorazepam?

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. WARNINGS Risks from Concomitant Use with Opioids Concomitantuse of benzodiazepines, including lorazepam,andopioidsmayresult in profoundsedation,respiratorydepression,coma,anddeath.Because of theserisks,reserveconcomitantprescribing of these drugs in patients for whomalternativetreatmentoptionsareinadequate. Observationalstudieshavedemonstratedthatconcomitantuse of opioid analgesicsandbenzodiazepinesincreases the risk of drug-relatedmortalitycompared to use of opioidsalone. If a decision is made to prescribelorazepam concomitantlywithopioids,prescribe the lowesteffectivedosagesandminimumdurations of concomitantuse,andfollowpatientsclosely for signsandsymptoms of respiratorydepression andsedation. CONTRAINDICATIONS Lorazepam is contraindicated in patientswith: hypersensitivity to benzodiazepines or to anycomponents of the formulation acutenarrow-angleglaucoma.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.