Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U32’ on one side and plain on the other side. Bottles of 10 tablets NDC 13107-083-11 Bottles of 100 tablets NDC 13107-083-01 Bottles of 500 tablets NDC 13107-083-05 Bottles of 1000 tablets NDC 13107-083-99 1 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U33’ on one side and bisect on the other side. Bottles of 10 tablets NDC 13107-084-11 Bottles of 100 tablets NDC 13107-084-01 Bottles of 500 tablets NDC 13107-084-05 Bottles of 1000 tablets NDC 13107-084-99 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 10 tablets NDC 13107-085-11 Bottles of 100 tablets NDC 13107-085-01 Bottles of 500 tablets NDC 13107-085-05 Bottles of 1000 tablets NDC 13107-085-99 Keep bottles tightly closed. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 06/2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle) NDC 13107-083-01 Rx only Lorazepam Tablets, USP 0.5 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle) NDC 13107-084-01 Rx only Lorazepam Tablets, USP 1 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle) NDC 13107-085-01 Rx only Lorazepam Tablets, USP 2 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle)
- HOW SUPPLIED Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U32’ on one side and plain on the other side. Bottles of 10 tablets NDC 13107-083-11 Bottles of 100 tablets NDC 13107-083-01 Bottles of 500 tablets NDC 13107-083-05 Bottles of 1000 tablets NDC 13107-083-99 1 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U33’ on one side and bisect on the other side. Bottles of 10 tablets NDC 13107-084-11 Bottles of 100 tablets NDC 13107-084-01 Bottles of 500 tablets NDC 13107-084-05 Bottles of 1000 tablets NDC 13107-084-99 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 10 tablets NDC 13107-085-11 Bottles of 100 tablets NDC 13107-085-01 Bottles of 500 tablets NDC 13107-085-05 Bottles of 1000 tablets NDC 13107-085-99 Keep bottles tightly closed. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 06/2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle) NDC 13107-083-01 Rx only Lorazepam Tablets, USP 0.5 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle) NDC 13107-084-01 Rx only Lorazepam Tablets, USP 1 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle) NDC 13107-085-01 Rx only Lorazepam Tablets, USP 2 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle)
Overview
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
Indications & 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 & 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. The dosageoflorazepam tablets should be increasedgraduallywhenneeded to helpavoidadverse effects.Whenhigherdosage is indicated, the eveningdoseshouldbeincreasedbefore the daytimedoses. Discontinuation or Dosage Reduction of Lorazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).
Warnings & Precautions
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. In patientsalreadyreceivinganopioidanalgesic,prescribe a lowerinitialdose of lorazepam thanindicated in theabsence of anopioidandtitratebased on clinicalresponse. If an opioid is initiated in a patientalreadytakinglorazepam,prescribe a lowerinitialdose of the opioidandtitratebased upon clinicalresponse. Advise both patientsandcaregiversabout the risks of respiratorydepressionandsedationwhenlorazepam is usedwithopioids.Advisepatients not to drive or operateheavymachineryuntil the effects of concomitantusewith the opioidhavebeendetermined(see PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including lorazepam, 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 lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of lorazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of lorazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of lorazepam ). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence ). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence ). Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis. Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression (see PRECAUTIONS: Drug Interactions ). As with all patients on CNS-depressant drugs, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other CNS depressants will be diminished. Neonatal Sedation and Withdrawal Syndrome Use of lorazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS: Pregnancy ). Monitor neonates exposed to lorazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to lorazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.
Boxed 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. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage ( DOSAGE AND ADMINISTRATION and WARNINGS ).
Contraindications
Lorazepam is contraindicated in patientswith: hypersensitivity to benzodiazepines or to anycomponents of the formulation acutenarrow-angleglaucoma.
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. Otheradversereactions to benzodiazepines,includinglorazepam arefatigue,drowsiness,amnesia,memoryimpairment,confusion,disorientation,depression,unmasking of depression,disinhibition,euphoria,suicidalideation/attempt,ataxia,asthenia,extrapyramidalsymptoms,convulsions/seizures,tremor,vertigo,eyefunction/visualdisturbance(includingdiplopiaandblurredvision),dysarthria/slurred speech,change in libido,impotence,decreasedorgasm;headache,coma;respiratorydepression,apnea,worsening of sleepapnea,worsening of obstructivepulmonarydisease;gastrointestinalsymptoms includingnausea,change in appetite,constipation,jaundice,increase in bilirubin,increase in liver transaminases,increase in alkalinephosphatase;hypersensitivityreactions,anaphylactoidreactions;dermatologicalsymptoms,allergicskinreactions,alopecia;syndrome of inappropriateantidiuretic hormone(SIADH),hyponatremia;thrombocytopenia,agranulocytosis,pancytopenia;hypothermia;andautonomicmanifestations. Paradoxicalreactions,includinganxiety,excitation,agitation,hostility,aggression,rage,sleepdisturbances/insomnia,sexualarousal,andhallucinationsmayoccur.Small decreases in blood pressure andhypotensionmayoccur but areusually not clinicallysignificant,probablybeingrelated to therelief of anxietyproducedbylorazepam. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. The benzodiazepines, including lorazepam, 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 coadministered with probenecid. The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation. Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.
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