MEDICATION GUIDE
LORAZEPAM Tablets, USP CIV
What is the most important information I should know about LORAZEPAM?
· LORAZEPAM isa benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Getemergencyhelpright away if any of the following happens:
shallow or slowedbreathing
breathingstops(whichmaylead to the heartstopping)
excessivesleepiness(sedation)
Do not drive or operate heavy machinery until you know how taking LORAZEPAM with opioids affects you.
Risk of abuse,misuse, and addiction.There is a risk of abuse,misuse,andaddictionwithbenzodiazepinesincludingLORAZEPAM whichcanlead to overdoseandserioussideeffects including comaanddeath.
Serioussideeffects including comaanddeathhavehappened in peoplewho have abused or misusedbenzodiazepines,includingLORAZEPAM.Theseserioussideeffectsmayalsoincludedelirium,paranoia,suicidalthoughts or actions,seizures,anddifficultybreathing.Call your healthcareprovider or go to thenearest hospital emergencyroomrightaway if you getany of theseserioussideeffects.
Youcandevelop an addictioneven if you take LORAZEPAM exactly as prescribed by your healthcareprovider.
TakeLORAZEPAM exactly as your healthcareproviderprescribed.
Do not share your LORAZEPAM withotherpeople.
Keep LORAZEPAM in a safeplaceandaway from children.
Physicaldependence and withdrawalreactions.LORAZEPAM cancausephysicaldependenceandwithdrawalreactions.
Do not suddenlystoptakingLORAZEPAM. StoppingLORAZEPAM suddenlycancauseseriousandlife-threateningsideeffects,including,unusualmovements,responses or expressions,seizures,suddenandseveremental or nervoussystemchanges,depression,seeing or hearingthingsthatothersdo not see or hear,anextremeincrease in activity or talking,losingtouchwithreality,andsuicidalthoughts or actions.Callyourhealthcareprovider or go to the nearest hospital emergencyroomrightaway if youget any of thesesymptoms.
Somepeoplewhosuddenlystopbenzodiazepines have symptoms that canlast for severalweeks to more than 12 months,includinganxiety,troubleremembering,learning, or concentrating,depression,problemssleeping,feelinglikeinsectsarecrawlingunder your skin,weakness,shaking,muscletwitching,burning or pricklingfeeling in your hands,arms,legs or feet, and ringing in your ears.
Physicaldependence is not the sameas drug addiction.Yourhealthcareprovidercantell you moreabout the differencesbetweenphysicaldependenceand drug addiction.
Do not takemore LORAZEPAM than prescribed or takeLORAZEPAM for longerthanprescribed.
What is LORAZEPAM?
LORAZEPAM is a prescriptionmedicineused:
to treatanxietydisorders
for the short-termrelief of the symptoms of anxiety or anxietythatcanhappenwith symptoms of depression
LORAZEPAM is a federalcontrolledsubstance(CIV)because it contains Lorazepam thatcan be abused or lead to dependence.KeepLORAZEPAM in a safeplace to preventmisuseandabuse.Selling or givingawayLORAZEPAM may harm others, and is againstthelaw.Tell your healthcareprovider if youhaveabused or beendependent on alcohol,prescriptionmedicines or streetdrugs.
It is not known if LORAZEPAM issafeandeffective for use in childrenlessthan 12 years of age.
It is not known if LORAZEPAM issafeandeffective for use for longerthan 4 months.
Donot take LORAZEPAM if you:
areallergic to Lorazepam, other benzodiazepines, or any of the ingredients in LORAZEPAM. See the end of this MedicationGuidefor a completelist of ingredients in LORAZEPAM.
Beforeyou take LORAZEPAM, tell your healthcare provider about all of your medical conditions, including if you:
have or havehaddepression,moodproblems, or suicidalthoughts or behavior
have a history of drug or alcoholabuse or addiction
have lung disease or breathingproblems(suchasCOPD,sleepapneasyndrome)
haveliver or kidneyproblems
have or havehadseizures
arepregnant or plan to becomepregnant.LORAZEPAM mayharm your unbornbaby.Youand your healthcare provider shoulddecide if you shouldtakeLORAZEPAM while you arepregnant.
arebreastfeeding or plan to breastfeed.LORAZEPAM passes into your breastmilkandmayharm your baby.Talkto your healthcareprovideraboutthebestway to feed your baby if you takeLORAZEPAM.YoushouldnotbreastfeedwhiletakingLORAZEPAM.
Tellyour healthcare provider about all the medicines you take,includingprescriptionandover­the-countermedicines,vitamins,andherbalsupplements.
TakingLORAZEPAM withcertainothermedicinescancausesideeffectsor affect how well LORAZEPAM or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
HowshouldI take LORAZEPAM?
TakeLORAZEPAM exactlyas your healthcareprovidertells you totake it. Yourhealthcareproviderwilltell you how muchLORAZEPAM to take andwhentotake it.
If you taketoomuchLORAZEPAM,call your healthcareprovider or go to the nearesthospitalemergency room right away.
What are the possible side effects of LORAZEPAM?
LORAZEPAM may cause serious side effects, including:
· See“What is the most important information I should know about LORAZEPAM?”
LORAZEPAM can make you sleepy or dizzy and canslow your thinking and motorskills.
Do not drive,operateheavymachinery,or do otherdangerousactivities until you know how LORAZEPAM affects you.
Do not drinkalcohol or takeother drugs that maymake you sleepy or dizzy while taking LORAZEPAM withoutfirst talking to your healthcareprovider.Whentakenwithalcohol or drugsthatcausesleepiness or dizziness,LORAZEPAM maymake your sleepiness or dizzinessmuchworse.
Depression.Pre-existingdepressionmayemerge or worsenduringuse of benzodiazepinesincludingLORAZEPAM.
The most common side effects of LORAZEPAM include:
• sedation • dizziness
• weakness • unsteadiness
These are not all the possible side effects of LORAZEPAM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LORAZEPAM?
Store LORAZEPAM in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
Keep LORAZEPAM and all medicines out of the reach of children.
General information about the safe and effective use of LORAZEPAM
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LORAZEPAM for a condition for which it was not prescribed. Do not give LORAZEPAM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LORAZEPAM that is written for health professionals.
What are the ingredients in LORAZEPAM?
Active ingredient: lorazepam
Inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.

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

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 01/2022