Lorazepam: Package Insert and Label Information (Page 2 of 3)

ADVERSE REACTIONS

Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.
In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye function/visual disturbance(including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreasedorgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hyper sensitivity reactions, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; syndrome of in appropriate antidiuretic hormone (SIADH), hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam.
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 ABUSE AND DEPENDENCE

Controlled Substance

Lorazepam tablets contains lorazepam, a Schedule IV controlledsubstance.

Abuse

Lorazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.
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. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS: Abuse, Misuse, and Addiction).
The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.
The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

Dependence

Physical Dependence
Lorazepam may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS: Dependence and Withdrawal Reactions).
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (see DOSAGE and ADMINISTRATION: Discontinuation or Dosage Reduction of Lorazepam and WARNINGS).
Acute Withdrawal Signs and Symptoms
Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment,muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality.
Protracted Withdrawal Syndrome
Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re‑ emergence or continuation of symptoms for which the benzodiazepine was being used.
Tolerance
Tolerance to lorazepam may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of lorazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

OVERDOSAGE

In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. Therefore, in the management of overdosage, it should be borne in mind that multiple agents may have been taken.
Symptoms
Overdosage of benzodiazepines is usually manifested by varying degrees of CNS depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria, and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death.
Management
General supportive and symptomatic measures are recommended; vital signs must be monitored, and the patient closely observed. When there is a risk of aspiration, induction of emesis is not recommended.
Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit drug absorption. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.
The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections should be consulted prior to use.

DOSAGE AND ADMINISTRATION

Lorazepam tablets are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given two times a day or three times a day.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam tablets should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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).

HOW SUPPLIED

Lorazepam Tablets, USP are available in the following dosage strengths:
2 mg, while to off-white, round, flat-faced beveled edge tablets debossed with a bisect separating “U” and “34” on one side and “2” on the other side.
Bottles of 30 NDC 68788-7533-03

Bottles of 60 NDC 68788-7533-06

Bottles of 90 NDC 68788-7533-09

Bottles of 100 NDC 68788-7533-01

Bottles of 120 NDC 68788-7533-08
Keep bottles tightly closed.
Keep out of reach of children.
STORE AT 20°C 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
Revised: 01/2022

Repackaged by Preferred Pharmaceuticals, Inc.

Medication Guide

MEDICATION GUIDE LORAZEPAM Tablets, USP CIV

What is the most important information I should know about LORAZEPAM? · LORAZEPAM is a 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. Get emergency help right away if any of the following happens:

shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (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, and addiction with benzodiazepines including LORAZEPAM which can lead to overdose and serious side effects including coma and death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including LORAZEPAM. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
You can develop an addiction even if you take LORAZEPAM exactly as prescribed by your healthcare provider.
Take LORAZEPAM exactly as your healthcare provider prescribed.
Do not share your LORAZEPAM with other people.
Keep LORAZEPAM in a safe place andaway from children.
Physical dependence and withdrawal reactions. LORAZEPAM can cause physical dependence and withdrawal reactions.
Do not suddenly stop taking LORAZEPAM. Stopping LORAZEPAM suddenly can cause serious and life-threatening side effects, including, unusual movements, responses or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Do not take more LORAZEPAM than prescribed or take LORAZEPAM for longer than prescribed.

What is LORAZEPAM?

LORAZEPAM is a prescription medicine used:
to treat anxiety disorders
for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression
LORAZEPAM is a federal controlled substance (CIV) because it contains Lorazepam that can be abused or lead to dependence. Keep LORAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away LORAZEPAM may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
It is not known if LORAZEPAM is safe and effective for use in children less than 12 years of age.
It is not known if LORAZEPAM is safe and effective for use for longer than 4 months.

Donot take LORAZEPAM if you:

are allergic to Lorazepam, other benzodiazepines, or any of the ingredients in LORAZEPAM. See the end of this Medication Guide for a complete list of ingredients in LORAZEPAM.

Before you take LORAZEPAM, tell your healthcare provider about all of your medical conditions, including if you:

have or have had depression, mood problems, or suicidal thoughts or behavior
have a history of drug or alcohol abuse or addiction
have lung disease or breathing problems (such as COPD, sleep apnea syndrome)
have liver or kidney problems
have or have had seizures
are pregnant or plan to become pregnant. LORAZEPAM may harm your unborn baby. You and your healthcare provider should decide if you should take LORAZEPAM while you are pregnant.
are breastfeeding or plan to breastfeed. LORAZEPAM passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take LORAZEPAM. You should not breastfeed while taking LORAZEPAM.

Tell your healthcare provider about all the medicines you take , including prescription and over‑-the counter medicines, vitamins, and herbal supplements.Taking LORAZEPAM with certain other medicines can cause side effects or affect how well LORAZEPAM or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take LORAZEPAM?

Take LORAZEPAM exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much LORAZEPAM to take and when to take it.
If you take too much LORAZEPAM, call your healthcare provider or go to the nearest hospital emergency 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 motor skills.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how LORAZEPAM affects you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking LORAZEPAM without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, LORAZEPAM may make your sleepiness or dizziness much worse.
Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including LORAZEPAM.

The most common side effects of LORAZEPAM include: sedation • dizziness• weakness • unsteadinessThese 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: lorazepamInactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.Dispense with Medication Guide available at: www.aurobindousa.com/medication-guidesDistributed by:Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 01/2022

Repackaged by Preferred Pharmaceuticals, Inc.

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