Brand Name: Ativan
Generic Name: LORAZEPAM
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET
Packager: Bausch Health US LLC
Data Current As Of: 2021-02-11
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 use in 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 Ativan, 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 Ativan and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS).
- The continued use of benzodiazepines, including Ativan for several days to weeks may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Ativan 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 Ativan or reduce the dosage (DOSAGE AND ADMINISTRATION and WARNINGS).
Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Ativan (lorazepam) is contraindicated in patients with:
- hypersensitivity to benzodiazepines or to any components of the formulation
- acute narrow-angle glaucoma.
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 Ativan (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, decreased orgasm; 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; hypersensitivity reactions, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; syndrome of inappropriate 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 Ativan (lorazepam).
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What is the most important information I should know about Ativan?
- Ativan 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 ATIVAN with opioids affects you.
- Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with Ativan treatment which can lead to overdose or death. You can develop an addiction even if you take Ativan exactly as prescribed by your healthcare provider.
- o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Ativan. These serious side effects may 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.
- o Take Ativan exactly as your healthcare provider prescribed.
- oDo not share your Ativan with other people.
- oKeep Ativan in a safe place and away from children.
- Physical dependence and withdrawal reactions. Ativan can cause physical dependence and withdrawal reactions, especially if you continue to take Ativan for several days to several weeks.
- o Do not stop taking Ativan all of the sudden. Stopping Ativan 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, homicidal thoughts, 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.
- o Some people who stop Ativan suddenly 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.
- oPhysical 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 Ativan than prescribed or take Ativan for longer than prescribed.
What is Ativan?
- Ativan is a prescription medicine used:
- oto treat anxiety disorders
- ofor the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression
- Ativan is a federal controlled substance (CIV) because it contains lorazepam that can be abused or lead to dependence. Keep Ativan in a safe place to prevent misuse and abuse. Selling or giving away Ativan 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 Ativan is safe and effective for use in children less than 12 years of age.
- It is not known if Ativan is safe and effective for use for longer than 4 months.
Do not take Ativan if you:
- are allergic to lorazepam, other benzodiazepines, or any of the ingredients in Ativan. See the end of this Medication Guide for a complete list of ingredients in Ativan.
Before you take Ativan, 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. Ativan may harm your unborn baby. You and your healthcare provider should decide if you should take Ativan while you are pregnant.
- are breastfeeding or plan to breastfeed. Ativan 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 Ativan. You should not breastfeed while taking Ativan.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking Ativan with certain other medicines can cause side effects or affect how well Ativan or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take Ativan?
- Take Ativan exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Ativan to take and when to take it.
- If you take too much Ativan, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of Ativan?
Ativan may cause serious side effects, including:
- See “What is the most important information I should know about Ativan?”
- Ativan can make you sleepy or dizzy and can slow your thinking and motor skills.
- oDo not drive, operate heavy machinery, or do other dangerous activities until you know how Ativan affects you.
- oDo not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Ativan without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Ativan may make your sleepiness or dizziness much worse.
- Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including Ativan.
The most common side effects of Ativan include:
These are not all the possible side effects of Ativan. 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 Ativan?
- Store Ativan in a tightly closed container at room temperature between 68°F to 77°F (20°F to 25°C).
- Keep Ativan and all medicines out of the reach of children.
General information about the safe and effective use of Ativan
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ativan for a condition for which it was not prescribed. Do not give Ativan 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 Ativan that is written for health professionals.
What are the ingredients in Ativan?
Active ingredient: lorazepam
Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.
Distributed by: Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
Ativan is a trademark of Bausch Health Companies Inc. or its affiliates. For more information, call 1-800-321-4576.
© 2020 Bausch Health Companies Inc. or its affiliates
This Medication Guide has been approved by the U.S. Food and Drug Administration