MEDICATION GUIDE

Lorazepam (lor azʹ e pam)
Tablets, USP  C-IV

What is the most important information I should know about lorazepam tablets?

• 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.
• Lorazepam tablets can make you sleepy or dizzy, and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how lorazepam tablets affect you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking lorazepam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, lorazepam tablets may make your sleepiness or dizziness much worse.
• Do not take more lorazepam tablets than prescribed.

What are lorazepam tablets?

• Lorazepam tablets are 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 tablets are a federal controlled substance (C-IV) because they can be abused or lead to dependence. Keep lorazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away lorazepam tablets 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 tablets are safe and effective in children less than 12 years of age.
• It is not known if lorazepam tablets are safe and effective for use for longer than 4 months.

Do not take lorazepam tablets if you:

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

Before you take lorazepam tablets, 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 tablets may harm your unborn baby. You and your healthcare provider should decide if you should take lorazepam tablets 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 tablets. You should not breastfeed while taking lorazepam tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking lorazepam tablets with certain other medicines can cause side effects or affect how well lorazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take lorazepam tablets?

• Take lorazepam tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how many lorazepam tablets to take and when to take it.
• If you take too many lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking lorazepam tablets?

• Lorazepam tablets can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how lorazepam tablets affect you.
• You should not drink alcohol while taking lorazepam tablets. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of lorazepam tablets?

Lorazepam tablets may cause serious side effects, including:

• See “What is the most important information I should know about lorazepam tablets?”
• Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam tablets.
• Abuse and dependence. Taking lorazepam tablets can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Withdrawal symptoms. You may have withdrawal symptoms if you stop taking lorazepam tablets suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping lorazepam tablets to avoid withdrawal symptoms.

The most common side effects of lorazepam tablets include:

• sedation
• weakness
• dizziness
• unsteadiness

These are not all the possible side effects of lorazepam tablets. 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 tablets?

• Store lorazepam tablets in a tightly closed container at 68° to 77°F (20° to 25°C).
• Keep lorazepam tablets and all medicines out of the reach of children.

General information about the safe and effective use of lorazepam tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lorazepam tablets for a condition for which it was not prescribed. Do not give lorazepam tablets 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 tablets that is written for health professionals.

What are the ingredients in lorazepam tablets?

Active ingredient: lorazepam, USP

Inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose and polacrilin potassium

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

For more information, call Actavis at 1-800-272-5525.

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

Issued: May 2017

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