Lorazepam Tablets, USP CIV
|What is the most important information I should know about lorazepam tablets?
Lorazepam tablets are 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 tablets with opioids affects you.
Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including lorazepam tablets 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 tablets. 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 tablets exactly as prescribed by your healthcare provider.
Take lorazepam tablets exactly as your healthcare provider prescribed.
- Do not share your lorazepam tablets with other people.
- Keep lorazepam tablets in a safe place and away from children.
Physical dependence and withdrawal reactions. Lorazepam tablets can cause physical dependence and withdrawal reactions.
Do not suddenly stop taking lorazepam tablets. Stopping lorazepam tablets 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 tablets than prescribed or take lorazepam tablets for longer 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 (CIV) because it contains lorazepam that 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 for use 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:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- 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.
- Taking lorazepam tablets late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with lorazepam tablets.
- There is a pregnancy registry for women who take lorazepam tablets during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with lorazepam tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/pregnancyregistry/.
- are breastfeeding or plan to breastfeed. Lorazepam passes into your breast milk.
- Breastfeeding during treatment with lorazepam tablets may cause your baby to have sleepiness, feeding problems, and decreased weight gain.
- Talk to your healthcare provider about the best way to feed your baby if you take lorazepam tablets.
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 much lorazepam tablets to take and when to take it.
- If you take too much lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
|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?”
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 affects 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.
Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam tablets.
|The most common side effects of lorazepam tablets include:
• sedation • dizziness
• weakness • 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 room temperature between 20° to 25°C (68° to 77°F).
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
Inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 032, India
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.