Lorazepam belongs to a class of medications called benzodiazepines. It is thought that benzodiazepines work by enhancing the activity of certain neurotransmitters in the brain.

Lorazepam is used in adults and children at least 12 years old to treat anxiety disorders.

Loreev XR extended-release capsules are used to treat anxiety disorders in adults only.

Lorazepam is also used to treat insomnia caused by anxiety or temporary situational stress.

Lorazepam is sometimes used to treat nausea and vomiting from cancer treatment and to control agitation caused by alcohol withdrawal.

Lorazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. These effects can be fatal.

MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Lorazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be shared with another person, especially someone who has a history of drug abuse or addiction.

Do not stop using lorazepam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using lorazepam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not use lorazepam if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.

You should not use this medicine if you have narrow-angle glaucoma, severe respiratory insufficiency, myasthenia gravis, or if you are allergic to Valium or a similar medicine.

Take lorazepam exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use lorazepam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of lorazepam.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Measure the oral concentrate (liquid) with the supplied measuring device (not a kitchen spoon). Mix the liquid with water, juices, soda or soda-like beverages, or with semi-solid foods such as applesauce or puddings. Swallow this mixture right away.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Do not stop using lorazepam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store tightly closed at room temperature, away from moisture and heat.

Store the liquid form of this medicine in the refrigerator. Throw away any liquid not used within 90 days.

Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose for Anxiety:

Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
Maintenance dose: 1 to 2 mg orally 2 to 3 times a day.

Usual Adult Dose for Insomnia:

2 to 4 mg orally once a day at bedtime

Comments:
-The dosage should be increased gradually when needed to help avoid adverse effects.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Use: Management of insomnia due to anxiety of transient situational stress

Usual Geriatric Dose for Anxiety:

Older or debilitated patients:
-Initial dose: 1 to 2 mg orally per day, given in divided doses.

Usual Pediatric Dose for Anxiety:

12 years or older:
-Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
-Maintenance dose: 1 to 2 mg orally 2 to 3 times a day

-The daily dosage may vary from 1 to 10 mg/day.
-The dosage 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.
-Use of anxiolytic agents is typically not needed to treat anxiety/tension associated with the stress of everyday life.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Usual Pediatric Dose for Insomnia:

12 years or older: 2 to 4 mg orally once a day at bedtime

Comments:
-For debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended.
-The dosage should be increased gradually when needed to help avoid adverse effects.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

You should not use lorazepam if you have:

• narrow-angle glaucoma; or

• a history of allergic reaction to any benzodiazepine (alprazolam, diazepam, Valium, Xanax, Versed, Klonopin, and others).

To make sure lorazepam is safe for you, tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;

• drug or alcohol addiction;

• depression, mental illness or psychosis, mood changes, or suicidal thoughts or actions;

• seizures;

• an allergy to aspirin or yellow food dye; or

• kidney or liver disease.

Tell your doctor if you are pregnant or plan to become pregnant. If you use lorazepam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lorazepam on the baby.

You should not breastfeed.

If you do breastfeed, tell your doctor if you notice drowsiness, feeding problems, or slow weight gain in the nursing baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of lorazepam can be fatal if you also drink alcohol or use other drugs that cause drowsiness or slow breathing.

Overdose symptoms may include severe drowsiness, confusion, slurred speech, feeling restless, muscle weakness, loss of balance or coordination, feeling light-headed, slow heartbeats, weak or shallow breathing, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how lorazepam will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to lorazepam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Lorazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Lorazepam may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness;

• unusual changes in mood or behavior, being agitated or talkative;

• sudden restless feeling or excitement;

• seizures, depression, thinking problems, thoughts of suicide or hurting yourself;

• confusion, aggression, hallucinations;

• sleep problems (insomnia);

• vision changes; or

• dark urine, or jaundice (yellowing of the skin or eyes).

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common lorazepam side effects may include:

• dizziness, sedation, drowsiness;

• weakness; or

• feeling unsteady.

You will need frequent blood tests to check your blood counts and liver function.

After you stop using lorazepam, seek medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking lorazepam with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• valproate, probenecid, aminophylline, or theophylline;

• medicine to treat mental illness; or

• medicine that contains an antihistamine (such as sleep medicine, cold or allergy medicine).

This list is not complete and many other drugs may interact with lorazepam. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to lorazepam.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Lorazepam starts to work in about 20 to 30 minutes. Its full effects take place after about an hour and last around six to eight hours.

If you’re taking lorazepam for anxiety or sleep issues, doctors usually only recommended that you use it for up to four weeks.

Your dosage will depend on your medical condition, your age, your weight, and other factors.

The typical dosage range is between 2 and 6 milligrams per day, in divided doses.

When you stop taking lorazepam, your doctor will lower your dose gradually.

Lorazepam is sometimes used “off-label” for the following:

• Sleep problems
• Vertigo
• Depression
• Pain
• Agitation
• Alcohol withdrawal
• Panic attacks
• Nausea and vomiting from chemotherapy
• Before a medical or dental procedure