Loreev XR

Loreev XR is used in adults and children who are at least 12 years old to treat anxiety disorders.

Extended-release Loreev XR is used in adults to treat anxiety disorders.

Loreev XR may also be used for other reasons not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Loreev XR in larger amounts or for longer than prescribed. Tell your doctor if you feel a stronger urge to use more of Loreev XR.

Never share this medicine with anyone else, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine out of reach of others. Selling or giving away this medicine is against the law.

Measure the oral concentrate (liquid) using the supplied measuring device (not a kitchen spoon). Mix the liquid with water, juices, soda or soda-like beverages, or with semi-solid foods like 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 Loreev XR without asking your doctor. You may have life-threatening withdrawal symptoms if you suddenly stop using the medicine after long-term use.

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

Store the liquid form of lorazepam in the refrigerator. Throw away any liquid that is not used within 90 days.

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

Loreev XR can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

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

You may experience withdrawal symptoms if you stop using Loreev XR suddenly. Ask your doctor before stopping the medicine.

You should not use Loreev XR if you have:

• narrow-angle glaucoma; or
• a history of allergic reaction to any benzodiazepine (Loreev XR, alprazolam, diazepam, Valium, Xanax, Versed, Klonopin, and others).

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 Loreev XR 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.

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

Loreev XR 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.

Loreev XR 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 side effects of Loreev XR 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 Loreev XR, 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 Loreev XR 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.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Loreev XR 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.

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

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

Taking Loreev XR with other medications that slow your breathing can lead to serious side effects or even death. Consult your doctor before using opioid medications, sleeping pills, muscle relaxers, or medications for anxiety or seizures.

Inform your doctor about all other medications you are taking, especially:

• valproate, probenecid, aminophylline, or theophylline;
• medications for mental health conditions; or
• medications that contain an antihistamine (like sleep aids, cold, or allergy medicines).

This list is not exhaustive, and many other medications may interact with Loreev XR. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are mentioned here.