IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LORAZEPAM EXTENDED-RELEASE - ORAL

(lor-AZ-e-pam)

COMMON BRAND NAME(S): Loreev XR

WARNING: Lorazepam has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of lorazepam that works, and take it for the shortest possible time. Be sure you know how to take lorazepam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To help prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

USES: This form of lorazepam is used to treat anxiety in people who are taking lorazepam in a stable, evenly divided dose (usually 3 times a day). Lorazepam belongs to a class of drugs known as benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

HOW TO USE: See also Warning section. Read the Medication Guide provided by your pharmacist before you start taking lorazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. The dosage is based on your medical condition, age, and response to treatment. If you have trouble swallowing the capsule whole, you may open the capsule and sprinkle the contents on a tablespoon of applesauce. Swallow all of the mixture right away without chewing. After swallowing the mixture, drink some water to make sure you have taken all your dose. The mixture should be used within 2 hours. Do not store it for later use. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not suddenly stop using this drug without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your doctor may lower your dose slowly. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your condition does not get better or if it gets worse.

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, loss of coordination, headache, nausea, blurred vision, change in sexual interest/ability, constipation, heartburn, or change in appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as hallucinations, depression, thoughts of suicide), trouble speaking, vision changes, unusual weakness, trouble walking, memory problems, signs of infection (such as sore throat that doesn\'t go away, fever, chills). Get medical help right away if you have any very serious side effects, including: yellowing eyes or skin, seizures, slow/shallow breathing. This medication can rarely have the opposite of its usual calming effect. Symptoms of this opposite effect may include agitation, irritability, violent behavior, confusion, restlessness, excitement, and talking more than normal. Tell your doctor right away if you notice any of these effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lorazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as alprazolam, clonazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, glaucoma, lung/breathing problems (such as sleep apnea), mental/mood disorders (such as depression, psychosis, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol). This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness. Loss of coordination and drowsiness may increase the risk of falling. Also, lorazepam may have the opposite of its usual calming effect in older adults (see also Side Effects section). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lorazepam. Lorazepam may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. Tell the doctor right away if you notice symptoms in your newborn baby such as slowed breathing, feeding problems, or constant crying. Consult your doctor for more details. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug are: clozapine, kava, sodium oxybate (also known as gamma hydroxybutyrate or GHB). The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

NOTES: Do not share this medication with others. Sharing it is against the law. Lifestyle changes such as a stress reduction program may increase the effectiveness of this medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Lab and/or medical tests (such as blood counts, liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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