Oxybate, Lumryz

Sodium Oxybate

(SOW dee um ox i BATE)

Xyrem

This drug can cause severe side effects. These may include breathing problems, low blood pressure, changes in alertness, and passing out. If you have questions, talk with the doctor. Abuse and misuse of this drug by itself or with certain other drugs may cause seizures, slow or shallow breathing, changes in alertness, coma, or death.

It is used to treat sudden loss of muscle tone (cataplexy) in patients with narcolepsy. It is used to treat a lot of sleepiness during the day in patients with narcolepsy.

If you have an allergy to sodium oxybate or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have succinic semialdehyde dehydrogenase deficiency. If you drink alcohol or take any drugs that have alcohol. If you are taking any drugs or natural products used for sleep. There are many products used for sleep. Ask your doctor or pharmacist if you are not sure. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. If you have been taking this drug on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this drug all of a sudden without calling your doctor. Tell your doctor if you have any bad effects. Avoid driving and doing other tasks or actions that call for you to be alert for at least 6 hours after taking this drug. Avoid these tasks or actions until you feel fully awake. Avoid drinking alcohol while taking this drug. Talk with your doctor before you use other drugs and natural products that slow your actions. Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs. After taking this drug, it is likely you will fall asleep very fast (most of the time within 5 to 15 minutes). The time that it takes to fall asleep can change from night to night. Falling asleep all of a sudden when standing or rising from bed has led to falls and the need to go to the hospital. Be sure you take this drug while in bed and lie down right away after taking it. Talk with your doctor. If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium. If you are 65 or older, use this drug with care. You could have more side effects. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of depression, thoughts of suicide, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life. Hallucinations (seeing or hearing things that are not there). Feeling confused. Change in the way you act. Sleepwalking. Trouble breathing, slow breathing, or shallow breathing. Breathing problems during sleep (sleep apnea). Very bad dizziness or passing out.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: For all patients taking this drug: Dizziness. Feeling sleepy. Upset stomach or throwing up. Bedwetting. Shakiness. Children: Headache. Weight loss. Not hungry. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take 2 doses each night. Take on an empty stomach. Take the first dose at least 2 hours after eating. This drug needs to be mixed before use. Follow how to mix as you were told by the doctor. Prepare each dose before going to bed. Use within 24 hours after you mix this drug. Place in child-resistant dosing cups on bedside table. Take first dose at bedtime after getting into bed. Stay in bed after taking doses. Space doses by at least 2.5 to 4 hours. Set alarm clock to wake up for second dose.

If you miss the second dose, skip the missed dose. Do not take another dose until the next night. Do not take 2 doses at the same time or extra doses.

Store in the original container at room temperature. Store in a dry place. Do not store in a bathroom. Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.