Xyrem

GENERIC NAME(S): Sodium Oxybate

OTHER NAME(S): Xyrem Solution

WARNINGS:

Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It must be used only for the purpose that your doctor prescribes. It is against the law to use this drug for any other purposes. Abuse and even approved use can result in seizures, severe difficulty breathing, confusion, depression, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).

In the US, only patients who take part in a REMS (risk evaluation and mitigation strategy) Program may receive treatment with this medication. In Canada, a similar program is called the Xyrem Success Program. Before you receive your prescription, you must register with this program, and your doctor's office must provide educational materials to you. Your doctor must go over this material with you and instruct you how to use this medication safely and effectively. Only doctors enrolled in the program may prescribe sodium oxybate, and only the central pharmacy (not your local pharmacy) may dispense it.

Who should not take Xyrem?

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Uses

Uses

This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).

How to use Xyrem

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using sodium oxybate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth in 2 separate doses at bedtime (at least 2 hours after eating) as directed by your doctor. Prepare your 2 doses as directed. The doses must be mixed with 2 ounces (60 milliliters) of water. Take the first dose at bedtime while in bed. Set an alarm clock to awaken you for the second dose in 2-and-a-half hours to 4 hours. Take the second dose while sitting in bed, and turn off the alarm. If you have children or pets in the house, be sure to use the child-resistant caps that come with the medication cups.

The dosage is based on your medical condition, weight (for children), response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor will gradually increase your dose over 1 to 2 weeks to lessen the risk of side effects. This process will continue until your doctor has found the right dose for you. Follow your doctor's directions carefully. Do not increase your dose, take it more frequently, or use it for longer than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each night.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, psychosis, fast heartbeat, trouble sleeping). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used sodium oxybate solution for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition persists or worsens.

Side Effects

Side Effects

See also Warning section.

Drowsiness, dizziness, nausea, vomiting, stomach pain, diarrhea, increased sweating, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 (e.g., confusion, psychosis, hallucinations, agitation, depression, thoughts of suicide), bedwetting, weakness, ringing in the ears, sleepwalking.

Get medical help right away if you have any very serious side effects, including: difficult/slow/shallow breathing (especially during sleep).

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

Precautions

Before taking sodium oxybate, tell your doctor or pharmacist if you are allergic to it; 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: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency), liver disease, kidney disease, breathing problems (e.g., sleep apnea, asthma), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., heart failure, high blood pressure), mental/mood problems (e.g., depression, family/personal history of suicidal thoughts/attempts).

Sleep disorders may decrease your ability to react quickly. Though sodium oxybate helps keep you awake during the day, you still may not be able to safely perform tasks that require alertness (such as driving, flying). This drug may also make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. For these reasons, do not drive, use machinery, or do anything that needs alertness until you can do it safely. Always use great care when doing these activities, and avoid them completely during the first 6 hours after you take this medication. Avoid alcoholic beverages because they increase the risk of serious side effects. Talk to your doctor if you are using marijuana (cannabis).

This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if you have a condition that could be worsened by increased salt intake (e.g., heart failure, high blood pressure)

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 the reduced ability to drive/use machinery.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

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.

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 affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, marijuana (cannabis), medicine for sleep or anxiety (eszopiclone, zaleplon, zolpidem, benzodiazepines such as diazepam/temazepam, barbiturates such as pentobarbital), muscle relaxants, and narcotic pain relievers (such as codeine).

Overdose

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: lack of response, slow/shallow breathing, inability to control urine/stool.

Notes

Do not share this medication with others. Sharing it is against the law.

Keep all medical appointments. It is recommended that you visit your doctor at least every 3 months while taking this medication.

Missed Dose

If you miss your first dose of the night, take it as soon as you remember if it is before bedtime. If it is not at bedtime or if it is your second 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. Prepare each dose just before bedtime. Use or properly discard prepared doses within 24 hours. 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. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.Information last revised April 2019. Copyright(c) 2019 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.