Xyrem
 Xyrem

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Xyrem

Generic Name: sodium oxybate (SO dee um OX i bate)
Brand Names: Xyrem

What is sodium oxybate?

Sodium oxybate is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.

Sodium oxybate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sodium oxybate?

It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse and the serious side effects that may occur, sodium oxybate is available only through a special program. Your doctor will explain the risks and benefits of using sodium oxybate, and the medication will be delivered to you from a central pharmacy.

Sodium oxybate is habit-forming and you can become physically and psychologically dependent on it. Sodium oxybate should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take sodium oxybate for longer than your doctor has prescribed. Talk with your doctor if you feel that the medication is not working. Sodium oxybate will cause drowsiness and must be taken while you are in bed. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking sodium oxybate. You may still feel sleepy the morning after taking the medication. Use caution when driving or doing anything else that requires you to be alert and awake.

Sodium oxybate must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed, so that you will not have to get up to prepare the second dose. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.

Do not take other medicines that make you sleepy (such as alcohol, cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

What should I discuss with my healthcare provider before taking sodium oxybate?

It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

Do not take sodium oxybate if you:
  • are taking another medication that causes drowsiness; or

  • have a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency.

Before taking sodium oxybate, tell your doctor if you have:

  • liver disease;
  • heart disease, high blood pressure, or kidney disease;

  • a history of alcohol or drug abuse;

  • a lung disorder such as asthma, emphysema, or bronchitis;

  • sleep apnea (breathing stops during sleep);

  • depression or suicidal thoughts; or

  • mental illness such as bipolar disorder or schizophrenia.

If you have any of the conditions listed above, you may not be able to take sodium oxybate, or you may require a dosage adjustment or special monitoring during treatment.

Sodium oxybate is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sodium oxybate passes into breast milk. Do not take sodium oxybate without telling your doctor if you are breast-feeding a baby.

How should I take sodium oxybate?

Sodium oxybate is habit-forming and you can become physically and psychologically dependent on it. Sodium oxybate should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take sodium oxybate for longer than your doctor has prescribed. Talk with your doctor if you feel that the medication is not working.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Do not allow anyone else to use your medication.

Take sodium oxybate on an empty stomach several hours after a meal. It is important to take sodium oxybate at the same time each night.

Sodium oxybate must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed, so that you will not have to get up to prepare the second dose. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.

Each dose of sodium oxybate must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any sodium oxybate dose that has been mixed with water but not used within 24 hours of mixing.

You may need to be on a low-salt diet while you are using sodium oxybate, especially if you have high blood pressure, kidney disease, or heart disease.

Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse and the serious side effects that may occur, sodium oxybate is available only through a special program. Your doctor will explain the risks and benefits of using sodium oxybate, and the medication will be delivered to you from a central pharmacy.

To be sure this medication is helping your condition, your doctor will need to see you on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Do not stop using sodium oxybate suddenly or you may have withdrawal effects. Your doctor may recommend a gradual reduction in dose.

Store sodium oxybate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a sodium oxybate overdose may include extreme sleepiness or confusion, fainting, vomiting, sweating, difficulty breathing, muscle weakness, slow heartbeat, or seizure (convulsions).

What should I avoid while taking sodium oxybate?

Sodium oxybate must not be taken with other drugs that are used for sleep or sedation.

Avoid drinking alcohol while taking sodium oxybate. Alcohol may increase drowsiness and dizziness caused by sodium oxybate. Sodium oxybate can cause side effects that may impair your thinking or reactions. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking sodium oxybate. You may still feel sleepy the morning after taking the medication. Use caution when driving or doing anything else that requires you to be alert and awake

Sodium oxybate side effects

Stop using sodium oxybate and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using sodium oxybate and call your doctor at once if you have any of these serious side effects:
  • hallucinations or severe confusion;

  • shallow breathing;

  • sleepwalking; or

  • waking and confused behavior at night.

Other, less serious side effects may be more likely to occur. Continue to take sodium oxybate and talk to your doctor if you have:

  • agitation or paranoia;

  • problems with bladder or bowel control;

  • depression;

  • nausea, vomiting, loss of appetite;

  • runny or stuffy nose and sore throat;

  • numbness or tingling;

  • tremors (uncontrolled shaking); or

  • blurred vision.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect sodium oxybate?

The sedative effects of sodium oxybate can be made worse by also taking other medicines that make you sleepy (such as alcohol, cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

There may be other drugs that can affect sodium oxybate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has additional information about sodium oxybate written for health professionals that you may read.

What does my medication look like?

Sodium oxybate is available with a prescription under the brand name Xyrem. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Xyrem 500 mg/mL-clear to slightly opalescent oral solution

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ("Multum") is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum"s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum"s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 1/14/07 12:10:28 PM.




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