sodium oxybate

(SO dee um ox IH bate)
Xyrem

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

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Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse of this medication and the serious side effects that may occur, sodium oxybate is only available through the Xyrem Success Program. Your healthcare provider will explain the risks and benefits of taking sodium oxybate, and the medication will be delivered to you from a single, centralized pharmacy. Monitoring of your treatment must be performed on a regular basis in order to continue taking sodium oxybate.

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

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Sodium oxybate will cause drowsiness. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking sodium oxybate. Since the medication may have some carryover effect in the daytime, use caution performing these activities when starting treatment with sodium oxybate and following an increase in dosage.

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Avoid alcohol while taking sodium oxybate. Alcohol may increase drowsiness and dizziness caused by sodium oxybate.

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Sodium oxybate may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

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Sodium oxybate is habit forming. You can become physically and psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if sodium oxybate is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

What is sodium oxybate?

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Sodium oxybate is a central nervous system depressant. The exact way the sodium oxybate works is unknown.

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Sodium oxybate is used in the treatment of cataplexy (sudden loss of muscle strength) in patients with narcolepsy.

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

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

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Do not take sodium oxybate if you

have succinic semialdehyde dehydrogenase deficiency; or

are taking another medication that causes drowsiness.

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Before taking this medication, tell your doctor if you

have liver disease;

have a history of alcohol or drug abuse;

have asthma, bronchitis, emphysema, or another respiratory disease;

have sleep apnea (periods of decreased breathing during sleep);

are depressed or have suicidal thoughts;

have mania, bipolar disorder, schizophrenia, or another psychiatric condition; or

are on a salt-restricted diet or have heart failure, high blood pressure, or kidney disease.

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

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Sodium oxybate is in the FDA pregnancy category B. This means that sodium oxybate is not expected to be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

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It is not known whether sodium oxybate passes into breast milk. Do not take sodium oxybate without first talking to your doctor if you are breast-feeding a baby.

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If you are over 65 years of age, you may be more likely to experience side effects from sodium oxybate. Your doctor may prescribe a lower dose of the medication or special monitoring during treatment.

How should I take sodium oxybate?

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Take sodium oxybate exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

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Sodium oxybate must be taken at bedtime while in bed, and again two and a half to four hours later while sitting in bed. You will most likely need to set an alarm to awaken for the second dose. After taking each dose, lie down and remain in bed.

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Before bedtime, prepare both doses of sodium oxybate. Each dose must be diluted with two ounces (60 mL, one quarter cup, or 4 tablespoons) of water in the child resistant dosing cups provided prior to ingestion. The second dose must be prepared prior to ingesting the first dose and should be placed where it can be reached while sitting in bed.

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

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

What happens if I miss a dose?

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Skip the missed dose. Do not take a double dose of this medication. A double dose could be dangerous.

What happens if I overdose?

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Seek emergency medical attention if an overdose is suspected.

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Symptoms of an sodium oxybate overdose may include sleepiness, dizziness, confusion, sweating, vomiting, difficulty breathing, seizures, and unconsciousness.

What should I avoid while taking sodium oxybate?

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Avoid alcohol while taking sodium oxybate. Alcohol may increase drowsiness and dizziness caused by sodium oxybate.

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What are the possible side effects of sodium oxybate?

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If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; or hives);

hallucinations or severe confusion; or

sleepwalking.

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

drowsiness;

dizziness;

confusion;

headache;

nausea, vomiting, diarrhea, or abdominal pain;

weakness;

depression;

urinary or fecal incontinence;

nervousness;

increased sweating; or

abnormal dreams.

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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?

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Avoid alcohol while taking sodium oxybate. Alcohol may increase drowsiness and dizziness caused by sodium oxybate.

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Drugs other than those listed here may also interact with sodium oxybate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

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

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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.

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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.