Xyrem

DRUG DESCRIPTION

Xyrem (sodium oxybate) is a central nervous system depressant that reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy. Sodium oxybate is intended for oral administration. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3 and the molecular weight is 126.09 grams/mole. The chemical structure is:

Xyrem®
  (sodium oxybate) Structural Formula Illustration

Sodium oxybate is a white to off-white, crystalline powder that is very soluble in aqueous solutions. Xyrem oral solution contains 500 mg of sodium oxybate per milliliter of USP Purified Water, neutralized to pH 7.5 with malic acid.

What are the possible side effects of sodium oxybate (Xyrem)?

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.

Less serious side effects may include:

  • agitation or...

Read All Potential Side Effects and See Pictures of Xyrem »

What are the precautions when taking sodium oxybate (Xyrem)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, breathing problems (e.g., sleep apnea), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., heart failure, high blood...

Read All Potential Precautions of Xyrem »


Xyrem Consumer (continued)

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 immediately if any of these unlikely but serious side effects occur: difficult/slow/shallow breathing (especially during sleep), mental/mood changes (e.g., confusion, psychosis, hallucinations, agitation, depression, rare thoughts of suicide), bedwetting, weakness, ringing in the ears.

Tell your doctor immediately if any of these rare but very serious side effects occur: sleepwalking.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, breathing problems (e.g., sleep apnea), 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 task that require alertness (e.g., driving, flying). This drug may also make you dizzy. For these reasons, do not drive, use machinery, or do any other activity that requires alertness until you know how this medication affects you. 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.

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., congestive heart failure, high blood pressure)

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the 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.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Xyrem Patient Information Including Side Effects

Brand Names: Xyrem

Generic Name: sodium oxybate (Pronunciation: SO dee um OX i bate)

  • What is sodium oxybate (Xyrem)?
  • What are the possible side effects of sodium oxybate (Xyrem)?
  • What is the most important information I should know about sodium oxybate (Xyrem)?
  • What should I discuss with my healthcare provider before taking sodium oxybate (Xyrem)?
  • How should I take sodium oxybate (Xyrem)?
  • What happens if I miss a dose (Xyrem)?
  • What happens if I overdose (Xyrem)?
  • What should I avoid while taking sodium oxybate (Xyrem)?
  • What other drugs will affect sodium oxybate (Xyrem)?
  • Where can I get more information?

What is sodium oxybate (Xyrem)?

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 other purposes not listed in this medication guide.

What are the possible side effects of sodium oxybate (Xyrem)?

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.

Less serious side effects may include:

  • 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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 may be habit-forming and should be used only by the person it was prescribed for. Sodium oxybate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Never take more than your prescribed dose of sodium oxybate. Tell your doctor if the medicine seems to stop working as well.

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).

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