Xyrem

 
Generic Name: sodium oxybate

Brands: Xyrem

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What is the most important information I should know about Xyrem?

· Xyrem 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, Xyrem is only available through the Xyrem Success Program. Your healthcare provider will explain the risks and benefits of taking Xyrem, 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 Xyrem.

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

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

· Avoid alcohol while taking Xyrem. Alcohol may increase drowsiness and dizziness caused by Xyrem.

· Xyrem 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.

· Xyrem 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 Xyrem is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

 

What is Xyrem?

· Xyrem is a central nervous system depressant. The exact way the Xyrem works is unknown.

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

· Xyrem may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before taking Xyrem?

· Do not take Xyrem if you     ·have succinic semialdehyde dehydrogenase deficiency; or     ·are taking another medication that causes drowsiness.

· 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.

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

· Xyrem is in the FDA pregnancy category B. This means that Xyrem 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.

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

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

 

How should I take Xyrem?

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

· Xyrem 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, Xyrem is only available through the Xyrem Success Program. Your healthcare provider will explain the risks and benefits of taking Xyrem, 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 Xyrem.

· Xyrem 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.

· Before bedtime, prepare both doses of Xyrem. 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.

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

· Xyrem 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 Xyrem is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

· Store Xyrem at room temperature away from moisture and heat.

 

What happens if I miss a dose?

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

 

What happens if I overdose?

· Seek emergency medical attention if an overdose is suspected.

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

 

What should I avoid while taking Xyrem?

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

· Avoid alcohol while taking Xyrem. Alcohol may increase drowsiness and dizziness caused by Xyrem.

· Xyrem 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.

 

What are the possible side effects of Xyrem?

· 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.

· Other, less serious side effects may be more likely to occur. Continue to take Xyrem 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.

· 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 Xyrem?

· Avoid alcohol while taking Xyrem. Alcohol may increase drowsiness and dizziness caused by Xyrem.

· Xyrem 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.

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

 

Where can I get more information?

· Your pharmacist has additional information about Xyrem written for health professionals that you may read.

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