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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.
General medical information 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 you should find out 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 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.
If you 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 you 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.
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.
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.
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