Xyrem information

[Guest guest]

This certainly looks like a drug to be extra careful using and keeping it

out of the reach of others. This information comes from

www.fda.gov/cder/drug/infopage. The directions with pictures about just how

to open the package and mix this drug are at that site.

Kaylene

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MEDICATION GUIDE

Xyrem® (ZÎE-rem) oral solution

(sodium oxybate)

It is very important that you carefully read and follow all instructions

before using Xyrem®. Read this information carefully before you begin

treatment. Read the information you get whenever you get refills. There may

be new information. This Medication Guide does not take the place of talking

with your doctor about your medical condition or your treatment. Your doctor

must instruct you in the safe and effective use of Xyrem®. If you have any

questions about Xyrem®, ask your doctor or call the central pharmacy that

sent you the medicine at the toll free number 1-866-XYREM88SM

(1-). Do not throw away this Medication Guide. You may need to

refer to it again later.

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

Xyrem® is a Schedule III, federally controlled substance. This means that if

you sell, distribute, or give your Xyrem® to anyone else, or if you use your

Xyrem® for purposes other than what it was prescribed for, you may be

punished under federal and state law by jail and fines. Your Xyrem® should

be used only by you, as prescribed.

It is critical to keep Xyrem® out of the reach of children.

Xyrem® can cause serious side effects including trouble breathing while

asleep, confusion, abnormal thinking, depression, and loss of consciousness.

Tell your doctor if you have any of these problems while taking Xyrem®.

The active ingredient in Xyrem® is gamma-hydroxybutyrate (GHB), a chemical

that has been abused (misused). Abuse can cause serious medical problems,

including trouble breathing, seizures (convulsions), loss of consciousness,

coma, and death. Abuse of Xyrem® could also lead to dependence, craving for

the medicine, and severe withdrawal symptoms.

Xyrem® causes sleep very quickly. Therefore, take Xyrem® only at bedtime and

while in bed.

Do not drive a car, operate heavy machinery, or perform any activity that is

dangerous or that requires mental alertness for at least 6 hours after

taking Xyrem®. When you first start taking Xyrem®,until you know whether it

makes you sleepy the next day, use extreme care while driving a car,

operating heavy machinery or doing anything else that could be dangerous or

needs you to be fully mentally alert.

You can get Xyrem® only by prescription. You must get it from one central

pharmacy. Before you use Xyrem®, your doctor should teach you about the safe

and effective use of this medicine. You cannot get the medicine until you

have read the information the pharmacy will send you about Xyrem®.

What is Xyrem®?

Xyrem® is a brand of medicine used to reduce the number of cataplexy (weak

or paralyzed muscles) attacks in patients with narcolepsy. Xyrem® is a

controlled drug. This means anyone who misuses, sells, or distributes it may

be prosecuted under federal and state law. You must not share it with anyone

else.

Who should not take Xyrem®?

Do not take Xyrem® if you

take other sleep medicines or sedatives (medicines that cause sleepiness),

have a rare condition called succinic semialdehyde dehydrogenase deficiency

Tell your doctor if you

are pregnant or plan to become pregnant or are breastfeeding. It is not

known whether Xyrem® can pass through your milk and harm the baby.

have had depression. You may be more likely to get depressed taking Xyrem®.

have liver problems. Your dose may need to be adjusted.

have sleep apnea, snoring, or breathing or lung problems. You may be more

likely to get serious side effects.

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

Xyrem® contains a lot of sodium (salt) and may not be right for you.

Tell your doctor about all the medicines you take, including prescription

and non-prescription medicines, vitamins, and supplements.

How should I take Xyrem®?

Take Xyrem® exactly as prescribed by your doctor.

Xyrem® works very fast. Take it only while in bed when you are ready to fall

asleep.

Take Xyrem® two times each night. Take the first dose right at bedtime and

the second dose 2 ½ to 4 hours later. You will probably need to set an alarm

clock to make sure you wake up to take the second dose. To get the most

benefit from Xyrem®, it is important that you take both doses each night,

exactly as prescribed by your doctor.

Food will decrease the amount of Xyrem® that is absorbed by your body.

Therefore, it is best to take Xyrem® well after a meal (several hours).You

need to take your second dose 2 ½ to 4 hours after that first dose. If you

miss the second dose, skip that dose and do not take Xyrem® again until the

next night. Never take two Xyrem® doses at once.

If you take more Xyrem® than prescribed or take it by accident, get

emergency medical help right away.

To take Xyrem®, you must first mix it with water. See " Directions for using

Xyrem® " at the end of this Medication Guide for detailed information about

taking Xyrem®.

Your doctor will want to see you often to check your response to Xyrem®

therapy, including any side effects you may be experiencing.

What should I avoid while taking Xyrem®?

Do not drive a car, operate heavy machinery, or perform any activity that is

dangerous or that requires mental alertness for at least 6 hours after

taking Xyrem®. When you first start taking Xyrem® or any other sleep

medicine until you know whether the medicine will still have some carryover

effect in you the next day, use extreme care while undertaking similar

activities the next day.

Do not drink alcohol or take sedatives. Alcohol and certain medicines can

increase the chance of dangerous side effects. Tell your doctor about all

the medicines you take including non-prescription medicines and supplements.

What are the possible side effects of Xyrem®?

The most common side effects of Xyrem® are nausea, dizziness, headache,

sleep problems, confusion, vomiting, and bed-wetting. Tell your doctor if

you develop these less common but possibly serious side effects:

sleepwalking (confused behavior during the night that may include walking

around and doing other activities while not aware of what you are doing),

increased sleepiness during the day, snoring, you stop breathing for a short

time while you sleep (sleep apnea), breathing problems, depression, and

abnormal thinking.

These are not all of the side effects of Xyrem®. If you are concerned about

any possible side effects consult your doctor.

Effects of abusing (misusing) Xyrem® (GHB)

Some people who repeatedly abuse GHB become addicted to it. People who

repeatedly abuse GHB can develop withdrawal symptoms. These symptoms include

the need to continue taking the drug, anxiety, trouble sleeping, and

abnormal thinking.

How should I store Xyrem®?

Always store Xyrem® in the original bottle in a safe and secure place

(locked up if appropriate), out of the reach of children. Pour any unused

Xyrem® down the drain. Destroy the drug name on the label with a marker.

Place the empty bottle in the trash so it is not used for illegal purposes.

Always place your nightly doses of Xyrem® safely out of the reach of

children.

General advice about Xyrem®

Medicines are sometimes prescribed for purposes not mentioned in Medication

Guides. Do not use Xyrem® for a condition for which it was not prescribed.

Do not give Xyrem® to other people. It may harm them, and it is against the

law. This Medication Guide summarizes the most important information about

Xyrem®. If you want more information, talk with your doctor. You can ask

your doctor for information about Xyrem® that is written for health

professionals. Also, you can call the central pharmacy at the toll free

number 1-866-XYREM88SM (1-).

Directions for Using Xyrem®

CAUTION: Be very careful not to leave your Xyrem® in a place where children

or pets can get to it.

The Xyrem® carton contains 1 bottle of medicine, 2 dosing cups with

child-resistant caps, 1 liquid measuring device and printed product

information.