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|Xyrem

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SODIUM OXYBATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

Xyrem

Other commonly used names are

GHB

† Not commercially available in Canada.

Description

Sodium Oxybate (SOE-dee-um OX-ee-bait) is used to reduce the number of cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. This medicine is available only with your healthcare professional"s prescription, and you can only get it from one central pharmacy. Before you use sodium oxybate your healthcare professional 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 sodium oxybate. Sodium oxybate is available only in the following dosage forms:

Oral
Oral Solution (U.S.)

Note:

Sodium oxybate is a Schedule III, federally controlled substance. This means that if you sell, distribute, or give your medicine to anyone else, or if you use your sodium oxybate for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines. Your sodium oxybate should be used only by you, as prescribed by your healthcare professional.

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For sodium oxybate, the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to sodium oxybate. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sodium oxybate has not been studied in pregnant women. However, studies in animals have shown that sodium oxybate may slow weight gain in baby animals. Before taking this medicine, make sure your healthcare professional knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether sodium oxybate passes into human breast milk. However, sodium oxybate is not recommended during breast-feeding because it may cause unwanted effects in nursing babies. Tell your healthcare professional if you are breast feeding.

Children—Studies in this medicine have only been done in adult patients, and there is no specific information comparing the use of sodium oxybate in children with other age groups.

Older adults—Elderly patients may be sensitive to the effects of sodium oxybate. This may increase the chance of side effects during treatment especially difficulty in movement or in thinking.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your healthcare professional may want to change the dose, or other precautions may be necessary. When you are taking sodium oxybate it is especially important that your healthcare professional and pharmacist know if you are taking any of the following:

Central Nervous System Depressants (medicines that make you drowsy or less alert) or alcohol, especially sedatives, drugs that relax you (e.g. Valium [diazepam], Xanax [alprazolam]) or hypnotics, drugs that help you sleep (e.g. Dalmane [flurazepam])—May increase the chance of serious side effects if taken when you are using sodium oxybate

Other medical problems—The presence of other medical problems may affect the use of sodium oxybate. Make sure you tell your healthcare professional if you have any other medical problems, especially:

Breathing problems such as:
- Hypopnea (abnormally slow, shallow breathing) or
- Sleep apnea (stopping breathing during sleep)
  Use of sodium oxybate may make these conditions worse

Depression, history of, or
Suicide, attempted—Use of sodium oxybate may worsen these conditions

Drug abuse or dependence, history of—Dependence on sodium oxybate may be more likely to develop

Heart failure, history, or
Hypertension (high blood pressure) or
Kidney problems—The amount of sodium in this medicine may make these conditions worse

Liver problems—May increase the amount of sodium oxybate in the body and a smaller dose may be needed

Succinic semialdehyde dehydrogenase deficiency (a rare, inborn metabolism deficiency)—Sodium oxybate should not be taken

Proper Use of This Medicine

Dosing—The dose of sodium oxybate will be different for different patients. Follow your healthcare professional"s orders or the directions in the medication guide that comes with your medicine. It is very important that you carefully read and follow all instructions before using sodium oxybate. Your healthcare professional must instruct you in the safe and effective use of sodium oxybate. If you have any questions about sodium oxybate, ask your healthcare professional or call the central pharmacy that sent you the medicine at the toll free number 1-866-997-3688. The following information includes only the average doses of sodium oxybate. If your dose is different, do not change it unless your healthcare professional tells you to do so.

For oral dosage form (oral solution):
- For treatment of cataplexy
  - Adults—2.25 grams given at bedtime and repeated one time during the night. The first dose should be taken at bedtime and the second dose taken 2.5 to 4 hours later. The dose will be increased as needed by your healthcare professional up to a maximum of 9 grams.
    Food will decrease the amount of sodium oxybate that is absorbed by your body. It it best to take this medicine several hours after a meal.

Note:

Sodium oxybate causes sleep very quickly. Take it only at bedtime and while in bed. Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away. Right before going to sleep place your second dose (already prepared) in a secure location (locked if needed) near your bed. You may need to set an alarm to wake up to take the second dose. When you wake up to take the second dose, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

To take sodium oxybate, you must first mix it with water. Your healthcare professional and the medication guide that comes with your medicine will tell you how to prepare sodium oxybate. Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap so it locks in its child resistant position.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. If you miss the second dose, skip that dose and do not take sodium oxybate again until the next day. Never take two doses of sodium oxybate at the same time. If you have any questions about this ask your healthcare professional.

Storage—To store this medicine:

Store in the original bottle in a safe and secure place (locked up if appropriate)
Keep out of the reach of children and pets.Always place your nightly doses of sodium oxybate out of the reach of children.
Do not keep any outdated medicine or medicine that is no longer needed. Pour any unused sodium oxybate down the drain
Destroy the drug name on the label with a marker when you are finished with the medicine.
Place the empty bottle in the trash so it is not used for illegal purposes.

Precautions While Using This Medicine

It is very important that your healthcare professional check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects. . This is especially important for elderly patients who may be more sensitive to the effects of this medicine.

Do not take other medicines unless they have been discussed with your healthcare professional. This medicine will add to the effects of CNS depressants (medicines that make you drowsy or less alert).Check with your healthcare professional or dentist before taking any of the above medicines while you are taking sodium oxybate.

While you are taking sodium oxybate, you should not drink alcohol. The effects of alcohol can increase the chance of dangerous side effects of sodium oxybate.

Other people living in your house should monitor you for the possibility of sleepwalking. If this happens, tell your healthcare professional.

Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or requires mental alertness for at least 6 hours after taking sodium oxybate. When you first start taking sodium oxybate, until you know whether it makes you sleepy the next day, use extreme care while driving a car or doing anything else that could be dangerous or needs you to be fully mentally alert. .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your healthcare professional immediately if any of the following side effects occur:

More common

Blurred vision; burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feeling; change in vision; confusion; discouragement; dizziness; feeling sad or empty; headache; impaired vision; irritability; lack of appetite; lack or loss of strength; loss of bladder control; loss of interest or pleasure; loss of memory; loss of strength or energy; muscle pain or weakness; nervousness; pounding in the ears; problems with memory; sleepwalking; slow or fast heartbeat; tiredness; trouble concentrating; trouble sleeping

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Alternating periods of shallow and deep breathing; bluish lips or skin, not breathing; chest pain or discomfort; clumsiness; coma; confusion; confusional, agitated combative state; consciousness, depressed; convulsions; drowsiness; generalized slowing of mental and physical activity; headache; inability to hold bowel movement and/or urine; increased sweating; lightheadedness, dizziness or fainting; loss of strength or energy; low body temperature; muscle aches or weakness; muscle pain or weakness; shakiness and unsteady walk; shivering; shortness of breath; sleepiness; slow or irregular heartbeat; trembling, or other problems with muscle control or coordination; unusual tiredness; unusual weak feeling; weak or feeble pulse; vision, blurred; vomiting

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

More Common

Abdominal pain; abnormal thinking; acid or sour stomach; back pain; belching; body aches or pain; chills; congestion; cold ; cough or hoarseness; cramps; diarrhea; dizziness; dreams, abnormal; dryness or soreness of throat; fear; fever; flu-like symptoms; general feeling of discomfort or illness; heartburn; heavy bleeding; hoarseness; indigestion; joint pain; lower back or side pain; nausea; pain; pain or tenderness around eyes and cheekbones; painful or difficult urination; runny nose; shivering; shortness of breath or troubled breathing; sleep disorder; sleepiness or unusual drowsiness; sneezing; sore throat; stomach discomfort, upset, or pain; stuffy nose; sweating; tender, swollen glands in neck; tightness of chest or wheezing; trouble in swallowing; unusual tiredness or weakness; voice changes; vomiting

Less common

Sleeplessness; unable to sleep

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Developed: 04/11/2003

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Typical mistypes for Xyrem
zyrem, cyrem, dyrem, syrem, xtrem, xgrem, xhrem, xurem, x7rem, x6rem, xyeem, xydem, xyfem, xytem, xy5em, xy4em, xyrwm, xyrsm, xyrdm, xyrrm, xyr4m, xyr3m, xyren, xyrek, xyrej, yrem, xrem, xyem, xyrm, xyre, yxrem, xryem, xyerm, xyrme, xxyrem, xyyrem, xyrrem, xyreem, xyremm, etc.