SODIUM OXYBATE (Systemic)?
Some commonly used brand names are:
In the U.S.?
Other commonly used names are
GHB? Not commercially available in Canada.
Category
Description
SodiumOxybate (SOE-dee-um OX-ee-bait) is usedto reduce the number of cataplexy (weak or paralyzed muscles) attacks in peoplewith narcolepsy. This medicine is available only with your healthcare professional'sprescription, and you can only get it from one central pharmacy. Before youuse sodium oxybate your healthcare professional should teach you about thesafe and effective use of this medicine. You cannot get the medicine untilyou have read the information the pharmacy will send you about sodium oxybate.Sodium oxybate is available only in the following dosage forms:
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 prescribedfor, you may be punished under federal and state law by jail and fines. Yoursodium oxybate should be used only by you, as prescribed by your healthcareprofessional. |
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 sodiumoxybate, the following should be considered:
Allergies?Tell your healthcare professional if you have everhad any unusual or allergic reaction to sodium oxybate. Also tell your healthcareprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Sodium oxybate has not been studied in pregnantwomen. However, studies in animals have shown that sodium oxybate may slowweight gain in baby animals. Before taking this medicine, make sure your healthcareprofessional knows if you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether sodium oxybate passesinto human breast milk. However, sodium oxybate is not recommended duringbreast-feeding because it may cause unwanted effects in nursing babies. Tellyour healthcare professional if you are breast feeding.
Children?Studies in this medicine have only been done inadult patients, and there is no specific information comparing the use ofsodium oxybate in children with other age groups.
Older adults?Elderly patients may be sensitive to the effectsof sodium oxybate. This may increase the chance of side effects during treatmentespecially difficulty in movement or in thinking.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your healthcare professionalmay want to change the dose, or other precautions may be necessary. When youare taking sodium oxybate it is especially important that your healthcareprofessional and pharmacist know if you are taking any of the following:
- Central Nervous System Depressants (medicines that make you drowsyor 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 sideeffects if taken when you are using sodium oxybate
Other medical problems?The presence of other medicalproblems may affect the use of sodium oxybate. Make sure you tell your healthcareprofessional 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 oxybatemay be more likely to develop
- Heart failure, history, or
- Hypertension (high blood pressure) or
- Kidney problems?The amount of sodium in this medicine may makethese conditions worse
- Liver problems?May increase the amount of sodium oxybate inthe body and a smaller dose may be needed
- Succinic semialdehyde dehydrogenase deficiency (a rare, inborn metabolismdeficiency)?Sodium oxybate should not be taken
Proper Use of This Medicine
Dosing?The dose of sodium oxybate willbe different for different patients. Follow your healthcareprofessional's orders or the directions in the medication guide that comeswith your medicine. It is very important that you carefully read and followall instructions before using sodium oxybate.Your healthcare professionalmust instruct you in the safe and effective use of sodium oxybate. If youhave any questions about sodium oxybate, ask your healthcare professionalor call the central pharmacy that sent you the medicine at the toll free number1-866-997-3688. The following information includes onlythe average doses of sodium oxybate. If your dose isdifferent, do not change it unless your healthcare professional tellsyou to do so.
- For oral dosage form (oral solution):
- For treatment of cataplexy
- Adults?2.25 grams given at bedtime and repeated one time duringthe night. The first dose should be taken at bedtime and the second dose taken2.5 to 4 hours later. The dose will be increased as needed by your healthcareprofessional up to a maximum of 9 grams.
Food will decrease the amount of sodium oxybate that is absorbed by yourbody. It it best to take this medicine several hours after a meal.
Note: | Sodium oxybate causes sleep very quickly. Take it only at bedtimeand while in bed. Drink all of the first dose while sitting in bed, recapthe cup, and then lie down right away. Right before going to sleep place yoursecond dose (already prepared) in a secure location (locked if needed) nearyour 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 dosingcup. While sitting in bed, drink all of the second dose right before lyingdown to continue sleeping. Recap the second cup. |
To take sodium oxybate, you must first mix it with water. Your healthcareprofessional and the medication guide that comes with your medicine will tellyou how to prepare sodium oxybate. Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn eachcap so it locks in its child resistant position.Missed dose?If you miss a dose of this medicine, take itas soon as possible. If you miss the second dose, skip that dose and do nottake sodium oxybate again until the next day. Never take two doses of sodiumoxybate at the same time. If you have any questions about this ask your healthcareprofessional.
Storage?To store this medicine:
- Store in the original bottle in a safe and secure place (locked upif appropriate)
- Keep out of the reach of children and pets.Alwaysplace 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 finishedwith the medicine.
- Place the empty bottle in the trash so it is not used for illegalpurposes.
Precautions While Using This Medicine
It is very important that your healthcare professional checkyour progress at regular visits to make sure the medicine is working properlyand to check for any unwanted effects.. This is especially importantfor elderly patients who may be more sensitive to the effects of this medicine.
Do not take other medicines unless they have been discussed with yourhealthcare professional. This medicine will add to the effects of CNS depressants(medicines that make you drowsy or less alert).Check withyour healthcare professional or dentist before taking any of the above medicineswhile you are taking sodium oxybate.
While you are taking sodium oxybate, you should not drink alcohol. Theeffects of alcohol can increase the chance of dangerous side effects of sodiumoxybate.
Other people living in your house should monitor you for the possibilityof sleepwalking. If this happens, tell your healthcare professional.
Make sure you know howyou react to this medicine before you drive, use machines, or do anythingelse that could be dangerous if you are dizzy or are not alert. Do not drivea car, operate heavy machinery, or perform any activity that is dangerousor requires mental alertness for at least 6 hours after taking sodium oxybate.When you first start taking sodium oxybate, until you know whether it makesyou sleepy the next day, use extreme care while driving a car or doing anythingelse that could be dangerous or needs you to be fully mentally alert..
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your healthcareprofessional 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 painor 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 followingsymptoms 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 physicalactivity; headache; inabilityto hold bowel movement and/or urine; increased sweating; lightheadedness, dizziness or fainting; loss of strength or energy; low bodytemperature; muscle aches or weakness; muscle pain or weakness; shakiness andunsteady walk; shivering; shortness of breath; sleepiness; slow or irregular heartbeat; trembling, or otherproblems with muscle control or coordination; unusualtiredness; unusual weak feeling; weak or feeble pulse; vision, blurred; vomiting
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your healthcare professional if any ofthe 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; drynessor 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 tendernessaround eyes and cheekbones; painful or difficulturination; runny nose; shivering; shortness of breath or troubled breathing; sleep disorder; sleepinessor unusual drowsiness; sneezing; sore throat; stomach discomfort, upset, or pain; stuffy nose; sweating; tender, swollen glands in neck; tightnessof chest or wheezing; trouble in swallowing; unusual tiredness or weakness; voicechanges; vomiting
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your healthcare professional.
Developed: 04/11/2003
