Obtundation and respiratory depression may occur with sodium oxybate use. Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB is associated with CNS adverse reactions, including seizures, respiratory depression, decreased consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, sodium oxybate is available only through a restricted distribution program called the Xyrem Success Program(R), using a centralized pharmacy. Prescribers and patients must enroll in the program; call 1-866-XYREM88 or go to www.XYREM.com .
Central Nervous System Agent
Sodium oxybate is used to treat excessive daytime sleepiness and to reduce the number of cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.
This medicine is available only with your doctor's prescription, and you can only get it from one central pharmacy. Before you use sodium oxybate 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 sodium oxybate.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sodium oxybate in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (eg, headache) or age-related liver disease, which may require caution and an adjustment in the dose for patients receiving sodium oxybate.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.
It is very important that you understand the requirements of the Xyrem® success program, and become familiar with the Xyrem® Medication Guide and patient instructions. Direct any questions to your doctor or pharmacist before starting treatment.
Take the medicine at least 2 hours after eating. This medicine will make you drowsy very quickly. It is best to take the medicine only at bedtime or when you are ready to fall asleep.
You must first mix each dose with 2 ounces (60 mL) of water. 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. Use the oral liquid within 24 hours after mixing.
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 in a secure place near your bed. You might 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.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Empty any unused medicine down the sink drain, after you have finished using a Xyrem® bottle. Use a marker to cross out the label on the bottle. Then, place the empty bottle in the trash.
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.
Do not use this medicine if you are also taking another sedative or hypnotic medicine (eg, Ambien®, Phenergan®, Seconal®). Also, do not drink alcohol while you are using this medicine. Doing so may increase risk of serious unwanted effects.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, a sleeping medicine, certain medicines for depression or anxiety, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
This medicine may make you dizzy, drowsy, or less alert than you are normally. Avoid driving, using machines, or doing any activity that could be dangerous if you are not alert for at least 6 hours after taking sodium oxybate.
Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.
This medicine may cause feeling sad or hopeless, change in weight or appetite, loss of interest or pleasure in usual activities, increased tiredness or weakness, or have suicidal thoughts and tendencies. If you notice any of these side effects, call your doctor right away.
Other people living in your house should monitor you for the possibility of urinary or fecal incontinence (loss of bladder or bowel control), or sleepwalking. Tell your doctor if these symptoms occur.
Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
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 doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.