What is the most important information I should know about sodium oxybate?
Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines.
Misuse of sodium oxybate can cause breathing problems, seizure, loss of consciousness, or death. Sodium oxybate is available only from a certified pharmacy. Do not allow anyone else to use your medication.
What is sodium oxybate?
Sodium oxybate is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.
Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse and serious side effects, sodium oxybate is available only from a certified pharmacy under a special program called Xyrem Success Program. Your doctor must be registered in the program in order to prescribe sodium oxybate for you.
Sodium oxybate may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking sodium oxybate?
Do not drink alcohol or take other sleep medicines together with sodium oxybate. Dangerous side effects or death could occur.
Do not give sodium oxybate to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
To make sure sodium oxybate is safe for you, tell your doctor if you have ever had:
- a breathing disorder such as asthma, emphysema, or bronchitis;
- snoring, or sleep apnea (breathing stops during sleep);
- kidney or liver disease;
- heart disease, high blood pressure;
- a drug or alcohol addiction;
- depression or suicidal thoughts;
- mental illness such as bipolar disorder or schizophrenia; or
- if you also take divalproex sodium (Depakote).
You may need to be on a low-salt diet while you are using sodium oxybate, especially if you have high blood pressure, kidney disease, or heart disease.
It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.
Sodium oxybate is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Sodium oxybate can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
Sodium oxybate is not approved for use by anyone younger than 18 years old.
How should I take sodium oxybate?
Follow all directions on your prescription label. Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine. Never use sodium oxybate in larger amounts, or for longer than prescribed.
Sodium oxybate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Misuse of this medicine can cause breathing problems, seizure, loss of consciousness, or death. Selling or giving away sodium oxybate is against the law.
Read all patient information, medication guides, and instruction sheets provided to you. Do not allow anyone else to use your medication.
Take sodium oxybate on an empty stomach at least 2 hours after a meal. It is important to take sodium oxybate at the same time each night.
Sodium oxybate must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.
Each dose of sodium oxybate must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any sodium oxybate dose that has been mixed with water but not used within 24 hours of mixing.
Do not stop using sodium oxybate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using sodium oxybate.
Your doctor will need to check your progress every 3 months. If you need surgery, tell the surgeon ahead of time that you are using sodium oxybate.
Store at room temperature away from moisture and heat.
Keep track of your medicine. Sodium oxybate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover sodium oxybate liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused liquid medicine down the toilet.
What happens if I miss a dose?
Take the missed dose as soon as you remember, but only at bedtime or during your normal sleeping hours. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of sodium oxybate can be fatal.
Overdose symptoms may include sweating, vomiting, severe confusion, loss of balance or coordination, or seizure (convulsions).
What should I avoid while taking sodium oxybate?
Do not drink alcohol. Dangerous side effects or death could occur.
Sodium oxybate will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Do not take other sleep medicines together with sodium oxybate.
What are the possible side effects of sodium oxybate?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using sodium oxybate and call your doctor at once if you have:
- weak or shallow breathing, breathing that stops for short periods of time;
- aggression, paranoia, hallucinations (seeing or hearing things);
- sleepwalking, waking and confused behavior at night;
- depression, agitation, unusual or unpleasant thoughts; or
- suicidal thoughts or actions.
Common side effects may include:
- drowsiness, dizziness;
- bed-wetting;
- nausea, vomiting; or
- tremors.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect sodium oxybate?
Taking sodium oxybate with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness.
Your doctor may need to change your treatment plan if you need to use any of these other medicines.
This list is not complete. Other drugs may interact with sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about sodium oxybate.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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