SODIUM OXYBATE

(SO dee um OX i bate) Brand: Xyrem

What is the most significant information I must know about sodium oxybate?

• Because of the potential for abuse and the serious side effects that may occur, sodium oxybate is accessible only from a certified pharmacy. Do not let anyone else to use your medication.

• Do not drink alcohol or take another medicines that create you sleepy or slow your breathing (such as cool medication, pain medicine, muscle relaxants, sleep medicine, or medication for depression or anxiety). Dangerous side effects or death may occur.

• Do not give sodium oxybate to anyone who has a rare metabolic mess called succinic semialdehyde dehydrogenase deficiency (which can reason mental or physical impairment).

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 the serious side effects that may occur, sodium oxybate is accessible only from a certified pharmacy under a particular program called Xyrem Success Program. Your doctor should 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 medicine guide.

What must I discuss with my healthcare provider till taking sodium oxybate?

• Do not drink alcohol or take another medicines that create you sleepy or slow your breathing (such as cool medication, pain medicine, muscle relaxants, sleep medicine, or medication for depression or anxiety). Dangerous side effects or death may occur.

• Do not give sodium oxybate to anyone who has a rare metabolic mess called succinic semialdehyde dehydrogenase deficiency (which can reason mental or physical impairment).

• To create certain sodium oxybate is safety for you, speak your doctor if you have:

· a breathing mess such as asthma, emphysema, or bronchitis;

· snoring, or sleep apnea (breathing stops during sleep);

· kidney or liver disease;

· heart malady, tall blood pressure;

· a history of alcohol or drug abuse;

· a history of depression or suicidal thoughts;

· mental diseases such as bipolar mess or schizophrenia; or

· if you are on a low-salt diet.

• You may need to be on a low-salt diet while you are using sodium oxybate, especially if you have tall blood pressure, kidney malady, or heart disease.

• Sodium oxybate may be habit forming. Never share sodium oxybate with other face, especially somebody with a history of drug abuse or addiction. Hold the medicine in a seat where others can't get to it.

• It is dangerous to try and purchase sodium oxybate on the Internet or from vendors external of the United States. The sale and distribution of sodium oxybate external of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safety use of this medication.

• FDA pregnancy category B. Sodium oxybate is not expected to harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant during treatment.

• It is not known whether sodium oxybate passes into breast milk or if it could harm a nursing child. Speak your doctor if you are breast-feeding a baby.

• Do not give this medicine to anyone under 18 years old without medical advice.

How must I take sodium oxybate?

• Follow all directions on your prescription label. Never take more than your predesigned doze of sodium oxybate. This medicine can slow your breathng. If you take too many, your breathing may stop.

• This medicine comes with patient instructions for safety and effective use. Follow these directions carefully. Do not let anyone else to use your medication.

• Take sodium oxybate on an empty stomach at least 2 hours after a meal. It is significant to take sodium oxybate at the same time every night.

• Sodium oxybate should be taken at bedtime and again two and a half to four hours later. This medication works very quick and must be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed. Seat the second doze following 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.

• Every doze of sodium oxybate should be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medicine. Both doses should be used within the same night. Throw away any sodium oxybate doze 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 each 3 months.

• Store at room temperature away from moisture and heat. After you have stopped using sodium oxybate, flush any unused medication down the toilet.

• Hold track of the amount of medication used from every new bottle. Sodium oxybate is a drug of abuse and you must be aware if anyone is using your medication improperly or without a prescription.

What happens if I miss a dose?

• Take the missed doze as soon as you remember, but only at bedtime or during your usual sleeping hours. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. An overdose of sodium oxybate can be fatal.

What must I avoid while taking sodium oxybate?

• Do not drink alcohol. Dangerous side effects or death may occur. Check your food and medication labels to be certain these commodity do not contain alcohol.

• Sodium oxybate will reason 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 before you are fully awake till you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

What are the possible side effects of sodium oxybate?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, 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;

· hallucinations (seeing or hearing things), severe confusion, seizure (convulsions);

· sleepwalking, waking and confused behavior at night;

· depression, agitation, unusual or unpleasant thoughts; or

· suicidal thoughts or actions;

• General side effects may include:

· dizziness, tremors;

· bed-wetting;

· nausea, vomiting; or

· diarrhea.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect sodium oxybate?

• Another drugs may interact with sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Speak every of your health care providers about all medicines you use now and any medication you start or stop using.

Where can I get more information?

• Your pharmacist can provide more information about sodium oxybate.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.