Sodium Oxybate Oral Solution 500 mg/mL (SODIUM OXYBATE SOLUTION - ORAL)

For narcolepsy.

Brand Name(s): Xyrem

Generic Name: Sodium Oxybate

Instructions

Mix each dose with 2 ounces (60 mL) of water.

Drink the medicine.

Take the medicine on an empty stomach.

Empty stomach means waiting at least 2 hours after a meal.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

If you take your medicine only at bedtime, do not take a missed dose in the morning.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine contains sodium. If you are on a low sodium diet, consider this as part of your total sodium diet.

If you have been told to follow a low sodium diet, speak to your doctor before using this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

This medicine can be habit-forming. If you use this medicine regularly for a long time, it can lead to withdrawal symptoms when you stop. Please use this medicine only as directed.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

It is very important that you carefully measure the amount of medicine you take. Your healthcare provider or pharmacist should show you the correct way to measure this medicine.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Family should check on the patient often. Call the doctor if patient becomes more depressed, has thoughts of suicide, or shows changes in behavior.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

The side effects may improve with continued use.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • bed wetting
  • diarrhea
  • dizziness or drowsiness
  • headaches
  • nausea and vomiting
  • stomach upset or abdominal pain
  • sweating

If you have any of the following side effects, you may be getting too much medicine. Please contact your doctor to let them know about these side effects.

  • seizures

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • agitated feeling or trouble sleeping
  • decreased awareness or responsiveness
  • inability to control bladder or bowel movements
  • breathing interruption during sleep
  • shallow, irregular breathing
  • fainting
  • hallucinations (unusual thoughts, seeing or hearing things that are not real)
  • mood changes
  • sleep walking

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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