Sodium Oxybate oral solution

What is this medicine?

SODIUM OXYBATE (SOE dee um OX i bate) is used to treat excessive sleepiness and cataplexy in patients with narcolepsy. Cataplexy causes a sudden muscle weakness due to a strong emotional response.

This medicine may be used for other purposes; ask your healthcare provider or pharmacist if you have questions.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Mix the dose with water as directed. Take this medicine on an empty stomach, at least 2 hours after food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 7 years for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• anxiety

• breathing problems

• confusion

• hallucinations

• seizures

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• sleepwalking

• suicidal thoughts, mood changes

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bedwetting

• dizziness

• drowsiness

• headache

• loss of appetite

• nausea

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alcohol

• medicines for sleep

This medicine may also interact with the following medications:

• antihistamines for allergy, cough, and cold

• certain medicines for depression, like amitriptyline, fluoxetine, sertraline

• certain medicines for seizures like phenobarbital, primidone

• divalproex sodium

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• medicines that relax muscles for surgery

• narcotic medicines for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• valproate or valproic acid

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet or empty down the sink drain to reduce the chance of harm. Do not use the medicine after the expiration date.

After preparing a dose of this medicine with water, the medicine should be taken within 24 hours or emptied down the sink drain.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• diet low in salt

• heart disease

• high blood pressure

• history of drug or alcohol abuse problem

• if you drink alcohol

• kidney disease

• liver disease

• lung or breathing disease, like sleep apnea

• mental illness

• succinic semialdehyde dehydrogenase deficiency

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to oxybate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse. This medicine has a risk of abuse and dependence. Your health care provider will check you for this while you take this medicine.

You may get drowsy or dizzy. This medicine causes sleep very quickly. You should only take your first dose at bedtime, while in bed. The second dose should be taken 2.5 to 4 hours after your first dose. Do not drive, use machinery, or do anything that needs mental alertness for at least 6 hours after taking this drug. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

After taking this medicine, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening. Do not take it if you have taken another medicine for sleep. The risk of doing these sleep-related activities is higher.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your healthcare professional right away.