Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb) 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 is not available in retail pharmacies. Your doctor will enroll you in a program that will provide the drug to you.

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

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, psychosis, or other mood disorders

• heart disease or high blood pressure

• if you are on a salt-restricted diet

• if you frequently drink alcohol containing beverages

• if you have a history of drug or alcohol abuse

• kidney disease

• liver disease

• lung or breathing disease, like sleep apnea

• seizures

• 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 sodium oxybate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Take this medicine on an empty stomach, or at least 2 hours after food. Do not take with food. Do not take your medicine more often than directed.

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. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Skip the missed dose. If it is almost time for your next dose, take only that dose. Allow at least two and one-half hours between each nightly dose. Do not take double or extra doses.

What may interact with this medicine?

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

• alcohol

• barbiturates, like phenobarbital

• medicines used for sedation or to help you sleep

This medicine may also interact with the following medications:

• bupropion

• divalproex sodium

• dronabinol

• marijuana

• medicines for depression, anxiety, or psychotic disturbances

• muscle relaxants

• other stimulants, although these are commonly used with sodium oxybate

• prescription pain medicines, including tramadol

• valproate or valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

The use of this medicine requires careful supervision. Visit your doctor or health care professional for regular checks on your progress. Do not suddenly stop taking this medicine if you have been taking it for a long time. Withdrawal symptoms may occur. Your doctor or health care professional may need to slowly stop your doses.

This medicine may affect your concentration or function. Let your doctor or health care professional know if you have increased sleepiness or confusion during the day.

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 a car, operate heavy machinery or perform any activities that require mental alertness for at least 6 hours after taking this drug. Use extreme care in any such daily activities until you know how this medicine affects you.

Because alcohol may interfere with this medicine and may cause serious side effects, you must avoid alcohol-containing beverages while on this medicine. Do not take this medicine along with sleep medicines or other drugs with strong sedative effects, serious side effects may occur.

This medicine can be dangerous in overdose. If you take more than prescribed or take it by accident, get emergency medical help right away.

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

• breathing problems

• changes in alertness

• confusion

• fast, irregular heartbeat

• hallucination, loss of contact with reality

• increased blood pressure, particularly if you already have high blood pressure

• memory loss

• seizures

• sleepwalking

• tremors or shaking movements

• unusual changes in emotions or moods

• urinary incontinence

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

• diarrhea

• dizziness

• drowsiness

• headache

• increased urination

• nausea, vomiting or stomach upset

• unusual dreams

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children. This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. 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.

Dispose of properly. Empty any unused medicine down the sink drain, then cross out the label on the medicine bottle with a marker and place the empty bottle in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.