Valproate Sodium Solution for injection

What is this medicine?

VALPROATE SODIUM (val PRO ate SO dee um) is used to treat certain types of seizures in patients with epilepsy.

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:

• blood disease
• brain damage or disease
• kidney disease
• liver disease
• low blood proteins
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• urea cycle disorder (UCD)
• an unusual or allergic reaction to divalproex sodium, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

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?

This does not apply.

What may interact with this medicine?

• aspirin
• barbiturates, like phenobarbital
• diazepam
• isoniazid
• medicines for depression, anxiety, or psychotic disturbances
• medicines that treat or prevent blood clots like warfarin
• meropenem
• other seizure medicines
• rifampin
• tolbutamide
• zidovudine

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?

Your condition will be monitored carefully while you are receiving this medicine.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

This medicine can cause blood problems. This can mean slow healing and a risk of infection. Problems can arise if you need dental work, and in the day to day care of your teeth. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional 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
• changes in vision
• changes in the frequency or severity of seizures
• nausea, vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• stomach pain or cramps
• trembling of hands or arms
• unusual bleeding or bruising or pinpoint red spots on the skin
• unusual swelling of the arms or legs
• unusually weak or tired
• worsening of mood, thoughts or actions of suicide or dying
• yellowing of the eyes or skin

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

• change in menstrual cycle
• diarrhea or constipation
• headache
• loss of bladder control
• loss of hair or unusual growth of hair
• loss or increase in appetite
• weight gain or loss

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?

This drug is given in a hospital or clinic and will not be stored at home.

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.

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.