Valproate Sodium (VAL-proe-ate SOE-dee-um)

Treats seizures.

Brand Name(s):

PremierPro Rx Valproate Sodium, Valproate Sodium Novaplus

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to stay in place for at least 60 minutes.
• A nurse or other health provider will give you this medicine.
• You may be given a few doses of this medicine until your condition improves, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
• Your doctor may also give you other medicines (including folic acid supplements), especially before and during the first 3 months of pregnancy, to prevent serious unwanted effects to your unborn baby.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how valproate sodium works. Tell your doctor if you are using any of the following:
  • Amitriptyline, aspirin, chlorpromazine, clonazepam, diazepam, lorazepam, nortriptyline, rifampin, ritonavir, propofol, rufinamide, tolbutamide, zidovudine
  • Birth control pill
  • Blood thinner (including warfarin)
  • Carbapenem antibiotic (including ertapenem, imipenem, meropenem)
  • Other seizure medicine (including carbamazepine, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, primidone, topiramate)
• Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used together with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, blood disease, pancreas problems, a viral infection (including HIV or cytomegalovirus infection), or head trauma.
• This medicine may cause the following problems:
  • Liver problems
  • Pancreatitis (swelling of the pancreas)
  • Bleeding problems (including thrombocytopenia)
  • Hyperammonemic encephalopathy (high levels of ammonia in the blood)
  • Hypothermia (low body temperature)
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which may damage organs, including the liver, kidney, or heart
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Confusion, problems with memory, unusual drowsiness, clumsiness
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Fever, rash, swollen glands in the neck, armpit, or groin
• Sudden and severe stomach pain, nausea, vomiting
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach upset
• Hair loss
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness, sleepiness
• Trouble sleeping, tremor
• Vision changes, dizziness, headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088