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Valproate Sodium (Injection) (Injectable)

(NOVAPLUS VALPROATE SODIUM)
Valproate Sodium (By injection)
Valproate Sodium (VAL-proe-ate SOE-dee-um)Treats seizures.
Depacon , Novaplus Valproate Sodium , PremierPro RX Valproate Sodium

When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to divalproex, valproate sodium, or valproic acid, if you are pregnant, or if you have liver disease or certain genetic disorders (such as urea cycle disorder or mitochondrial disorder).

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.
  • A nurse or other health provider will give you this medicine.

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 also use the following:
    • Amitriptyline, aspirin, clonazepam, diazepam, nortriptyline, rifampin, ritonavir, rufinamide, tolbutamide, zidovudine
    • Carbapenem antibiotic (including ertapenem, imipenem, meropenem)
    • Blood thinner (including warfarin)
    • 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 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, a blood disease, or pancreas problems.
  • This medicine may cause the following problems:
    • Liver problems
    • Pancreatitis
    • Thrombocytopenia (decrease in blood cells that affect clotting)
    • 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 such as the liver, kidney, or heart
  • This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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, or 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
  • Unusual bleeding, bruising, or weakness

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

  • Diarrhea, stomach upset
  • 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