Libervant: Uses, Side Effects & Warnings

Generic name: Diazepam (buccal)

Pregnancy & Lactation: Risk data not available

What is Libervant?

Diazepam buccal is used in children 2 to 5 years old to occasionally treat a certain type of seizure that is different from their usual pattern. Diazepam buccal is not for long-term use.

Diazepam may also be used for purposes not listed in this medication guide.

Warnings

You should not use diazepam buccal if you are allergic to it or any of its ingredients, or if you have narrow-angle glaucoma.

Tell your doctor if you have or have ever had:

  • asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis or other breathing disorder;
  • open-angle glaucoma;
  • depression, a mood disorder, or suicidal thoughts or actions; or
  • kidney or liver disease.

Some people have thoughts about suicide while taking diazepam. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Diazepam buccal is not approved for use in children younger than 2 years old, children older than 5 years old, adults, and teenagers.

Do not give this medicine to a child without medical advice.

How should I use Libervant

Use Libervant (Buccal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Never use diazepam in larger amounts, or for longer than prescribed.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Diazepam doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

Read and carefully follow the Instructions for Use provided with your medicine. Your healthcare provider will show you how to properly give this medicine to a child and what type of seizures to give it for. Make sure you know how to recognize the signs of a seizure in the person you are caring for. Ask your doctor or pharmacist if you do not understand these instructions.

Diazepam buccal may be taken with or without food.

Do not split the diazepam buccal film or give with liquids. Allow the buccal film to dissolve in the child's mouth without chewing or swallowing.

Your child's doctor may prescribe up to 2 doses to treat a single seizure episode. If you need to give a second dose, it should be given 4 hours after the first dose. Do not give more than 2 doses per seizure episode.

Keep diazepam with you at all times and make sure you know what symptoms to watch for.

The caregiver should note when the dose was given and should watch the child closely to check their breathing, skin color, and condition. Do not give a second dose if your child's condition gets worse.

Do not give this medicine for more than 1 seizure episode every 5 days, or more than 5 episodes each month.

If your child spits the medicine out shortly after taking it, attempt to give another dose using a new film. If you are unable to give the dose, get emergency medical help.

You may have life-threatening withdrawal symptoms that may last for several weeks to more than 12 months if you stop using diazepam suddenly. Do not change or stop your dose without your doctor's advice.

Do not keep leftover medicine. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion. Just one dose can cause death in someone using it accidentally or improperly.

Store at room temperature away from moisture, heat, and light. Keep the medicine in the foil pouch until ready to use. Keep your medicine in a place where no one can use it improperly.

What should I do if I missed a dose of Libervant (Buccal)?

Diazepam buccal is used when needed and you are not likely to miss a dose. Call your doctor if the medicine is not effective.

Libervant side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, a sleeping pill, or use other medicines that cause drowsiness or slow breathing. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • severe drowsiness or dizziness;
  • unusual skin color;
  • trouble breathing;
  • confusion; or
  • new or worsening seizures.

Common side effects may include:

  • drowsiness; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Libervant?

Avoid drinking alcohol or alcohol containing products. Dangerous side effects or death could occur.

Avoid hazardous activities that could be life-threatening if you have an unexpected seizure and until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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