Libervant 10 mg buccal film

Generic name:
Diazepam film - buccal

Pronunciation
(dye-AZ-e-pam)

Brand name(s)
Libervant

Diazepam has a risk for abuse and addiction, which can lead to overdose and death. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your child's risk, the doctor should have you use the smallest dose of diazepam that works, and use it for the shortest possible time. Be sure you know how to use diazepam and what other drugs your child should avoid taking with it. See also Drug Interactions section. Get medical help right away if your child has any of these very serious side effects: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

This medication should not be used regularly. If your child uses it regularly, suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if they have used it for a long time or in high doses. To prevent withdrawal, the doctor may lower the dose slowly. Tell the doctor or pharmacist right away if your child has any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures that will not stop. Withdrawal symptoms may sometimes last weeks to months.

This form of diazepam is given to children with epilepsy to treat a certain type of serious seizure that doesn't stop (seizure clusters). Diazepam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.

See also Warning section.

Read the Medication Guide and Instructions for Use provided by the pharmacist before your child starts diazepam and each time you get a refill. Be sure to keep this medication handy in case it is needed. Learn ahead of time how to properly use this medication. Caregivers should learn when this medication should be used and what to watch for after using this medication. If there are any questions, ask the doctor or pharmacist.

This medication is given by mouth with or without food as directed by the doctor. Do not give with any liquids. The dosage is based on your child's weight and response to treatment.

Remove the diazepam film from the foil package only when you are ready to use it. Do not cut the film. Make sure your hands are clean and dry before touching the film. Stretch your child's mouth open with one hand. With the other hand, place one film flat inside either cheek. Do not rub the film into the cheek. Do not place the film on the teeth. The film should stay in place on its own after this. Leave it in place until it is dissolved. The film should not be chewed or swallowed whole. If your child spits or blows out the film right away, you may give a new film.

In some cases, a second dose may be prescribed and given at least 4 hours after the first dose. Do not use more than 2 doses to treat a seizure cluster episode.

Do not use this product to treat episodes more often than once every 5 days, or more than 5 times in a month. Doing so may make this medication stop working well. Your child's seizures may get worse or happen more often. Talk with the doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if your child has a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask the doctor or pharmacist for more details.

Get emergency help right away if your child's seizures last or get worse after using the medication as directed, if you are unable to give the medication, or if there is a change in your child's breathing, coloring, behavior, or condition that alarms you.

See also Warning section.

Drowsiness or headache may occur. If either of these effects lasts or gets worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including:

• uncontrolled movements (such as shaking/tremor)

Get medical help right away if your child has any very serious side effects, including:

• slow/shallow breathing
• unusual drowsiness/difficulty waking up

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell the doctor right away if there are any unusual/sudden changes in your child's mood, thoughts, or behavior such as signs of depression, suicidal thoughts/attempts, thoughts about harming themselves.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call the doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call the doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before giving diazepam, tell the doctor or pharmacist if your child is allergic to it; or to other benzodiazepines (such as lorazepam); or if they have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

• glaucoma
• breathing problems (such as chronic obstructive lung disease-COPD, asthma)
• mental/mood disorders (such as depression, thoughts of suicide, psychosis)

This drug may make your child feel dizzy or drowsy. Do not let them ride a bicycle, drive, use machinery, or do anything that needs alertness until your child can do it safely.

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

See also Warning section.

Drug interactions may change how your child's medications work or increase their risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

A product that may interact with this drug is:

• sodium oxybate

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell the doctor or pharmacist if your child is using other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your child's medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask the pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: confusion, slow/shallow breathing, coma.

Do not share this medication with others. Sharing it is against the law.

Not applicable.

Store at room temperature away from light and moisture in the foil packaging. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult the pharmacist or local waste disposal company.

Your child's condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.