Diazepam buccal may cause serious or life-threatening breathing problems, drowsiness, or coma if used along with certain medications. Tell your doctor if you are taking or planning to take medications for cough or for pain. Call your doctor immediately or seek emergency medical care if you experience: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to do so.
Diazepam buccal may be habit forming. Do not use a larger dose, use it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you or your child has or has ever had depression or another mental illness.
Do not stop using this medication or use fewer doses without talking to your doctor. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) and instructions for use when you begin treatment with diazepam buccal and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ) or the manufacturer's website to obtain the Medication Guide.Talk to your doctor about the risks of using diazepam buccal.
Why is this medicine prescribed?
Diazepam buccal is used for emergency situations to control a certain type of seizure. Diazepam is in a class of medications called benzodiazepines. It works by calming unusual activity in the brain.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Diazepam buccal comes as a film to apply to inside of the cheek. Use when needed, according to your doctor's directions.
Use diazepam buccal exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Before diazepam buccal is prescribed, the doctor will talk to you and your caregiver about how to recognize signs of the type of seizure activity that should be treated with this medication. Your caregiver will also be taught how to administer the buccal film.
If your seizure does not respond to the first dose of diazepam buccal, your doctor may tell you to use a second dose at least 4 hours after the first dose. Follow your doctor's directions for using a second dose.
To use diazepam buccal film, remove the film from the foil pouch with clean dry hands and place the film inside the cheek. Leave the film in place until it dissolves completely. The mouth can be closed or open. Do not drink anything until the film dissolves completely.
Do not chew or swallow the buccal film. If the film is accidentally swallowed or chewed, do not apply a new buccal film. If the buccal film is spit out or blown out of the mouth immediately after it is applied in the cheek, use a new buccal film. Call your doctor or get emergency medical treatment if another dose cannot be given.
Keep diazepam buccal with you or available at all times so that you will be able to use it to control your seizures when they occur.
Diazepam buccal should not be used more than 5 times a month or more often than every 5 days. If you think that you need diazepam buccal more often than this, talk to your doctor.
What special precautions should I follow?
Before using diazepam buccal,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking while taking diazepam. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- the following nonprescription or herbal products may interact with diazepam buccal: allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine), cimetidine, omeprazole, St. Johns's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using diazepam buccal. Do not start any of these medications while using diazepam buccal without discussing with your healthcare provider.
- tell your doctor if you have glaucoma (a serious eye condition that may cause loss of vision). Your doctor may tell you not to use diazepam buccal.
- tell your doctor if you have or have ever had lung problems such as asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, or pneumonia; or liver or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using diazepam buccal, call your doctor.
- you should know that this drug may make you drowsy. Do not drive a car, operate machinery, or ride a bicycle until you know how this medication affects you.
- you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are using diazepam buccal. There is a chance that you may experience changes in your mental health if you take an anticonvulsant medication such as diazepam, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. Call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to do so.
- talk to your doctor about the safe use of alcoholic beverages during your treatment with diazepam buccal. Alcohol can make the side effects of diazepam buccal worse.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- drowsiness, confusion
- coma
- unsteadiness, slow reflexes
What side effects can this medicine cause?
Diazepam buccal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- headache
- diarrhea
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
- rash
Diazepam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor.
If you have symptoms that are different from your usual seizures, you or your caregiver should call your doctor immediately.
Do not let anyone else take your medication. Diazepam buccal is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.