Diazepam Buccal

Diazepam buccal may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use diazepam buccal with any medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: 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 seek treatment on your own.

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. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with diazepam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness. Also tell your doctor if you or your child has or has ever had depression or another mental illness.

Diazepam buccal may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or used in smaller doses), especially if you use it more frequently than recommended. Do not stop using this medication or use fewer doses without talking to your doctor. Stopping diazepam buccal suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your diazepam buccal dose gradually. 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.

Diazepam buccal is used for emergency situations to stop cluster seizures (episodes of increased seizure activity) in children 2 to 5 years of age who are taking other medications to treat epilepsy (seizures). Diazepam is in a class of medications called benzodiazepines. It works by calming unusual activity in the brain.

Diazepam buccal comes as a film to apply inside of the cheek. It is used when needed, according to your doctor's directions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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 an initial 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.

Diazepam buccal is not meant to be used on a daily basis. Diazepam buccal should not be used more than 5 times a month or more often than every 5 days. If you or your caregiver think that you need diazepam buccal more often than this, talk to your doctor.

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.

To use diazepam buccal film, remove the film from the foil pouch with clean dry hands and place the film inside the cheek. The film will stick in place. Leave the film in place until it dissolves completely. Your child's mouth can be closed or open. Do not drink anything until the film dissolves completely.

Do not chew or swallow the buccal film. However, 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, give another dose using a new buccal film. Call your doctor or get emergency medical treatment if another dose cannot be given.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using diazepam buccal,

• tell your doctor and pharmacist if you are allergic to diazepam, any other medications, or any of the ingredients in diazepam buccal. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• The following nonprescription or herbal products may interact with diazepam buccal: 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 for the treatment of epilepsy. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as diazepam to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk 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. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should 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 seek treatment on your own.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Diazepam buccal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• headache
• diarrhea
• unsteadiness
• lack of coordination
• abnormal 'high' mood
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• problems falling asleep or staying asleep
• trouble breathing
• changes in skin color
• rage
• hallucinations (seeing things or hearing voices that do not exist)

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).

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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
• slow reflexes

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. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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