This medication is used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment of seizure attacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus).

This medication is not recommended for children younger than 6 months of age because of the risk of serious side effects.

Diazepam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.

See also Warning section.

Read the Patient/Caregiver Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This drug is given rectally by a caregiver trained to recognize the difference between your cluster and ordinary seizures. You and your caregiver must be comfortable with following all instructions from your doctor, pharmacist, and the product package. Be sure you understand when this medication should be used, how to use it, and how to check for side effects/seizure control.

Before using, check the syringe for the correct dose. For some brands, your pharmacist should set the correct dose and lock the syringe in the "ready" position before giving you the product. For those brands, check to see if the correct dose is in the display window and the word "ready" is at the bottom of the syringe barrel. Also, for all products, look to make sure you have the correct syringe tip (for example, a smaller tip for a child) and that there are no cracks around the syringe tip. Return the product to the pharmacist if there is a problem or if you have any questions.

Cracks can cause the medication to leak out and not provide the correct amount of medication. If you see a crack, use a different syringe. Cracks can appear over time, so keep checking your syringes to make sure you have good ones ready to use.

The dosage is based on age, weight, medical condition, and response to treatment. In some cases, a second dose may be prescribed and given 4 to 12 hours after the first dose. Usually, this medication should not be used to treat more than 5 episodes per month and no more than one episode every 5 days. Do not stop taking your regular seizure control medications when you are given this drug.

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

Get emergency help right away if seizures continue after using this product (for example, no change 15 minutes after the dose is given), or if there is a change in the person's breathing, coloring, behavior, or condition that alarms you.

See also Warning section.

Drowsiness, dizziness, or unsteadiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Stay with the patient for at least 4 hours after giving the medication and watch for any side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as anxiety, restlessness, hallucinations)
• trouble speaking
• trouble walking

Get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing

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 your doctor or pharmacist.

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

Before using diazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as oxazepam, temazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain muscle disease (myasthenia gravis)
• lung/breathing problems (such as asthma, pneumonia, COPD, sleep apnea)
• mental/mood disorders (such as depression, thoughts of suicide, psychosis)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• glaucoma
• brain problems that could affect breathing (such as decreased consciousness, head injury)
• kidney disease
• liver disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and loss of coordination. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Warning section.

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

Some products that may interact with this drug include:

• clozapine
• fluvoxamine
• 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 your doctor or pharmacist if you are taking 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 medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medicine may be harmful if swallowed. 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: severe drowsiness, confusion, slow reflexes, slow/shallow breathing, fainting, loss of consciousness.

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

Not applicable.

Store at room temperature. 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. For more details, read the Patient/Caregiver Information Leaflet, or consult your pharmacist or local waste disposal company.

Your 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).