Diastat AcuDial

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.

Read the Patient/Caregiver Information Leaflet provided by 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. Your pharmacist should set the correct dose and lock the syringe in the "ready" position before giving you the product. Before leaving the pharmacy, look at each syringe. The dose should be in the display window on the side. You should see a green band with the word "ready" at the bottom of the syringe barrel. 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.

This medication should not be used regularly. If you suddenly stop using this medication, you may have withdrawal symptoms (such as increased seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used diazepam for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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 your doctor has prescribed this medication because he or she 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. This medication stays in the body for a long time. 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.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. 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, discuss with your doctor right away the benefits and risks of using this medication during pregnancy.

This drug may pass into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, confusion, slow reflexes, slow/shallow breathing, fainting, loss of consciousness.

Not applicable.

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