Diazepam Rectal Gel

What is this medication?

DIAZEPAM (dye AZ e pam) treats seizures. Call emergency services right away if seizures do not stop. You may need additional treatment. It works by helping your nervous system calm down. It belongs to a group of medications called benzodiazepines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Diastat

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Glaucoma
• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Mental health conditions
• Myasthenia gravis
• Sleep apnea
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to diazepam, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for rectal use only. Do not give it by mouth. Give it as directed on the prescription label. Do not use more often than directed. Check that the correct dose and green "ready" band are visible on the syringe before use is needed. If you do not see the correct dose or the green "ready" band on the syringe, do not use it. Contact your pharmacist or care team for help.

Wash your hands before and after use. Lubricate the tip of the syringe. Lie the patient on their side with their lower leg straightened out and their upper leg bent forward toward their stomach. Lift upper buttock to expose the rectal area. Gently insert the syringe tip into the rectum and push the plunger slowly until it stops. Wait 3 seconds before removing the syringe. Hold buttocks together for 3 seconds. Keep the patient on their side. Observe the patient for 4 hours.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

Do not take this medication with any of the following:

• Sodium oxybate

This medication may also interact with the following:

• Alcohol
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Opioids for pain or cough
• Other benzodiazepines
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Some antihistamines
• Some medications for depression, such as amitriptyline or trazodone
• Some medications for seizures, such as phenobarbital or primidone
• Supplements, such as green tea, melatonin, St. John's wort, valerian

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Call emergency services if your seizures do not stop after you use this medication.

There is a risk of abuse, misuse, and addiction with this medication. It is important to take this medication as directed by your care team.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication is a CNS depressant. This is a type of medication or substance that slows down your brain and nervous system. Taking it with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, alcohol, and street drugs. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake.

This medication is used to treat higher than usual seizure activity. It is not for daily use. If you have taken this medication for a long time or take a high dose, your body may rely on it. Stopping it suddenly may cause a severe reaction. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects.

This medication may worsen depression and cause thoughts of suicide. This can happen at any time but is more common after first starting treatment and after a change in dose. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Headache
• Rectal pain, burning, or bleeding after use

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it, or it is expired. To get rid of this medication:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
• If other options are not available, remove the medication from the syringe. Flush it down the toilet or rinse it down the sink until it is no longer visible.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.