Diazepam Rectal Gel

What is this medication?

DIAZEPAM (dye AZ e pam) treats seizures. 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, like asthma
• Suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to diazepam, other benzodiazepines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for rectal use only. Do not give it by mouth. Use it as directed on the prescription label. 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 rectal tip of the syringe. Lie the patient on their side with the lower leg straightened out and the upper leg bent forward toward the 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. Do not use more often than directed.

Talk to your care team regarding the use of this medication in children. While this medication 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:

• Narcotic medications for cough
• Sodium oxybate

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain antibiotics like clarithromycin, erythromycin, rifampin
• Certain medications for anxiety or sleep
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, like amitriptyline, fluoxetine, sertraline, tranylcypromine
• Certain medications for fungal infections like ketoconazole, itraconazole, clotrimazole
• Certain medications for psychotic disturbances
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone, valproate
• Cimetidine
• Cyclosporine
• Dexamethasone
• General anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Omeprazole
• Paclitaxel
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Theophylline
• Warfarin

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 right away if seizures do not stop.

Visit your care team for regular checks on your progress.

Do not stop taking this medication except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication.

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.

If you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have problems breathing or unusual sleepiness.

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

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

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
• Rectal pain, burning, or bleeding after use
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

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

• Dizziness
• Drowsiness
• Headache

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. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away 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. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.