Diazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen).

Diazepam rectal (for use in the rectum) is used to treat occasionally increased seizures (cluster seizures) in people with epilepsy who also take other seizure medicines. Diazepam rectal is not for long-term daily use to prevent seizures.

Diazepam rectal may also be used for purposes not listed in this medication guide.

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not stop using diazepam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using diazepam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

This medicine is not for all types of seizures. If you are a caregiver, do not give this medicine unless you know how to recognize a seizure that should be treated with diazepam rectal.

Diazepam comes as a gel to instill rectally using a prefilled syringe with a special plastic tip. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Before diazepam rectal gel is prescribed, the doctor will talk to 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 rectal gel.

Diazepam rectal gel is not meant to be used on a daily basis. Diazepam rectal gel 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 rectal gel more often than this, talk to your doctor.

1. Put the person having seizures on his/her side in a place where he/she cannot fall.
2. Remove the protective cover from the syringe by pushing it up with your thumb and then pulling it off.
3. Put lubricating jelly on the rectal tip.
4. Turn the person on his/her side facing you, bend his/her upper leg forward, and separate his/her buttocks to expose the rectum.
5. Gently insert the syringe tip into the rectum until the rim is snug against the rectal opening.
6. Slowly count to 3 while pushing in the plunger until it stops.
7. Slowly count to 3 again, and then remove the syringe from the rectum.
8. Hold the buttocks together so the gel doesn't leak from the rectum, and slowly count to 3 before letting go.
9. Keep the person on his/her side. Take note of what time diazepam rectal gel was given, and continue to watch the person.
10. To dispose of the remaining diazepam gel, remove the plunger from the syringe body and point the tip over a sink or toilet. Insert the plunger into the syringe and gently push it to release the medication into the toilet or sink. Then flush the toilet or rinse the sink with water until the diazepam gel is no longer visible. Discard all used materials in the trash away from children and pets.

• seizures continue for 15 minutes after diazepam rectal gel was given (or follow the doctor's instructions).
• the seizures seem different or worse than usual.
• you are worried about how often seizures are happening.
• you are worried about the skin color or breathing of the person with seizures.
• the person is having unusual or serious problems.

Ask your pharmacist or doctor for a copy of the manufacturer's administration instructions.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use diazepam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Diazepam rectal is usually given by a caregiver to the person having a seizure. Be sure a responsible household member knows where the medicine is and how to give it to you.

Diazepam rectal is not for all types of seizures. Do not give this medicine unless you know how to recognize the symptoms of a seizure episode that should be treated with diazepam rectal.

After giving diazepam rectal to another person, stay with the person for at least 4 hours. Watch for changes in breathing or any other side effects.

Get emergency medical help if:

• the seizure has not stopped within 15 minutes;

• the seizure is different from the person's usual seizures;

• the seizures are closer together or more severe than the person's usual seizures; or

• the person has breathing problems, pale or blue-colored skin, or any other serious problems.

Diazepam doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Use all seizure medications as directed and read all medication guides you receive. Do not stop using diazepam without asking your doctor. You may have increased seizures or life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Call your doctor if this medicine seems to stop working as well in treating seizures.

Do not use diazepam rectal for long-term daily use to prevent seizures or your seizures could get worse or happen more often. You should not use this medicine more than 5 times in 1 month, or to treat more than 1 episode every 5 days.

Store at room temperature away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

After giving a dose of diazepam rectal, empty the syringe into a toilet and flush, or into a sink and rinse down the drain. Do not reuse the syringe. Throw it away where children and pets cannot get to it.

You should not use diazepam rectal if you are allergic to diazepam (Valium). You may not be able to use diazepam rectal if you have glaucoma.

Tell your doctor if you have ever had:

• glaucoma;

• asthma, pneumonia, or other breathing disorder;

• liver or kidney disease;

• a drug or alcohol addiction; or

• depression, a mood disorder, or suicidal thoughts or behavior.

May harm an unborn baby. Tell your doctor if you are pregnant. If you use diazepam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not start or stop seizure medication during pregnancy without your doctor's advice. Diazepam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

You should not breastfeed while using diazepam rectal, and for a short time after you stop using it. Ask your doctor when you can start breastfeeding again.

Not approved for use by anyone younger than 2 years old.

Diazepam rectal is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include drowsiness, confusion, muscle weakness, or loss of consciousness.

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). Talk to your pharmacist about the proper disposal of your medication.

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. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medicine.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how diazepam rectal will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if the person receiving diazepam rectal has:

• new or worsening seizures;

• unusual changes in mood or behavior;

• thoughts of suicide or hurting yourself;

• confusion, hallucinations;

• sleep problems; or

• anxiety, excitement, anger, or feeling restless.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of diazepam rectal may include:

• drowsiness, dizziness, headache, feeling nervous;

• problems with coordination or muscle movement;

• flushing (sudden warmth, redness, or tingly feeling);

• stomach pain, diarrhea; or

• rash.

After you stop using diazepam, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using diazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect diazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor. Your doctor will need to examine you about every 6 months to check if your dose of diazepam rectal should be changed.

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 use 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.