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

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

Diastat Pediatric 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 Diastat Pediatric.

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.

Diastat Pediatric 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.

Diastat Pediatric 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 this medicine.

After giving Diastat Pediatric 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 Diastat Pediatric 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 Diastat Pediatric if you are allergic to diazepam (Valium). You may not be able to use Diastat Pediatric 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 Diastat Pediatric, 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.

Diastat Pediatric 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.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how Diastat Pediatric 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 Diastat Pediatric 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 Diastat Pediatric 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.