Diazepam (dye-AZ-e-pam)

Treats seizures (including seizure clusters, acute repetitive seizures) in patients who have epilepsy.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly, Kit

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Never take rectal medicine by mouth.
• This medicine is not to be used every day. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
• If a second dose is needed, use it at least 4 to 12 hours after the first dose.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions. This medicine will need to be given to you while you are having a seizure. A family member or other caregiver will give the medicine to you, since you will be unable to give it to yourself. It is very important for your caregiver to understand how and when to use this medicine.
• This medicine comes in a prefilled plastic applicator. Remove the cap from the prefilled applicator before inserting it. To make the applicator easier to insert, use the lubricating gel that comes with the medicine.
• Before using the Diastat® Acudial™ syringe, make sure you can see the prescribed dose in the dose display window and that it is correct. Also, look for the green "ready" band on the syringe before inserting it. If the dose is not correct, or if the green band is not on the syringe, call your doctor or pharmacist right away.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how diazepam works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cimetidine, clotrimazole, cyclosporine, dexamethasone, imipramine, ketoconazole, omeprazole, paclitaxel, phenobarbital, phenytoin, propranolol, quinidine, rifampin, terfenadine, theophylline, tranylcypromine, troleandomycin, valproate, warfarin
  • Medicine to treat depression, including MAO inhibitor
  • Phenothiazine medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later part of a pregnancy may cause problems in your newborn baby (including sedation or withdrawal symptoms). Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding or planning to breastfeed. This medicine passes into your breast milk and may cause problems in your baby. Talk to your doctor about the best way to feed your baby.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, open angle glaucoma, or a history of drug or alcohol problems.
• This medicine may cause the following problems:
  • Increased risk of overdose, which can be life-threatening
  • Respiratory depression (serious breathing problem that can be life-threatening), when used with narcotic pain medicines
  • Unusual thoughts or behavior
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin, trouble breathing, fast or slow heartbeat
• Change or loss of consciousness, confusion, dizziness, faintness, lightheadedness, problems with coordination or walking, sleepiness or unusual drowsiness
• Seizures
• Unusual mood or behavior, trouble sleeping

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea, vomiting, diarrhea, loss of appetite, stomach pain
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088