When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to diazepam, or if you are pregnant or you have narrow-angle glaucoma.

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. After you use the medicine for a seizure, it is best to wait at least 5 days before using it again. Do not use this medicine for more than 5 seizures per month, unless your doctor tells you to.
• 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. Read and follow the patient/caregiver instructions carefully. Ask your doctor or pharmacist if you or your caregiver have any questions.
• 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.

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

• Make sure your doctor knows if you are also using other medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, valproate, Depakene®, Dilantin®, Tegretol®), phenothiazine medicines (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®), an MAO inhibitor (such as tranylcypromine, Eldepryl®, Marplan®, Nardil®, Parnate®), or medicine for depression (such as amitriptyline, Effexor®, Paxil®, Zoloft®).
• Tell your doctor if you are also using cimetidine (Tagamet®), quinidine, ketoconazole (Nizoral®), troleandomycin (Tao®), clotrimazole (Femcare®), rifampin (Rimactane®), dexamethasone (Decadron®), omeprazole (Prilosec®), propranolol (Inderal®), imipramine (Tofranil®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), paclitaxel (Taxol®), terfenadine (Seldane D®), theophylline (Theo-Dur®), or a blood thinner such as warfarin (Coumadin®).
• 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:

• Make sure your doctor knows if you are pregnant or may become pregnant. Using this medicine during pregnancy could affect your unborn baby. However, it may be important for you to use this medicine to control your seizures during pregnancy. Carefully follow your doctor's instructions. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, breathing problems, glaucoma, or a history of drug or alcohol problems.
• This medicine should be used only for the specific kind of cluster seizure for which it was prescribed. Do not use this medicine for any other type of seizure.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• 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.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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
• Increased energy, anxiety, nervousness, anger, or muscle spasms.
• Seeing, hearing, or feeling things that are not there.
• Severe confusion, drowsiness, or muscle weakness.
• Severe nausea or vomiting, stomach pain, or increased sweating.
• Tremors or muscle cramps.
• Trouble breathing.
• Trouble sleeping.
• Unusual or increased seizure symptoms or a seizure that does not stop.

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

• Clumsiness or dizziness.
• Diarrhea.
• Headache.
• Skin rash or itching.

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