Diazepam (Rectal)

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 may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to 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.

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

Introduction

Diazepam (dye-AZ-e-pam)

Treats a type of seizure called "cluster seizures" in people who have epilepsy. This medicine is used together with other medicines for seizures. This medicine is a benzodiazepine.

Brand Name(s)

Diastat AcuDial, Diastat Pediatric, Diastat

When This Medicine Should Not Be Used

How to Use This Medicine

Gel/Jelly

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• 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.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Flush all leftover medicine down the toilet after you have finished your treatment. Also flush old medicine after the expiration date has passed. This medicine is one of only a few medicines that should be disposed of this way. Ask your pharmacist about the best way to dispose of the used medicine applicator and container.
• Keep all medicine away from children and never share your medicine with anyone.

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 are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

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.