Diazepam Gel, Rectal dy-AZ-e-pam

What are other names for this medicine?

Type of medicine: antiseizure; benzodiazepine

Generic and brand names: diazepam gel, rectal; Diastat; Diastat AcuDial

What is this medicine used for?

This medicine is a gel that is used in the rectum to control clusters of epileptic seizures in people who are already taking medicines to control seizures. The rectal gel helps people who cannot swallow pills after seizures. This medicine is available in child and adult sizes.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• breathing problems or lung disease such as asthma, pneumonia, or COPD
• depression
• glaucoma
• kidney disease
• liver disease

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not become pregnant during treatment with this medicine because it may harm the baby. If you become pregnant while using this medicine, contact your healthcare provider right away. Do not breast-feed while receiving this medicine.

How do I use it?

You cannot use this medicine to treat yourself. A caregiver must give the medicine. The caregiver must be able to tell the difference between a cluster seizure and an ordinary one.

Give this medicine exactly as your healthcare provider prescribes. Do not give more or less than prescribed. Read the information sheet that comes in the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand. If the caregiver does not feel comfortable deciding when to give the medicine, he or she should contact your healthcare provider.

This medicine is available in a prefilled syringe with a special plastic tip. The syringes should never be reused and must be discarded safely. Talk with your healthcare provider about proper disposal of the used syringe.

Before giving the medicine, make sure you can see the correct dose in the dose display window. 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 healthcare provider right away.

The caregiver must stay with you for 4 hours after the treatment. Someone needs to:

• Check for changes in your breathing or skin color.
• Watch for any side effects that need to be reported to your healthcare provider.
• Make sure the cluster seizure has stopped.

Your healthcare provider may prescribe a second dose to be given 4 to 12 hours after the first dose.

Continue to take other medicines for seizures unless your healthcare provider tells you otherwise.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness, confusion, muscle weakness, slurred speech, trouble breathing, coma.

What should I watch out for?

This medicine should not be used for more than one episode every 5Â days or for more than 5 episodes per month. If you think you need this medicine more often, talk with your healthcare provider.

This medicine will cause drowsiness. Do not drive or operate machinery until you are fully alert. Also, drinking alcohol will make you drowsier. Do not drink alcohol while you are taking this medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Carry some form of ID stating that you have seizures and are taking this medicine. If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away). If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Continued seizures, very slow breathing or trouble breathing, long periods of drowsiness, overexcitement, hallucinations, confusion, unusual thoughts or behavior.

Other: Dizziness, headache, nervousness, diarrhea, runny or stuffy nose, rash, flushing, stomach pain, lack of coordination, trouble sleeping, loss of appetite, nightmares.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, and rifampin (Rifadin, Rimactane)
• antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), protriptyline (Vivactil), and trimipramine (Surmontil)
• antifungals such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• anti-HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), and saquinavir (Invirase)
• antinausea medicines such as prochlorperazine and promethazine (Phenergan)
• antipsychotic medicines such as chlorpromazine, clozapine (Clozaril), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), risperidone (Risperdal), thioridazine, and trifluoperazine
• antiseizure medicines such as carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), and valproic acid (Depacon, Depakene, Depakote)
• barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), and phenobarbital
• benzodiazepines such as chlordiazepoxide (Librium), diazepam (Valium), lorazepam (Ativan), and triazolam (Halcion)
• bronchodilators such as aminophylline, dyphylline (Lufyllin), and theophylline
• conivaptan (Vaprisol)
• cyclosporine (Sandimmune, Gengraf, Neoral)
• dexamethasone
• heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia), nicardipine (Cardene), propranolol (Inderal), and quinidine
• hormonal birth control pills, patches, rings, or injections
• imatinib (Gleevec)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• modafinil (Provigil)
• muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• narcotic analgesics (painkillers) such as codeine, fentanyl (Duragesic, Actiq), hydrocodone (Vicodin, Lortab), meperidine (Demerol), oxycodone (OxyContin), oxycodone/acetaminophen (Percocet, Tylox), and pentazocine (Talwin)
• natural remedies such as gotu kola, kava, St. John's wort, and valerian
• paclitaxel (Taxol)
• sleeping pills such as eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien)
• stomach medicine such as cimetidine (Tagamet), lansoprazole (Prevacid), and omeprazole (Prilosec)
• warfarin (Coumadin)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.