Diazepam Rectal (patient information)

Why this medication is prescribed

Diazepam rectal is used in emergency situations to stop cluster seizures (episodes of increased seizure activity) in people who are taking other medications to treat epilepsy (seizures). Diazepam rectal is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.

How this medication should be used

Diazepam comes as a gel to instill rectally using a prefilled syringe with a special plastic tip. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Before diazepam rectal gel is prescribed, the doctor will talk to your caregiver about how to recognize signs of the type of seizure activity that should be treated with this medication. Your caregiver will also be taught how to administer the rectal gel.

If used regularly, diazepam may be habit forming. Do not use a larger dose than your doctor tells you to. Diazepam rectal gel is not meant to be used on a daily basis. Diazepam rectal gel should not be used more than five times a month or more often than every 5 days. If you or your caregiver think that you need diazepam rectal more often than this, talk to your doctor.

Directions for the caregiver to administer the rectal gel:

1. Put the person having seizures on his/her side in a place where he/she cannot fall.
2. Remove the protective cover from the syringe by pushing it up with your thumb and then pulling it off.
3. Put lubricating jelly on the rectal tip.
4. Turn the person on his/her side facing you, bend his/her upper leg forward, and separate the his/her buttocks to expose the rectum.
5. Gently insert the syringe tip into the rectum until the rim is snug against the rectal opening.
6. Slowly count to 3 while pushing in the plunger until it stops.
7. Slowly count to 3 again, and then remove the syringe from the rectum.
8. Hold the buttocks together so the gel doesn't leak from the rectum, and slowly count to 3 before letting go.
9. Keep the person on his/her side. Take note of what time diazepam rectal gel was given, and continue to watch the person.

After administering the rectal gel, the caregiver should watch the person with seizures carefully. If any of the following occur, call 911:

• seizures continue for 15 minutes after diazepam rectal gel was given (or follow the doctor's instructions).
• the seizures seem different or worse than usual.
• you are worried about how often seizures are happening.
• you are worried about the skin color or breathing of the person with seizures.
• the person is having unusual or serious problems.

Ask your pharmacist or doctor for a copy of the manufacturer's administration instructions.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before using diazepam rectal gel:

• tell your doctor and pharmacist if you are allergic to diazepam (Valium) or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antidepressants ('mood elevators') including fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil),nefazodone,sertraline (Zoloft), and tranylcypromine (Parnate);antihistamines; aprepitant (Emend); carbamazepine (Carbatrol, Epitol, Tegretol); certain antifungals such as clotrimazole (Lotrimin), fluconazole (Diflucan),griseofulvin (Fulvicin, Grifulvin, Gris-PEG), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); cyclosporine (Neoral, Sandimmune);delavirdine (Rescriptor); dexamethasone (Decadron, Dexpak); diltiazem (Cardizem, Dilacor, Tiazac, others);efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); hormonal contraceptives (birth control pills, rings, and patches); lansoprazole (Prevacid); lovastatin (Advicor, Altocor, Mevacor); modafinil (Provigil); medications for anxiety, mental illness, nausea, or pain; nevirapine (Viramune); omeprazole (Prilosec); paclitaxel (Taxol); phenobarbital; phenytoin (Dilantin, Phenytek); propranolol (Inderal); quinidine (Quinidex); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; theophylline (Theo-Dur, Theo-24); ticlopidine (Ticlid); tranquilizers; troleandomycin (TAO); valproate (Depacon, Depakene, Depakote); verapamil (Calan, Covera, Isoptin, Verelan); warfarin (Coumadin); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you drink large amounts of alcohol or use or have used street drugs and if you have or have ever had glaucoma, lung problems such as asthma or pneumonia, or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using diazepam rectal gel, call your doctor.
• you should know that diazepam rectal gel may make you drowsy. Do not drive a car, operate machinery, or ride a bicycle until the effects of diazepam rectal gel have passed.
• remember that alcohol can add to the drowsiness caused by this medication.

Special dietary instructions

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Side effects

Minor side effects

Diazepam rectal gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• headache
• pain
• stomach pain
• nervousness
• flushing
• diarrhea
• unsteadiness
• abnormal 'high' mood
• lack of coordination
• runny nose
• problems falling asleep or staying asleep

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• rash
• trouble breathing
• overexcitement
• hallucinating (seeing things or hearing voices that do not exist)
• rage

Diazepam rectal gel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• confusion
• coma
• slow reflexes

Other information

Keep all appointments with your doctor. Your doctor will need to examine you about every 6 months to check if your dose of diazepam rectal should be changed.

If you have symptoms that are different from your usual seizures, you or your caregiver should call your doctor immediately.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Diastat®