Diazepam

Not applicable.

Read the Patient/Caregiver Information Leaflet provided by your pharmacist before you use this product and each time you get a refill. If you have questions, consult your doctor or pharmacist. This drug is given rectally by a caregiver trained to recognize the symptoms of your seizures and to correctly give the product. You and your caregivers must follow all instructions from your doctor and pharmacist exactly. Review all the instructions on how to give this medication in the product package. If you have any questions or feel unsure about using this medication, call the doctor or pharmacist before using this product. Get emergency help if the person is having a seizure and you do not feel comfortable using this product. Before using, check the syringe for the correct dose. Your pharmacist should set the correct dose and lock the syringe in the "ready" position before giving you the product. Before leaving the pharmacy, look at each syringe. The dose should be in the display window on the side. You should see a green band with the word "ready" at the bottom of the syringe barrel. Look to make sure you have the correct syringe tip (e.g., smaller tip for a child) and that there are no cracks around the syringe tip. Return the product to the pharmacist if there is a problem or if you have any questions Cracks can cause the medication to leak out and not provide the correct amount of medication. If you see a crack, use a different syringe. Cracks can appear over time, so keep checking your syringes to make sure you have good ones ready to use. Also check the expiration date on the package, and refill your prescription before the medication expires. The dosage is based on age, weight, medical condition, and response to therapy. Be sure you understand when this medication should be used, how to use it, and how to check for side effects/seizure control. In some cases, a second dose may be prescribed and given 4 to 12 hours after the first dose. Usually, this medication should not be used to treat more than 5 episodes per month and no more than one episode every 5 days. If seizures continue after using this product as prescribed (e.g., no change 15 minutes after dose is given), or if there is a change in the person's breathing, behavior, or condition that alarms you, get emergency help right away. This medication should not be used regularly. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as increased seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Dispose of this medication properly. Follow the directions in the Patient Information Leaflet. Do not reuse the syringe. Do not stop taking your regular seizure control medications when you are given this drug.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because a very serious interaction may occur: sodium oxybate, fluvoxamine. If you are currently using either of these medications, tell your doctor or pharmacist before using diazepam. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cimetidine, clozapine, MAO inhibitors such as furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antidepressants (e.g., amitriptyline, nefazodone), certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenobarbital, valproate), medicine for sleep or anxiety (e.g., alprazolam, kava, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone). This medication contains a small amount of alcohol. Tell your doctor if you are taking drugs such as disulfiram or metronidazole that can can cause an unpleasant reaction when combined with alcohol. Avoid alcohol when using this medication because it may increase side effects such as difficulty breathing and drowsiness. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. It is against the law.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

Before using this product, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., oxazepam, temazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain eye problem (narrow-angle glaucoma), a certain muscle disease (myasthenia gravis), breathing trouble during sleep (sleep apnea). Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, pneumonia), brain problems that could affect breathing (e.g., decreased consciousness, head injury), a certain eye problem (wide-angle glaucoma), kidney disease, liver disease, history of drug/alcohol abuse. This drug may make you dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug, especially the drowsiness effect. This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. This drug may pass into breast milk. Because of the possible harm to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Drowsiness, dizziness, diarrhea, and unsteadiness may occur. If these persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication stays in the body for a long time. Be sure to watch for reactions for at least 4 hours after giving the medication. Seek immediate medical attention if any of these unlikely but very serious side effects occur: slow/shallow/difficult breathing, mental/mood changes (e.g., anxiety, restlessness, hallucinations, sleep problems), slurred speech, trouble walking. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.