Warnings:

Diazepam has a risk for abuse and addiction, which can lead to overdose and death. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you use the smallest dose of diazepam that works, and use it for the shortest possible time. Be sure you know how to use diazepam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

This medication should not be used regularly. If you use it regularly, suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

How to use Diastat Kit

See also Warning section.

Read the Patient/Caregiver Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This drug is given rectally by a caregiver trained to recognize the difference between your cluster and ordinary seizures. You and your caregiver must be comfortable with following all instructions from your doctor, pharmacist, and the product package. Be sure you understand when this medication should be used, how to use it, and how to check for side effects/seizure control.

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 (for example, a 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.

The dosage is based on age, weight, medical condition, and response to treatment. 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. Do not stop taking your regular seizure control medications when you are given this drug.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Get emergency help right away if seizures continue after using this product (for example, no change 15 minutes after the dose is given), or if there is a change in the person's breathing, coloring, behavior, or condition that alarms you.

Side Effects

See also Warning section.

Drowsiness, dizziness, or unsteadiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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. Stay with the patient for at least 4 hours after giving the medication and watch for any side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, restlessness, hallucinations), trouble speaking, trouble walking.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using diazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain muscle disease (myasthenia gravis), lung/breathing problems (such as asthma, pneumonia, COPD, sleep apnea), mental/mood disorders (such as depression, thoughts of suicide, psychosis), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), glaucoma, brain problems that could affect breathing (such as decreased consciousness, head injury), kidney disease, liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and loss of coordination. These side effects can increase the risk of falling.

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 using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy.

This drug may pass into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: clozapine, fluvoxamine, sodium oxybate.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, confusion, slow reflexes, slow/shallow breathing, fainting, loss of consciousness.

Notes

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

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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. For more details, read the Patient/Caregiver Information Leaflet, or consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.