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Diastat: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) TARGETED SUBSTANCES (CDSA IV)
Strength:
5 mg, 10 mg, 15 mg
Active ingredient:
ATC code:

Patient Medication Information: uses, side effects, how to take - Diastat

Serious warnings and precautions box

Addiction, Abuse and Misuse

Even if you take DIASTAT exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in an overdose or death, especially if you take DIASTAT with:

  • opioids
  • alcohol or
  • illicit drugs

Your healthcare professional should:

  • talk to you about the risks of treatment with DIASTAT as well as other treatment (including non-drug) options
  • assess your risk for these behaviours before prescribing DIASTAT
  • monitor you while you are taking DIASTAT for the signs and symptoms of misuse and abuse. If you feel like you are craving DIASTAT, or not using it as directed, talk to your healthcare professional right away.

Store DIASTAT in a secure place to avoid theft or misuse.

Withdrawal

If you suddenly stop taking DIASTAT, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see Other warnings you should know about)

  • Always talk to your healthcare professional before stopping, or lowering your dose of DIASTAT or changing your medicine.

DIASTAT with Opioids

Taking DIASTAT with opioid medicines can cause:

  • severe drowsiness
  • decreased awareness
  • breathing problems
  • coma
  • death

What DIASTAT is used for:

  • DIASTAT is used in addition to other anti-epileptic medicines to help control bouts of increased seizure activity. It is given through the rectum in a pre-filed syringe.
  • DIASTAT is not for use in children less than 2 years of age.

  • If you are 60 years or older, talk to your healthcare professional before starting DIASTAT. DIASTAT may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

How DIASTAT works:

DIASTAT works by increasing the actions of an amino acid in the brain called “gamma-aminobutyric acid" (GABA). By increasing the action of GABA in the brain, DIASTAT is able to help control seizures.

The ingredients in DIASTAT are:

Medicinal ingredient: Diazepam

Non-medicinal ingredients: Benzoic Acid, Benzyl Alcohol (1.5%), Ethyl Alcohol (10%), Hydroxypropyl Methylcellulose, Propylene Glycol, Sodium Benzoate, and Water.

DIASTAT comes in the following dosage form:

gel, 5 mg / mL, 10 mg / 2mL, 15 mg / 3mL.

Do not use DIASTAT if:

  • you are allergic to diazepam or any of the non-medicinal ingredients in DIASTAT (see The ingredients in DIASTAT are).
  • you have a serious eye condition that may cause loss of visions (narrow angle glaucoma).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DIASTAT. Talk about any health conditions or problems you may have, including if you:

  • have ever had a problem with:

    • substance use, including prescribed or illegal drugs, or
    • alcohol,
  • have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness),
  • are pregnant or trying to become pregnant. DIASTAT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus,

  • are breast feeding,
  • have kidney problems, liver problems, or respiratory problems (asthma, pneumonia),
  • are 60 years of age or older.

Other warnings you should know about:

Withdrawal

If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop DIASTAT.

Your risk of going through withdrawal is higher if you are taking DIASTAT for a long time or at high doses. However, symptoms can still occur if you are taking DIASTAT as directed for a short period of time or slowly reducing the dose.

The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).

Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment.

Severe symptoms of withdrawal include:

  • feeling like you cannot move or respond (catatonia),
  • severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
  • feeling depressed,
  • feeling disconnected from reality (dissociation),
  • seeing or hearing things that are not there (hallucinations),
  • overactive behavior and thoughts (mania),
  • believing in things that are not true (psychosis),
  • convulsions (seizures), including some that do not stop,
  • thoughts or actions of suicide.

For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).

To reduce your chances of going through withdrawal:

  • always talk to your healthcare professional before stopping or reducing your dose of DIASTAT or changing medications,
  • always follow your healthcare professional’s instructions on how to reduce your dose carefully and safely,
  • tell your healthcare professional right away if you experience any unusual symptoms after changing or stopping your treatment.

DIASTAT with Opioids

Taking DIASTAT with opioid medicines can cause severe drowsiness and breathing problems.

Tell your healthcare professional if you:

  • are taking opioid medicines,
  • are prescribed an opioid medicine after you start taking DIASTAT.

Do NOT drive or operate heavy machinery or do tasks that require special attention or coordination until you know how taking an opioid medicine and DIASTAT affects you.

Falls and Fractures

Benzodiazepines like DIASTAT can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:

  • take other sedatives,
  • consume alcohol,
  • are elderly or,
  • have a condition that causes weakness or frailty.

Driving and Using Machines

Before you drive or do tasks that require special attention or coordination, wait until you know how DIASTAT affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

Taking DIASTAT and opioids may cause:

  • severe drowsiness
  • trouble breathing
  • coma
  • death

The following may also interact with DIASTAT:

  • Medicines to treat ulcers or gastroesophageal reflux disease (GERD) (such as cimetidine).
  • Medicines to treat heart problems (such as quinidine, propranolol, warfarin).
  • Medicines to treat depression (such as tranylcypromine, imipramine, monoamine oxidase inhibitors).
  • Medicines to treat bacterial infections (such as rifampicin).
  • Medicines to treat fungal infections (such as ketoconazole).
  • Medicines to treat skin infections (such as clotrimazole).
  • Medicines to treat seizures (such as carbamazepine, phenytoin, phenobarbital, valproate).
  • Medicines to treat inflammatory conditions (such as dexamethasone).
  • Immunosuppressants (used to weaken the immune system) (such as cyclosporine).
  • Medicines used to treat cancer (such as paclitaxel).
  • Antihistamines (drugs used to treat allergies) (such as terfenadine).
  • Antipsychotics (drugs to stabilize thinking and behavior) (such as phenothiazines).
  • Narcotics (used to treat pain).
  • Alcohol.

How to take DIASTAT:

  • DIASTAT will be given to you by your caregiver or healthcare professional.

    • If you are a caregiver, give DIASTAT exactly as directed.

Usual dose:

  • Your dose will depend on your age and weight.
  • Your healthcare professional will monitor your health throughout your treatment. Your healthcare professional may interrupt or lower your dose or stop your treatment.

    • Your healthcare professional will slowly decrease your dose and will tell you when to stop taking the medicine.
    • Always follow your healthcare professional’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.

Overdose:

Some of the signs of an overdose could be:

  • sleepiness,
  • confusion,
  • unconsciousness, and
  • slow reactions.
If you think you, or a person you are caring for, have taken too much DIASTAT, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using DIASTAT:

These are not all the possible side effects you may have when taking DIASTAT. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

  • Falls and fractures
  • Sleepiness
  • Dizziness
  • Headache
  • Pain
  • Diarrhea
  • Sense of well being
  • Clumsiness
  • Nervousness
  • Movement disorder
  • Weakness
  • Hiccups
  • Vomiting
  • Nausea
  • Shakiness
  • Twitching
  • Increased cough
  • Changes in skin color
  • Sweating

Serious side effects and what to do about them

Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking this drug and get immediate medical help
Only if severeIn all cases
Only if severeIn all cases
Uncommon
Increased acid levels of the blood and body tissues.√
Convulsion: seizure, spasms, shaking or fits, with or without loss of consciousness.√
Difficulty breathing.√
Not enough oxygen being supplied to body tissues.√
Kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain.√
Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath.√
Stupor (unconsciousness).√
Unknown
Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure.√

Respiratory depression: slow,

shallow or weak breathing.

√
Withdrawal:√

Severe symptoms include:

Catatonia: feeling like you cannot move or respond.

Delirium Tremens: severe confusion, shivering, irregular heartrate and excessive sweating.

Feeling depressed dissociation: feeling disconnected from reality.

Hallucinations: seeing or hearing things that are not there.

Mania: overactive behaviour and thoughts.

Psychosis: believing in things that are not true.

Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking.

Thoughts or actions of suicide.

Other symptoms include: stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety or panic-attacks; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; sweating.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at controlled room temperature (15 - 30ºC).

DIASTAT should be stored securely to avoid theft or misuse.

Keep out of reach and sight of children.

If you want more information about DIASTAT:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca; or by calling 1-800-361-4261.

Bausch Health, Canada Inc.

2150 St-Elzear Blvd. West

Laval, QC, H7L 4A8

www.bauschhealth.ca

Date of Authorization: 2026-10-05

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02238162

Approved according to the text: October 5, 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Diastat

Rx or OTC
Prescription (Rx)?
DIN 02238162, 02519070, 02519089
Schedule(s) TARGETED SUBSTANCES (CDSA IV)
Active ingredient(s) Diazepam
Dosage form(s) Gel
Route(s) of administration Rectal
Drug class (WHO ATC)
  1. N Nervous system drugs
    1. N05 Psycholeptics
      1. N05B Anxiolytics
        1. N05BA Benzodiazepine derivative anxiolytics
          1. N05BA01 Diazepam
Company BAUSCH HEALTH, CANADA INC.
Current status Marketed
Strengths and forms
DIN Strength Dosage form(s) Current status
02238162 5 MG Gel Marketed August 18, 2021
02519070 10 MG Gel Marketed April 21, 2022
02519089 15 MG Gel Marketed April 21, 2022

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.