Patient Medication Information: uses, side effects, how to take - Diazepam Injection USP (Hikma Canada)
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take Diazepam Injection USP as prescribed, you are at risk for abuse, misuse and addiction. This can result in overdose or death, especially if it is taken with:
- opioids
alcohol or
- illicit drugs
Your doctor should:
- talk to you about the risks of treatment with Diazepam Injection USP as well as other treatment (including non-drug) options
- assess your risk for these behaviours before prescribing Diazepam Injection USP
- monitor you while you are taking Diazepam Injection USP for the signs and symptoms of misuse and abuse. If you feel like you are craving Diazepam Injection USP, or not using it as directed, talk to your doctor right away.
Store Diazepam Injection USP in a secure place to avoid theft or misuse.
Withdrawal: If you suddenly stop taking Diazepam Injection USP, 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 contact your doctor before stopping, or lowering your dose of Diazepam Injection
USP or changing your medicine.
Diazepam Injection USP with Opioids: Taking Diazepam Injection USP with opioid medicines can cause:
- severe drowsiness
- decreased awareness
- breathing problems
- coma
- death
What is Diazepam Injection USP used for?
Diazepam Injection USP is used to:
- relieve anxiety,
- control agitation caused by alcohol withdrawal and
- control seizures
It is also used to control muscle spasms and spasticity caused by certain neurological disorders such as
- cerebral palsy,
- athetosis (involuntary movements), and
- stiff-man syndrome (body stiffness).
Diazepam Injection USP is not for use in children less than 12 years of age.
If you are 65 years or older, talk to your doctor before starting Diazepam Injection USP. Diazepam Injection USP may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
How does Diazepam Injection USP work?
Diazepam Injection USP works by calming the brain and nerves.
What are the ingredients in Diazepam Injection USP
Medicinal ingredients: Diazepam
Non-medicinal ingredients: anhydrous ethyl alcohol, benzoic acid, benzyl alcohol as preservative, propylene glycol, sodium hydroxide to adjust pH and water for injection..
Diazepam Injection USP comes in the following dosage forms:
Sterile Solution for Injection, 5 mg / mL
Do not use Diazepam Injection USP if:
- you are allergic to it; or to other benzodiazepines.
- you have a disorder of the nervous system that causes muscle weakness (myasthenia gravis).
you have a serious eye condition that may cause loss of vision (narrow angle glaucoma). Diazepam
Injection USP is not for use in children less than 12 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Diazepam Injection USP. 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)
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 Diazepam Injection USP.
Your risk of going through withdrawal is higher if you are taking Diazepam Injection USP for a long time or at high doses. However, symptoms can still occur if you are taking Diazepam Injection USP 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 doctor 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 behaviour 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 contact your doctor before stopping or reducing your dose of Diazepam Injection USP or changing medications
- always follow your doctor’s instructions on how to reduce your dose carefully and safely
- tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment
Diazepam Injection USP with Opioids: Taking Diazepam Injection USP with opioid medicines can cause severe drowsiness and breathing problems.
Tell your doctor if you:
- are taking opioid medicines
- are prescribed an opioid medicine after you start taking Diazepam Injection USP
Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and Diazepam Injection USP affects you.
Falls and Fractures: Benzodiazepines like Diazepam Injection USP can cause you to feel sleepy, dizzy and affect your balance. This increases the 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
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Diazepam Injection USP
Serious Drug Interactions
Taking Diazepam Injection USP and opioids may cause:
- severe drowsiness
- trouble breathing
- coma
- death
How to take Diazepam Injection USP:
Your doctor will slowly decrease your dose and will tell you when to stop taking the medicine.
Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Usual dose:
Diazepam Injection USP will be given by your health care professional who will determine your dose and the best way to give it to you.
Overdose:
Signs that you have taken too much Diazepam Injection USP include
- Drowsiness and confusion,
- reduced reflexes and
loss of consciousness (coma).
If you think you, or a person you are caring for, have taken too much Diazepam Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using Diazepam Injection USP?
These are not all the possible side effects you may have when taking Diazepam Injection USP. If you experience any side effects not listed here, tell your healthcare professional.
- Falls and fractures
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare | Stop taking drug and | ||||||||
| professional | get immediate | |||||||||
| Only if severe | In all cases | medical help | ||||||||
| 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. | ✓ | |||||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare | Stop taking drug and | ||||||||
| professional | get immediate | |||||||||
| Only if severe | In all cases | medical help | ||||||||
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.
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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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store between 15 and 30 °C. Protect from light.
Keep out of reach and sight of children.
If you want more information about Diazepam Injection USP
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html; or by calling 1-800-656-0793.
Hikma Canada Limited
Mississauga, Ontario
L5R3P9