Patient Medication Information: uses, side effects, how to take - Diacetylmorphine Hydrochloride
Serious Warnings and Precautions
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What is Diacetylmorphine Hydrochloride used for?
Diacetylmorphine Hydrochloride is used in adults (18 years of age and older) to manage severe opioid addiction.
It should only be given to adults:
- that are already taking high doses or high concentrations of injectable opioids;
- that have previously attempted to use other alternative treatments for opioid addiction and were not successful;
- along with a complete treatment program that includes medical, social, and psychological support;
- alone or together with methadone to prevent withdrawal symptoms;
- under the close supervision of a specialized healthcare professional trained in treating opioid use disorders; and
- in a facility that is equipped and staffed to immediately recognize and treat serious side effects.
How does Diacetylmorphine Hydrochloride work?
Diacetylmorphine Hydrochloride belongs to the class of medications known as opioid agonists. It is part of a complete treatment program that includes medical, social, and psychological support. Diacetylmorphine Hydrochloride helps to prevent withdrawal and reduce cravings for opioids.
What are the ingredients in Diacetylmorphine Hydrochloride?
Medicinal ingredient: Diamorphine hydrochloride.
Non-medicinal ingredients: none
Diacetylmorphine Hydrochloride comes in the following dosage forms:
Powder for injection: 100 mg / mL after reconstitution.
Do not use Diacetylmorphine Hydrochloride if:
- your healthcare professional did not prescribe it for you.
- you are not currently taking high doses or high concentrations of opioids.
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- you are allergic to diamorphine hydrochloride, other opioids, or to any of the other ingredients in Diacetylmorphine Hydrochloride.
- you have severe asthma, trouble breathing, or other breathing problems.
- you have any heart problems.
- you have a bowel blockage or narrowing of the stomach or intestines.
- you have increased pressure in your skull or a head injury.
you suffer from alcoholism or alcohol withdrawal.
- you are taking or have taken within the past 2 weeks a monoamine oxidase (MAO) inhibitor (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
- you are going to have, or recently had a planned surgery.
- you have recently taken alcohol, benzodiazepines (also known as “downers”), stimulants (also known as “uppers”) or other street drugs.
- you have severe CNS depression (nervous system slows down).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Diacetylmorphine Hydrochloride. 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 kidney problems.
- have liver problems.
- have lung problems.
- have heart problems.
- have low blood pressure.
- have past or current depression
- suffer from chronic or severe constipation.
- have, or had in the past, hallucinations, or other severe mental problems.
- have suffered a head injury.
- are drinking or plan to drink alcohol. Do not drink alcohol while taking Diacetylmorphine Hydrochloride.
are at a high risk of having seizures. This includes if you:
- have a head injury;
- have problems with your metabolism;
- are undergoing withdrawal from drinking alcohol and taking drugs;
- have infections involving your brain or the tissue surrounding the brain and spinal cord;
- are taking medicines that may increase your risk of having seizures such as antidepressants (used to treat depression), anorectics (used to reduce appetite), other opioids, and neuroleptics (used to treat some psychotic disorders).
- have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness).
- have suffered a head injury.
- have adrenal gland problems.
- have circulatory problems (e.g., body does not get enough oxygen and nutrients to function properly due to a lack of blood flow).
- have blood clotting problems.
- have chronic medical conditions.
- have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea).
- have an existing infection.
cannot safely self-inject your own medicine due to:
- non-visible or difficult to find veins, or
- poor injecting technique.
- are undergoing or plan to get dialysis.
- have difficulty urinating.
- have developed psychosis (distortion or loss of touch with reality) from taking too much of a certain drug.
- have an underactive thyroid (thyroid gland does not produce enough thyroid hormone).
- have a condition that causes weakness or frailty.
- are 65 years of age or older.
- have severe pain in your abdomen.
Other warnings you should know about:
Taking Diacetylmorphine Hydrochloride can cause:
- Biliary spasm (loss of control of a muscular valve in the gastrointestinal tract): This can cause a backup of digestive juices and severe pain in the abdomen.
- Breathing problems: This includes pulmonary edema (excess fluid in the lungs) and bronchoconstriction (narrowing of the airway). This can lower the oxygen levels in your body and may be life-threatening.
Disorders of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones.
You may experience:
- nausea, vomiting,
- feeling tired, weak, dizzy, or
- decreased appetite.
You may be more likely to have problems with your adrenal gland if you have been taking opioids for a long time. Your healthcare professional may do tests or give you another medication.
- Bowel blockage (impaction): This can be caused by the decrease in bowel movements. Diacetylmorphine Hydrochloride may also mask the diagnosis or clinical course of abdominal conditions.
- Hypotension (low blood pressure): This is more likely to happen after starting your treatment, after changing your dose, or if the injection of Diacetylmorphine Hydrochloride is received too quickly. You should avoid rapid intravenous injection of Diacetylmorphine Hydrochloride to reduce the risk of hypotension.
- Respiratory depression (also known as hypoventilation): This is a serious and life-threatening condition that can occur even if Diacetylmorphine Hydrochloride is used as recommended. You may be more likely to have problems when you first start taking Diacetylmorphine Hydrochloride or following a dose increase.
- Seizures (fits): Even if you use Diacetylmorphine Hydrochloride exactly as you were told to, you are at risk of having a seizure.
Serotonin toxicity (also known as serotonin syndrome): Diacetylmorphine Hydrochloride can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles, and digestive system work. You may develop serotonin toxicity if you take Diacetylmorphine Hydrochloride with certain anti-depressant or migraine medications.
Serotonin toxicity symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches, or stiffness, overreactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusions, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
- Sleep apnea: Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea) and hypoxia (including sleep-related hypoxia). If you already have a sleep-related disorder your problem may worsen.
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your healthcare professional if you have questions or concerns about abuse, addiction, or physical dependence.
Pregnancy, nursing, labour, and delivery:
- Do not use Diacetylmorphine Hydrochloride while pregnant, nursing, during labour, or delivery. Opioids can be transferred from your body to your baby through breast milk, or while still in the womb. Diacetylmorphine Hydrochloride can then cause life-threatening problems in your unborn baby or nursing infant.
- If you are pregnant and are taking Diacetylmorphine Hydrochloride it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your healthcare professional will monitor and guide you on how to slowly stop taking Diacetylmorphine Hydrochloride. This may help avoid serious harm to your unborn baby.
- If you are able to become pregnant, you should use an effective birth control methods. This may include using barrier method of birth control such as a condom for your partner. Ask your healthcare professional about options for effective birth control.
Driving and using machines: Do not drive or engage in hazardous activities when you are taking Diacetylmorphine Hydrochloride. Diacetylmorphine Hydrochloride can cause drowsiness, dizziness, or light-headedness. This can usually occur after you take your first dose and when your dose is increased.
Sexual function and reproduction: Long-term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
Serious Drug Interactions Serious drug interactions with Diacetylmorphine Hydrochloride include:
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The following may interact with Diacetylmorphine Hydrochloride:
- barbiturates, used to relax the body and help with sleeping (e.g., secobarbital);
- triptans, used to treat migraines;
- lithium, used to treat mental health disorders;
- medicines used to treat and prevent certain types of stomach ulcers (e.g., ranitidine and cimetidine);
- antiretrovirals used to treat viral infections (e.g., zidovudine, and ritonavir);
- antibiotics used to treat bacterial infections (e.g., rifampin and cloramphenicol);
- quinidine, used to treat or prevent irregular heartbeats;
- probenecid, used to treat gout;
- valspodar, used to treat cancer;
- acetaminophen, a non-steroidal anti-inflammatory drug (NSAID) used to reduce pain and swelling;
- oral contraceptives, used for birth control;
- medicines used to prevent blood clotting (e.g., ticagrelor, prasugrel, and clopidogrel).
How to take Diacetylmorphine Hydrochloride:
Take Diacetylmorphine Hydrochloride exactly as directed by your healthcare professional trained in opioid use disorders. This should be in a medically supervised place where there is equipment available for the healthcare professional to monitor and provide immediate care in case you
- experience any serious side effects (e.g., naloxone). If you develop any side effects tell your healthcare professional right away.
Diacetylmorphine Hydrochloride must be injected directly:
- into the vein (intravenously or IV) or
- into the muscle (intramuscularly or IM).
You should NOT inject Diacetylmorphine Hydrochloride anywhere else as this can cause serious harm, including death.
- You should slowly inject Diacetylmorphine Hydrochloride intravenously to reduce the risk of hypotension.
- Diacetylmorphine Hydrochloride should be prescribed in combination with a complete treatment program that includes medical, social, and psychological support.
Usual dose:
Your healthcare professional will decide your dose of Diacetylmorphine Hydrochloride based on your medical condition, age, current health, and if you take certain other medications. Your dose will be personalized just for you. Be sure to follow your healthcare professional’s dosing instructions exactly. Do NOT increase or decrease your dose without first talking to your healthcare professional.
Your healthcare professional will closely monitor your health before, during, and after your injection to ensure your safety. They may also prescribe oral methadone to help you with your cravings and prevent withdrawal symptoms.
Stopping your medication:
If you have been taking injectable opioids, such as Diacetylmorphine Hydrochloride, for long periods of time, your body will become physically dependent on them. Do not stop taking Diacetylmorphine Hydrochloride without first talking to your healthcare professional. Your healthcare professional will monitor and guide you on how to safely stop taking it. You should do it slowly to avoid uncomfortable withdrawal symptoms such as having:
- body aches,
- diarrhea,
- goosebumps,
- loss of appetite,
- nausea,
- feeling nervous or restless,
- runny nose,
- sneezing,
- tremors or shivering,
- stomach cramps,
- rapid heart rate,
- have trouble sleeping,
- an unusual increase in sweating,
- heart palpitations,
- an unexplained fever,
- weakness,
- yawning,
- lack of energy,
- chills,
- seizures,
- irritability,
- aggressive behaviour,
- vomiting, or
- increased blood pressure.
If you develop any side effects tell your healthcare professional right away.
Overdose:
Signs of an overdose with Diacetylmorphine Hydrochloride may include:
- breathing problems (including unusually slow or weak breathing),
- dizziness,
- confusion,
- extreme drowsiness,
- changes to your mental state,
- lack of muscle shape and tone,
- cold and clammy skin,
- shrinking of pupils,
- slow heart rate,
- low blood pressure,
- sleeping problems,
- circulatory failure, or
- cardiac arrest.
| If you think you, or a person you are caring for, have taken too much Diacetylmorphine Hydrochloride, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget or miss a dose, talk to your healthcare professional right away as this may cause withdrawal symptoms. They will tell you what to do, including if you should change your dose before you can restart your medication to help prevent serious side effects and overdose. Do not try to make up for the missed dose by taking two doses at once.
What are possible side effects from using Diacetylmorphine Hydrochloride?
These are not all the possible side effects you may have when taking Diacetylmorphine Hydrochloride. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain;
- anxiety;
- confusion;
- constipation;
- dizziness;
- drowsiness;
- dry mouth;
- fainting;
- headache;
- itching;
- injection site reaction;
- insomnia;
- light-headedness;
- low sex drive, impotence (erectile dysfunction), infertility;
- nausea, vomiting, or a poor appetite;
- problems with vision;
- sweating;
- weakness, uncoordinated muscle movement.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, dizziness, floppy muscles, low muscle tone, or cold and clammy skin. | √ | ||
| Seizures (fit): loss of consciousness with uncontrollable shaking. | √ | ||
| UNKNOWN FREQUENCY | |||
| Respiratory depression: slow, shallow, or weak breathing. | √ | ||
| Allergic reaction: rash, hives. swelling of the face, lips, tongue or throat, difficulty swallowing, or difficulty breathing. | √ | ||
| Bowel blockage (impaction): abdominal pain, severe constipation, or nausea. | √ | ||
| Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, or loss of appetite. | √ | ||
| Fast, slow, or irregular heartbeat: heart palpitations | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Serotonin toxicity (also known as serotonin syndrome): a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38 °C) or rigid muscles. | √ | ||
| Biliary spasm (loss of control of a muscular valve in the gastrointestinal tract): pain in the upper right or center of the abdomen. | √ | ||
| Central nervous system (CNS) depression (nervous system slows down): ineffective breathing, low blood pressure, drowsiness, or coma. | √ | ||
| Disorders of the adrenal gland (including adrenal insufficiency): nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up). | √ | ||
| Sleep apnea: stop breathing for short periods during your normal nightly sleep. | √ | ||
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:
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:
Your healthcare professional will store this medication for you. This is to ensure that the vials of Diacetylmorphine Hydrochloride are stored securely to avoid theft or misuse. The unopened vials will be stored at room temperature (15oC to 30oC) and protected from light.
If you want more information about Diacetylmorphine Hydrochloride
- 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); the manufacturer’s website at www.pharmascience.com or by calling 1-800-550-6060.