Patient Medication Information: uses, side effects, how to take - Morphine Sulfate Injection BP (Sterimax, 15 mg)

Serious Warnings and Precautions

Even if you take Morphine Sulfate Injection BP as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
You may get life-threatening breathing problems while taking Morphine Sulfate Injection BP. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
If a person has not been prescribed Morphine Sulfate Injection BP taking even one dose can cause a fatal overdose. This is especially true for children.
If you took Morphine Sulfate Injection BP while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
o has changes in their breathing (such as weak, difficult or fast breathing)
o is unusually difficult to comfort o has tremors (shakiness) o has increased stools, sneezing, yawning, vomiting, or fever
Seek immediate medical help for your baby.
Taking Morphine Sulfate Injection BP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

What is Morphine Sulfate Injection BP used for?

Morphine Sulfate Injection BP is an injection containing morphine sulfate (an opioid analgesic) used to control your pain.

How does Morphine Sulfate Injection BP work?

Morphine Sulfate Injection BP is a painkiller belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in Morphine Sulfate Injection BP?

Medicinal ingredient: Morphine sulfate Non-medicinal ingredients: 10 mg/mL, 15 mg/mL: sodium metabisulfite, sodium hydroxide and/or sulfuric acid and water for injection

Morphine Sulfate Injection BP comes in the following dosage form:

Solution for injection of 10 mg/mL and 15 mg/mL

Do not use Morphine Sulfate Injection BP if:

your doctor did not prescribe it for you
you are allergic to morphine sulfate or any of the other ingredients in Morphine Sulfate Injection BP
you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
you have severe asthma, trouble breathing, or other breathing problems
you have any heart problems
you have bowel blockage or narrowing of the stomach or intestines
you have severe pain in your abdomen
you have a head injury
you are at risk for seizures
you suffer from alcoholism
you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
you are going to have, or recently had, a planned surgery

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

have a history of illicit or prescription drug or alcohol abuse
have severe kidney, liver or lung disease
have heart disease
have low blood pressure
have past or current depression
suffer from chronic or severe constipation
have problems with your thyroid, adrenal or prostate gland
have, or had in the past hallucinations or other severe mental problems
suffer from migraines
are planning to become pregnant

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Morphine Sulfate Injection BP can then cause life- threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Morphine Sulfate Injection BP outweigh the risks to your unborn baby or nursing infant.

If you are pregnant and are taking Morphine Sulfate Injection BP, 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 doctor will monitor and guide you on how to slowly stop taking Morphine Sulfate Injection BP. This may help avoid serious harm to your unborn baby.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Morphine Sulfate Injection BP. Morphine Sulfate Injection BP can cause:

drowsiness
dizziness or
lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder 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 symptoms such as:

nausea, vomiting
feeling tired, weak or dizzy
decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Morphine Sulfate Injection BP.

Serotonin Syndrome: Morphine Sulfate Injection BP can cause Serotonin Syndrome, 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 Syndrome if you take Morphine Sulfate Injection BP with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

fever, sweating, shivering, diarrhea, nausea, vomiting;
muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
fast heartbeat, changes in blood pressure;
confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/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.

The following may interact with Morphine Sulfate Injection BP:

Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Morphine Sulfate Injection BP. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
other sedative drugs which may enhance the drowsiness caused by Morphine Sulfate Injection BP
other opioid analgesics (drugs used to treat pain)
general anesthetics (drugs used during surgery)
benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
antidepressants (for depression and mood disorders). Do not take Morphine Sulfate Injection BP with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
drugs used to treat serious mental or emotional disorders (such as schizophrenia)
antihistamines (drugs used to treat allergies)
anti-emetics (drugs used for the prevention of vomiting)
drugs used to treat muscle spasms and back pain
drugs used to treat migraines (e.g. triptans)
St. John’s Wort

How to take Morphine Sulfate Injection BP:

Morphine Sulfate Injection BP 10 mg/mL and 15 mg/mL Usual Adult dose: 5 mg to 20 mg by intravenous, intramuscular or subcutaneous every 4 hours. Not for intrathecal or epidural use.

Usual Adult Starting Dose:

Your dose is tailored/personalized just for you.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take Morphine Sulfate Injection BP for up to 7 days. If you need to take Morphine Sulfate Injection BP for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need Morphine Sulfate Injection BP. Be sure to use Morphine Sulfate Injection BP only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking Morphine Sulfate Injection BP tell your doctor immediately.

Stopping your Medication

If you have been taking Morphine Sulfate Injection BP for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking Morphine Sulfate Injection BP. You should do it slowly to avoid uncomfortable 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 (tachycardia)
having trouble sleeping
an unusual increase in sweating
heart palpitations
an unexplained fever
weakness
yawning

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking Morphine Sulfate Injection BP.

Refilling your Prescription for Morphine Sulfate Injection BP:

A new written prescription is required from your doctor each time you need more Morphine Sulfate Injection BP. Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

If you think you, or a person you are caring for, have taken too much Morphine Sulfate Injection BP, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Signs of overdose may include:

unusually slow or weak breathing
dizziness
confusion
extreme drowsiness

What are possible side effects from using Morphine Sulfate Injection BP?

These are not all the possible side effects you may feel when taking Morphine Sulfate Injection BP. If you experience any side effects not listed here, contact your healthcare professional. Side effects may include:

Drowsiness
Insomnia
Dizziness
Fainting
Nausea, vomiting, or a poor appetite
Dry mouth
Headache
Problems with vision
Weakness, uncoordinated muscle movement
Itching
Sweating
Constipation • Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using Morphine Sulfate Injection BP.

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
RARE Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin.			✓
Respiratory Depression: slow, shallow, or weak breathing.			✓
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing			✓
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea			✓
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating.		✓
Fast, Slow or Irregular Heartbeat: heart palpitations.		✓
Low Blood Pressure: dizziness, fainting, light-headedness.	✓
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea			✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to 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 (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:

Keep unused or expired Morphine Sulfate Injection BP in a secure place to prevent theft, misuse or accidental exposure.
Store between 15°C to 30°C. Protect from light and freezing.
Keep Morphine Sulfate Injection BP under lock, out of sight and reach of children and pets.
Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes Morphine Sulfate Injection BP, get emergency help right away.

If you want more information about Morphine Sulfate Injection BP:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Drug Product Database (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.sterimaxinc.com, or by calling 1-800-881-3550.

Rx or OTC	Prescription (Rx)?
DIN	02474999
Schedule(s)	NARCOTICS (CDSA I)
Risk Management Plans	A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
Active ingredient(s)	Morphine sulfate 15 MG
Dosage form(s)	Solution
Route(s) of administration	Subcutaneous, Intramuscular, Intravenous
Drug class (WHO ATC)	N Nervous system drugs N02 Analgesics N02A Opioid analgesics N02AA Natural opium alkaloid analgesics N02AA01 Morphine
Company	STERIMAX INC
Current status	Approved
Current status date	April 20, 2018

Morphine Sulfate Injection BP (Sterimax, 15 mg): Uses, Side Effects and Dosage