Statex: Uses, Side Effects and Dosage

Serious warnings and precautions box

What STATEX is used for:

STATEX is used in adults to manage severe pain. It is used when continuous treatment is required for several days or more. STATEX is not used "as needed" to treat pain that you only have once in a while.

How STATEX works:

STATEX is a painkiller belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

The ingredients in STATEX are:

Medicinal ingredient: morphine sulfate

Non-medicinal ingredients: FD&C Blue No.1 Lake 13%, lactose monohydrate, lake blend yellow 17% LB-111 (5 mg), magnesium stearate, and microcrystalline cellulose.

STATEX comes in the following dosage form:

Tablets: 5 and 10 mg.

Do not use STATEX if:

• your healthcare professional did not prescribe it for you.
• you are allergic to morphine sulfate, other opioids or any of the other ingredients in STATEX.
• you can control your pain by the occasional use of other pain medications. This includes those available without prescription.
• you have severe asthma, trouble breathing, or cor pulmonale (a heart problem related to lung issues).
• you have any heart problems.
• you have bowel blockage or narrowing of the stomach or intestines.
• you have a condition where the bowel does not work properly (ileus) or have severe pain in your abdomen.
• you have a head injury.
• you are at risk for seizure.
• you suffer from alcoholism or alcohol withdrawal.
• you are taking, or have taken within the past 14 days, a certain type of antidepressant called Monoamine Oxidase inhibitors (MAOIs).
• you are going to have a surgery or operation, or have had a surgery within the last 24 hours.
• are emotionally unstable or have suicidal thoughts.

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

• have a history of illicit or prescription drug or alcohol abuse.
• are taking any other medications.
• are drinking or planning to drink alcohol, or take medications that contain alcohol.
• have kidney or liver problems.
• have low blood pressure.
• have circulatory shock (i.e., your body does not get enough oxygen and nutrients to function properly due to lack of blood flow).
• suffer from chronic or severe constipation.
• have problems with your thyroid, adrenal or prostate gland.
• have, or have a history of, problems with your mood (such as depression or anxiety), or other mental problems.
• have difficulty urinating.
• are severely malnourished.
• have been told by a healthcare professional that you have low levels of red blood cells.
• are breastfeeding or planning to breast-feed.
• have diabetes or high blood sugar levels.
• are pregnant or planning to become pregnant or are in labour or delivery.
• have sickle cell disease.
• have a history of pancreas or gall bladder problems.
• have a condition that causes weakness or frailty.
• have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea).

Other warnings you should know about:

Opioid dependence and addiction: Like any opioid, STATEX may cause mental and physical dependence; it also has the potential to cause addiction even at regular doses. There are important differences between physical dependence and addiction. If you use opioids for a long time, you may develop tolerance. This means that you may need higher doses of STATEX to feel the same level of pain relief. It is important that you talk to your healthcare professional if you have questions or concerns about addiction, physical dependence, or tolerance. Your healthcare professional should prescribe and administer STATEX with the same degree of caution appropriate to the use of other oral opioid medications. It is not recommended to use these products for a long period of time.

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

If you are pregnant and are taking STATEX, 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 STATEX. 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 STATEX. STATEX can cause:

• drowsiness,
• dizziness or
• lightheadedness.

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

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.

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 healthcare professional may do tests, give you another medication, and slowly take you off STATEX.

Serotonin Toxicity (also known as serotonin syndrome): STATEX 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 STATEX 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

Sleep Apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.

Worsening Pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your healthcare professional if you notice a change like this in your pain while you are taking STATEX.

Testing and check-ups: Your healthcare professional will regularly monitor your health. This includes monitoring for signs of:

• misuse and abuse
• sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping)
• respiratory depression and sedation (e.g., slow, shallow, or weak breathing)
• low blood pressure

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

Serious drug interactions:

The following may also interact with STATEX:

• anticoagulants, used to thin the blood and prevent blood clots (e.g., warfarin and other coumarins, clopidogrel, prasugrel, ticagrelor)
• medicines called “antimuscarinic”
• drugs used to treat migraines (e.g. triptans)
• medicines used to help reduce fluid build-up in the body, also known as diuretics (e.g., furosemide, indapamide, spironolactone)
• rifampin, used to treat bacterial infections including tuberculosis
• ritonavir, used to treat HIV infection

How to take STATEX:

• STATEX must be taken orally, by mouth. Do NOT administer the STATEX tablets via any other route as this can cause serious harm, including death.
• Swallow the tablet whole. Do not cut, break, crush, chew or dissolve STATEX tablets. This can be dangerous and can lead to death or seriously harm you.

• Take STATEX with or without food, with a glass of water.

Usual dose:

Your dose is tailored/personalized just for you. Be sure to follow your healthcare professional’s dosing instructions exactly. Do not increase or decrease your dose without consulting your healthcare professional.

Your healthcare professional will prescribe the lowest dose that works to control your pain and 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 healthcare professional to determine if you still need STATEX. Be sure to use STATEX only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking STATEX, tell your healthcare professional immediately.

Stopping your Medication:

If you have been taking STATEX for more than a few days you should not stop taking it all of a sudden. Your healthcare professional will monitor and guide you on how to slowly stop taking STATEX.

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
• an unexplained fever
• heart palpitations
• 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 STATEX.

Refilling your Prescription for STATEX:

A new written prescription is required from your healthcare professional each time you need more STATEX. Therefore, it is important that you contact your healthcare professional before your current supply runs out.

Only obtain prescriptions for this medicine from the healthcare professional in charge of your treatment. Do not seek prescriptions from other healthcare professionals unless you switch to another healthcare professional for your pain management.

Overdose:

Signs of overdose with STATEX may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness
• cold or clammy skin
• floppy muscles/low muscle tone
• shrinking or widening of the pupils
• slow heart rate
• low blood pressure
• low blood sugar
• muscle weakness, cramping, or aching
• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter)
• sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping)
• cardiac arrest (heart stops beating suddenly)
• aspiration pneumonia (lung infection caused by inhaling food, liquid or other substances into the lungs)

Missed dose:

It is important that you do not miss any doses. If you miss:

• One dose: Skip the missed dose and take your next dose as scheduled. Do not take two doses at once to make-up for a missed dose.
• Several doses in a row: Talk to your healthcare professional before restarting your medication.

Possible side effects from using STATEX:

These are not all the possible side effects you may have when taking STATEX. If you experience any side effects not listed here, tell 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. Talk with your healthcare professional about ways to prevent constipation when you start taking STATEX.
• low sex drive, impotence (erectile dysfunction), infertility
• worsening abdominal pain of biliary or pancreatic origin

Serious side effects and what to do about them

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

Storage:

• Store STATEX between 15-30^oC in a well closed light resistant container.
• Keep unused or expired STATEX in a secure place to prevent theft, misuse or accidental exposure.
• Keep STATEX 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 STATEX, get emergency help right away.
• STATEX should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about STATEX:

• 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); manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.

Date of Authorization: 2026-03-05