Statex Drops 20mg/mL: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is STATEX used for?

STATEX is used to manage your pain.

How does STATEX work?

STATEX 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 STATEX?

Medicinal ingredient: morphine sulfate

Non-medicinal ingredients:

Drops and unflavoured syrup: citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water

Orange flavoured syrup: citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water.

Suppositories: hydrogenated vegetable oil

Tablets: FD&C Blue No.1 Lake, lactose monohydrate, lake blend yellow, magnesium stearate, microcrystalline cellulose

STATEX comes in the following dosage forms:

STATEX is available in oral drops (20 and 50 mg/mL), suppositories (5, 10, 20, 30 mg), syrup (1, 5 and 10 mg/mL) and tablets (5, 10, 25 and 50 mg).

Do not use STATEX if:

• your doctor did not prescribe it for you
• you are allergic to morphine sulfate 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 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 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.
• 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.
• have a biliary tract disorder.
• are pregnant or planning to become pregnant.
• suffer from migraines.

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. STATEX can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor 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 doctor 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.

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 STATEX.

Serotonin Syndrome: STATEX 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 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.

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 STATEX:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking STATEX. 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 STATEX;
• 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 STATEX 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;
• warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots);
• some heart medication (such as beta blockers);
• antimuscarinic medicine;
• drugs used to treat migraines (e.g. triptans);
• St. John’s Wort.

How to take STATEX:

STATEX drops, syrup and tablets are not indicated for rectal administration

Swallow STATEX tablets whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

You can take your dose of STATEX with or without food. You can take you STATEX tablet with a glass of water.

To improve the taste, you can dilute STATEX oral unflavoured drops and syrup in a glass of fruit juice just before taking your dose.

You should place your STATEX suppository against the rectal mucosa. The medicine will not be absorbed if you push the suppository into a mass of stool or if you place it in the anal canal.

Usual Adult Starting Dose:

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

Your doctor 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 doctor 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 doctor 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 doctor 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 doctor each time you need more STATEX. Therefore, it is important that you contact your doctor before your current supply runs out.

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:

Signs of overdose may include:

• unusually slow or weak breathing;
• dizziness;
• confusion;
• extreme drowsiness;
• cold or clammy skin;
• low muscle tone.

Missed Dose:

If you miss one dose, take your next dose at the scheduled time as usual. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using STATEX?

These are not all the possible side effects you may feel when taking STATEX. 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 STATEX.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Store all preparations 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.

Disposal:

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 this consumer 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 www.paladinlabs.com, or by calling 1-888-867-7426.

Last Revised: April 5, 2018