Methylprednisolone Sodium Succinate for Injection (Teva Canada, 40 mg, ..., 1 G): Uses, Side Effects and Dosage

What is methylPREDNISolone SODIUM SUCCINATE FOR INJECTION used for?

• Methylprednisolone Sodium Succinate for Injection is used in adults and children to treat many conditions. These include allergic reactions and inflammation.

What does methylPREDNISolone SODIUM SUCCINATE FOR INJECTION work?

Methylprednisolone Sodium Succinate for Injection is a synthetic corticosteroid. It decreases the body’s reaction to some severe conditions and reduces inflammation.

What are the ingredients in methylPREDNISolone SODIUM SUCCINATE FOR INJECTION?

Medicinal ingredients: methylprednisolone sodium succinate

Non-medicinal ingredients: dibasic sodium phosphate dried and monobasic sodium phosphate anhydrous. When needed, the pH is adjusted with sodium hydroxide. The 40mg strength also contains lactose produced from cow’s milk.

methylPREDNISolone SODIUM SUCCINATE FOR INJECTION comes in the following dosage forms:

Methylprednisolone Sodium Succinate for Injection comes in vials containing sterile powder.

The available formulations are:

• 40 mg per vial
• 125 mg per vial
• 500 mg per vial
• 1 g per vial

Do not use methylPREDNISolone SODIUM SUCCINATE FOR INJECTION if:

• you are allergic to methylprednisolone sodium succinate or any ingredient in this medicine.
• you are lactose intolerant. 40mg strength contains lactose.
• you have a fungal infection or any untreated infection.
• you have recently received a type of vaccine called a live or live / attenuated vaccine. Do not receive this vaccine during treatment with Methylprednisolone Sodium Succinate for Injection.
• you have a blood condition called idiopathic thrombocytopenic purpura (low platelet count), for intramuscular use.

Methylprednisolone Sodium Succinate for Injection should not be used in premature and low-birth infants. The diluent contains benzyl alcohol, which can cause serious side effects and death.

This medicine is not injection via the spinal cord or brain (intrathecal or epidural).

Except for short-term or emergency use such as severe allergic reactions, do not use Methylprednisolone Sodium Succinate for Injection if you have:

• viral diseases like vaccinia (cowpox), varicella (chickenpox), and herpes simplex of the eye
• a serious lung infection (tuberculosis)
• a serious mental disorder (psychoses)
• Cushing's syndrome (a condition caused by excess corticosteroids)
• a stomach ulcer
• kidney problems

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

• have an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm); If you or your child is exposed to measles or chickenpox during treatment with Methylprednisolone Sodium Succinate for Injection, contact your healthcare professional immediately. Serious or fatal side effects can occur if you or your child have not already had these infections.
• have recently had or are about to have any vaccine
• recently had heart problems such as a heart attack, heart failure or heart disease
• have bleeding or blood clotting problems
• have brittle bone (osteoporosis)
• have high blood pressure
• have water retention (oedema)
• have or had seizures or other nervous system problems
• have thyroid problems
• have muscle pain or muscle weakness (such as myasthenia gravis)
• have a tumor of the adrenal glands (pheochromocytoma)
• have certain eye diseases such as glaucoma, cataracts, herpes infection or any problems with the retina
• have a condition known as systemic sclerosis, in which your body makes too much of a protein called collagen.
• have kidney disease
• have liver disease such as cirrhosis
• have diabetes (high blood sugar)
• have certain mental or mood conditions (such as depression)
• have stomach or gut problems (ulcer, ulcerative colitis)
• have low potassium or calcium
• have Cushing’s disease (caused by an excess of cortisol hormone)
• have a weak immune response. Tell your healthcare professional if you suspect an infection has occurred, as corticosteroids can make infections more likely and may mask their signs
• had any prior use of Methylprednisolone Sodium Succinate for Injection.

Other warnings you should know about:

Serious Side Effects: Methylprednisolone Sodium Succinate for Injection can cause serious side effects, including:

• skin cancer (Kaposi's sarcoma): Kaposi's sarcoma has been reported with corticosteroid therapy, such as Methylprednisolone Sodium Succinate for Injection. Stopping treatment of Methylprednisolone Sodium Succinate for Injection may result in signs of this cancer going away.
• tumor of the adrenal glands (pheochromocytoma). This tumor has been reported with corticosteroid therapy, such as Methylprednisolone Sodium Succinate for Injection. Pheochromocytoma may cause death.
• fat deposition on or outside the lining of the spine (epidural lipomatosis). Taking corticosteroids in high doses for a long period of time can cause epidural lipomatosis.

Surgery: Before you have any operation, tell your doctor, dentist or anesthetist that you are taking Methylprednisolone Sodium Succinate for Injection.

Pregnancy and breastfeeding:

• If you are pregnant, or still able to get pregnant and/or breast-feed, there are specific risks you must discuss with your healthcare professional. Taking Methylprednisolone Sodium Succinate for Injection may:

  • slow the growth and cause low birth weight of the baby.
  • cause cataracts in babies. This risk is associated with mothers who take corticosteroids for a long period of time during pregnancy.
• If you are breastfeeding or planning to breastfeed, tell your healthcare professional.

Male fertility: Taking Methylprednisolone Sodium Succinate for Injection may affect male fertility.

Stopping treatment: If you suddenly stop taking Methylprednisolone Sodium Succinate for Injection, you may experience:

• Serious adrenal insufficiency. Adrenal insufficiency is when the body does not make enough of the cortisol hormone. This may cause death.
• “Withdrawal syndrome”. This includes symptoms such as anorexia, nausea, vomiting, lack of energy, headache, fever, joint pain, peeling of skin, muscle pain, weight loss, and/or low blood pressure.

Skin:

• Dents/holes may appear at the site of injection.
• Tell your healthcare professional you are taking Methylprednisolone Sodium Succinate for Injection since it can affect the results of skin tests.

Driving and Using Machines: Methylprednisolone Sodium Succinate for Injection may cause dizziness, vertigo, vision problems and fatigue. If you experience these side effects you should not drive or operate machinery.

Children (less than 18 years of age):

• Children may experience a decrease in the speed of their growth. The healthcare provider will prescribe the lowest dose to minimize this risk.
• The healthcare professional will conduct frequent tests on the child if they are taking Methylprednisolone Sodium Succinate for Injection for a long period of time. Taking methylprednisolone for a long period of time increases the risk of developing a high intracranial pressure (growing pressure in skull).
• If methylprednisolone is given to a prematurely born baby, monitoring of the heart may be needed.

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 methylPREDNISolone SODIUM SUCCINATE FOR INJECTION:

• Medicines used to:

  • treat cancer such as cyclophosphamide
  • prevent or relieve a sudden worsening of shortness of breath and wheezing (Beta2 agonists such as salbutamol, budesonide and salmeterol)
  • treat bacterial and fungal infections (antibiotics/antifungals such as rifampin, itraconazole, clarithromycin, ketoconazole, troleandomycin*, erythromycin and amphotericin B)
  • prevent the elimination of a neurotransmitter, acetylcholine (such as neostigmine and pyridostigmine)
  • prevent blood clotting (such as warfarin or heparin) treat epilepsy (such as phenobarbital, phenytoin or carbamazepine)
  • treat diabetes (such as insulin, glibenclamide or metformin)
  • treat high blood pressure (such as amlodipine or quinapril)
  • prevent nausea and vomiting associated with cancer chemotherapy treatment (such as aprepitant or fosaprepitant)
  • treat high cholesterol (such as cholestyramine)
  • treat tuberculosis (such as isoniazid)
  • treat HIV infections
  • treat Cushing’s syndrome, breast or ovarian cancer (aromatase inhibitors such as aminoglutethimide*)
  • treat heart problems (such as digoxin, calcium channel blockers)
  • reduce extra fluid in the body (diuretics such as furosemide)
  • help prevent organ rejection such as cyclosporine or tacrolimus
  • to treat inflammatory diseases (including rheumatoid arthritis) such as azathioprine or methotrexate
  • treat anxiety or mental health disorders/mental illnesses (like diazepam or clozapine)
  • treat diarrhea

*not marketed in Canada

• Vaccines
• Neuromuscular Blocking Agents (agents that block signals between nerves and muscles such as pancuronium)
• Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen
• Sympathomimetic Agents (agents that mimic the effects of adrenaline like salbutamol, used to treat asthma)
• Hormone replacement therapy or hormonal oral birth control

Do not drink grapefruit juice while taking Methylprednisolone Sodium Succinate for Injection.

How to take methylPREDNISolone SODIUM SUCCINATE FOR INJECTION:

• Methylprednisolone Sodium Succinate for Injection will be given to you by your healthcare professional. They will decide to give Methylprednisolone Sodium Succinate for Injection to you by either:

  • Infusion into your vein (intravenous infusion) over 1 hour; or
  • Slow injection into your vein (intravenous injection); or
  • Injection into your muscle (intramuscular).
• Your healthcare professional will decide on the site of injection, as well as how much of the medicine and how many injections you will receive.
• The healthcare professional will prescribe the lowest possible dose for the minimum period of time.

Usual dose:

• The dose you will receive depends on the:

  • type of condition being treated;
  • severity of the condition;
  • your response to the treatment, and
  • your exposure to physical stress like infection, surgery or injury.

Overdose:

What are possible side effects from using methylPREDNISolone SODIUM SUCCINATE FOR

INJECTION?

These are not all the possible side effects you may have when taking Methylprednisolone Sodium Succinate for Injection. If you experience any side effects not listed here, tell your healthcare professional.

Infections:

Methylprednisolone Sodium Succinate for Injection may:

• hide symptoms of infections

• reactivate dormant infections

  • induce infections due to lowered body resistance

Heart problems:

• Low blood pressure
• Fainting
• Blood clots

• Thrombophlebitis (vein inflammation)

  • Pediatric hypertrophic cardiomyopathy (thickening of heart muscle)
  • Facial blushing

Skin problems:

• Ecchymoses (spots caused by ruptured blood vessels)

  • Petechiae (reddish spot containing blood that appears in skin)
• Acne
• Rash, redness, itchy skin
• Dry scaly skin
• Increased sweating
• Lightening or darkening of an area of the skin

• Abscess

  • Thinning scalp hair
  • Injection site infections/reactions: blistering, pain, skin changes/depressions, tenderness, warmth in the area around the injection

Endocrine and metabolism problems:

• Development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids)
• Moon face (enlargement of face and forehead)
• Weight gain
• Abnormal fat deposits
• hypopituitarism (a condition in which your pituitary gland fails to produce one or more of its hormones or does not produce enough of them).

• Suppression of hypothalamic pituitary-adrenal axis (a condition that could lead to disabling the body’s responses to physiological

  • trauma)
  • Tumor lysis syndrome (TLS): This is the sudden, rapid death of cancer cells due to treatment. TLS can cause life-threatening kidney failure and heart problems.
  • Suppression of growth in children
  • Sodium retention and excretion
  • Increased urination
  • Decreased carbohydrate (sugar) tolerance
  • New symptoms of diabetes, need for higher doses of insulin or sugar lowering pills in diabetics

Gastrointestinal problems:

• Stomach ulcer or bleeding
• Inflammation of the pancreas, esophagus, peritoneum
• Perforation of the bowel

• Nausea, vomiting, diarrhea

  • Altered sense of taste (with rapid administration of large doses)
  • Abdominal pain, bloating
  • Bowel/bladder dysfunction
  • Increased or decreased appetite

Liver problems:

• Enlarged liver

• Liver injury

  • Hepatitis (liver inflammation)

Musculoskeletal problems:

• Muscle disease
• Muscle pain
• Loss of muscle mass
• Malaise (feeling of general discomfort or uneasiness)

• Aseptic necrosis (tissue death)

  • Fractures caused by disease, spine fractures
  • Tendon rupture, particularly of the Achilles tendon
  • Charcot joint disease (foot and ankle problems)

Nervous system problems:

• Increased pressure within the skull with oedema and inflammation of the optic nerve
• Headache
• Pain and tenderness

• Impaired sensation, strength and reflexes

  • Sensation of tingling, tickling, prickling or burning of a person’s skin
  • Vertigo, dizziness
  • Meningitis (inflammation of membranes that surround brain and spinal cord)
  • Amnesia

Eye problems:

• Protrusion of the eyeball

  • Blindness

Psychiatric problems:

• Emotional instability
• Euphoria (intense feelings of well-being, elation, happiness, excitement, and joy)

• Personality changes

  • Delusion
  • Hallucination
  • Confusion
  • Schizophrenia
  • Irritability

Sexual Function/Reproduction:

• Irregular periods

  • Increased or decreased mobility and number of sperm

Blood problems:

• Above normal white blood cell count

• Above normal cholesterol or triglycerides/blood fats

  • Abnormal blood tests (ex. liver enzymes and urea)

Other:

• Hiccups

  • Fatigue

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:

Before Reconstitution: Store Methylprednisolone Sodium Succinate for Injection at room temperature (15°C - 25°C). Protect from light. Keep out of the reach of children.

After Reconstitution: Store reconstituted solution at room temperature (15°C - 25°C). Use reconstituted solution within 24 hours after mixing Sterile Water for Injection, (without bacteriostatic) and 48 hours after mixing with Bacteriostatic Water for Injection. Protect from light. Keep out of the reach of children.

If you want more information about methylPREDNISolone SODIUM SUCCINATE FOR INJECTION:

• 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 http://www.tevacanada.com ; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com .

Last Revised: OCT 9, 2024