Patient Medication Information: uses, side effects, how to take - Methylprednisolone Sodium Succinate for Injection, USP (Hikma Canada)
What Methylprednisolone Sodium Succinate for Injection, USP is used for:
Methylprednisolone Sodium Succinate for Injection, USP is used in adults and children to treat many conditions. These include allergic reactions and inflammation.
How Methylprednisolone Sodium Succinate for Injection, USP works:
Methylprednisolone Sodium Succinate for Injection, USP contains a corticosteroid hormone. It decreases the body’s immune response to certain diseases and reduces inflammation.
The ingredients in Methylprednisolone Sodium Succinate for Injection, USP are:
Medicinal ingredient: methylprednisolone sodium succinate
Non-medicinal ingredients: Dextrose anhydrous (present in 40 mg/vial strength only), Monobasic sodium phosphate dihydrate, Dibasic sodium phosphate anhydrous, Sodium hydroxide.
Methylprednisolone Sodium Succinate for Injection, USP comes in the following dosage forms:
Methylprednisolone Sodium Succinate for Injection, USP comes in vials:
- Sterile powder: 40 mg/vial and 125 mg/vial
Do not use Methylprednisolone Sodium Succinate for Injection, USP if:
- you are allergic to methylprednisolone sodium succinate, to any other steroid medicine or any of the other ingredients in Methylprednisolone Sodium Succinate for Injection, USP;
- 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, USP.
- you have a blood condition called idiopathic thrombocytopenic purpura if Methylprednisolone Sodium Succinate for Injection, USP is given to you through injection into your muscle. This condition is when you have a low blood platelet count.
Methylprednisolone Sodium Succinate for Injection, USP can be reconstituted using either sterile Bacteriostatic Water for Injection (which contains benzyl alcohol as a preservative) or Sterile Water for Injection (which contains no preservative).
Methylprednisolone Sodium Succinate for Injection, USP should not be used in premature and low birth weight infants if the diluent used contains benzyl alcohol. Benzyl alcohol can cause serious side effects and death.
Methylprednisolone Sodium Succinate for Injection, USP should not be injected into your spine 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, USP 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 are given Methylprednisolone Sodium Succinate for Injection, USP. Talk about any health conditions or problems you may have, including if you:
- have an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm);
- 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 disease (osteoporosis);
- have high blood pressure;
- have water retention (edema);
- have or had seizures or other nervous system problems;
- have thyroid problems;
- have muscle pain or muscle weakness (such as myasthenia gravis);
- have a tumour 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 or high blood sugar;
- have certain mental or mood conditions (such as depression);
- have stomach or gut problems (such as ulcer or ulcerative colitis);
- have low blood 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 (such as Methylprednisolone Sodium Succinate for Injection, USP) can make infections more likely and may mask their signs;
- had any prior use of Methylprednisolone Sodium Succinate for Injection, USP.
Other warnings you should know about:
Methylprednisolone Sodium Succinate for Injection, USP can cause serious side effects, including:
- Kaposi's sarcoma (skin cancer): Kaposi's sarcoma has been reported with corticosteroid therapy, such as Methylprednisolone Sodium Succinate for Injection, USP. Stopping treatment of Methylprednisolone Sodium Succinate for Injection, USP may result in signs of this cancer going away.
- Pheochromocytoma (tumour of the adrenal glands): This tumour has been reported with corticosteroid therapy, such as Methylprednisolone Sodium Succinate for Injection, USP. Pheochromocytoma may cause death.
- Epidural lipomatosis (fat deposition on or outside the lining of the spine): Taking corticosteroids in high doses for a long period of time can cause epidural lipomatosis.
Surgery: Before you have any operation, tell your healthcare professional (for example your doctor, dentist or anesthetist) that you are taking Methylprednisolone Sodium Succinate for Injection, USP.
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, USP 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.
- You should tell your healthcare professional if you are breast-feeding or planning to breastfeed as small amounts of corticosteroid medicines (such as Methylprednisolone Sodium Succinate for Injection, USP) may get into breast milk.
Male fertility: Taking Methylprednisolone Sodium Succinate for Injection, USP may affect male fertility.
Stopping treatment: Talk to your healthcare professional before stopping Methylprednisolone Sodium Succinate for Injection, USP. If you suddenly stop taking Methylprednisolone Sodium Succinate for Injection, USP, you may experience:
- Serious adrenal insufficiency: This 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
Immune system:
- If you or your child is exposed to measles or chickenpox during treatment with Methylprednisolone Sodium Succinate for Injection, USP, contact your healthcare professional immediately. Serious or fatal side effects can occur if you or your child have not already had these infections or immunized/vaccinated for these infections previously.
Methylprednisolone Sodium Succinate for Injection, USP may:
- hide symptoms of infection;
- worsen symptoms of existing infections;
- cause new infections due to lowered body resistance.
Skin:
- Dents/holes may appear at the site of injection.
- Tell your healthcare professional you are taking Methylprednisolone Sodium Succinate for Injection, USP since it can affect the results of skin tests.
Driving and Using Machines: Methylprednisolone Sodium Succinate for Injection, USP 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 professional 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, USP 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.
- Methylprednisolone Sodium Succinate for Injection, USP is not recommended to be used in premature and low birth weight infants when sterile Bacteriostatic Water for Injection is used as a diluent. Sterile Bacteriostatic Water for Injection contains benzyl alcohol which has been reported to cause “gasping syndrome” that may result in death.
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, USP:
Medicines used to:
- treat cancer such as cyclophosphamide
- prevent or relieve a sudden worsening of shortness of breath and wheezing (Beta-2 agonists) such as salbutamol, budesonide and salmeterol
- treat bacterial and fungal infections (antibiotics and antifungals) such as rifampin, itraconazole, clarithromycin, ketoconazole, troleandomycin, erythromycin and amphotericin B
- treat myasthenia gravis (a muscle condition) such as neostigmine and pyridostigmine
- “thin” the blood or prevent blood clotting (anticoagulants) such as acenocoumarol, warfarin or heparin
- treat epilepsy such as phenobarbital, phenytoin or carbamazepine
- treat diabetes such as insulin, glibenclamide or metformin
- prevent or treat 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 such as indinavir or ritonavir
- in surgery to block signals between nerves and muscles (neuromuscular blocking agents) such as pancuronium or vecuronium
- treat Cushing’s syndrome, breast or ovarian cancer (aromatase inhibitors) such as aminoglutethimide
- treat heart problems or high blood pressure such as digoxin, diltiazem, amlodipine or quinapril
- reduce extra fluid in the body (diuretics, also know as “water pills”) 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
- vaccines. Tell your healthcare professional if you have recently had, or are about to have any vaccination
- treat inflammation such as aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen
- for hormone replacement therapy or hormonal oral contraceptives such as ethinyl estradiol and norethindrone
Do not eat grapefruit or drink grapefruit juice while taking Methylprednisolone Sodium Succinate for Injection, USP.
How Methylprednisolone Sodium Succinate for Injection, USP is given:
Methylprednisolone Sodium Succinate for Injection, USP will be given to you by your healthcare professional. They will decide to give Methylprednisolone Sodium Succinate for Injection, USP 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 condition you are being treated for;
- the severity of your condition;
- your response to the treatment; and
- your exposure to physical stress like infection, surgery or injury.
Overdose:
If you think you, or a person you are caring for, have taken too much Methylprednisolone Sodium Succinate for Injection, USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using Methylprednisolone Sodium Succinate for Injection, USP:
These are not all the possible side effects you may have when taking Methylprednisolone Sodium Succinate for Injection, USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Methylprednisolone Sodium Succinate for Injection, USP may include:
- facial blushing;
- skin problems such as reddish spot containing blood that appears in skin, acne, red or tender bumps on your skin, rash, redness, itchy skin, dry and scaly skin, increased sweating, lightening or darkening of an area of skin, abscess (pocket of pus), thinning of hair, and stretch marks;
- abnormal hair growth;
- gastrointestinal problems such as nausea, vomiting, diarrhea, altered sense of taste, abdominal pain, bloating, abnormal appetite, and indigestion;
- loss of muscle mass and muscle weakness;
- muscle cramps and spasms;
- nervous system problems (including nerve inflammation and damage) such as headache, pain, tenderness, impaired sensation, strength and reflexes, sensation of heat, cold, numbness, sensation of tingling, tickling, prickling, or burning of a person's skin, vertigo, dizziness, forgetfulness, twitching, drowsiness, ringing in ears, and tremors;
- abnormal behaviour such as anxiety, nervousness, confusion, euphoria (intense feelings of well-being, elation, happiness, excitement and joy), personality changes, irritability, mood swings/emotional instability, mania (feeling high), drug dependence, and trouble sleeping;
- irregular periods;
- memory loss;
- suppressed growth in children.
Methylprednisolone Sodium Succinate for Injection, USP can cause abnormal blood test results. Your healthcare professional will decide when to perform the tests and interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Abnormal (high or low) blood pressure: headaches, dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up), racing pulse, or heart palpitations. | √ | ||
| Allergic reactions: rash, hives, swelling of the face, lips, tongue, or throat, itching, difficulty swallowing, difficulty breathing, drop in blood pressure, dizziness, fainting, wheezing, nausea, or vomiting. | √ | ||
| Arrhythmia (abnormal heart rhythms): fast, slow, pounding, or irregular heartbeat. | √ | ||
| Aseptic necrosis (tissue death): progressive or persistent pain, limited range of motion in a joint or limb, joint pain, swelling, tenderness, weakness, or joint stiffness. | √ | ||
Bladder problems: not reaching the bathroom in time, or having to pee multiple times during the night. | √ | ||
| Bleeding, poor wound healing | √ | ||
| Blood clots: swelling, pain or tenderness, usually in the arm or leg, tingling, numbness, pale skin, muscle pain, or muscle spasms. | √ | ||
| Breathing problems or breathing stops | √ | ||
| Cardiac arrest (heart stops beating suddenly): fatigue, loss of consciousness, dizziness, nausea, chest pain, shortness of breath, or pounding heart beat. | √ | ||
| Cardiomyopathy in children (thickening of the heart muscle): fatigue, cough, shortness of breath, swelling, poor growth, or difficulty gaining weight. | √ | ||
| Charcot joint disease (foot and ankle issues due to nerve-related problems): joint swelling, foot pain, or heat or redness over the joint. | √ | ||
| Coma (deep loss of consciousness) | √ | ||
| Cushingoid syndrome (increased cortisol levels): weight gain, rounded “moon” face, thin and fragile skin, easy bruising, fatigue, headache, or weak muscles. | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping, sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, or reduced libido (sex drive). | √ | ||
| Diabetes (high blood sugar) or decreased sugar tolerance: increased thirst, increased urination, increased appetite, or have blurry vision. | √ | ||
| Edema (swelling or fluid retention): unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages. | √ | ||
| Epidural lipomatosis (fat build-up around the spine): back pain, weakness, loss of sensation, or reflexes that are too slow or too fast. | √ | ||
| Eye problems including cataracts: retina pulled away from normal position, double vision, blurry vision, eye pain, increased pressure in the eyes, blindness in one or both eyes, or bulging eyes. | √ | ||
| Flare up of a previous tuberculosis: cough that does not go away, fever, loss of weight, coughing blood, or pain in the chest. | √ | ||
| Fractures (broken bones): pain, bruising, swelling over the broken bone, or sudden pain that is worse when walking or standing. | √ | ||
| Heart attack: pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, or irregular heartbeat. | √ | ||
| Heart failure: dizziness, fatigue, weakness, shortness of breath, fainting, irregular heart rate, or fast pounding heart beat. | √ | ||
| Increased intracranial pressure (pressure within the skull with swelling) | √ | ||
Infections: symptoms of an existing infection worsen, reactivation of a dormant infection, persistent fever, cough, feeling unwell, sore throat, painful urination, eye pain, eye discharge. | √ | ||
| Injection site infections/reactions: blistering, pain, skin changes or depressions, tenderness, warmth in the area around the injection, or inflammation. | √ | ||
| Kaposi's sarcoma (cancer that causes tumours in the blood vessels and skin): slightly elevated purple, pink, brown, black, blue, or red blotches or bumps anywhere on the skin or in the mouth and/or throat. | √ | ||
| Liver problems including liver injury and hepatitis (inflammation of the liver): yellowing of the skin or whites of eyes, urine turns dark, nausea, vomiting, lower stomach pain, fatigue, fever, light-coloured stool, or unusual tiredness. | √ | ||
| Meningitis (infection of membranes that surround brain and spinal cord): fever, nausea, vomiting, headache, stiff neck, extreme sensitivity to bright light, confusion, seizures, sleepiness, difficulty waking, no appetite or thirst, or skin rash. | √ | ||
| Metabolic acidosis (high level of acid in the blood): fatigue, abdominal pain, confusion, dizziness, loss of appetite, headache, nausea, vomiting, weakness, or increased heart rate. | √ | ||
| Osteoporosis (thin, fragile bones): broken bones, joint pain, bone pain, or back pain that gets worse when standing or walking. | √ | ||
| Pancreatitis or esophagitis (inflammation of the pancreas or esophagus): abdominal pain, nausea, vomiting, hard or painful swallowing, heartburn, fever, rapid heart beat, or tenderness when touching the abdomen. | √ | ||
| Perforation of the bowel (a hole in the intestines): abdominal pain, feeling bloated, nausea, vomiting, chills, or fever. | √ | ||
| Peritonitis (inflammation of the stomach lining): severe abdominal pain that is worse when you move, feeling sick to your stomach or throwing up, fever, or swollen belly. | √ | ||
| Pheochromocytoma (adrenal gland tumour): high blood pressure, sweating, rapid heartbeat, pale appearance, or headache. | √ | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle pain that you cannot explain, muscle tenderness or weakness, dark urine. | √ | ||
| Schizophrenia or worsening of schizophrenia: hallucinations (feeling, seeing, or hearing things which do not exist), delusions, disorganized or incoherent thinking, feeling paranoid, suspicious, or scared. | √ | ||
| Seizures (fits): loss of consciousness with uncontrollable shaking. | √ | ||
| Skin cancer (unusual skin growth): blotches of skin that may be red, purple, brown or black and may be raised. | √ | ||
| Stomach ulcers (burst or bleeding ulcers): stomach pain, bleeding from the rectum, black or bloodstained stools, vomiting blood, loss of appetite, or weight loss. | √ | ||
| Suicidal thoughts or actions | √ | ||
| Suppression of hypothalamic pituitary-adrenal axis: (body’s responses to natural stress do not work properly): fatigue, depression and anxiety, difficulty sleeping, weakness, or loss of muscle mass. | √ | ||
| Tendon rupture (particularly of the Achilles tendon): a snap or popping sound with severe pain at the site of the break, bruising, or inability to use the arm or leg with the break. | √ | ||
| Thinning of skin, fragile skin | √ | ||
| Tumour lysis syndrome (sudden, rapid death of cancer cells due to the treatment): life-threatening kidney failure and heart problems, nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, lack of urination, clouding of urine, muscle spasms, muscle twitching, tiredness, joint pain, severe muscle weakness, or seizures. | √ | ||
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.
Storage:
Before Reconstitution: Store Methylprednisolone Sodium Succinate for Injection, USP sterile powder at room temperature (15° - 30°C). Protect from light.
After Reconstitution: Store reconstituted solution at room temperature (15° - 30°C). Use reconstituted solution within 48 hours after mixing. Protect from light.
Keep out of reach and sight of children.
If you want more information about Methylprednisolone Sodium Succinate for Injection, USP:
- 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) or by calling 1-800-656-0793.
1050-55 Standish Court
Mississauga ON
Canada, L5R 0G3
Date of Authorization: 2026-02-09
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.