Methylprednisolone Sodium Succinate for Injection, USP (Hospira Healthcare, 1 G / 20 mL): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Methylprednisolone Sodium Succinate for Injection, USP is used in the treatment of various conditions such as allergic reactions or inflammation.

What it does:

Methylprednisolone Sodium Succinate for Injection, USP contains a synthetic corticosteroid and is usually used for short periods in severe conditions to decrease inflammation.

When it should not be used:

• you have any allergies to this medicine or to any of the ingredients of this medication.
• for fungal infections
• for patients taking live or live, attenuated vaccines
• for injection into the brain or the spine
• for a blood condition called idiopathic thrombocytopenic purpura (low platelet count), if Methylprednisolone Sodium Succinate for Injection, USP is administered intramuscularly

Except for short-term or emergency use such as severe allergic reactions, Methylprednisolone Sodium Succinate for Injection, USP should not be given to patients with:

• viral diseases including vaccinia (cowpox), varicella (chickenpox), and herpes simplex of the eye
• tuberculosis
• serious mental disorder (psychoses)
• Cushing's syndrome (abnormal bodily condition caused by excess corticosteroids)
• a stomach ulcer
• altered kidney function

Methylprednisolone Sodium Succinate for Injection, USP should not be given to premature infants because diluent for reconstitution contains benzyl alcohol.

Patients taking Methylprednisolone Sodium Succinate for Injection, USP should not receive live vaccines.

What the medicinal ingredient is:

methylprednisolone sodium succinate

What the important nonmedicinal ingredients are: Methylprednisolone Sodium Succinate for Injection, USP contains the following nonmedicinal ingredients: sodium phosphate, sodium acid phosphate, sodium hydroxide and water for injection.

The diluent for reconstitution of the vials is Bacteriostatic Water for Injection, which contains benzyl alcohol. Benzyl alcohol has been reported to be associated with fatal “Gasping Syndrome” in premature infants.

What dosage forms it comes in:

Methylprednisolone Sodium Succinate for Injection, USP comes in vials containing sterile powder for intravenous or intramuscular injection or for intravenous infusion. The available formulations are:

• 500 mg Vial
• 1 g Vial

WARNINGS AND PRECAUTIONS

BEFORE you use Methylprednisolone Sodium Succinate for Injection, USP talk to your doctor or pharmacist if:

• you have an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm)
• you recently had myocardial infarction (heart attack)
• you have thromboembolic disorders (bleeding or blood clotting problems)
• you have brittle bone (osteoporosis)
• you have high blood pressure (hypertension)
• you have water retention (oedema)
• you have seizures (fits)

• you have thyroid problems (hypothyroidism or

  hyperthyroidism)

• you have muscle pain or muscle weakness (such as myasthenia gravis)
• you have skin cancer (Kaposi’s sarcoma)

• you have certain eye diseases such as glaucoma,

  cataracts, herpes infection

• you have kidney disease
• you have liver disease
• you have heart disease
• you have diabetes (high blood sugar)
• you have certain mental or mood conditions (such as depression)
• you have stomach or gut problems (ulcer, ulcerative colitis)
• you have low potassium or calcium
• you have Cushing’s disease (caused by an excess of cortisol hormone)
• you have weak immune response
• you have thrombophlebitis (vein inflammation)

• you are pregnant, planning to be become pregnant or are breast-feeding (nursing).

• you had any prior use of Methylprednisolone Sodium Succinate for Injection, USP.

• you have a condition known as systemic sclerosis, in

  which your body makes too much of a protein called collagen.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all prescription and non-prescription medications you are using. The following may interact with Methylprednisolone Sodium Succinate for Injection, USP:

• Antibiotics/Antifungals (e.g. rifampin, ketoconazole,

  troleandomycin, erythromycin and amphotericin B)

• Anticholinesterase (drugs that prevent the

  elimination of a neurotransmitter, acetylcholine. e.g. neostigmine and pyridostigmine)

• Drugs that prevent blood clotting (e.g. warfarin or

  heparin)

• Epilepsy medication (e.g. phenytoin)
• Diabetes medication (e.g. insulin or metformin)

• High blood pressure treatment (e.g. amlodipine or

  quinapril)

• Diuretics (e.g. furosemide)

• Heart medication (e.g. digoxin, calcium

  channel blockers)

• Vaccines

• Drugs that suppress the immune system

  (methotrexate or cyclosporine)

• Neuromuscular Blocking Agents (agents that block

  signals between nerves and muscles. e.g. pancuronium)

• Drugs that act on the nervous system (e.g. diazepam

  or clozapine)

• Aspirin and non-steroidal anti-inflammatory

  medicines (also called NSAIDs) such as ibuprofen

• Sympathomimetic Agents (agents that mimic the

  effects of adrenaline. e.g. salbutamol)

• Drugs to treat high cholesterol (e.g., cholestyramine)
• Drugs to treat diarrhea
• Drugs to treat tuberculosis

• Hormone replacement therapy or hormonal oral

  contraceptives

• Aromatase inhibitors (drugs to treat breast or

  ovarian cancer)

• Immunosuppressants (drugs that suppress or reduce

  the strength of the body's immune system

Do not drink grapefruit juice while taking

Methylprednisolone Sodium Succinate for Injection, USP.

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.

PROPER USE OF THIS MEDICATION

Methylprednisolone Sodium Succinate for Injection, USP may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

Usual dose:

Initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated. Larger doses may be required for short-term management of severe, acute conditions. Therapy may be initiated by administering Methylprednisolone Sodium Succinate for Injection, USP intravenously over a period of at least 5 minutes (e.g., doses up to 250 mg) to at least 30 minutes (e.g., doses greater than 250 mg). Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticosteroid therapy is used in combination with, and not replacement for, conventional therapy. The dose needs to be gradually decreased when the medication needs to be discontinued after several days of treatment.

Overdose:

If an overdose occurs, Methylprednisolone Sodium Succinate for Injection, USP can be eliminated through dialysis. Continuous overdosing would require careful gradual reduction of the dose of the medication.

In case of overdose, contact a health care practitioner, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Methylprednisolone Sodium Succinate for Injection, USP can have side effects although not everybody gets them.

Methylprednisolone Sodium Succinate for Injection, USP may hide symptoms of infections, may cause latent infections becoming active, and may induce infections by normally inoffensive organisms due to lowered body resistance.

Potential side effects with Methylprednisolone Sodium Succinate for Injection, USP include:

Allergic Reactions:

• Anaphylaxis (a severe, life-threatening allergic reaction)
• Cardiac arrest
• Bronchospasm (narrowing of the airway)
• Rapid swelling of the skin

Cardiovascular:

• Heart failure
• Heart attack
• Arrhythmia (irregular heartbeat)
• Slow heart beat
• High and low blood pressure
• Fainting
• Blood clots
• Thrombophlebitis (vein inflammation)

Dermatologic:

• Thin fragile skin
• Impaired wound healing

• Ecchymoses (spots caused by ruptured blood

  vessels)

• Petechiae (reddish spot containing blood that

  appears in skin)

• Skin changes (depressions) at the injection
• Acne
• Rash
• Itchiness
• Dry scaly skin
• Swelling
• Redness
• Increased sweating
• Lightening or darkening of an area of the skin
• Abscess
• Thinning scalp hair
• Injection site infections

Endocrine and Metabolism:

• Development of Cushingoid state (abnormal bodily

  condition caused by excess corticosteroids)

• Moon face (enlargement of face and forehead)
• Weight gain
• Abnormal fat deposits

• Suppression of pituitary-adrenal axis (a condition that

  could lead to disabling the body’s responses to physiological stress such as severe infections or trauma)

• Suppression of growth in children
• Abnormal hair growth
• Sodium retention and excretion
• Fluid retention
• Increased urination
• Decreased carbohydrate (sugar) tolerance
• New symptoms of diabetes

• Need for higher doses of insulin or sugar lowering

  pills in diabetics

Gastrointestinal:

• Stomach ulcer
• Stomach bleeding
• Inflammation of the pancreas and esophagus
• Perforation of the bowel
• Nausea

• Vomiting or altered sense of taste (with rapid

  administration of large doses)

• Abdominal pain

  • Bloating
  • Bowel/bladder dysfunction
  • Increased or decreased appetite
  • Peritonitis

Hepatic:

• Enlarged liver
• Liver injury
• Hepatitis

Musculoskeletal:

• Muscle disease
• Muscle weakness
• Muscle pain
• Loss of muscle mass

• Malaise (feeling of general discomfort or uneasiness)

  Osteoporosis

• Aseptic necrosis (tissue death) Pathologic fractures
• Vertebral compression fractures
• Tendon rupture, particularly of the Achilles tendon Charcot joint disease
• Pain and inflammation of the tissues surrounding the injection site

Neurologic:

• Increased pressure within the skull with oedema and inflammation of the optic nerve
• Seizures
• Headache
• Pain and tenderness
• Impaired sensation, strength and reflexes
• Sensation of tingling, tickling, prickling or burning of a person’s skin
• Vertigo
• Meningitis
• Amnesia
• Dizziness

Ophthalmologic:

• Cataracts
• Protrusion of the eyeball
• Increased intraocular pressure
• Glaucoma
• Blindness.

Psychiatric:

• Mental illness
• Depression
• Emotional instability
• Euphoria (intense feelings of well-being, elation, happiness, excitement, and joy)
• Insomnia (difficulty sleeping)
• Mood swings
• Personality changes
• Thoughts of suicide
• Delusion
• Hallucination
• Confusion
• Schizophrenia
• Anxiety
• Irritability

Sexual Function/Reproduction:

• Menstrual irregularities
• Increased or decreased motility and number of sperm

Hematology:

• Above normal white blood cell count
• Above normal cholesterol or triglycerides

• Abnormal blood tests (ex.

  Liver enzymes and urea)

Other: Methylprednisolone Sodium Succinate for Injection, USP may cause abnormal liver tests and may suppress reactions to skin tests. Methylprednisolone Sodium Succinate for Injection, USP may also cause hiccups and fatigue.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

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

After Reconstitution: When reconstituted with Bacteriostatic Water for Injection, the resulting solution may be stored for up to 48 hours at 15 -25 °C. When reconstituted with Sterile Water for Injection, the resulting solution may be stored for up to 24 hours at 15 -25 °C due to risk of microbial contamination. Protect from light. Keep out of the reach of children.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html;
• By calling 1-866-234-2345 (toll-free);
• By completing a Consumer Side Effect Reporting Form and sending it by:
• Fax to 1-866-678-6789 (toll-free), or

• Mail to: Canada Vigilance Program

  Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals may be obtained by contacting the sponsor, Hospira Healthcare Corporation at:

1-800-463-6001.

Hospira Healthcare Corporation.

Kirkland, Québec

H9J 2M5

Last revised: August 03, 2018