Methylprednisolone Sodium Succinate for Injection (Teva Canada, 5 G): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABOUT THIS MEDICATION

What the medication is used for:

methylPREDNISolone sodium succinate is used to relieve inflammation (swelling, heat, redness, and pain) caused by various conditions. For example, symptoms of inflammation are often seen with allergic reactions such as severe allergic skin reactions, reactions to insect bites, and anaphylaxis (a severe, life-threatening allergic reaction).

Other conditions treated with methylPREDNISolone sodium succinate include: relief of asthma symptoms caused by inflamed breathing passages, severe skin diseases, and ulcerative colitis (an intestinal disorder). methylPREDNISolone sodium succinate is also used for the prevention of rejection of organ transplants. methylPREDNISolone sodium succinate can be used in combination with other drugs (short term treatment) in some forms of arthritis. methylPREDNISolone sodium succinate can also be used in some surgical procedures.

What it does:

methylPREDNISolone sodium succinate belongs to a group of medicines known as corticosteroids. methylPREDNISolone sodium succinate is a synthetic corticosteroid and is usually used for short periods in severe conditions to decrease

inflammation.

When it should not be used:

Except for short-term or emergency use such as severe allergic reactions, methylPREDNISolone sodium succinate should not be given to patients with:

• viral diseases including vaccinia (cowpox), varicella (chickenpox), and herpes simplex of the eye
• fungal infections

• tuberculosis

  • serious mental disorder (psychoses)
  • Cushing's syndrome (abnormal bodily condition caused by

excess corticosteroids)

• a stomach ulcer
• altered kidney function-

methylPREDNISolone sodium succinate should not be given to patients who are allergic to this medicine or any ingredient of this medication.

What the medicinal ingredient is:

methylprednisolone sodium succinate

What the important nonmedicinal ingredients are:

Lactose hydrous. methylPREDNISolone sodium succinate also contains the following nonmedicinal ingredients: dibasic sodium phosphate dried and monobasic sodium phosphate anhydrous. When needed, the pH is adjusted with sodium hydroxide.

What dosage forms it comes in:

methylPREDNISolone sodium succinate comes in vials containing sterile powder for intravenous or intramuscular injection or for intravenous infusion. The available formulations are:

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

WARNINGS AND PRECAUTIONS

BEFORE you use SOLU-MEDROL talk to your doctor or pharmacist:

• if you have had tuberculosis or any other recent infections.
• if you have or have ever had liver, kidney, intestinal, or heart

• disease; diabetes; an underactive thyroid gland;

  high blood

• pressure; mental illness; myasthenia gravis (a disease
• causing muscle weakness); osteoporosis; herpes eye
• infection; seizures; or ulcers.

• if you are pregnant, planning to be become pregnant or are

• breast-feeding (nursing).

• if you have any allergies to this medicine or to

  any of the

• ingredients of this medication.

• if you had any prior use of

  methylPREDNISolone sodium succinate.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all prescription and non-prescription medications you are using. It is especially important that your doctor or pharmacist know if you are taking medication from the following categories of drugs:

• Antibiotics/Antifungals (e.g. rifampin and
• ketoconazole)

• 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)
• Vaccines

• Drugs that suppress the immune system

  (methotrexate

• or cyclosporin)

• 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)
• Salicylates (e.g. aspirin)
• Sympathomimetic Agents (agents that mimic the
• effects of adrenaline. e.g. salbutamol)

PROPER USE OF THIS MEDICATION

methylPREDNISolone sodium succinate may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer intravenous (or

intramuscular) injection, the solution is prepared as follows:

DIRECTIONS FOR USING THE methylPREDNISolone sodium succinate

1. 1. Remove the protective plastic flip-top seal.
2. 2. Swab the rubber stopper with an antiseptic solution and introduce the required quantity of the diluent by means of a syringe into the vial.
3. 3. Shake the vial thoroughly to dissolve the powder content.
4. 4. Withdraw the dose in the usual manner with the help of a syringe.

lReconstitute with Sterile Water for Injection, or, if required, Bacteriostatic Water for Injection

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 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:

There is no easily noticeable symptom of an acute overdose of methylPREDNISolone sodium succinate. If an overdose occurs, methylPREDNISolone sodium succinate can be eliminated through dyalisis. Continuous overdosing would require careful gradual reduction of the dose of the medication in order to prevent the occurrence of a condition where the body would be unable to normally produce certain hormones.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been reported with the systemic use of corticosteroid preparations such as methylPREDNISolone sodium succinate. Their inclusion below does not necessarily mean that the specific event has been observed with

methylPREDNISolone sodium succinate.

methylPREDNISolone sodium succinate may hide symptoms of infections, may cause latent infections becoming active, may induce infections by normally inoffensive organisms due to lowered body resistance.

Immune System Disorders: allergic reactions, including anaphylaxis (a severe, life-threatening allergic reaction), cardiac arrest, bronchospasm (airway constriction), suppression of reactions to skin tests.

Endocrine Disorders: development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids), 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.

Metabolism and Nutrition Disorders: sodium retention and excretion, fluid retention, increased urination, decreased carbohydrate tolerance, manifestation of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics, negative nitrogen balance due to protein breakdown.

Psychiatric Disorders: mental illness.

Nervous System Disorders: increased pressure within the skull with edema and inflammation of the optic nerve, seizures.

Eye Disorders: cataracts, protrusion of the eyeball, increased intraocular pressure.

Cardiac Disorders: heart failure, heart attack, arrhythmia (irregular heartbeat), high and low blood pressure.

Vascular Disorders: ecchymosis (spots caused by ruptured blood vessels), petechiae (reddish spot containing blood that appears in skin).

Gastrointestinal Disorders: 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).

Skin and Subcutaneous Tissue Disorders: thin fragile skin, impaired wound healing

Musculoskeletal and Connective Tissue Disorders: muscle disease, muscle weakness, osteoporosis, aseptic necrosis (tissue dealth), pathologic fractures, vertebral compression fractures, tendon rupture, particularly of the Achilles tendon.

Reproductive System and Breast Disorders: menstrual irregularities.

methylPREDNISolone sodium succinate may cause abnormal blood and liver tests as well as, sodium and fluid retention.

*An allergic reaction can be a rash, itching, a swollen face, swollen lips or shortness of breath. If this ever happens to you, discontinue methylPREDNISolone

sodium succinate and notify your doctor or pharmacist.

Before Reconstitution: Store methylPREDNISolone sodium succinate Sterile Powder 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

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at

www.healthcanada.gc.ca/medeffect

$ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form

and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, contact your health professional. The Canada Vigilance Program does not provide medical advice. MORE IORMA

TION

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: May 5, 2014