Solu-Medrol (Pfizer Canada, 125 mg, 40 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

SOLU-MEDROL belongs to a group of medicines known as corticosteroids. SOLU-MEDROL 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, SOLU-MEDROL 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-

SOLU-MEDROL 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. SOLU-MEDROL also contains the following nonmedicinal ingredients: dibasic sodium phosphate dried and monobasic sodium phosphate anhydrous. When needed, the pH is adjusted with sodium hydroxide.

The diluent for reconstitution of the vials is Bacteriostatic Water for Injection (included in the Act-O-Vials), 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:

SOLU-MEDROL comes in vials containing sterile powder for intravenous or intramuscular injection or for intravenous infusion. The available formulations are:

• 40 mg Act-O-Vial
• 125 mg Act-O-vial
• 500 mg Act-O-Vial
• 1 g Act-O-Vial
• 40 mg Vial
• 125 mg Vial
• 500 mg Vial
• 1 g 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 SOLU-MEDROL.

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

SOLU-MEDROL 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 ACT-O-VIAL SYSTEM

1. 1.

   Press down on plastic activator to force diluent into the lower

   compartment.

2. 2. Gently agitate to effect solution.
3. 3. Remove plastic tab covering center of stopper.
4. 4. Sterilize top of stopper with suitable germicide.
5. 5.

   Insert needle squarely through center of stopper until tip is

   just visible. Invert vial and withdraw dose.

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 SOLU-MEDROL 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 SOLU-MEDROL. If an overdose occurs, SOLU-MEDROL 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 SOLU-MEDROL. Their inclusion below does not necessarily mean that the specific event has been observed with SOLU-MEDROL.

SOLU-MEDROL 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.

SOLU-MEDROL 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 SOLU-MEDROL and notify your doctor or pharmacist

HOW TO STORE IT

Before Reconstitution: store SOLU-MEDROL Sterile Powder at room temperature (15° - 30°C). Protect from light. Keep out of the reach of children

.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 the reach of children

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals may be obtained by contacting the sponsor, Pfizer Canada Inc., at:

1-800-463-6001

Pfizer Canada Inc

Kirkland, Quebec

H9J 2M5

Last revised: May 15, 2006