Methylprednisolone Acetate Injectable Suspension USP: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Methylprednisolone Acetate Injectable Suspension USP is used in the treatment of various conditions such as allergy or inflammation.

What it does:

Methylprednisolone Acetate Injectable Suspension USP contains a corticosteroid hormone. It decreases the body’s immune response to certain diseases and reduces inflammation.

When it should not be used:

Do not take Methylprednisolone Acetate Injectable Suspension USP if you have:

• allergies to methylprednisolone acetate or any other steroid medicine or any of the other ingredients in Methylprednisolone Acetate Injectable Suspension USP; or
• any fungal infection; or
• a blood condition called idiopathic thrombocytopenic purpura (low platelet count), if Methylprednisolone Acetate Injectable Suspension USP is administered intramuscularly; or
• received certain types of vaccines (shots) that are live or live-attenuated; or
• viral diseases including vaccinia (cowpox), varicella (chicken pox), and herpes simplex of the eye; or
• unstable joints, when Methylprednisolone Acetate Injectable Suspension USP is injected into the joint.

Methylprednisolone Acetate Injectable Suspension USP should not be injected into your veins or your spine.

Methylprednisolone Acetate Injectable Suspension USP with benzyl alcohol should not be given to premature infants. However, Methylprednisolone Acetate Injectable Suspension USP with myristyl gamma picolinium chloride (MGPC) may be used.

What the medicinal ingredient is:

Methylprednisolone acetate

What the nonmedicinal ingredients are:

Each mL of sterile aqueous suspension of Methylprednisolone Acetate Injectable Suspension USP multidose formulation contains: polyethylene glycol-3350, benzyl alcohol as preservative, polysorbate-80, monobasic sodium phosphate, dibasic sodium phosphate, sodium chloride for tonicity, sodium hydroxide and/or hydrochloric acid, if necessary, to adjust pH and water for injection.

Each mL of sterile aqueous suspension of Methylprednisolone Acetate Injectable Suspension USP preservative free formulation contains: polyethylene glycol-3350, myristyl-gamma-picolinium chloride, sodium chloride for tonicity, sodium hydroxide and/or hydrochloric acid, if necessary, to adjust pH and water for injection.

What dosage forms it comes in:

Methylprednisolone Acetate Injectable Suspension USP is available in two different formulations:

1. 1) Methylprednisolone Acetate Injectable Suspension USP multidose formulation:
2. • 40 mg/mL dose, supplied in 2 mL vials and packaged in boxes of 5 and supplied in 5 mL vials and packaged in boxes of 5.
3. • 80 mg/mL dose, supplied in 5 mL vials and packaged in boxes of 1.
4. 2) Methylprednisolone Acetate Injectable Suspension USP preservative free formulation:
5. • 40 mg/mL dose, supplied in 1 mL vials and packaged in boxes of 10.
6. • 80 mg/mL dose, supplied in 1 mL vials and packaged in boxes of 5.

WARNINGS AND PRECAUTIONS

Methylprednisolone Acetate Injectable Suspension USP with preservative benzyl alcohol is not recommended for injection into the joint (intra-synovial or intra-articular injection).

Before taking Methylprednisolone Acetate Injectable Suspension USP, talk to your doctor if you have:

• an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm);
• recently had myocardial infarction (heart attack);
• thromboembolic disorders (bleeding or blood clotting problems);
• brittle bone (osteoporosis);
• high blood pressure;
• water retention (oedema);
• seizures (fits);
• thyroid problems;
• muscle pain or weakness (such as myasthenia gravis);
• skin cancer (Kaposi’s sarcoma);
• heart problems such as heart failure;
• certain eye diseases such as glaucoma, cataracts; herpes infection;
• kidney disease;
• liver disease such as cirrhosis;
• certain mental or mood conditions (such as depression);
• stomach or gut problems (ulcer, ulcerative colitis);
• low potassium or calcium;
• Cushing’s disease (caused by an excess of cortisol hormone);
• weak immune response;
• high blood sugar.
• a condition known as systemic sclerosis, in which your body makes too much of a protein called collagen.

Before you have any operation, tell your doctor, dentist or anesthetist that you are taking Methylprednisolone Acetate Injectable Suspension USP.

Pregnancy and breast feeding

You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the baby’s growth.

You should also tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk.

Children:

Corticosteroids can affect growth in children.

Methylprednisolone Acetate Injectable Suspension USP with preservative benzyl alcohol is not recommended to be used in infants since benzyl alcohol has been reported to cause “gasping syndrome” that may result in death.

INTERACTIONS WITH THIS MEDICATION

Before taking Methylprednisolone Acetate Injectable Suspension USP talk to your doctor about all your other medications, including those you bought without prescription, herbal or natural products. The following may interact with Methylprednisolone Acetate Injectable Suspension USP:

• drugs to treat glaucoma and epilepsy such as acetazolamide
• drugs to prevent or alleviate nausea and vomiting such as aprepitant or fosaprepitant
• drugs to treat cancer such as aminoglutethimide or cyclophosphamide
• drugs to “thin” the blood; anticoagulants such as acenocoumarol, phenindione and warfarin
• drugs to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine

• antibiotics and antifungals (such as ketoconazole,

  • itraconazole amphotericin B, erythromycin, clarithromycin, troleandomycin, rifampicin and rifabutin)
  • aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen
  • drugs to treat epilepsy such as barbiturates, carbamezipine, phenytoin and primidone
  • drugs for heartburn and acid indigestion such as cimetidine
  • cyclosporine
  • drugs for heart problems or high blood pressure such as calcium channel blockers, digoxin and diltiazem
  • water pills (diuretics)
  • hormone replacement therapy or hormonal oral contraceptives
  • drugs to treat HIV infections such as indinavir or ritonavir
  • pancuronium or vercuronium – or other medicines called neuromuscular blocking agents which are used in some surgical procedures
  • tacrolimus – used following an organ transplant to prevent rejection of the organ
  • vaccines – tell your doctor or nurse if you have recently had, or are about to have any vaccination
  • drugs to treat diabetes
  • drugs to treat tuberculosis
  • drugs to treat high cholesterol (cholestyramine)
  • 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 Acetate Injectable Suspension USP.

Driving and Using Machines: Methylprednisolone Acetate Injectable Suspension 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 Acetate Injectable Suspension USP is to be given to you as an injection to the joint (intra-articular or intra-synovial injection), or into a muscle (intramuscular injection) by your health care provider. The dose of Methylprednisolone Acetate Injectable Suspension USP will depend on your condition and how severe it is.

When your condition has improved, your dose will be reduced gradually.

Methylprednisolone Acetate Injectable Suspension USP should not be stopped abruptly.

Overdose:

If you think you have taken too much Methylprednisolone Acetate Injectable Suspension USP, contact your healthcare professional, 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 Acetate Injectable Suspension USP can have side effects although not everybody gets them.

Methylprednisolone Acetate Injectable Suspension USP may hide symptoms of infections, may cause latent infections to become active, and may induce infections by normally inoffensive organisms due to lowered body resistance.

Potential side effects with Methylprednisolone Acetate Injectable Suspension USP include:

Allergic Reactions:

• anaphylaxis (a severe, life-threatening allergic reaction)
• cardiac arrest
• bronchospasm (narrowing of the airway)

Cardiovascular:

• heart failure
• heart attack
• arrhythmia (irregular heartbeat)
• high and low blood pressure
• blood clots
• thrombophlebitis (vein inflammation)

Dermatologic:

• thin fragile skin
• impaired wound healing
• swelling
• ecchymosis (spots caused by ruptured blood vessels)
• petechiae (reddish spot containing blood that appears in skin)
• stretch marks
• dry, scaly skin
• rash
• redness
• itching
• acne
• increased sweating
• injection site reaction
• lightening or darkening of an area of skin
• abscess
• suppressed reaction to skin tests
• thinning hair

Endocrine and Metabolism:

• development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids)

  • moon face (enlargement of chin 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
  • new symptoms of diabetes

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
• diarrhea
• indigestion
• bowl/bladder dysfunction
• increased appetite
• peritonitis

Hematology:

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

Hepatic:

• enlarged liver

Musculoskeletal:

• loss of muscle mass
• muscle weakness
• muscle pain
• malaise (feeling of general discomfort or uneasiness)
• osteoporosis
• pathological fractures
• vertebral compression fractures
• tendon rupture, (particularly of the Achilles tendon)
• Charcot joint disease (neuropathic arthropathy)
• pain and inflammation of the tissues surrounding the injection site
• joint pain

Neurologic:

• seizures
• headache
• vertigo
• pain and tenderness
• impaired sensation, strength, and reflexes
• sensation of tingling, tickling, prickling, or burning of a person's skin
• amnesia
• dizziness

Ophthalmologic:

• cataracts
• increased intraocular pressure
• glaucoma
• bulging of the eye
• blindness

Psychiatric:

• depression
• emotional instability
• euphoria (intense feelings of well-being, elation, happiness, excitement and joy)
• insomnia
• mood swings
• personality changes
• thoughts of suicide
• delusion
• hallucination
• confusion
• schizophrenia
• anxiety

Sexual Function/Reproduction:

• menstrual irregularities
• increased or decreased motility and number of sperm

Other:

• hiccups, fatigue, irritability, swelling

This is not a complete list of side effects. For any unexpected effects while taking Methylprednisolone Acetate Injectable Suspension USP, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C. Protect from light. Protect from freezing.

Keep out of reach and sight of children.

Shake vigorously until total dispersion of the suspension before using. Discard unused portions of the multidose vials 28 days after initial puncture.

Reporting Side Effects

MORE INFORMATION

If you want more information about Methylprednisolone Acetate Injectable Suspension USP:

• 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 or Sandoz Canada Inc. website www.sandoz.ca , or by calling at: 1-800-361-3062,

or by written request at:

145, Jules-Léger

Boucherville, (QC), Canada

J4B 7K8

or by e-mail at : medinfo@sandoz.com

Last revised: July 20, 2018