A-Methapred

In the U.S.

• A-Methapred
• Depo-Medrol
• SoluMEDROL

Available Dosage Forms:

• Powder for Solution
• Solution
• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

This section provides information on the proper use of a number of products that contain methylprednisolone. It may not be specific to A-Methapred. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine may be given through a needle placed in one of your veins, as a shot into a muscle or joint, or as a shot into a lesion on your skin.

Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Aggression
• agitation
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• mental depression
• mood changes
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Cough
• difficulty with swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• trouble breathing
• unusual tiredness or weakness

• Abdominal or stomach cramping and/or burning (severe)
• abdominal or stomach pain
• backache
• bloody, black, or tarry stools
• dark urine
• darkening of the skin
• decrease in height
• decreased vision
• diarrhea
• eye pain
• eye tearing
• general feeling of illness
• general tiredness or weakness
• facial hair growth in females
• fainting
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• hoarseness
• increased hunger
• increased thirst
• increased urination
• light-colored stools
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• sore throat
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• pain, redness, or hard skin at the injection site
• pitting or depression of the skin at the injection site
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For all uses of this medicine:

• If you have an allergy to methylprednisolone or any other part of A-methapred.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: A fungal infection or malaria infection in the brain.
• If you have a herpes infection of the eye.

Injection (if given in the muscle):

• If you have idiopathic thrombocytopenic purpura (ITP).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take A-methapred with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Not able to sleep.
• Restlessness.
• Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Do not receive a "live" vaccine while using methylprednisolone. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Other drugs may interact with methylprednisolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Methylprednisolone is a prescription medication used to treat:

• low corticosteroid levels. Corticosteroids are steroids naturally produced by the body that are required for normal body function.
• arthritis
• allergic reactions
• asthma
• multiple sclerosis. Multiple sclerosis is a disease in which nerves do not function properly due to inflammation.
• lupus. Lupus is a disease in which the body’s immune system attacks itself.
• severe psoriasis. Psoriasis is a disease in which the skin becomes red, irritated, and flaky.
• certain conditions affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines. Methylprednisolone frequently treats diseases of these organs by reducing inflammation.
• some types of cancer such as leukemia (cancer in bone marrow) and lymphoma (cancer of white blood cells)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 

Serious side effects have been reported with methylprednisolone including:

• Hypersensitivity reaction: Methylprednisolone may trigger an allergic response. Symptoms of a hypersensitivity reaction include:
  • hives
  • difficulty breathing or swallowing
  • swelling
  • rash
  • itching
• Cardiac and renal problems: Methylprednisolone can increase blood pressure, cause water and sodium retention, and increase potassium and calcium excretion. Tell your doctor if you have a history of heart or kidney disease.
• Immunosuppression: Methylprednisolone decreases your body’s immune response to infections. In addition, methylprednisolone can increase sensitivity to vaccines since the immune response is reduced with methylprednisolone use.
• Reactivation of tuberculosis: Tell your doctor if you have had tuberculosis.
• Perforation of the gastrointestinal tract: Methylprednisolone can cause holes in the stomach or intestinal lining.  Tell your doctor if you have a history of ulcers or other digestive system problems.
• Decreased bone formation: Methylprednisolone can prevent the formation of bones, which may result in decreased bone density and osteoporosis.
• Eye damage: Long-term use may lead to cataracts, glaucoma, damage to the optic (eye) nerves, and may worsen an eye infection.
• Electrolyte changes: Corticosteroids can cause a rise sodium and a decrease of potassium. Corticosteroids also cause a loss in calcium.
• Extreme mood changes: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • euphoria (intense feeling of happiness or joy)
  • insomnia
  • mood swings
  • personality changes
  • severe depression
• Stunted growth in children: Growth should be monitored with long-term use of methylprednisolone.
• Kaposi's sarcoma: This type of cancer has been reported to occur in patients receiving corticosteroid therapy. Stopping its use may result in clinical remission.
• Steroid withdrawal: To avoid withdrawal side effects, do not stop taking methylprednisolone suddenly. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

Methylprednisolone can cause dizziness. Do not drive or operate heavy machinery until you know how methylprednisolone affects you.

Do not take methylprednisolone if you:

• have an active fungal infection
• are allergic to methylprednisolone, aspirin, or any ingredient within this medication product

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Methylprednisolone falls into category C.This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

It is not known if methylprednisolone will harm your unborn baby.

Take methylprednisolone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will determine the appropriate dosage and schedule of prednisone depending the disease being treated and your response to the medication. The starting dosage of methylprednisolone may vary from 4 mg to 48 mg a day depending on reason for use.