Methylprednisolone Tablets

• If you have an allergy to methylprednisolone or any other part of this medicine.
• 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.
• If you have nerve problems in the eye.

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

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine (methylprednisolone tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this medicine (methylprednisolone tablets). Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Talk with your doctor before you drink alcohol.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• If you are 65 or older, use this medicine (methylprednisolone tablets) with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine (methylprednisolone tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take in the morning if taking once a day.
• Take with food.
• If you have been taking this medicine (methylprednisolone tablets) for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped this medicine (methylprednisolone tablets).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Chest pain or pressure.
• Period (menstrual) changes.
• Bone or joint pain.
• Change in eyesight.
• Change in the way you act.
• Low mood (depression).
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Fluid and Electrolyte Disturbances

Sodium retention

Congestive heart failure in susceptible patients

Hypertension

Fluid retention

Potassium loss

Hypokalemic alkalosis

Musculoskeletal

Muscle weakness

Loss of muscle mass

Vertebral compression fractures

Pathologic fracture of long bones

Tendon rupture, particularly of the Achilles tendon

Steroid myopathy

Osteoporosis

Aseptic necrosis of femoral and humeral heads

Gastrointestinal

Peptic ulcer with possible perforation and hemorrhage

Ulcerative esophagitis

Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Pancreatitis

Abdominal distention

Dermatologic

Impaired wound healing

Petechiae and ecchymoses

May suppress reactions to skin tests

Thin fragile skin

Facial erythema

Increased sweating

Neurological

Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment

Convulsions

Vertigo

Headache

Endocrine

Development of Cushingoid state

Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness

Menstrual irregularities

Decreased carbohydrate tolerance

Increased requirements of insulin or oral hypoglycemic agents in diabetics

Suppression of growth in children

Manifestations of latent diabetes mellitus

Ophthalmic

Posterior subcapsular cataracts

Glaucoma

Increased intraocular pressure

Exophthalmos

Metabolic

Negative nitrogen balance due to protein catabolism

The following additional reactions have been reported following oral as well as parenteral therapy:

Urticaria and other allergic, anaphylactic or hypersensitivity reactions.