Methylprednisolone Injection

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This medication is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. Methylprednisolone is a corticosteroid hormone. This injectable form of methylprednisolone is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions.Methylprednisolone may also be used with other medications in hormone disorders.

This medication is usually given by slow injection into a vein or directly into a muscle, as directed by your doctor. The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Do not stop using this medication without consulting your doctor. Some conditions may worsen or you may experience withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness) when this drug is suddenly stopped. To prevent these withdrawal symptoms when stopping methylprednisolone, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details and report any withdrawal reactions immediately. See also Precautions section.Tell your doctor if your condition does not improve or if it worsens.

Nausea, vomiting, heartburn, headache, dizziness, trouble sleeping, appetite changes, increased sweating, acne, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough, white patches in the mouth).Tell your doctor right away if you have any serious side effects, including: unusual weight gain, menstrual period changes, bone/joint pain, easy bruising/bleeding, mental/mood changes (such as mood swings, depression, agitation), muscle weakness/pain, puffy face, slow wound healing, swelling of the ankles/feet/hands, thinning skin, unusual hair/skin growth, vision problems, fast/slow/irregular heartbeat.This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, consult your doctor or pharmacist immediately: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds.Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aldesleukin, mifepristone, other drugs that can also cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/dabigatran, NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Other medications can affect the removal of methylprednisolone from your body, which may affect how methylprednisolone works. Examples include azole antifungals (such as ketoconazole), boceprevir, cyclosporine, estrogens, HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), St. John's wort, some drugs used to treat seizures (such as phenytoin, phenobarbital, carbamazepine), telaprevir, among others.This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Your doctor will check your progress closely while you are receiving methylprednisolone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood or urine tests may be needed to check for unwanted effects.

Using methylprednisolone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using methylprednisolone, tell your doctor right away.

If you are using methylprednisolone for a long time, the skin at the injection site may become slightly depressed or wrinkled. Talk to your doctor if you notice any of these changes at the injection site: depressed or indented skin, or pain, redness, or sloughing (peeling) of the skin.

methylprednisolone may cause an allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using methylprednisolone.

If you are using methylprednisolone for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of methylprednisolone might need to be changed for a short time while you have extra stress.

Using too much of methylprednisolone or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using methylprednisolone: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

methylprednisolone may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving methylprednisolone.

While you are being treated with methylprednisone injection, do not have any immunizations (vaccines) without your doctor's approval. Methylprednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

methylprednisolone might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using methylprednisolone, tell the doctor if you think your child is not growing properly.

methylprednisolone may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while using methylprednisolone.

Make sure any doctor or dentist who treats you knows that you are using methylprednisolone. methylprednisolone may affect the results of certain skin tests.

Do not stop using methylprednisolone suddenly without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

A. FOR INTRAMUSCULAR ADMINISTRATION

When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows:

Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions.

Dermatologic Diseases

Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Gastrointestinal Diseases

To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.

Hematologic Disorders

Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.

Miscellaneous

Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Neoplastic Diseases

For palliative management of leukemias and lymphomas.

Nervous System

Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.

Ophthalmic Diseases

Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal Diseases

To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.

Respiratory Diseases

Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

B. FOR INTRA-ARTICULAR OR SOFT TISSUE ADMINISTRATION

(See WARNINGS)

Methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

C. FOR INTRALESIONAL ADMINISTRATION

Methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata, discoid lupus erythematosus, keloids, localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques, necrobiosis lipoidica diabeticorum. Methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).