Solu-MEDROL injection

Methylprednisolone is a steroid that prevents the release of substances in the body that cause inflammation.

Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

Methylprednisolone may also be used for purposes not listed in this medication guide.

You should not use methylprednisolone if you have a fungal infection anywhere in your body. Methylprednisolone injection should not be given to a premature baby.

You should not use methylprednisolone if you are allergic to it, or if you have a fungal infection anywhere in your body. Methylprednisolone injection should not be given to a premature baby.

Methylprednisolone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure methylprednisolone is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• kidney disease;

• cirrhosis or other liver disease;

• past or present tuberculosis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• seizures, epilepsy or recent head injury;

• stomach ulcers, ulcerative colitis, diverticulitis, or recent intestinal surgery;

• a parasite infection that causes diarrhea (pinworms, or threadworms);

• a thyroid disorder;

• osteoporosis or low bone mineral density (steroid medication can increase your risk of bone loss);

• depression or mental illness;

• a muscle disorder such as myasthenia gravis;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• high levels of calcium in the blood related to cancer (also called hypercalcemia of malignancy);

• if you use insulin or oral diabetes medication; or

• if you take aspirin on a daily basis or at high doses.

It is not known whether methylprednisolone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether methylprednisolone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child (especially a baby) without medical advice.

Applies to methylprednisolone: compounding powder, injectable powder for injection, injectable suspension, oral tablet

General

The most commonly occurring side effects have included fluid retention, alteration in glucose tolerance, increased blood pressure, behavioral and mood changes, increased appetite, and weight gain; the incidence generally correlates with dosage, timing of administration, and duration of treatment.[Ref]

Hypersensitivity

Frequency not reported: Allergic or hypersensitivity reactions; anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, edema, hypotension[Ref]

Endocrine

Frequency not reported: Cushingoid state, hirsutism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), moon face[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine, ulcerative esophagitis, gastric hemorrhage, vomiting, abdominal pain, diarrhea, dyspepsia, nausea[Ref]

Hepatic

Frequency not reported: Hepatomegaly, elevation in liver enzymes, toxic hepatitis[Ref]

Reversible transaminase elevations (AST, ALT) have been observed following corticosteroid therapy. These changes have generally been small and not associated with any clinical syndrome. Toxic hepatitis has been reported with high doses of cyclically pulsed IV therapy, onset has been several weeks or longer. Resolution has been reported with discontinuation; however, recurrence has been reported with rechallenge.[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, manifestations of latent diabetes, hypokalemic alkalosis, potassium loss, sodium retention, increased appetite, negative nitrogen balance due to protein catabolism, weight gain, metabolic acidosis, dyslipidemia, lipomatosis[Ref]

Musculoskeletal

Frequency not reported: Suppression of growth in pediatric patients, aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like atrophy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare, steroid myopathy, tendon rupture, particularly of the Achilles tendon, vertebral compression fractures, myalgia, muscle atrophy, osteonecrosis, neuropathic arthralgia, growth retardation[Ref]

Hematologic

Frequency not reported: Leucocytosis[Ref]

Immunologic

Frequency not reported: Opportunistic infection[Ref]

Ocular

Blindness has been reported with corticosteroid injection to scalp, tonsillar fauces, sphenopalatine ganglion.[Ref]

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, blindness, chorioretinopathy[Ref]

Psychiatric

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders, confusional states, anxiety, abnormal behavior, irritability[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymosis, petechiae, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis, angioedema, skin atrophy, hyperhidrosis, pruritus[Ref]

Local

Frequency not reported: Injection site infections, injection site reactions[Ref]

Nervous system

Frequency not reported: Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, paresthesia, amnesia, dizziness[Ref]

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise, sterile abscess, impaired healing, fatigue[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma[Ref]

Respiratory

Frequency not reported: Pulmonary edema, pulmonary embolism, hiccups[Ref]

Genitourinary

Frequency not reported: Menstrual irregularities, increased or decreased motility and number of spermatozoa, increased urine calcium, glycosuria[Ref]

Some side effects of Solu-Medrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.