Methylprednisolone (injection)

Methylprednisolone (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]

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Overview

Methylprednisolone (injection) is an anti-inflammatory glucocorticoid that is FDA approved for the treatment of allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system disease, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders. Common adverse reactions include hypertension, atrophic condition of skin, impaired wound healing, body fluid retention, decreased body growth, hypernatremia, hypokalemia, disorder of gastrointestinal tract, peptic ulcer disease, liver function tests abnormal (Mild), infection, muscle weakness, depression, and euphoria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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 intravenous or intramuscular use of SOLU-MEDROL Sterile Powder 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, perennial or seasonal 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), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected 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 the 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, 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, temporal arteritis, polymyositis, and systemic lupus erythematosus.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Methylprednisolone (injection) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Methylprednisolone (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Methylprednisolone (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Methylprednisolone (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Methylprednisolone (injection) in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Methylprednisolone (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Methylprednisolone (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methylprednisolone (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Methylprednisolone (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Methylprednisolone (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Methylprednisolone (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Methylprednisolone (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Methylprednisolone (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Methylprednisolone (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Methylprednisolone (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Methylprednisolone (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Methylprednisolone (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Methylprednisolone (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intramuscular

• Intravenous

Monitoring

There is limited information regarding Monitoring of Methylprednisolone (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Methylprednisolone (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Methylprednisolone (injection) in the drug label.

Pharmacology

There is limited information regarding Methylprednisolone (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Methylprednisolone (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Methylprednisolone (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Methylprednisolone (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Methylprednisolone (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Methylprednisolone (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Methylprednisolone (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Methylprednisolone (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Methylprednisolone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• SOLU-MEDROL ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.