Methylprednisolone (injection): Difference between revisions

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*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.
*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.
====Dosage====
When high dose therapy is desired, the recommended dose of SOLU-MEDROL Sterile Powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.
In other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the specific disease entity being treated.
It Should Be Emphasized that Dosage Requirements are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=====Indications====
 
*Acute lymphoid leukemia, Palliative (older than 1 month)
*Allergic condition, Severe or intractable
*Asthma
*Collagen disease
*Crohn's disease
*Disorder of endocrine system
*Disorder of eye
*Disorder of hematopoietic structure
*Disorder of respiratory system
*Disorder of skin
*Exacerbation of multiple sclerosis (Acute)
*Hypercalcemia of malignancy
*Inflammatory disorder of musculoskeletal system; Adjunct
*Mycosis fungoides
*Nephrotic syndrome (older than 2 years)
*Pulmonary tuberculosis; Adjunct
*Rheumatoid carditis, Acute; Adjunct
*Temporal arteritis
*Trichinosis, With neurologic and myocardial involvement
*Tuberculosis of meninges, With subarachnoid block or impending block; Adjunct
*Ulcerative colitis


* Dosing Information
====Dosage====


:* Dosage
In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m2bsa/day).


=====Condition2=====
The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1–2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer.


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.


<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport======Condition1=====



Revision as of 20:19, 20 May 2015

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]

Disclaimer

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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.

Dosage

When high dose therapy is desired, the recommended dose of SOLU-MEDROL Sterile Powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.

In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.

In other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the specific disease entity being treated.

It Should Be Emphasized that Dosage Requirements are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.

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)

Indications

  • Acute lymphoid leukemia, Palliative (older than 1 month)
  • Allergic condition, Severe or intractable
  • Asthma
  • Collagen disease
  • Crohn's disease
  • Disorder of endocrine system
  • Disorder of eye
  • Disorder of hematopoietic structure
  • Disorder of respiratory system
  • Disorder of skin
  • Exacerbation of multiple sclerosis (Acute)
  • Hypercalcemia of malignancy
  • Inflammatory disorder of musculoskeletal system; Adjunct
  • Mycosis fungoides
  • Nephrotic syndrome (older than 2 years)
  • Pulmonary tuberculosis; Adjunct
  • Rheumatoid carditis, Acute; Adjunct
  • Temporal arteritis
  • Trichinosis, With neurologic and myocardial involvement
  • Tuberculosis of meninges, With subarachnoid block or impending block; Adjunct
  • Ulcerative colitis

Dosage

In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m2bsa/day).

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1–2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer.

Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.

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

{{#ask: Page Name::Methylprednisolone (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Methylprednisolone (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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 ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. "SOLU-MEDROL- methylprednisolone sodium succinate injection, powder, for solution".
  2. "http://www.ismp.org". External link in |title= (help)