Prednisolone (injection)

Prednisolone (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: Kiran Singh, M.D. [2]

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Overview

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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, A-METHAPRED™ sterile powder is indicated for intravenous or intramuscular use in the following conditions:

• 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

There is limited information regarding Off-Label Guideline-Supported Use of Prednisolone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Prednisolone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Prednisolone (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Prednisolone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Prednisolone in pediatric patients.

Contraindications

There is limited information regarding Prednisolone (injection) Contraindications in the drug label.

Warnings

There is limited information regarding Prednisolone (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Prednisolone (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Prednisolone (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Prednisolone (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prednisolone (injection) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Prednisolone (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Prednisolone (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Prednisolone (injection) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Prednisolone (injection) Administration in the drug label.

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Prednisolone (injection) and IV administrations.

Overdosage

There is limited information regarding Prednisolone (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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

Mechanism of Action

There is limited information regarding Prednisolone (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Prednisolone (injection) Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Prednisolone (injection) How Supplied in the drug label.

Storage

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

Precautions with Alcohol

Alcohol-Prednisolone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Prednisolone (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Prednisolone (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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