Fludrocortisone Acetate

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Fludrocortisone Acetate
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

Fludrocortisone Acetate is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Dosage

  • Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remission or exacerbations of the disease and stress (surgery, infection, trauma)

Addison's Disease

  • In Addison's disease, the combination of fludrocortisone acetate tablets with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects.
  • The usual dose is 0.1 mg of fludrocortisone acetate tablets daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Fludrocortisone acetate tablets are preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses).

Salt-Losing Adrenogenital Syndrome

  • The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocortisone acetate tablets daily.

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 Fludrocortisone Acetate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.

When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.

Musculoskeletal—muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures.

Gastrointestinal—peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic—impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions and hives; reactions to skin tests may be suppressed.

Neurological—convulsions, increased intracranial pressure with papilledema (psuedotumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances.

Endocrine—menstrual irregularities; development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic—posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic—hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.

Allergic Reactions—allergic skin rash, maculopapular rash, and urticaria.

Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Fludrocortisone Acetate in the drug label.

Drug Interactions

There is limited information regarding Fludrocortisone Acetate Drug Interactions in the drug label.

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 Fludrocortisone Acetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fludrocortisone Acetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fludrocortisone Acetate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fludrocortisone Acetate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fludrocortisone Acetate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fludrocortisone Acetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fludrocortisone Acetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fludrocortisone Acetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fludrocortisone Acetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fludrocortisone Acetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fludrocortisone Acetate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Fludrocortisone Acetate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Fludrocortisone Acetate in the drug label.

Overdosage

  • Development of hypertension, edema, hypokalemia, excessive increase in weight, and increase in heart size are signs of overdosage of fludrocortisone acetate. When these are noted, administration of drugs should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate should be with a reduced dose. Muscular weakness may develop due to excessive potassium loss and can be treated by administering a potassium supplement. Regular monitoring of blood pressure and serum electrolytes can help to prevent overdosage.

Pharmacology

There is limited information regarding Fludrocortisone Acetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Fludrocortisone Acetate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fludrocortisone Acetate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fludrocortisone Acetate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fludrocortisone Acetate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fludrocortisone Acetate in the drug label.

How Supplied

  • Fludrocortisone Acetate Tablets USP, 0.1 mg—Each white to off-white, round, convex tablet debossed with a "7033" on one side and with a bisect on the other side.
  • 10 tablets per card 5 cards per carton......NDC 50268-330-15

Storage

  • Store at controlled room temperature 15° to 30°C (59° to 86°F)(see USP). Avoid excessive heat.

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 Fludrocortisone Acetate in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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