Florinef Acetate

Mechanism of Action

Potent mineralocorticoid with high glucocorticoid activity; promotes increased reabsorption of sodium and excretion of potassium from renal distal tubules

Absorption

Bioavailability: 100%

Peak plasma time: ≤1.7 hr

Distribution

Protein bound: 42%

Metabolism

Metabolized in liver

Elimination

Half-life: Plasma, 3.5 hr; biologic, 18-36 hr

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Steroid medication 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. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

Other medical conditions you should tell your doctor about before taking fludrocortisone include:

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• diabetes;

• a history of malaria;

• tuberculosis;

• osteoporosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• stomach ulcers, ulcerative colitis, or diverticulitis;

• depression or mental illness;

• congestive heart failure; or

• high blood pressure

If you have any of these conditions, you may need a dose adjustment or special tests to safely take fludrocortisone.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Fludrocortisone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• problems with your vision;

• swelling, rapid weight gain, feeling short of breath;

• severe depression, unusual thoughts or behavior, seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Used for oral mineralocorticoid replacement therapy; use is contraindicated in all conditions except those that require a high degree of mineralocorticoid activity.b

Adrenocortical Insufficiency

Partial replacement therapy, in combination with hydrocortisone or cortisone, for treatment of primary and secondary adrenocortical insufficiency in Addison’s disease after electrolyte balance has been restored.a b

Hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy; concomitant administration of fludrocortisone may be required in some patients.

Adrenogenital Syndrome

Treatment of salt-losing congenital adrenogenital syndrome after electrolyte balance has been restored.a b

Postural Hypotension

Has been used with some success to increase SBP and DBP in patients with severe, chronic postural hypotension† (e.g., secondary to autonomic dysfunction, levodopa therapy) that does not respond adequately to nondrug therapy.b

Storage

Oral

Room temperature; avoid excessive heat.a

• Importance of notifying a clinician of any infections, signs of infections (e.g., fever, sore throat, pain during urination, muscle aches), or injuries that develop during therapy or within 12 months after therapy is discontinued.a

• Importance of carrying identification cards listing the diseases being treated, the glucocorticoid regimen, and the name and telephone number of the clinician.a

• In immunosuppressed patients, importance of avoiding exposure to certain infections (e.g., chickenpox, measles) and of obtaining medical advice if such exposure occurs.a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a

• Importance of regular follow-up visits and of promptly notifying clinician of dizziness, severe or continuing headaches, swelling of feet or lower legs, or unusual weight gain.a

• Importance of taking medication only as directed, taking a missed dose as soon as possible, and not doubling the next dose.a

• Importance of keeping medication out of reach of children.a

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

• Importance of informing patients of other important precautionary information. (See Cautions.)a

In the U.S.

• Florinef Acetate

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Mineralocorticoid

Your doctor may want you to control the amount of sodium in your diet. When fludrocortisone is used to treat certain types of kidney diseases, too much sodium may cause high blood sodium, high blood pressure, and excess body water.

Take this medicine only as directed by your doctor . Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  • Adults
    • For adrenal gland deficiency: 50 to 200 micrograms a day.
    • For adrenogenital syndrome: 100 to 200 micrograms a day.
  • Children: For adrenal gland deficiency: 50 to 100 micrograms a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

0.1 to 0.2 mg orally/24 hours

Infant: 0.1 to 0.2 mg orally/24 hours.
Child: 0.05 to 0.1 mg orally/24 hours (range 0.1 mg 3 times a week to 0.2 mg/day)