Fludrocortisone

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with fludrocortisone. Vaccines may not work as well while you are taking a steroid.

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• aspirin (taken on a daily basis or at high doses);
• amphotericin B (Fungizone);
• a diuretic (water pill);
• digoxin (digitalis, Lanoxin);
• phenytoin (Dilantin);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• birth control pills or hormone replacement therapy;
• a blood thinner such as warfarin (Coumadin);
• insulin or diabetes medications you take by mouth;
• an anabolic steroid such as oxymetholone (Anadrol-50), nandrolone (Durabolin, others), and others; or
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with fludrocortisone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using fludrocortisone.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication.

Store fludrocortisone at room temperature away from moisture and heat.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, weight gain, feeling short of breath, confusion, uneven heart rate, increased thirst or urination, leg discomfort, and muscle pain or weakness.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Florinef Acetate (Fludrocortisone Acetate Tablets USP) contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate; its graphic formula is:

Florinef (fludrocortisone) Acetate is available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: calcium phosphate, corn starch, lactose, magnesium stearate, sodium benzoate, and talc.

Corticosteroids are thought to act, at least in part, by controlling the rate of synthesis of proteins. Although there are a number of instances in which the synthesis of specific proteins is known to be induced by corticosteroids, the links between the initial actions of the hormones and the final metabolic effects have not been completely elucidated.

The physiologic action of fludrocortisone acetate is similar to that of hydrocortisone. However, the effects of fludrocortisone acetate, particularly on electrolyte balance, but also on carbohydrate metabolism, are considerably heightened and prolonged. Mineralocorticoids act on the distal tubules of the kidney to enhance the reabsorption of sodium ions from the tubular fluid into the plasma; they increase the urinary excretion of both potassium and hydrogen ions. The consequence of these three primary effects together with similar actions on cation transport in other tissues appear to account for the entire spectrum of physiological activities that are characteristic of mineralocorticoids. In small oral doses, fludrocortisone acetate produces marked sodium retention and increased urinary potassium excretion. It also causes a rise in blood pressure, apparently because of these effects on electrolyte levels.

In larger doses, fludrocortisone acetate inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion; promotes the deposition of liver glycogen; and, unless protein intake is adequate, induces negative nitrogen balance. The approximate plasma half-life of fludrocortisone (fluorohydrocortisone) is 3.5 hours or more and the biological half-life is 18 to 36 hours.

Fludrocortisone is available in the following forms:

• Oral Tablet

Fludrocortisone is in a class of drugs called steroids. Fludrocortisone prevents the release of substances in the body that cause inflammation.

Fludrocortisone is used to treat conditions in which the body does not produce enough of its own steroids, such as Addison's disease, and salt-losing adrenogenital syndrome.

Fludrocortisone may also be used for other purposes not listed in this medication guide.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Fludrocortisone is a corticosteroid (cortisone-like medicine). It belongs to the family of medicines called steroids. Your body naturally produces similar corticosteroids, which are necessary to maintain the balance of certain minerals and water for good health. If your body does not produce enough corticosteroids, your doctor may have prescribed fludrocortisone to help make up the difference.

Fludrocortisone may also be used to treat other medical conditions as determined by your doctor.

Fludrocortisone is available only with your doctor's prescription.

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 fludrocortisone 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 fludrocortisone 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 fludrocortisone. 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 fludrocortisone, 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.

Your doctor should check your progress at regular visits to make sure fludrocortisone does not cause unwanted effects.

If you will be using fludrocortisone for a long time, your doctor may want you to carry a medical identification card stating that you are using fludrocortisone.

While you are taking fludrocortisone, be careful to limit the amount of alcohol you drink.

Addison disease: Partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison disease

Salt-losing adrenogenital syndrome: Treatment of salt-losing adrenogenital syndrome (congenital adrenal hyperplasia)

Animal reproduction studies have not been conducted with fludrocortisone; adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010). Fludrocortisone may be used to treat women during pregnancy who require therapy for congenital adrenal hyperplasia or primary adrenal insufficiency (Bornstein 2016; Speiser 2010).