In the U.S.—

In Canada—

• Corticosteroid, mineralocorticoid
• Antihypotensive, idiopathic orthostatic
• Diagnostic aid, renal tubular acidosis

Fludrocortisone ( floo-droe-KOR-tis-sone) is a corticosteroid (kor-ti-koe-STE-roid) (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 this medicine 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, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fludrocortisone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fludrocortisone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—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.

Pregnancy—Studies on birth defects in humans have not been done with fludrocortisone. Adequate studies have not been done with fludrocortisone in animals, however many corticosteroids have been shown to cause birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Fludrocortisone passes into the breast milk and may cause problems with growth or other unwanted effects in the nursing baby.

Children—Fludrocortisone may slow or stop growth in children or growing adolescents when used for a long time. The natural production of corticosteroids by the body may also be decreased by the use of this medicine. Before this medicine is given to a child or adolescent, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it. Follow the doctor's directions very carefully to lessen the chance that these unwanted effects will occur.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of fludrocortisone in the elderly with its use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fludrocortisone, it is especially important that your health care professional know if you are taking any of the following:

• Acetazolamide (e.g., Diamox) or
• Amphotericin B by injection (e.g., Fungizone) or
• Azlocillin (e.g., Azlin) or
• Bronchodilators (asthma medicine e.g., albuterol) or
• Capreomycin (e.g., Capastat) or
• Carbenicillin by injection (e.g., Geopen) or
• Corticotropin (ACTH) or
• Dichlorphenamide (e.g., Daranide) or
• Diuretics (water pills) or
• Insulin or
• Laxatives (with overdose or chronic misuse) or
• Methazolamide (e.g., Neptazane) or
• Mezlocillin (e.g., Mezlin)
• Piperacillin (e.g., Pipracil) or
• Piperacillin and tazobactam (e.g., Zosyn) or
• Salicylates or
• Sirolimus (e.g., Rapamune) or
• Sodium bicarbonate (e.g., baking soda) or
• Sodium Polystrene Sulfonate (e.g., Kayexalate) or
• Ticarcillin (e.g., Ticar) or
• Ticarcillin and clavulanate (e.g., Timentin)—Fludrocortisone and these medicines decrease the amount of potassium in the blood, which may increase the chance of severe low blood potassium

• Alcohol—Alcohol and fludrocortisone decrease the amount of potassium in the blood, which may increase the chance of severe low blood potassium; alcohol may also make fludrocortisone less effective by causing the body to get rid of it faster

• Barbiturates or
• Carbamazepine (e.g., Tegretol) or
• Efavirenz (e.g., Sustiva) or
• Griseofulvin (e.g., Fulvicin) or
• Modafinil (e.g., Provigil) or
• Nevirapine (e.g., Viramune) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin)
• Primidone (e.g., Mysoline) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin)
• Rifapentine (e.g., Priftin)—Using these medicines may make fludrocortisone less effective because they cause the body to get rid of it faster

• Digitalis glycosides (heart medicine)—Fludrocortisone decreases the amount of potassium in the blood, which may increase the chance of irregular heartbeat

• Other corticosteroids (cortisone-like medicine)—Using any corticosteroid medicine with fludrocortisone will cause the body to get rid of both medicines faster. This may make either or both medicines less effective. Also, fludrocortisone and other corticosteroids decrease the amount of potassium in the blood, which may increase the chance of severe low blood potassium

• Sodium-containing medicine—When using fludrocortisone to treat certain types of kidney diseases, too much sodium may cause high blood sodium, high blood pressure, and excess body water

• Bleeding problems—Using fludrocortisone and also using aspirin may cause bleeding problems to become worse.

• Bone disease—Fludrocortisone may make bone disease worse because it causes more calcium to pass into the urine

• Edema (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Kidney disease—Fludrocortisone causes the body to retain (keep) more salt and water. These conditions may be made worse by this extra body water

• Herpes infection of the eye—may cause a hole in the cornea of the eye.

• Liver disease or
• Abdominal surgery (fresh) or
• Diseases of the intestines or
• Myasthenia gravis or
• Tuberculosis or
• Ulcers in the stomach or intestines—Fludrocortisone suppresses the immune system. Infections with these conditions may be made worse by this suppression.

• Thyroid disease—The body may not get fludrocortisone out of the bloodstream at the usual rate, which may increase the effect of fludrocortisone or cause more side effects

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 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.

• 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 you remember. 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

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

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common or rare
  • Abdominal pain;  agitation or combativeness ;  anxiety;  back or rib pain ;  blindness;  bloating;  bloody or black, sticky stools;  blurred vision;  burning in stomach;  changes in skin color;  chest pain or tightness;  chills;  confusion;  constipation;  convulsions;  cough;  coughing up blood;  darkened urine;  decrease in height;  decreased range of motion;  decreased urine output;  decreased vision;  depression;  difficulty swallowing;  dry mouth;  expressed fear of impending death;  eye pain;  eyeballs bulge out of eye sockets;  fainting or lightheadedness when getting up from a lying or sitting position;  fast or slow heartbeat;  fever;  flushed dry skin;  fractures in arms or legs without any injury ;  fractures in the neck or back;  fruit-like breath odor;  hallucinations;  headache;  heartburn;  hives;  increased fat deposits on face, neck, and trunk;  increased hunger;  increased thirst;  increased urination;  indigestion;  irregular breathing or shortness of breath;  irregular heartbeat;  joint pain;  lack or slowing of normal growth in children;  walking with a limp;  loss of appetite;  loss of consciousness ;  muscle cramps or pain;  nausea or vomiting;  nervousness;  pain, tenderness, or swelling of foot or leg;  pains in stomach or side, possibly radiating to the back;  patients taking oral medicines or insulin for diabetes may need to increase the amount they take;  pounding in the ears;  problems with wound healing;  redness and itching of skin;  redness of eyes;  redness of face;  severe or continuing dizziness;  severe weakness of arms and legs;  skin rash;  sweating;  swelling of face, fingers, feet, or lower legs;  swelling of nasal passages, face, or eyelids;  swollen neck veins;  tearing of eyes;  unexplained weight loss;  unusual tiredness or weakness ;  vision changes;  weight gain;  wheezing;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• Less common or rare
  • Acne, pimples;  bruising, large, flat, blue or purplish patches in the skin;  change in color of skin or nails;  increased sweating;  loss of muscle mass;  menstrual changes ;  muscle weakness;  reddish purple lines on arms, face, legs, trunk, or groin;  sleeplessness, trouble sleeping, unable to sleep;  small, red, or purple spots on skin;  swelling of abdominal or stomach area, full or bloated feeling or pressure in the stomach ;  thin, fragile skin;  unusual increase in hair growth 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fludrocortisone is used in certain patients with the following medical conditions:

• Idiopathic orthostatic hypotension (a certain type of low blood pressure)
• Too much acid in the blood, caused by kidney disease

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.