Fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. It is used along with other medications (e.g., hydrocortisone) to treat low glucocorticoid levels caused by disease of the adrenal gland (e.g., Addison's disease, adrenocortical insufficiency, salt-losing adrenogenital syndrome). Glucocorticoids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal. They are also needed to break down carbohydrates in your diet.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Your doctor will adjust your dose to the one that is best for you. The dosage is based on your medical condition and response to therapy.

In order to get the most benefit from this medication, follow the dosing schedule carefully, and take this medication exactly as prescribed. To help you remember, take it at the same time each day. If you are taking this medication on another schedule besides every day (e.g., only 3 days a week), it may help to mark your calendar with a reminder. Do not increase or decrease your dose, take this drug more often, or stop taking this medication without your doctor's approval. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens.

You should not use Florinef Acetate if you are allergic to it, or if you have a fungal infection anywhere in your body.

Florinef Acetate can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Tell your doctor if you have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• a thyroid disorder;
• heart problems, high blood pressure;
• diabetes;
• glaucoma or cataracts;
• herpes infection of the eyes;
• a stomach ulcer;
• ulcerative colitis, diverticulitis;
• a colostomy or ileostomy;
• cirrhosis or other liver disease;
• kidney disease;
• mental illness or psychosis;
• osteoporosis; or
• myasthenia gravis.

Tell your doctor if you are pregnant. Taking Florinef Acetate during pregnancy may cause adrenal gland problems in the baby. Make sure any doctor caring for your pregnancy or your baby knows you haven taken this medicine during pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Florinef Acetate is not approved for use by anyone younger than 18 years old.

Stomach upset, headache, and menstrual changes (e.g., delayed/irregular/absent periods) may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: change in skin appearance (e.g., color changes, thinning, fatty areas), easy bleeding/bruising, dizziness, slow wound healing, signs of infection (e.g., fever, persistent sore throat, skin sores), bone/joint/muscle pain, stomach/abdominal pain, puffy face, swelling of the hands/feet, severe tiredness, increased thirst/urination, unusual weight gain, muscle weakness.

Tell your doctor right away if any of these rare but very serious side effects occur: black stools, eye problems (e.g., pain, redness, vision changes), severe/continuous headaches, fast/pounding/irregular heartbeat, mental/mood changes (e.g., agitation, depression, mood swings), seizure, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Cushing's syndrome
• diabetes
• heart problems or disease
• high blood pressure
• infection like herpes, measles, tuberculosis, or chickenpox
• liver disease
• myasthenia gravis
• osteoporosis
• stomach, ulcer or intestine disease including colitis and diverticulitis
• thyroid problem
• an unusual or allergic reaction to fludrocortisone, corticosteroids, other medicines, lactose, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take it with food or milk to avoid stomach upset. If you are taking this medicine once a day, take it in the morning. Do not take more medicine than you are told to take. Do not suddenly stop taking your medicine because you may develop a severe reaction. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose may be slowly lowered over time to avoid any side effects.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• mifepristone
• RU-486

This medicine may also interact with the following medications:

• amphotericin B
• aspirin and aspirin-like drugs
• barbiturates like phenobarbital
• digoxin
• diuretics
• female hormones, like estrogens or progestins and birth control pills
• male hormones
• medicines for diabetes like insulin
• medicines that treat or prevent blood clots like warfarin
• phenytoin
• rifampin
• vaccines