Pronunciation:

floo-droe-KOR-ti-sone

Brand Names:

• Florinef Acetate

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Adrenal Mineralocorticoid

Uses of This Medicine:

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 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin
• Balofloxacin
• Besifloxacin
• Bupropion
• Carbamazepine
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Levofloxacin
• Lomefloxacin
• Macimorelin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Ofloxacin
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sargramostim
• Sparfloxacin
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Furosemide
• Licorice
• Phenytoin
• Rifampin
• Rifapentine
• Saiboku-To

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.