Florinef Acetate

Generic Name: fludrocortisone (Oral route)

floo-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

  • Florinef Acetate

Available Dosage Forms:

  • Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Mineralocorticoid

Uses For Florinef Acetate

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.

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

Fludrocortisone is available only with your doctor's prescription.

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

Before Using Florinef Acetate

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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.

  • 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.

  • Bupropion
  • Itraconazole

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.

  • Alatrofloxacin
  • Balofloxacin
  • Cinoxacin
  • Ciprofloxacin
  • Clinafloxacin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Fosphenytoin
  • Furosemide
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Licorice
  • Lomefloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Phenytoin
  • Prulifloxacin
  • Rifampin
  • Rifapentine
  • Rosoxacin
  • Rufloxacin
  • Saiboku-To
  • Sparfloxacin
  • Temafloxacin
  • Tosufloxacin
  • Trovafloxacin Mesylate

Interactions with Food/Tobacco/Alcohol

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 Florinef Acetate

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 Florinef Acetate

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.

Florinef Acetate Side Effects

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.

See also: Side effects (in more detail)

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