Fludrocortisone (oral)

Fludrocortisone is usually prescribed to patients whose adrenal glands do not make enough corticosteroids, which are natural steroid hormones necessary to help maintain health.

Overview

Fludrocortisone is a man-made medicine that is used to supplement the level of corticosteroids in patients whose bodies do not make enough of this natural hormone. Such deficiency can result in Addison's disease or adrenogenital syndrome.

The medicine essentially replaces the steroid hormones that are otherwise naturally produced in the adrenal cortex. It mimics the functions of natural corticosteroids.

These functions include balancing water and minerals, such as sodium (salt), to maintain the patient's health.

The medication has the potential to weaken the immune system. This may expose patients to the risk of getting infections, including serious infections such as tuberculosis, measles, and chicken pox.

Long-term treatment with the drug in children is also known to affect their growth.

Fludrocortisone is supplied to patients by doctor's prescription only and is sold under the US brand name, Florinef Acetate. It may also be used to treat other conditions not discussed in this guide.

This medicine may put patients at a greater risk of contracting serious infections and may mask the symptoms of infections. Long-term treatment with it may also cause or affect other medical problems in patients.

For these and other reasons, you should decide if the medicine is right for you. In helping to determine if Fludrocortisone is safe for you, your doctor will consider your medical history and the potential risks and benefits involved.

Condition treated:

  • Corticosteroid hormone deficiency

Type Of Medicine

  • Steroid

Side Effects

Fludrocortisone may cause some expected side effects. But some unwanted side effects may occur which may or may not require medical attention.

Call your right away if you experience any of the following side effects:

Less commonly or rarely occur

  • Chills
  • Hives
  • Excessive thirst or hunger
  • Combativeness or agitation
  • Pain in the rib or back
  • Anxiety
  • Changes in the color of the skin
  • Tightness or pain in the chest
  • Blindness
  • Joint pain
  • Growth in children that is slow or stops
  • Bloating
  • Excess fat deposits on the neck, face or trunk of the body
  • Excess urination
  • Indigestion
  • Stools black in color, bloody or sticky
  • Shortness of breath
  • Irregular breathing
  • Blurred vision
  • Pain in the abdomen
  • Difficulty swallowing
  • Confusion
  • Burning sensation in the stomach
  • Heartburn
  • Coughing up blood
  • Irregular heartbeat (slow or fast)
  • Limping
  • Constipation
  • Loss of appetite
  • Fever
  • Headache
  • Cramps or pain in the muscle
  • Swollen feet, lower legs, face or fingers
  • Decrease in height
  • Cough
  • Vision problems
  • Depression
  • Dry mouth
  • Unusual fears (such as imminent death)
  • Swollen nasal passages, eyelids or face
  • Eye pain
  • Dark-colored urine
  • Bulging eyeballs
  • Reduced range of motion
  • Feeling lightheaded or fainting (especially when getting up from a sitting or lying position)
  • Decreased urination
  • Sweating
  • Convulsions
  • Flushed dry skin
  • Nervousness
  • Neck or back fractures
  • Wheezing
  • Loss of consciousness
  • Breath odor that smells fruity
  • Swollen neck veins
  • Hallucinations
  • Nausea or vomiting
  • Fractures in legs or arms not due to any injury
  • Redness of the face or eyes
  • Dizziness (severe or continuous)
  • Weakness of legs and arms (severe)
  • Tearing of eyes
  • Unexplained weight loss
  • Redness, rash or itching of the skin
  • Feeling unusually weak or tired
  • Vision changes
  • Pounding sensation in the ears
  • Unexplained weight gain
  • Yellow skin or eyes
  • Wounds taking longer to heal
  • Tenderness, swelling or pain in foot or leg
  • Pain in the side or stomach (may radiate to the back)

The following other side effects may occur. If they become bothersome, severe or do not go away, tell your doctor.

  • Restlessness
  • Stomach irritation
  • Menstrual problems (absent or irregular)
  • Acne
  • Dizziness
  • Upset stomach
  • Anxiety
  • Insomnia
  • Depression
  • Vomiting
  • Headache
  • Bruising easily
  • Increased hair growth

Some patients may experience other side effects not listed here. You can ask your doctor or health care professional about ways to prevent or reduce side effects. You may also call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

Fludrocortisone is supplied as a tablet to be taken by mouth only. It may be taken with food or milk to prevent upset stomach.

Take your dose as directed and follow all other directions given to you by your doctor or pharmacist.

Dosage and other directions can be found on the prescription label. They usually include the strength of your dose, time between each dose, and the duration of treatment.

The following is only a recommended dosage guide. You should stick to the dosage directions given to you by your doctor.

Treating corticosteroids deficiency

Adults: Take 50 to 200 micrograms per day.

Children: Take 50 to 100 micrograms per day.

Treating adrenogenital syndrome

Adults: Take 100 to 200 micrograms a day.

Children: Treatment must be determined by a doctor.

Because Fludrocortisone helps the body retain a healthy level of salt, your doctor may place you on a special diet to ensure you have the right salt intake.

Missed dose

If you missed a dose of the tablet, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and take the next dose on time. An extra dose should not be taken to make up for the missed dose.

Overdose

Taking more of the medicine than you were told to may cause overdose. Call the local poison control center at 1-800-222-1222 or seek urgent medical care if you overdose on this drug. If the patient collapses or is not breathing, call 911.

Interactions

Using other medicines during treatment with Fludrocortisone may cause interaction. Sometimes, it may be best for the patient's health that other medicines are used. In such cases, your doctor may treat you with caution.

To avoid a significant interaction, Fludrocortisone should not be used with the following medicine. Your doctor may change your dose or how often you take any of your medicines.

  • Rotavirus Vaccine, Live

It is not recommended that you use the following medicines while taking this steroid. If you are required to take both medicines together, your doctor may change your dose or how often you take any of them.

  • Bupropion

The risk of side effects may increase if this medicine is taken with any of the medicines on the following list.
If one or more of them must be used during your treatment, your doctor may change the dose or how often you take any of your medicines.

  • Sparfloxacin
  • Licorice
  • Besifloxacin
  • Furosemide
  • Ofloxacin
  • Gatifloxacin
  • Rufloxacin
  • Balofloxacin
  • Levofloxacin
  • Rifapentine
  • Moxifloxacin
  • Flumequine
  • Saiboku-To
  • Nadifloxacin
  • Pazufloxacin
  • Lomefloxacin
  • Phenytoin
  • Gemifloxacin
  • Rifampin
  • Fosphenytoin
  • Prulifloxacin
  • Enoxacin
  • Pefloxacin
  • Tosufloxacin
  • Ciprofloxacin
  • Norfloxacin
  • Fleroxacin

Other medicines not included in the lists may also interact with Fludrocortisone. You may ask your doctor for more information.

Other Interactions

Food, alcohol, tobacco, and other medical problems may interact with this medicine.

Your doctor may advise you to use food or milk when taking the tablet.

Other medical problems

The presence of other medical problems may affect or be affected by the medicine. Using fludrocortisone with aspirin may worsen the following condition:

  • Bleeding problems

The medication may worsen the following condition because more calcium is passed into the urine during treatment:

  • Bone disease

Fludrocortisone may cause excess retention of salt and water. This may cause the following conditions to worsen:

  • High Blood pressure
  • Edema (swelling of the lower legs or feet)
  • Kidney disease
  • Heart disease

Using the medicine in patients with the following condition may cause a hole to develop in the cornea:

  • Herpes infection in the eyes

The medication usually weakens the immune system and may worsen the following conditions:

  • Tuberculosis
  • Ulcers in the stomach or intestines
  • Liver disease
  • Abdominal surgery (recent)
  • Myasthenia gravis (severe muscle disorder)
  • Diseases of the intestines

Patients with the following condition may be at risk for increased side effects because Fludrocortisone's removal from the bloodstream is slower in these patients.

  • Thyroid disease

Warnings

  • Do not use it if you are pregnant or breastfeeding unless your doctor approves.
  • Do not use the medicine if you have a fungal infection of the blood or other infections that occur in places other than on the skin.
  • Do not take a vaccine or other immunization, or any skin test during treatment, unless your doctor approves.
  • During treatment, avoid contact with persons infected with tuberculosis, chicken pox, shingles or measles. Call your doctor if you suspect you were exposed to these infections.
  • Report injuries or symptoms such as sore throat, pain during urination, and muscle aches or pains that occur during treatment. They may be signs of an infection.
  • Report weight gain if you were instructed to do so.
  • If you have diabetes, report abnormal blood sugar levels or sugar in your urine to your doctor.
  • Limit your use of alcohol during treatment.
  • Do not suddenly stop taking this drug. Doing so may cause unwanted reactions or worsen certain medical conditions you may have. Your doctor should gradually reduce your dose before finally stopping treatment.
  • If you are having a medical or dental surgery or procedure, let the doctor or dentist know that you are using Fludrocortisone.
  • Tell your doctor if your child has difficulty walking or moving. This medicine may weaken certain bones (osteoporosis) and muscles in children.
  • Also tell your doctor if your child's growth slows down or stops.
  • Always carry the identification card given to you that will state that you are using this medicine.
  • Keep all follow-up appointments with your doctor and lab. Your doctor will regularly check your blood pressure and your response to the medication.
  • Take your dose exactly as prescribed. If you do not feel better or your condition worsens, call your doctor.

Extra precautions may be taken for children, pregnant or breastfeeding women, and elderly adults.

Tell your doctor if you have had an unusual or allergic reaction to Fludrocortisone or any of its inactive ingredients. Also let your doctor know if you are allergic to other medicines, especially aspirin.

Tell your doctor of any allergies you have to preservatives, dyes, foods, or animals.

Give your doctor a list of all medications you are taking or plan to take, especially Rotavirus Vaccine, Live. Include prescription and over-the-counter medicines (OTC's), vitamins, nutritional supplements, and herbal products in the list.

Certain medical conditions may affect or be affected by the medicine. Tell your doctor if you have or had a fungal infection of the blood, herpes of the eyes, ulcers, tuberculosis, diabetes, or liver, kidney or heart problems.

Pediatrics

The medicine is safe for use in children. However, if used for a long time it may slow or stop growth in these patients. It may also cause their bones to become weaker (osteoporosis) and their body to make less of the natural corticosteroids.

Geriatrics

There are no specific problems found that would limit the use of this medication in elderly patients. Sometimes the risk of side effects may be greater in elderly patients compared to younger adults.

Pregnancy

Tell your doctor if you are pregnant or may be pregnant. Adequate studies have not been done to determine if using the medicine during pregnancy may cause harm to an unborn baby.

Breastfeeding

There is no specific information available that suggests the medicine can pass through breast milk and harm a breastfeeding infant.

Storage

Fludrocortisone should be stored kept away from heat, moisture, and direct light. Keep it from freezing and out of the reach of children.

Throw away medicine that is expired or no longer needed. You may ask your healthcare professional or local waste disposal agency how to safely dispose of it.

Summary

Fludrocortisone is a safe and effective medicine used in adults and children for steroid hormone replacement therapy.

It does, however, have the potential to weaken the immune system which may put patients at a greater risk of contracting certain serious infections. This risk may be far greater in children, especially those who are not fully immunized.

Long-term treatment with the drug in children is also known to affect their growth, weaken certain bones (osteoporosis) and muscles, and lessen the production of natural corticosteroids.

Once necessary precautions are taken by the doctor and patient, Fludrocortisone may still be safely and effectively used.