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HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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.
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used for a certain type of low blood pressure (chronic postural hypotension).
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.
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.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking fludrocortisone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: fungal infection in your blood (e.g., candidiasis, valley fever). Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood clots, brittle bones (osteoporosis), diabetes, eye problems (e.g., cataracts, glaucoma, infection of the eye), heart problems (e.g., congestive heart failure), high blood pressure, infections (e.g., herpes, tuberculosis), kidney disease, liver disease (e.g., cirrhosis), mental/mood disorders (e.g., anxiety, depression, psychosis), low blood minerals (e.g., calcium, potassium), stomach/intestinal problems (e.g., diverticulitis, peptic ulcer disease, ulcerative colitis), seizures, thyroid problems.
Fludrocortisone makes your body hold on to salt (sodium) and get rid of other salts (e.g., calcium, potassium). Follow your doctor’s advice on how much salt, potassium, and calcium should be in your diet. This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any injuries or signs of infection (e.g., persistent sore throat/fever/cough, pain while urinating, skin sores) that occur during treatment. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Avoid exposure to chickenpox or measles infection while taking this medication unless you have previously had these infections (e.g., in childhood). If you are exposed to either of these infections and you have not previously had them, seek immediate medical attention. Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.
If you have a history of ulcers or take large doses of aspirin or other arthritis medicine, limit alcoholic beverages while taking this medication to lower the risk of stomach/intestinal bleeding. If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and inform your doctor of the results. Your diabetic medication or diet may need to be adjusted. This medication may slow down a child’s growth if used for a long time. Consult the doctor or pharmacist for more details.
See the doctor regularly so your child’s height and growth can be checked. The elderly may be more sensitive to the effects of this drug, especially water retention. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone.
Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: aldesleukin, digoxin, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen), hormones (e.g., androgens, birth control pills, estrogens), immunosuppressants (e.g., cyclosporine), mifepristone, vaccines, drugs affecting liver enzymes that remove fludrocortisone from your body (e.g., rifamycins such as rifampin/rifabutin, certain anti-seizure medicines such as barbituates/phenytoin).
If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This medication may interfere with certain laboratory tests, possibly causing false results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include high blood pressure, water retention, extreme weight gain, and muscle weakness.
Do not share this medication with others. Laboratory and/or medical tests (e.g., blood pressure, eye exams, sodium/potassium levels) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Different brands of this product have different storage needs. Check the product package for instructions on how to store your brand or ask the pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
FLUDROCORTISONE – ORAL