Fludrocortisone Acetate Oral tablet

FLUDROCORTISONE (floo droe KOR ti sone) treats low levels of cortisol in the body (adrenal insufficiency). It works by replacing cortisol normally made by the body. Cortisol is a hormone that plays an important role in how the body responds to stress, illness, and injury. It belongs to a group of medications called steroids.

People 65 years and older may have a stronger reaction and need a smaller dose.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Cushing syndrome—increased fat around the midsection, upper back, neck, or face, pink or purple stretch marks on the skin, thinning, fragile skin that easily bruises, unexpected hair growth
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Acne
• General discomfort and fatigue
• Headache
• Increase in appetite
• Nausea
• Trouble sleeping
• Weight gain

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from excessive heat. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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

• Cushing syndrome
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Infection, such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• Kidney disease
• Liver disease
• Mental health conditions
• Myasthenia gravis
• Osteoporosis
• Seizures
• Stomach or intestine problems
• Thyroid disease
• An unusual or allergic reaction to fludrocortisone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Live virus vaccines
• Metyrapone

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Warfarin

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.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

You may need to be on a special diet while you are taking this medication. Ask your care team. Also, find out how many glasses of fluids you need to drink each day.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.