Florinef

(Generic versions may still be available.)

DRUG DESCRIPTION

Florinef Acetate (Fludrocortisone Acetate Tablets USP) contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11?,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate; its graphic formula is:

Florinef Acetate (Fludrocortisone Acetate) structural formula illustration

Florinef (fludrocortisone) Acetate is available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: calcium phosphate, corn starch, lactose, magnesium stearate, sodium benzoate, and talc.

What are the possible side effects of fludrocortisone (Florinef Acetate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper...

Read All Potential Side Effects and See Pictures of Florinef

What are the precautions when taking fludrocortisone (Florinef)?

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...

Read All Potential Precautions of Florinef


Florinef Consumer (continued)

SIDE EFFECTS: 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 immediately 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 immediately 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 immediately 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.


Florinef Patient Information Including Side Effects

Brand Names: Florinef Acetate

Generic Name: fludrocortisone (Pronunciation: FLOO droe KOR ti sone)

  • What is fludrocortisone (Florinef)?
  • What are the possible side effects of fludrocortisone (Florinef)?
  • What is the most important information I should know about fludrocortisone (Florinef)?
  • What should I discuss with my healthcare provider before taking fludrocortisone (Florinef)?
  • How should I take fludrocortisone (Florinef)?
  • What happens if I miss a dose (Florinef)?
  • What happens if I overdose (Florinef)?
  • What should I avoid while taking fludrocortisone (Florinef)?
  • What other drugs will affect fludrocortisone (Florinef)?
  • Where can I get more information?

What is fludrocortisone (Florinef)?

Fludrocortisone is in a class of drugs called steroids. Fludrocortisone prevents the release of substances in the body that cause inflammation.

Fludrocortisone is used to treat conditions in which the body does not produce enough of its own steroids, such as Addison's disease, and salt-losing adrenogenital syndrome.

Fludrocortisone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fludrocortisone (Florinef)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • sleep problems (insomnia), mood changes;
  • acne, dry skin, thinning skin, bruising or discoloration;
  • slow wound healing;
  • increased sweating;
  • headache, dizziness, spinning sensation;
  • nausea, stomach pain, bloating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fludrocortisone (Florinef)?

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Before taking fludrocortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking fludrocortisone. Vaccines may not work as well while you are taking a steroid.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

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