INDICATIONS

Florinef is used for treating adrenocortical insufficiency in Addison disease and for treating salt-losing adrenogenital syndrome. Florinef is a corticosteroid. It works by causing the kidneys to retain sodium and acting as a replacement for cortisone when the body does not produce enough.

INSTRUCTIONS 

Use Florinef as directed by your doctor.

• Take Florinef by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Do not suddenly stop taking Florinef. You may have an increased risk of side effects. If you need to stop Florinef or add a new medicine, your doctor will gradually lower your dose.
• If you miss a dose of Florinef, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Florinef.

STORAGE

Store Florinef at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Florinef out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Fludrocortisone.

SAFETY INFORMATION

Do NOT use Florinef if:

• you are allergic to any ingredient in Florinef
• you have a systemic fungal infection
• you are scheduled to have a smallpox vaccination.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Florinef. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are scheduled for a vaccination with a live virus vaccine (eg, smallpox)
• if you have a history of an underactive thyroid, liver or kidney problems, heart problems or heart attack, bleeding problems, diabetes, high blood pressure, inflammation of the esophagus, stomach problems (eg, ulcers), bowel blockage or other bowel problems (eg, ulcerative colitis), recent bowel surgery, myasthenia gravis, or mental or mood problems (eg, depression)
• if you have measles, chickenpox, herpes infection of the eye, or any other type of bacterial, fungal, parasitic, or viral infection
• if you have recently had tuberculosis (TB) or have had a positive skin test for TB.

Some medicines may interact with Florinef. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anabolic steroids (eg, oxymetholone) or aprepitant because they may increase the risk of Florinef's side effects
• Barbiturates (eg, phenobarbital), carbamazepine, estrogens, hydantoins (eg, phenytoin), or rifampin because they may decrease Florinef's effectiveness
• Amphotericin B, azole antifungals (eg, ketoconazole), clarithromycin, digoxin, loop diuretics (eg, furosemide), steroidal contraceptives (eg, desogestrel), thiazide diuretics (eg, hydrochlorothiazide), or troleandomycin because side effects, such as weakness, confusion, muscle aches, irregular heartbeat, joint pain, or low blood sugar, may occur
• Methotrexate or ritodrine because they may increase Florinef's effectiveness
• Hydantoins (eg, phenytoin), live vaccines, or smallpox vaccine because the effectiveness of these medicines may be decreased
• Anticoagulants (eg, warfarin) or aspirin because their effectiveness may be decreased or the risk of their side effects may be increased by Florinef.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Florinef may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Florinef may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Florinef with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Florinef may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
• Carry an ID card at all times that says you take Florinef.
• Tell your doctor or dentist that you take Florinef before you receive any medical or dental care, emergency care, or surgery.
• Long-term use may cause cataracts, glaucoma, and eye infections. Contact your doctor right away if you develop any unusual changes in your vision.
• Florinef may cause an increase in blood pressure, salt and water retention, and calcium and potassium loss. Talk with your doctor to see if you need to decrease the amount of salt in your diet or take a calcium or vitamin D supplement.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Florinef. Talk with your doctor before you receive any vaccine.
• Diabetes patients - Florinef may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including blood electrolytes, blood calcium levels, blood pressure, and vision tests may be performed while you use Florinef. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Florinef in children; they may be more sensitive to its effects.
• Corticosteroids may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Florinef.
• Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Florinef while you are pregnant. Florinef is found in breast milk. If you are or will be breast-feeding while using Florinef, check with your doctor. Discuss any possible risks to your baby.

SIDE EFFECTS

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Difficulty sleeping; dizziness or lightheadedness; headache; increased appetite; increased sweating; indigestion; nervousness.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in menstrual periods; chest pain; eye pain or increased pressure in the eye; fever, chills, or sore throat; joint or bone pain; mood or mental changes (eg, depression); muscle pain or weakness; seizures; severe or persistent headache; severe or persistent nausea or vomiting; stomach pain or bloating; swelling of feet or legs; trouble sleeping; unusual weight gain or loss; vision changes; vomiting material that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.