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DANALONE (PREDNISOLONE) INDICATIONS

Danalone is used for treating allergies, arthritis, breathing problems (eg, asthma), certain blood disorders, collagen diseases (eg, lupus), certain eye diseases (eg, keratitis), cancer (eg, leukemia), endocrine problems (eg, adrenocortical insufficiency), intestinal problems (eg, ulcerative colitis), swelling due to certain conditions, or skin conditions (eg, psoriasis). Danalone is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.

DANALONE (PREDNISOLONE) INSTRUCTIONS

Use Danalone as directed by your doctor.

  • Take Danalone by mouth with food.
  • If you miss a dose of Danalone, 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 Danalone.

DANALONE (PREDNISOLONE) STORAGE

Store Danalone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Danalone out of the reach of children and away from pets.

Do NOT use Danalone if:

  • you are allergic to any ingredient in Danalone
  • you have a systemic fungal infection, a certain type of malaria, inflammation of the optic nerve, or herpes infection of the eye
  • you are scheduled to have a live or attenuated live vaccination (eg, smallpox)
  • you are taking mifepristone.

Contact your doctor right away if any of these apply to you.

Some medical conditions may interact with Danalone. 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 have a history of heart problems (eg, congestive heart failure), heart attack, high blood pressure, kidney problems, liver problems, diabetes, seizures, an underactive thyroid, adrenal gland problems, fluid retention (eg, swelling of the hands, ankles, or feet), or any mental or mood problems
  • if you have or have recently had a fungal, bacterial, viral, or other type of infection; herpes infection of the eye; chickenpox; measles; or shingles
  • if you have HIV infection or tuberculosis (TB) infection, or if you have had ever had a positive TB skin test
  • if you have any stomach problems (eg, ulcers), intestinal problems (eg, blockage, perforation, or infection; unexplained diarrhea; diverticulitis; ulcerative colitis), recent intestinal surgery, or inflammation of the esophagus
  • if you have weak bones (eg, osteoporosis) or muscle problems (eg, myasthenia gravis)
  • if you have had a recent vaccination (eg, smallpox).

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

  • Clarithromycin, cyclosporine, estrogens (eg, estradiol), oral contraceptives (eg, birth control pills), or ketoconazole because they may increase the risk of Danalone's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, ephedrine, hydantoins (eg, phenytoin), or rifampin because they may decrease Danalone's effectiveness
  • Anticholinesterases (eg, pyridostigmine), aspirin, diuretics (eg, hydrochlorothiazide, furosemide), methotrexate, mifepristone, quinolone antibiotics (eg, ciprofloxacin), ritodrine, or live or attenuated live vaccines because the risk of their side effects may be increased by Danalone
  • Anticoagulants (eg, warfarin), hydantoins (eg, phenytoin), or killed or inactivated vaccines because their effectiveness may be decreased by Danalone.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Danalone 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:

  • Avoid alcohol while you are using Danalone.
  • Danalone 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.
  • If you are taking Danalone regularly over a long period of time, carry an ID card at all times that says you take Danalone.
  • Do not receive a live vaccine (eg, measles, mumps, smallpox) while you are taking Danalone. Talk with your doctor before you receive any vaccine.
  • Tell your doctor or dentist that you take Danalone before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Danalone 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 adrenal function tests, may be performed while you use Danalone. 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 Danalone 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 take Danalone.
  • Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Danalone while you are pregnant. Danalone is found in breast milk. If you are or will be breast-feeding while you use Danalone, check with your doctor. Discuss any possible risks to your baby.

If you are on long-term or high dosage therapy and you suddenly stop taking Danalone, you may have withdrawal symptoms, including fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, joint or muscle pain.

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:

Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.

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 body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; increased hunger, thirst, or urination; mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; shortness of breath; signs of infection (eg, fever, chills, persistent sore throat); sudden severe dizziness or headache; swelling of ankles, feet, or hands; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit 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.



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