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|DexPak Tablets

DexPak

DexPak is used for:

Treating certain conditions associated with decreased adrenal gland function. It is also used to treat severe inflammation due to certain conditions, including severe asthma, severe allergies, rheumatoid arthritis, ulcerative colitis, certain blood disorders, lupus, multiple sclerosis, and certain eye and skin conditions. It may also be used for other conditions as determined by your doctor.

DexPak is a corticosteroid. It works by decreasing or preventing tissues from responding to inflammation. It also modifies the body"s response to certain immune stimulation.

Do NOT use DexPak if:

• you are allergic to any ingredient in DexPak
• you have a systemic fungal infection
• you are taking mifepristone

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

Before using DexPak:

Some medical conditions may interact with DexPak. 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 an underactive thyroid, liver or kidney problems, diabetes, or ulcerative colitis
• if you have heart problems, esophagitis, gastritis, stomach obstruction or perforation, or an ulcer
• if you have a history of mental problems (eg, depression), glaucoma, cataracts, or other eye problems
• if you have a herpes infection in your eye or any other type of infection (bacterial, fungal, or viral); have or recently had tuberculosis (TB) or tested positive for TB, measles, or chickenpox

Some MEDICINES MAY INTERACT with DexPak. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease DexPak"s effectiveness
• Clarithromycin, azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because because weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur
• Methotrexate or ritodrine because the risk of their side effects may be increased by DexPak
• Hydantoins (eg, phenytoin),mifepristone, or live vaccines because their effectiveness may be decreased by DexPak
• Anticoagulants (eg, warfarin) or aspirin because their actions and side effects may be increased or decreased by DexPak

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

How to use DexPak:

Use DexPak as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take DexPak by mouth with food.
• DexPak is a dose pack. Unless otherwise directed by your doctor, follow the instructions on the pack for taking DexPak.
• If you miss a dose of DexPak, 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 DexPak.

Important safety information:

• DexPak 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.
• Tell your doctor or dentist that you take DexPak before you receive any medical or dental care, emergency care, or surgery.
• DexPak may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.
• DexPak can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.
• Diabetes patients -- DexPak may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Caution is advised when using DexPak 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 DexPak.
• PREGNANCY and BREAST-FEEDING: It is not known if DexPak can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using DexPak while you are pregnant. DexPak is found in breast milk. Do not breast-feed while taking DexPak.

Possible side effects of DexPak:

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; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite loss; black, tarry stools; changes in menstrual periods; convulsions; depression; diarrhea; dizziness; exaggerated sense of well-being; fever; general body discomfort; headache; increased pressure in the eye; joint or muscle pain; mood swings; muscle weakness; personality changes; prolonged sore throat, cold, or fever; puffing of the face; severe nausea or vomiting; swelling of feet or legs; unusual weight gain; vomiting material that looks like coffee grounds; weakness; weight loss.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store DexPak 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 DexPak out of the reach of children and away from pets.

General information:

• If you have any questions about DexPak, please talk with your doctor, pharmacist, or other health care provider.
• DexPak is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about DexPak. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.