DexPak 13 Day should be used with caution in: children, the elderly, patients with a history of or family history of mental illness including depression, mental illness that was made worse be previous steroid medicine, renal disease, liver disease, heart failure, heart attack, diabetes or family history of diabetes, glaucoma (an eye condition) or family history of glaucoma, osteoporosis (a bone condition), high blood pressure, fitting (epilepsy), muscle weakness (myasthenia gravis), migraine, muscle weakness with dexamethasone or other steroids in the past, infection with parasites, stunted growth, Cushing's syndrome, head injury, stroke, patients who have been vaccinated against measles or chickenpox, underactive thyroid gland, history of tuberculosis (TB), herpes simplex infection of the eye, fungal infection of the eye, cold sores or genital herpes, asthma.

It should not be used in: patients with an allergy to dexamethasone or to any other ingredients contained in the medicine or an allergy to other corticosteroids, infection that affects the whole body, infection of a joint, unstable joints where joints such as the knee suddenly give way, ulcers of the stomach or duodenum, infection with tropical worms, fungal, viral or other infections of the eye, users of soft contact lenses (applies to eye drops only), patients vaccinated with a live virus.

Dexamethasone is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, certain bowel disorders, and certain cancers. It is also used as a test for an adrenal gland disorder (Cushing's syndrome).

This medication is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to prevent nausea and vomiting caused by cancer chemotherapy.

How to use DexPak 13 Day

Take this medication by mouth as directed by your doctor. Take with food or milk to prevent stomach upset. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. If you are using the liquid form of the medication, use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon.

If you take this medication once daily, take it in the morning before 9 AM. If you are taking this medication every other day or on another schedule besides a daily one, it may help to mark your calendar with a reminder.

The dosage and length of treatment are based on your medical condition and response to therapy. Your doctor may attempt to reduce your dose slowly from time to time to minimize side effects.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Follow the dosing schedule carefully, and take this medication exactly as prescribed.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition does not improve or worsens.

Stomach upset, headache, dizziness, menstrual changes, trouble sleeping, increased appetite, or weight gain may occur. If any of these effects persist or worsen, notify 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: signs of infection (e.g., fever, persistent sore throat), bone/joint pain, increased thirst/urination, fast/slow/irregular heartbeat, eye pain/pressure, vision problems, heartburn, black stools, vomit that looks like coffee grounds, puffy face, swelling of the ankles/feet, stomach/abdominal pain, pain/redness/swelling of arms/legs, tiredness, mental/mood changes (e.g., depression, mood swings, agitation), unusual hair/skin growth, muscle pain/cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

Before taking dexamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); 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: active fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other infections (e.g., tuberculosis, herpes), kidney disease, liver disease, mental/mood conditions (e.g., psychosis, anxiety, depression), low blood minerals (e.g., low potassium/calcium), thyroid disease, stomach/intestinal problems (e.g., ulcer, ulcerative colitis, diverticulitis, unexplained diarrhea), high blood pressure, heart problems (e.g., congestive heart failure, recent heart attack), diabetes, eye diseases (e.g., cataracts, glaucoma, herpes infection of the eye), brittle bones (osteoporosis), history of blood clots.

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 during urination, muscle aches) that occur during treatment.

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.

Do not have immunizations, vaccinations, or skin tests unless specifically directed by your doctor. Live vaccines may cause serious complications (e.g., infection) if given while you are taking this medication. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while taking this medication to decrease the risk of stomach/intestinal bleeding. Consult your doctor or pharmacist for more details.

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 medicine, exercise plan, or diet may need to be adjusted.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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.

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 and/or at high doses 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 drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast- feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aminoglutethimide, aprepitant, birth control pills, certain cancer drugs (dasatinib, lapatinib, sunitinib, aldesleukin), caspofungin, cholestyramine, cyclosporine, digoxin, drugs affecting liver enzymes that remove dexamethasone from your body (such as azole antifungals including ketoconazole, barbiturates including phenobarbital, rifamycins including rifampin, certain anti-seizure medications including phenytoin, carbamazepine), drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen), ephedrine, estrogen hormone replacement, HIV protease inhibitors (e.g., indinavir), isoniazid, mifepristone, temsirolimus, thalidomide, a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir).

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

If this medication is used for an extended time, laboratory and/or medical tests (e.g., blood sugar/mineral levels, blood pressure, eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Talk with your doctor about making changes to your lifestyle that may decrease the side effects of this medication (e.g., weight-bearing exercise, dietary changes including controlling salt intake and getting more potassium/calcium).

Missed Dose

If you are taking this medication daily and on a regular schedule, and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

If you are taking this medication every other day or are slowly reducing your dose, and you miss a dose, then contact your doctor or pharmacist immediately to establish a new dosing schedule.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.