Cortef (Hydrocortisone) 5 mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYDROCORTISONE - ORAL

(HYE-droe-KOR-ti-sone)

COMMON BRAND NAME(S): Cortef

USES: Hydrocortisone is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system\'s response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions. Hydrocortisone is also used to treat low hydrocortisone levels caused by diseases of the adrenal gland (such as Addison\'s disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

HOW TO USE: Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take hydrocortisone 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders or use a pill box. 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. If you suddenly stop using this medication, you may have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used hydrocortisone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, heartburn, headache, dizziness, menstrual period changes, trouble sleeping, increased sweating, or acne may occur. If any of these effects persist or worsen, tell 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. Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge. This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Tell your doctor right away if any of these unlikely but serious side effects occur: unusual tiredness, swelling ankles/feet, unusual weight gain, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, bone pain, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds). Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, 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: 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 or at www.fda.gov/medwatch. 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 hydrocortisone, 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), heart problems (such as heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), brittle bones (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, blood clots, mental/mood conditions (such as psychosis, anxiety, depression), low salts in the blood (such as low potassium or calcium), seizures. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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. This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Hydrocortisone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). 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. Older adults may be more sensitive to the effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion). During pregnancy, hydrocortisone 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 period of time may have hormone problems. Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: aldesleukin, mifepristone, other drugs that can cause bleeding/bruising (such as antiplatelet drugs like clopidogrel, NSAIDs like ibuprofen/naproxen, \"blood thinners\" like warfarin/dabigatran). Aspirin can increase the risk of bleeding when used with this medication. However, 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 lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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 (such as blood sugar/mineral levels, blood counts, blood pressure, bone density tests, eye exams, height/weight measurements, X-rays) should be performed regularly to check for side effects. Consult your doctor for more details. This medication may cause bone problems (osteoporosis). Lifestyle changes that may help reduce the risk of bone problems while taking this drug for an extended time include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.

MISSED DOSE: If you are taking this medication once daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. If you are taking this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

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 January 2020. Copyright(c) 2020 First Databank, Inc.