hydrocortisone (oral)

What is the most important information I should know about hydrocortisone?

Tell your doctor about any illness or infection you had within the past several weeks.

What is hydrocortisone?

Hydrocortisone is a steroid medicine that is used to treat many different conditions, including allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, lung disorders, and certain blood cell disorders such as anemia (low red blood cells) or thrombocytopenia (low platelets).

Hydrocortisone is also used to replace steroids in people with adrenal insufficiency (decreased production of natural steroids by the adrenal glands).

Hydrocortisone is also used in the treatment of certain cancers such as leukemia, lymphoma, and multiple myeloma.

Alkindi Sprinkle is approved for use in people from birth to 17 years of age.

Hydrocortisone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking hydrocortisone?

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• tuberculosis;
• kidney disease;
• cirrhosis or other liver disease;
• a thyroid disorder;
• low bone mineral density (osteoporosis);
• stomach ulcers, ulcerative colitis, diverticulitis;
• diabetes;
• a colostomy or ileostomy;
• depression or mental illness;
• glaucoma or cataracts;
• herpes infection of the eyes; or
• a muscle disorder such as myasthenia gravis.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

How should I take hydrocortisone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not swallow an Alkindi Sprinkle capsule whole. Open the capsule and pour the medicine granules onto the tongue before swallowing. You may also mix the granules with soft food such as yogurt or applesauce (not with liquid). Swallow the mixture right away without chewing.

Drink water right after taking the Alkindi Sprinkle granule mixture. If giving this medicine to a baby, give infant formula or breast milk.

If you have trouble sleeping, you may need to take this medicine early in the day. Follow your doctor's dosing instructions very carefully.

Your dose needs may change if you have a serious illness, fever or infection, surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Your doctor will need to check your progress on a regular basis.

You should not stop taking hydrocortisone suddenly. Follow your doctor's instructions about tapering your dose.

Wear a medical alert tag or carry an ID card to let others know you use steroid medication.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking hydrocortisone?

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using hydrocortisone. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using hydrocortisone.

What are the possible side effects of hydrocortisone?

• blurred vision, eye pain or redness, seeing halos around lights;
• muscle weakness, loss of muscle mass;
• new or unusual pain in your joints, bones, or muscles;
• severe headaches, ringing in your ears, pain behind your eyes;
• unusual changes in mood or behavior;
• a seizure;
• fluid retention --shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• new signs of infection --such as fever, chills, cough, trouble breathing, sores in your mouth or on your skin, diarrhea, or burning when you urinate;
• increased adrenal gland hormones --slow wound healing, skin discoloration, thinning skin, increased body hair, tiredness, menstrual changes, sexual changes; or
• decreased adrenal gland hormones --weakness, tiredness, diarrhea, nausea, menstrual changes, skin discoloration, craving salty foods, and feeling light-headed.

Hydrocortisone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• thinning skin, bruising or discoloration;
• increased sweating;
• stomach bloating;
• changes in your menstrual periods;
• increased appetite, weight gain;
• headache, dizziness; or
• trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect hydrocortisone, especially:

• birth control pills or hormone replacement therapy;
• heart medication;
• insulin or oral diabetes medicine;
• medicine to treat an infection;
• seizure medication;
• a blood thinner such as warfarin (Coumadin, Jantoven); or
• NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect hydrocortisone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about hydrocortisone.