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.

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

Hydrocortisone comes as a tablet and granules to take by mouth. If you are taking the tablets, your doctor will prescribe a dosing schedule that is best for you. Hydrocortisone granules come in capsules and are usually taken 2 or 3 times a day. Hydrocortisone may be taken with food or milk to prevent stomach upset. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydrocortisone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

To take the granules, open the capsule(s) and either pour all of the granules directly from the capsule(s) into your child's mouth or pour the granules onto a clean spoon and place the spoonful of medication in your child's mouth. You can also pour all of the granules from the capsule(s) onto a spoonful of cold or room temperature soft food such as yogurt or a fruit-based soft food, such as applesauce. Swallow the granules or the mixture of soft food and granules right away (within 5 minutes) without chewing or crushing the granules. Take several sips of liquid such as water, formula, or breast milk right away to be sure that any leftover granules have been swallowed. Do not swallow the capsules that contain the granules.

If your child vomits or spits up after taking a dose of hydrocortisone granules, call your doctor right away. Your doctor will tell you if you need to give your child another dose. Do not give another dose unless your doctor tells you to do so.

Your doctor may change your dose of hydrocortisone often during your treatment to be sure that you are always taking the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

Hydrocortisone may help control your condition but may not cure it. Continue to take hydrocortisone even if you feel well. Do not stop taking hydrocortisone without talking to your doctor. If you suddenly stop taking hydrocortisone, your body may not have enough natural steroids to function normally. This may cause extreme tiredness, weakness, loss of appetite, weight loss, an upset stomach, vomiting, drowsiness, joint and muscle pain, changes in skin color, and craving for salt. If you take large doses for a long time, your doctor probably will decrease your dose gradually to allow your body to adjust before stopping the drug completely. If these problems occur, call your doctor immediately. You may need to increase your dose of hydrocortisone temporarily or start taking it again.

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.

Take with food if hydrocortisone upsets your stomach.

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.

Store at room temperature away from moisture, heat, and light.

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

You should not use hydrocortisone if you are allergic to hydrocortisone, corticosteroids, or if you have a systemic fungal infection.

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.

It is not known whether this medicine will harm an unborn baby. However, using this medicine during pregnancy may cause a hormone deficiency in the newborn. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Your doctor may instruct you to follow a low-salt, high-potassium, or high-calcium diet. Follow these directions.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medication.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Hydrocortisone may cause serious side effects. Call your doctor at once if you have:

• 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 hydrocortisone.

Common side effects of hydrocortisone 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to hydrocortisone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.