Hydrocortisone (hye-droe-KOR-ti-sone)

Treats inflammation, adrenal problems, and many other medical conditions. This medicine is a corticosteroid.

Brand Name(s):

Alkindi Sprinkle, Cortef

When This Medicine Should Not Be Used:

How to Use This Medicine:

Granule, Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• The oral granules are contained within capsules. Do not swallow the capsule. Do not chew or crush the granules. Do not let the capsules get wet because some of the granules may stick to the capsule. Do not give the granules through a nasogastric or gastric tube because it may block the tube.
• If you are switching from other oral hydrocortisone medicine to Alkindi® Sprinkle, your doctor may give you a starting dose of this medicine that is different from the previous oral hydrocortisone medicine that you have been taking.
• Part of the oral granules may pass into your child's stool (bowel movement). This is normal and nothing to worry about.
• Granules:
  • Your doctor will tell you how to prepare or give the dose to your child. Ask your doctor or pharmacist if you have questions.
  • Take one capsule from the bottle.
  • Hold the capsule with the writing at the top. Tap the capsule to make sure the granules fall to the bottom.
  • Squeeze the bottom of the capsule gently to loosen the top of the capsule from the bottom.
  • Twist the top of the capsule carefully.
  • You may give the medicine with or without food onto a spoon or directly into the child's mouth. If you are taking this medicine with food, pour the granules onto a spoonful of cold or room temperature soft food (including yogurt, fruit puree).
  • Do not add the granules to a fluid because it may decrease the full dose and it may leave a bitter taste.
  • The medicine should be given and swallowed within 5 minutes to avoid a bitter taste.
  • Give a sip of fluids like water, milk, breast-milk, or formula right away to make sure all granules are swallowed.
  • Call your doctor right away if the granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing the granules. Your child may not receive the full dose of this medicine and another dose may be needed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Use the oral granules within 60 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how hydrocortisone works. Tell your doctor if you are using any of the following:
  • Cyclosporine, troleandomycin
  • Birth control pills
  • Blood thinner (including warfarin)
  • Insulin or other diabetes medicine
  • Medicine to treat infections (including clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, rifabutin, rifampin, voriconazole)
  • Medicine to treat HIV infection (including efavirenz, nevirapine, ritonavir)
  • NSAIDs (including aspirin, ibuprofen)
  • Seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including cirrhosis), cancer, diabetes, high blood pressure, depression or mental health problems, stomach or bowel problems (including ulcer, colitis, diverticulitis), myasthenia gravis, osteoporosis, pheochromocytoma (adrenal tumor), thyroid problems, or any type of infection (including herpes eye infection, tuberculosis, or threadworm). Also tell your doctor if you have a recent exposure to chickenpox or measles. Tell your doctor if you had surgery.
• This medicine may cause the following problems:
  • Eye or vision problems, including cataracts, glaucoma, central serous chorioretinopathy
  • High blood pressure
  • Thinning of the bones (osteoporosis) or slow growth in children
  • Increased risk of adrenal gland problems, including Cushing syndrome
  • Increased risk of infections
  • Changes in mood or behavior
  • Tumor lysis syndrome
  • Increased risk for cancer, including Kaposi's sarcoma
• Not giving enough, or stopping this medicine, or switching from other hydrocortisone medicine may cause serious adrenal gland problems (including adrenal crisis).
• This medicine may raise your blood sugar level, especially in people with diabetes.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Darkening of the skin, diarrhea, dizziness, joint pain, loss of appetite, unusual tiredness or weakness
• Depression, mood swings, trouble sleeping, unusual thoughts, feelings, or behavior
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Eye pain, vision changes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lower back, side, or stomach pain, swelling of the feet or lower legs
• Rapid weight gain, swelling in your hands, ankles, or feet
• Increased hunger or thirst, increase in how much or how often you urinate
• Weight gain around your neck, upper back, breast, face, or waist

If you notice these less serious side effects, talk with your doctor:

• Changes in menstrual periods
• Headache
• Muscle pain or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088