Hydrocortisone Oral Granules

What is this medication?

HYDROCORTISONE (hye droe KOR ti sone) treats low levels of cortisol in the body (adrenal insufficiency). It works by replacing cortisol normally made by the body. Cortisol is a hormone that plays an important role in how the body responds to stress, illness, and injury. It belongs to a group of medications called steroids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Alkindi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cushing's syndrome
• Diabetes
• Glaucoma
• Having surgery
• High blood pressure
• Infection
• Liver disease
• Mental health disease
• Osteoporosis
• Stomach or intestine problems
• An unusual or allergic reaction to hydrocortisone, corticosteroids, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Drink water or milk after you take it. Breast milk or formula can also be used. Take it as directed on the prescription label at the same time every day. Do not swallow the capsules. Open the capsule to take the medication. Do not crush or chew the medication inside the capsule. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Certain medications for diabetes, like glipizide or glyburide
• Certain antibiotics like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications that treat or prevent blood clots like warfarin
• Cyclosporine
• Female hormones, like estrogen and birth control pills
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Rifabutin
• Rifampicin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Cushing syndrome—increased fat around the midsection, upper back, neck, or face, pink or purple stretch marks on the skin, thinning, fragile skin that easily bruises, unexpected hair growth
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Acne
• General discomfort and fatigue
• Headache
• Increase in appetite
• Nausea
• Trouble sleeping
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medication in the original container. Protect from light. Throw away any unused medication 60 days after opening.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.