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 your child has any of these conditions:

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

How should I use this medication?

Give this medication by mouth. Give it as directed on the prescription label at the same time every day. The capsule must be opened to give the medication. Do not let your child swallow the capsule or chew or crush the granules in the capsule. Do not add the granules to a fluid before giving it because it can result in less than the full dose given, and it may leave a bitter taste in the mouth. Do not let the capsules get wet as this may make some granules stick to the capsule. Keep giving it unless your care team tells you to stop.

How to give the granules WITH food: Pour all granules from the capsule onto a spoonful of soft food (yogurt, fruit puree). Tap the capsule to make sure all granules are removed. Give the dose within 5 minutes to avoid a bitter taste. After giving the dose, give a sip of fluids such as water, milk, breast milk, or formula right away to make sure all granules are swallowed.

How to give the granules WITHOUT food: Pour all granules from the capsule directly onto the child's tongue or onto a spoon and place it in the child's mouth. Tap the capsule to make sure all granules are removed. After giving the dose, give a sip of fluids such as water, milk, breast milk, or formula right away to make sure all granules are swallowed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to give 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 your child misses a dose, give it as soon as you can. If it is almost time for their next dose, give only that dose. Do not give double or extra doses.

Contact your care team if your child spits up or vomits after swallowing the dose. Another dose may be needed.

What may interact with this medication?

• Certain medications for diabetes, such as glipizide or glyburide
• Certain antibiotics, such as erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, or posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin, or primidone
• Certain medications that treat or prevent blood clots, such as warfarin
• Cyclosporine
• Estrogen or progestin hormones
• NSAIDs, medications for pain and inflammation, such as 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 child's progress. Tell your care team if your child's symptoms do not start to get better or if they get worse.

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

This medication may slow your child's growth if it is taken for a long time at high doses. Your child's care team will monitor your child's growth.

Using this medication for a long time may weaken your child's bones. The risk of bone fractures may be increased. Talk to your care team about your child's bone health.

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

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

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

Your child may sometimes pass the granules in their stools. It does not mean that the medication is not working. Do not give your child another dose.

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 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from light. Get rid of any unused medication 60 days after opening.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.