ALKINDI SPRINKLE- hydrocortisone granule 
ALKINDI  SPRINKLE- hydrocortisone granule 
Eton Pharmaceuticals, Inc.

----------

Medication Guide

ALKINDI SPRINKLE® (ælˈkɪndi spr-en-kle)

(hydrocortisone) oral granules

Read this Medication Guide before you start giving ALKINDI SPRINKLE to your child, and each time your child gets a

refill. There may be new information. This information does not take the place of talking to your healthcare provider about your child’s medical condition or treatment.

What is the most important information I should know about ALKINDI SPRINKLE?

ALKINDI SPRINKLE may cause serious side effects, including:

Adrenal gland problems. Not giving enough ALKINDI SPRINKLE, stopping ALKINDI SPRINKLE, or switching to ALKINDI SPRINKLE after taking another hydrocortisone medicine (the same class of medicines as ALKINDI SPRINKLE) by mouth, can cause serious and life-threatening adrenal gland problems including death. Do not stop giving ALKINDI SPRINKLE without talking to your healthcare provider. Tell your healthcare provider if your child has any of these symptoms:

  1. loss of appetite
  2. joint pain
  3. low blood sugar
  4. fatigue
  5. nausea
  6. feeling lightheaded or dizzy
  7. weakness
  8. vomiting
  9. problems with body salt (electrolyte) levels

Your healthcare provider will change the dose of ALKINDI SPRINKLE depending on your child’s size. Tell your healthcare provider if your child cannot swallow medicines by mouth. During episodes of acute infections, surgery, major trauma or if your child cannot take medicines by mouth, your healthcare provider may recommend increased doses of ALKINDI SPRINKLE or use of corticosteroid medicines given directly into the bloodstream instead.

The amount of hydrocortisone in a dose of ALKINDI SPRINKLE may not be the same as in previous hydrocortisone medicines that your child takes by mouth if these oral hydrocortisone medicines have been changed (for example, crushed or compounded). When switching to ALKINDI SPRINKLE, your healthcare provider may need to prescribe a starting dose of ALKINDI SPRINKLE that is different from previous hydrocortisone medicines that your child may have been taking by mouth. Watch your child closely after being switched to ALKINDI SPRINKLE and contact your healthcare provider if your child has any symptoms of adrenal gland problems. Your healthcare provider may need to change the dose of ALKINDI SPRINKLE.

See “What are the possible side effects of ALKINDI SPRINKLE?” for more information about side effects.

What is ALKINDI SPRINKLE?

ALKINDI SPRINKLE is a prescription medicine that contains a medicine hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids. Hydrocortisone is a synthetic version of the hormone cortisol. Cortisol is made naturally by the adrenal glands in the body. ALKINDI SPRINKLE (hydrocortisone) is a man-made (synthetic) corticosteroid used to replace the body’s cortisol when the adrenal glands do not make enough (adrenal insufficiency) in

children from birth to 17 years of age.

Who should not take or be given ALKINDI SPRINKLE?

Do not give your child ALKINDI SPRINKLE if they:

What should I tell my healthcare provider before giving ALKINDI SPRINKLE?

Before you give your child ALKINDI SPRINKLE, tell your healthcare provider about all of your child’s medical conditions, including if they:

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines, food and drink can affect the way that ALKINDI SPRINKLE works and may mean that your healthcare

provider needs to change your child’s dose of ALKINDI SPRINKLE.

Especially tell your healthcare provider if your child:

Know the medicines your child takes. Keep a list of them to show your healthcare provider and pharmacist when your child gets a new medicine.

How should I give ALKINDI SPRINKLE?

What are the possible side effects of ALKINDI SPRINKLE?

ALKINDI SPRINKLE may cause serious side effects, including:

  1. fever
  2. stomach area (abdominal) pain
  3. cough
  4. diarrhea
  5. flu-like symptoms
  1. weight gain
  2. high blood sugar
  3. swelling
  4. muscle weakness
  5. feeling depressed
  6. slowed growth in height
  7. high blood pressure
  8. bruising easily
  9. red, round face
  10. mood swings

SPRINKLE. Tell your healthcare provider right away if your child develops any changes inbehavior including:

strong feelings of happiness and excitement
overexcited and overactivity
loss of contact with reality, with feelings that are not real, and mental confusion
depression

The most common side effects of ALKINDI SPRINKLE include:

  1. fluid retention
  2. change in blood sugar (glucose) tolerance
  3. increase in blood pressure
  4. behavioral and mood changes
  5. increased appetite and weight gain

These are not all the possible side effects of ALKINDI SPRINKLE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ALKINDI SPRINKLE?

Keep ALKINDI SPRINKLE and all medicines out of the reach of children.

General information about the safe and effective use of ALKINDI SPRINKLE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ALKINDI SPRINKLE for a condition for which it was not prescribed. Do not give ALKINDI SPRINKLE to other people, even if they

have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ALKINDI SPRINKLE that is written for health professionals.

What are the ingredients in ALKINDI SPRINKLE?

Active ingredient: hydrocortisone

Inactive ingredients:

granules: microcrystalline cellulose, hypromellose, magnesium stearate, ethyl cellulose.

capsule: hypromellose

printing ink: shellac, propylene glycol, concentrated ammonia solution.

ALKINDI SPRINKLE is manufactured for Eton Pharmaceuticals, Inc. by Glatt Pharmaceutical Services GmbH & Co. KG Werner-Glatt-Strasse 1, Binzen, Baden- Wuerttemberg, 79589, Germany

ALKINDI SPRINKLE® is a registered trademark of Neurocrine UK Limited.

ALKINDI is covered by the following US patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. For more information, go to www.alkindisprinkle.com or call 1-833-343-2500.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised 12/2024

Revised: 12/2024
Eton Pharmaceuticals, Inc.