ALKINDI SPRINKLE- hydrocortisone granule
ALKINDI SPRINKLE- hydrocortisone granule
ALKINDI SPRINKLE- hydrocortisone granule
Eton Pharmaceuticals, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug Administration | Revised: 04/2024 | ||||||
Medication Guide
ALKINDI SPRINKLE® (ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules |
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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: |
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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. |
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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. |
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Who should not take or be given ALKINDI SPRINKLE? Do not give your child ALKINDI SPRINKLE if they:
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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:
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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. |
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Especially tell your healthcare provider if your child:
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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?
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What are the possible side effects of ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including:
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The most common side effects of ALKINDI SPRINKLE include: | |||||||
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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?
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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 Diurnal 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. |