ALKINDI SPRINKLE- hydrocortisone granule ALKINDI SPRINKLE- hydrocortisone granule ALKINDI SPRINKLE- hydrocortisone granule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Eton Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ALKINDI SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. ALKINDI SPRINKLE is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. Anaphylactic reactions have occurred in patients receiving corticosteroids [see Adverse Reactions (6.2)] . Risk Summary Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. The use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. However, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications. In addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. Animal Data Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring. Risk Summary Cortisol is present in human milk. The use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. There are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ALKINDI SPRINKLE and any potential adverse effects on the breastfed infant from ALKINDI SPRINKLE or from the underlying maternal condition. The safety and effectiveness of ALKINDI SPRINKLE have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. Use of ALKINDI SPRINKLE in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. No new adverse reactions were identified [see Adverse Reactions (6) and Clinical Pharmacology (12.3)] . ALKINDI SPRINKLE are oral granules contained within capsules that must be opened and not swallowed whole to administer the granules. Additionally, ALKINDI SPRINKLE granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage [see Dosage and Administration (2.2)] . Instructions for Use ALKINDI® SPRINKLE(ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules Read this Instructions for Use before you start using ALKINDI SPRINKLE, and each time you get 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. Important information you need to know before giving ALKINDI SPRINKLE - ALKINDI SPRINKLE comes in a capsule that must be opened before use. - Do not let your child swallow the capsule. Small children may choke. - Do not let your child chew or crush the granules in the capsule. - Do not let the capsules get wet as this may make some of the granules stick to the capsule. - Your healthcare provider will decide the right dose of ALKINDI SPRINKLE for your child. Follow your healthcare provider's instructions for the dose of ALKINDI SPRINKLE to give your child. - Ask your healthcare provider or pharmacist if you are not sure how to prepare or give the prescribed dose of ALKINDI SPRINKLE to your child. - Call your healthcare provider if granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing ALKINDI SPRINKLE. Your child may not have received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI SPRINKLE may be needed. - Your child may sometimes pass the ALKINDI SPRINKLE granules in their stools (bowel movement). It does not mean that ALKINDI SPRINKLE is not working. Do not give your child another dose of ALKINDI SPRINKLE. Supplies needed to give ALKINDI SPRINKLE: - ALKINDI SPRINKLE capsule(s) for prescribed dose - 1 spoon - soft food such as yogurt or pureed fruit or sip of fluids such as water, milk, breastmilk or formula Preparing and giving ALKINDI SPRINKLE: Step 1: Check the expiration date on the ALKINDI SPRINKLE bottle. Do not use ALKINDI SPRINKLE after the expiration date on the bottle has passed. Step 2: Remove the prescribed dose of ALKINDI SPRINKLE capsules from the bottle. Step 6: Giving ALKINDI SPRINKLE ALKINDI SPRINKLE can be given (a) with food onto a spoon, (b) without food onto a spoon, or (c) directly into the child's mouth. Do not add the granules to a fluid before giving ALKINDI SPRINKLE because it can result in less than the full dose given and it may leave a bitter taste in the mouth. (c) Directly onto the child's tongue. Pour all granules that make up the prescribed dose directly onto the child's tongue. Tap the capsule to make sure all granules are removed. The ALKINDI SPRINKLE granules should be given and swallowed within 5 minutes to avoid a bitter taste. Step 7: Give Fluids After giving ALKINDI SPRINKLE, give a sip of fluids such as water, milk, breastmilk or formula right away to make sure all granules are swallowed. Throwing Away (disposal of) ALKINDI SPRINKLE: Ask your pharmacist how to throw away medicines you no longer use. How should I store ALKINDI SPRINKLE? - Store ALKINDI SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C). - Store in the original bottle to protect from light. - After the bottle has been opened, use the ALKINDI SPRINKLE capsules within 60 days. Keep ALKINDI SPRINKLE and all medicines out of the reach of children. 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® 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. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 12/2022

Product summary:

ALKINDI SPRINKLE oral granules are supplied as white to off-white granules in transparent capsules as follows: Store at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original bottle in order to protect from light. Once the bottle has been opened, use the capsules within 60 days.

Authorization status:

New Drug Application

Patient Information leaflet

ALKINDI SPRINKLE- HYDROCORTISONE GRANULE
ALKINDI SPRINKLE- HYDROCORTISONE GRANULE
Eton Pharmaceuticals, Inc.
----------
provider needs to change your child's dose of ALKINDI SPRINKLE.
Especially tell your healthcare provider if your child:
•
takes medicines used to treat fungal infections such as itraconazole,
posaconazole, and
voriconazole.
•
takes medicines used to treat bacterial infections such as rifampicin,
rifabutin, erythromycin,
andclarithromycin.
•
takes medicines used to treat human immunodeficiency virus (HIV)
infection and AIDS such as
ritonavir, efavirenz, and nevirapine.
•
takes seizure medicines such as phenytoin, carbamazepine,
oxcarbazepine, phenobarbital, and
primidone.
•
takes estrogen.
•
takes warfarin.
•
takes nonsteroidal anti-inflammatory medicines such as aspirin,
ibuprofen.
•
takes cyclosporine.
•
takes diabetes medicines.
•
drinks grapefruit juice.
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?
•
See the detailed Instructions for Use that comes with your ALKINDI
SPRINKLE for information
on how to give a dose of ALKINDI SPRINKLE the right way.
•
Give ALKINDI SPRINKLE exactly as prescribed by your healthcare
provider.
•
Do not stop giving ALKINDI SPRINKLE without talking to your healthcare
provider. See "What
is the most important information I should know about ALKINDI
SPRINKLE?"
•
Do not let your child chew or crush the granules. Do not let your
child swallow the capsule.
•
Do not let the capsules get wet as this may make some of the granules
stick to the capsule.
•
Call your healthcare provider if granules come back up into your
child's mouth (regurgitation) or
your child has vomiting after swallowing ALKINDI SPRINKLE. Your child
may not have
received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI
SPRINKLE may
be needed.
•
Your child may sometimes pass the ALKINDI SPRINKLE granules in their
stools (bowel
move

Summary of Product characteristics

ALKINDI SPRINKLE- HYDROCORTISONE GRANULE
ALKINDI SPRINKLE- HYDROCORTISONE GRANULE
ALKINDI SPRINKLE- HYDROCORTISONE GRANULE
ETON PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALKINDI SPRINKLE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALKINDI
SPRINKLE .
ALKINDI SPRINKLE (HYDROCORTISONE) ORAL GRANULES
INITIAL U.S. APPROVAL: 1952
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.9, 5.10)
02/2024
INDICATIONS AND USAGE
ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy
in pediatric patients with
adrenocortical insufficiency. (1)
DOSAGE AND ADMINISTRATION
Individualize the dose, using the lowest possible dosage. (2.1)
The recommended starting replacement dosage is 8 to 10 mg/m daily.
Higher doses may be needed
based on patient's age and symptoms of the disease. Use of lower
starting doses may be sufficient in
patients with residual but decreased endogenous cortisol production.
(2.1)
Round the dose to the nearest 0.5 mg or 1 mg. More than one capsule
may be needed to supply the
required dose. (2.1)
Divide the total daily dose in 3 doses and administer 3 times daily.
Older patients may have their daily
dose divided by 2 and administered twice daily. (2.1)
When switching from other oral hydrocortisone formulations, use the
same total daily hydrocortisone
dosage. If symptoms of adrenal insufficiency occur, increase total
daily dosage. (2.2)
ALKINDI SPRINKLE are oral granules contained within capsules. Do not
swallow the capsule. Do not chew
or crush the granules. (2.3)
See the Full Prescribing Information for detailed administration
instructions. (2.3)
DOSAGE FORMS AND STRENGTHS
Oral granules: 0.5 mg, 1 mg, 2 mg, 5 mg contained in capsules. (3)
CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the ingredients in
ALKINDI SPRINKLE. (4)
WARNINGS AND PRECAUTIONS
_Adrenal Crisis:_ Undertreatment, sudden discontinuation of therapy,
or switching from another oral
hydrocortisone formul