Alkindi Sprinkle 2 mg/1

Hydrocortisone · GRANULE · Eton Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Alkindi Sprinkle is a granule containing hydrocortisone at 2 mg/1, taken oral. Manufactured by Eton Pharmaceuticals, Inc..

Key Facts

Brand Name: Alkindi Sprinkle
Generic Name: Hydrocortisone
NDC Code (Product): 71863-111
Manufacturer: Eton Pharmaceuticals, Inc.
Strength: 2 mg/1
Dosage Form: GRANULE
Route: ORAL
Marketing Status
Application #: NDA213876
Drug Class: Corticosteroid [EPC]
Marketing Start: 09/29/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use9,172 reports

drug ineffective7,265 reports

fatigue5,740 reports

condition aggravated5,322 reports

nausea4,846 reports

rash4,747 reports

diarrhoea4,335 reports

pain4,323 reports

headache4,313 reports

arthralgia4,154 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ALKINDI SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ' • Individualize the dose, using the lowest possible dosage. (2.1) • The recommended starting replacement dosage is 8 to 10 mg/m2 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) 2.1 Dosage Information Individualize the dose for each patient, using the lowest possible dosage. The recommended starting replacement dosage …

Contraindications

4 CONTRAINDICATIONS 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 )] . Hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 Drug Interactions with ALKINDI SPRINKLE CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the use of excessive doses. Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin Antiretrovirals: ritonavir Grapefruit juice CYP3A4 Inducers Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal crisis. Intervention: Concomitant use of CYP3A4 inducers may require an increase in the ALKINDI SPRINKLE dose. Examples: Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirap…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Adrenal Crisis [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions ( 5.2 )] Growth Retardation [see Warnings and Precautions ( 5.3 )] Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids [see Warnings and Precautions ( 5.4 )] Decrease in Bone Mineral Density [see Warnings and Precautions ( 5.5 )] Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.7 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.8 )] Risk of Kaposi's Sarcoma with Use of Dosage Greater Than Replacement [see Warnings and Precautions (5.9)] Vaccinations [see Warnings and Precautions (5.10)] Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or F…

Frequently Asked Questions

What is Alkindi Sprinkle used for?

Alkindi Sprinkle contains Hydrocortisone. It is a granule taken oral. Consult your doctor for specific uses.

Is Alkindi Sprinkle a controlled substance?

Alkindi Sprinkle is not classified as a controlled substance by the DEA.

What is the generic name for Alkindi Sprinkle?

The generic name for Alkindi Sprinkle is Hydrocortisone. There are 12 other brand versions of Hydrocortisone.

What is the NDC code for Alkindi Sprinkle 2 mg/1?

The NDC (National Drug Code) for Alkindi Sprinkle 2 mg/1 is 71863-111, listed by Eton Pharmaceuticals, Inc..

Product NDC

71863-111

Package NDC

71863-111-50

Other Hydrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)