ALKINDI SPRINKLE

AbsorptionFollowing oral administration, a dose of ALKINDI SPRINKLE 4x5 mg was approximately 87% bioavailable when compared to intravenous hydrocortisone in dexamethasone-suppressed healthy adult male volunteers. The median time to peak serum concentration (Tmax) was 0.75 hours post-dose following oral administration. In an open label, single dose study in 24 pediatric patients with adrenocortical insufficiency, ALKINDI SPRINKLE (1-4 mg based on body surface area) increased cortisol levels from...

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 Precauti...

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 )

Adrenal Crisis: Undertreatment, sudden discontinuation of therapy, or switching from another oral hydrocortisone formulation may lead to adrenocortical insufficiency, adrenal crisis and death. Adrenal crisis may also be induced by stress events such as infections or surgery. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill or unable to take oral medications to parenteral corticosteroid formulations. (5.1) Immunosuppression and Increased Risk of Infection...

7 DRUG INTERACTIONS

Table 2Drug 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 ...