Indications for ALKINDI SPRINKLE:
Replacement therapy for adrenocortical insufficiency in pediatric patients.
See full labeling. Individualize. Use lowest effective dose. Do not swallow caps. Do not chew or crush granules. Do not use in NG or gastric tubes. Open and hold the caps appropriately. Pour the granules directly onto tongue, onto a spoon and place in the mouth, or sprinkling onto a spoonful of cold/room temperature soft food (eg, yogurt or fruit puree); swallow within 5mins. 8–10mg/m2/day in 3 divided doses; may give twice daily in older pediatric patients. Switching from other oral hydrocortisone: use same total daily dose.
ALKINDI SPRINKLE Warnings/Precautions:
Risk of adrenal crisis. Increase dose during periods of stress (eg, infections, gastroenteritis, surgery, or major trauma). Increased risk of new or exacerbation of latent infections with any pathogen (including viral, bacterial, fungal, protozoan or helminthic infections) with excessive doses. Monitor for adrenocortical insufficiency, infections, linear growth, weight gain, psychiatric reactions, visual disturbances. Monitor for Cushing’s syndrome every 6 months; may require more frequent monitoring in patients aged <1yr. Decrease in bone mineral density. Osteoporosis. May mask signs of GI perforation. Impending GI perforation, abscess, or other pyogenic infections. Diverticulitis. Fresh intestinal anastomoses. Peptic ulcer. Pregnancy. Nursing mothers.
ALKINDI SPRINKLE Classification:
ALKINDI SPRINKLE Interactions:
Potentiated by CYP3A4 inhibitors (eg, itraconazole, posaconazole, voriconazole, erythromycin, clarithromycin, ritonavir, grapefruit juice), cyclosporine (monitor). Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, oxcarbazepine, rifampin, rifabutin, efavirenz, nevirapine), estrogen/estrogen containing products. May potentiate cyclosporine (seizure risk). May antagonize anticoagulants (eg, warfarin); monitor. May need to adjust dose of antidiabetic agents. Increased risk of GI effects with aspirin, other NSAIDs; monitor. Caution with aspirin in hypoprothrombinemia.
Fluid retention, alteration in glucose tolerance, elevated BP, behavioral and mood changes (monitor), increased appetite, weight gain; ophthalmic reactions (with prolonged use).
Generic Drug Availability: