Alkindi Sprinkle

— THERAPEUTIC CATEGORIES —
  • Corticosteroid-responsive disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Alkindi Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hydrocortisone 0.5mg, 1mg, 2mg, 5mg; oral granules in caps.

    Pharmacological Class

    Glucocorticoid.

    How Supplied

    Caps—50

    Manufacturer

    Eton Pharmaceuticals, Inc

    Generic Availability

    NO

    Alkindi Sprinkle Indications

    Indications

    Replacement therapy for adrenocortical insufficiency in pediatric patients.

    Alkindi Sprinkle Dosage and Administration

    Adult

    Not established.

    Children

    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 sprinkle onto a spoonful of cold/room temperature soft food (eg, yogurt or fruit puree); swallow within 5mins. Immediately follow with ingestion of fluids (eg, water, milk, breastmilk, formula). Initially 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; monitor closely.

    Alkindi Sprinkle Contraindications

    Not Applicable

    Alkindi Sprinkle Boxed Warnings

    Not Applicable

    Alkindi Sprinkle Warnings/Precautions

    Warnings/Precautions

    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 Pharmacokinetics

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Half-life: 1.5 hours.

    Alkindi Sprinkle Interactions

    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.

    Alkindi Sprinkle Adverse Reactions

    Adverse Reactions

    Fluid retention, alteration in glucose tolerance, elevated BP, behavioral and mood changes (monitor), increased appetite, weight gain; ophthalmic reactions (with prolonged use).

    Alkindi Sprinkle Clinical Trials

    See Literature

    Alkindi Sprinkle Note

    Not Applicable

    Alkindi Sprinkle Patient Counseling

    See Literature

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