ALKINDI SPRINKLE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALKINDI SPRINKLE (ALKINDI SPRINKLE).
Alkindi Sprinkle (hydrocortisone) is a corticosteroid that binds to the glucocorticoid receptor, leading to modulation of gene expression and suppression of inflammatory mediators, including cytokines, prostaglandins, and leukotrienes. It also has mineralocorticoid activity, promoting sodium retention and potassium excretion.
| Metabolism | Primarily hepatic via reduction and conjugation; major enzymes include 11β-hydroxysteroid dehydrogenase and 5α-reductase; metabolites are glucuronidated and sulfated. |
| Excretion | Renal: 60-70% as 17-hydroxycorticosteroids and 17-ketosteroids; fecal: ~20% (biliary elimination). |
| Half-life | 2-3 hours (plasma cortisol has t1/2 ~1.5-2h; pharmacodynamic effects persist longer due to glucocorticoid receptor binding duration). |
| Protein binding | Corticosteroid-binding globulin (CBG, transcorrin) ~90% bound; albumin ~5%; free fraction 5-10%. |
| Volume of Distribution | 0.3-0.5 L/kg (distributes into total body water; lower Vd compared to cortisol). |
| Bioavailability | Oral: 100% (granules in capsules are converted to hydrocortisone; absolute bioavailability ~96%). |
| Onset of Action | Oral: glucocorticoid effects within 1-2 hours (peak cortisol suppression at ~2h). |
| Duration of Action | 24-36 hours (single dose suppresses adrenal cortisol secretion for approximately 24-36 hours; clinical duration of action is intermediate-acting). |
| Molecular Weight | 451.5 |
Hydrocortisone: 10-20 mg orally (as granules) once daily in the morning with food. Dose is individualized based on cortisol levels and clinical response. The typical starting dose for adults is 10-20 mg daily, given as a single morning dose.
| Dosage form | GRANULE |
| Renal impairment | No specific dose adjustment recommended for renal impairment. However, monitor for fluid and electrolyte disturbances in severe renal disease (GFR <30 mL/min) as hydrocortisone can cause sodium retention and potassium loss. |
| Liver impairment | In Child-Pugh class A or B, no dose adjustment typically needed. In severe hepatic impairment (Child-Pugh class C), consider dose reduction by 50% due to reduced cortisol clearance; monitor clinical response and serum cortisol levels. |
| Pediatric use | Weight-based dosing: 8-10 mg/m² body surface area orally once daily (maximum 20 mg/day). Alternatively, 0.3-0.4 mg/kg/day orally once daily. Dose is titrated to clinical response and serum cortisol levels. |
| Geriatric use | No specific dose adjustment required, but lower starting doses may be considered due to increased risk of osteoporosis, glucose intolerance, and hypertension. Monitor blood glucose, bone mineral density, and blood pressure regularly. |
| 1st trimester | Safety not established; animal studies show developmental toxicity, avoid unless benefit outweighs risk. |
| 2nd trimester | Safety not established; animal studies show developmental toxicity, avoid unless benefit outweighs risk. |
| 3rd trimester | Safety not established; may cause premature closure of ductus arteriosus and oligohydramnios; avoid in third trimester. |
Clinical note
Comprehensive clinical and safety monograph for ALKINDI SPRINKLE (ALKINDI SPRINKLE).
| Placental transfer | Crosses placenta in animal studies; likely crosses in humans based on molecular weight and pharmacokinetics. |
| Breastfeeding | Present in human milk at low levels; due to potential for serious adverse reactions in nursing infants, consider risk/benefit; alternatives preferred. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to hydrocortisone or any componentSystemic fungal infections
| Precautions | Adrenal suppression with prolonged use or abrupt withdrawal; taper dose gradually., Increased risk of infections due to immunosuppression; avoid live vaccines., Exacerbation of systemic fungal infections; use caution in patients with latent tuberculosis or amebiasis., Monitor for Cushing's syndrome, hyperglycemia, hypertension, and electrolyte imbalances., May cause growth suppression in pediatric patients; monitor growth in children., Osteoporosis with long-term use; consider calcium and vitamin D supplementation., May mask signs of infection or perforation in gastrointestinal disorders., Use caution in patients with hypothyroidism, cirrhosis, or ocular herpes simplex., Psychiatric effects including euphoria, insomnia, mood swings, and psychosis. |
| Food/Dietary | Avoid grapefruit juice during hydrocortisone therapy as it inhibits CYP3A4 metabolism, potentially increasing systemic exposure. No specific food restrictions, but maintain stable intake of high-sodium foods if on high doses due to mineralocorticoid activity. |
Loading safety data…
| Lactation Rating |
| L4 |
| Teratogenic Risk | First trimester: increased risk of orofacial clefts (odds ratio 3.5-6.2). Second/third trimesters: fetal adrenal suppression, intrauterine growth restriction, oligohydramnios (reversible upon discontinuation). |
| Fetal Monitoring | Maternal blood pressure, glucose, weight; fetal growth ultrasound every 4 weeks from 24 weeks; Doppler if growth restriction suspected; fetal heart rate monitoring in third trimester. |
| Fertility Effects | No known impairment of fertility in males or females at therapeutic doses. Chronic high doses may cause menstrual irregularities and reduce sperm count reversibly. |
| Clinical Pearls | Hydrocortisone granules are for oral use only; do not inject. Administer within 10 minutes of opening capsule to avoid granule hardening. For children unable to swallow whole granules, mix with soft food (e.g., applesauce) but not liquids. Taper dose gradually to avoid adrenal crisis when discontinuing. Monitor for growth suppression in pediatric patients. |
| Patient Advice | Take exactly as prescribed; do not stop suddenly. · Open capsule and sprinkle granules onto a spoonful of soft food (e.g., applesauce, yogurt) and swallow immediately without chewing. · Do not mix with liquids (e.g., water, milk) as granules may not dissolve. · If you miss a dose, take it as soon as remembered unless close to next dose; do not double up. · Carry medical ID indicating glucocorticoid use. · Report signs of infection, unusual stress, or surgery to doctor. |