- Alkindi Sprinkle
- Management of adrenocortical insufficiency; chronic use in other situations is limited because of mineralocorticoid activity.
Used systemically and locally in a wide variety of disorders including:
- Autoimmune disorders,
- Septic shock.
- In pharmacologic doses, suppresses inflammation and the normal immune response.
- Has numerous intense metabolic effects (see Adverse Reactions and Side Effects).
- Suppresses adrenal function at chronic doses of 20 mg/day.
- Replaces endogenous cortisol in deficiency states.
- Also has potent mineralocorticoid (sodium-retaining) activity.
- Replacement therapy in adrenal insufficiency.
- Suppression of inflammation and modification of the normal immune response.
Absorption: Well absorbed following oral administration. Sodium succinate salt is rapidly absorbed following IM administration. Absorption from local sites (intra-articular, intralesional) is slow but complete.
Distribution: Widely distributed, crosses the placenta, and probably enters breast milk.
Metabolism and Excretion: Metabolized mostly by the liver.
Half-life: 1.5–2 hr (plasma), 8–12 hr (tissue); adrenal suppression lasts 1.25–1.5 days.
TIME/ACTION PROFILE (anti-inflammatory activity)
|PO||unknown||1–2 hr||1.25–1.5 days|
- Active untreated infections (may be used in patients being treated for tuberculous meningitis or septic shock)
- Epidural use (may result in serious neurological injury or death)
- Known alcohol, bisulfite, or tartrazine hypersensitivity or intolerance (some products contain these and should be avoided in susceptible patients).
Use Cautiously in:
- Chronic treatment (will lead to adrenal suppression; use lowest possible dose for shortest period of time)
- Ulcerative colitis
- Stress (surgery, infections); supplemental doses may be needed
- Potential infections may mask signs (fever, inflammation)
- Pedi: Chronic use will result in ↓ growth; use lowest possible dose for shortest period of time.
Adverse Reactions/Side Effects
Adverse reactions/side effects are much more common with high-dose/long-term therapy
Derm: acne, ↓ wound healing, ecchymoses, fragility, hirsutism, petechiae
EENT: cataracts, glaucoma, ↑ intraocular pressure
Endo: adrenal suppression, cushingoid appearance (moon face, buffalo hump), hyperglycemia, PHEOCHROMOCYTOMA
F and E: fluid retention (long-term high doses), hypokalemia, hypokalemic alkalosis
GI: anorexia, nausea, PEPTIC ULCERATION, vomiting
Hemat: leukocytosis, THROMBOEMBOLISM, thrombophlebitis
Metabolic: weight gain, weight loss
MS: muscle wasting, osteoporosis, avascular necrosis of joints, muscle pain
Neuro: depression, euphoria, headache, ↑ intracranial pressure (children only), personality changes, psychoses, restlessness
Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis) , ↑ susceptibility to infection
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Additive hypokalemia with thiazide and loop diuretics, or amphotericin B.
- Hypokalemia may ↑ the risk of digoxin toxicity.
- May ↑ requirement for insulin or oral hypoglycemic agents.
- Phenytoin, phenobarbital, and rifampin ↑ metabolism; may ↓ effectiveness.
- Oral contraceptives may ↓ metabolism.
- ↑ risk of adverse GI effects with NSAIDs (including aspirin ).
- At chronic doses that suppress adrenal function, may ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.
PO (Adults and Children >12 yr): 20–240 mg/day in 1–4 divided doses.
PO (Children): Adrenocortical insufficiency/replacement therapy– 8–10 mg/m2 /day in 2–3 divided doses; Anti-inflammatory or immunosuppressive– 2.5–10 mg/kg/day or 75–300 mg/m2 /day in 3–4 divided doses.
PO (Neonates): Congenital adrenal hyperplasia– 10–20 mg/m2 /day in 3 divided doses.
PO IV (Neonates): Refractory hypoglycemia– 5 mg/kg/day divided every 8–12 hr or 1–2 mg/kg/dose every 6 hr.
Rect: (Adults): Retention enema– 100 mg nightly for 21 days or until remission occurs.
IM IV (Adults): 100–500 mg every 2–6 hr (range 100–8000 mg/day).
IM IV (Children and Infants): Adrenocortical insufficiency– 1–2 mg/kg/dose bolus, then 25–250 mg/day in divided doses every 6–8 hr. Anti-inflammatory or immunosuppressive– 1–5 mg/kg/day or 30–150 mg/m2 /day divided every 12–24 hr; Physiologic replacement– 0.25–0.35 mg/kg/day or 12–15 mg/m2 /day once daily; Shock– 50 mg/kg bolus then 50 mg/kg as a 24 hr infusion.
IV (Neonates): Bronchopulmonary dysplasia prevention in preterm neonates with prenatal inflammatory exposure– 1 mg/kg/day divided every 12 hr during the first 2 wk of life; Refractory hypotension– 3 mg/kg/day divided every 8 hr x 5 days.
Availability (generic available)
Tablets: 5 mg, 10 mg, 20 mg
Oral granules (Alkindi Sprinkle): 0.5 mg, 1 mg, 2 mg, 5 mg
Lyophilized powder for injection (sodium succinate): 100 mg/vial, 250 mg/vial, 500 mg/vial, 1 g/vial
Enema: 100 mg/60 mL
- Indicated for many conditions. Assess involved systems prior to and periodically during therapy.
- Assess patient for signs of adrenal insufficiency (hypotension, weight loss, weakness, nausea, vomiting, anorexia, lethargy, confusion, restlessness, poor feeding, fatigue, low muscle tone, joint pain, hypoglycemia) prior to and periodically during therapy.
- Monitor intake and output ratios and daily weights. Observe patient for peripheral edema, steady weight gain, rales/crackles, or dyspnea. Notify health care professional should these occur.
- Evaluate growth of children periodically during therapy. Monitor for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth and weight gain. Adjust doses accordingly.
- Monitor for signs and symptoms of Cushing's syndrome (weight gain, decreased height velocity, hyperglycemia, hypertension, edema, easy bruising, muscle weakness, red round face, depression, mood swings) every 6 months; pediatric patients under one year of age may require more frequent monitoring (every 3 to 4 months).
- Rect: Assess symptoms of ulcerative colitis (diarrhea, bleeding, weight loss, anorexia, fever, leukocytosis) periodically during therapy.
Lab Test Considerations:
Monitor serum electrolytes and glucose. May cause hyperglycemia, especially in persons with diabetes. May cause hypokalemia. Monitor hematologic values, serum electrolytes, and serum and urine glucose routinely in patients on prolonged therapy. May cause ↓ WBC counts. May cause ↓ serum potassium and calcium and ↑ serum sodium concentrations.
- Guaiac test stools. Promptly report presence of guaiac-positive stools.
- May cause elevated serum cholesterol and lipid values. May cause ↓ uptake of thyroid 123 I or 131 I.
- Suppresses reactions to allergy skin tests.
- Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal axis suppression in systemic and chronic topical therapy.
Do not confuse Solu-Cortef with Solu-Medrol (methylprednisolone).
- If dose is ordered daily or every other day, administer in the morning to coincide with the body's normal secretion of cortisol.
- Periods of stress, such as surgery, may require supplemental systemic corticosteroids.
- When switching from other oral formulations of hydrocortisone to Alkindi sprinkle , monitor for signs and symptoms of adrenal insufficiency.
- PO Administer with meals to minimize GI irritation.
- Tablets may be crushed and administered with food or fluids for patients with difficulty swallowing.
- Alkindi sprinkle are oral granules within capsules. DNC: Do not chew or crush the granules; do not swallow capsules. Open capsule and administer granules as follows: Hold capsule so that printed strength is at the top and tap to ensure all granules are in lower half of capsule. Squeeze bottom of capsule gently and twist off the top of capsule. Granules may be administered by pouring granules directly onto patient's tongue, pouring granules onto a spoon and placing in the patient's mouth, or sprinkling onto a spoonful of cold or room temperature soft food (yogurt or fruit puree). Administer and swallow granules within 5 min to avoid bitter taste as outer taste masking cover can dissolve. Tap capsule to ensure all granules are removed. Avoid wetting capsule on the tongue or soft food as this may result in granules remaining in the capsule. Immediately follow administration fluids (water, milk, breast milk, formula) to ensure all granules are swallowed. Do not add granules to liquid; may result in reductions in dose administered and may result in a bitter taste. Do not use granules in nasogastric or gastric tubes; may cause tube blockage.
- IM IM doses should not be administered when rapid effect is desirable. Do not dilute with other solution or admix.
- Rect: Position patient on left side and administer nightly for 21 days. Enema should be retained for at least 1 hr and preferably all night. May use sedatives and antidiarrheals to facilitate retention.
- IV Push: Reconstitution: Reconstitute with provided solution (i.e., Act-O-Vials) or 2 mL of bacteriostatic water or saline for injection.
- Rate: Administer each 100 mg over at least 30 sec. Doses ≥500 mg should be infused over at least 10 min.
- Intermittent Infusion: Dilution: May be added to 50–1000 mL of D5W or 0.9% NaCl. Concentration: Usual 1–5 mg/mL. Adults who are fluid restricted may received up to 60 mg/mL.
- Rate: Administer over 20–30 min
- Y-Site Compatibility:
- aminocaproic acid
- amphotericin B deoxycholate
- amphotericin B lipid complex
- amphotericin B liposomal
- arsenic trioxide
- ascorbic acid
- daunorubicin hydrochloride
- doxorubicin hydrochloride
- doxorubicin liposomal
- epoetin alfa
- folic acid
- insulin, regular
- leucovorin calcium
- penicillin G
- potassium acetate
- potassium chloride
- sodium acetate
- sodium bicarbonate
- zoledronic acid
- Y-Site Incompatibility:
- gemtuzumab ozogamicin
- magnesium sulfate
Instruct patient on correct technique of medication administration. Advise patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Instruct patient or caregiver to notify health care professional if they have prolonged vomiting, are severely ill or are unable to take oral medications.Stopping hydrocortisone suddenly may result in adrenal insufficiency (anorexia, nausea, weakness, fatigue, dyspnea, hypotension, hypoglycemia). If these signs appear, notify health care professional immediately. This can be life-threatening.Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
- Corticosteroids cause immunosuppression and may mask symptoms of infection. Instruct patient to avoid people with known contagious illnesses and to report possible infections immediately.
- Caution patient to avoid vaccinations without first consulting health care professional.
- Review side effects with patient. Instruct patient to inform health care professional promptly if severe abdominal pain or tarry stools occur. Patient should also report unusual swelling, weight gain, tiredness, bone pain, bruising, nonhealing sores, visual disturbances, or behavior changes.
- Advise patient to notify healthcare professional of all Rx or OTC medications, vitamins or herbal products being taken and to consult with healthcare professional before taking other medications.
- Advise patient to notify healthcare professional of medication regimen prior to treatment or surgery.
- Discuss possible effects on body image. Explore coping mechanisms.
- Instruct patient to inform health care professional if symptoms of underlying disease return or worsen.
- Advise patient to carry identification describing disease process and medication regimen in the event of emergency in which patient cannot relate medical history.
- Rep: Advise females of reproductive potential to notify healthcare professional if pregnancy is planned or suspected or if breastfeeding.
- Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests and eye exams may be needed.
- Long-term Therapy:
Encourage patient to eat a diet high in protein, calcium, and potassium, and low in sodium and carbohydrates (see food sources for specific nutrients). Alcohol should be avoided during therapy.
- If rectal dose used >21 days, decrease to every other night for 2–3 wk to decrease gradually.
- Decrease in presenting symptoms with minimal systemic side effects.
- Suppression of the inflammatory and immune responses in autoimmune disorders, allergic reactions, and neoplasms.
- Management of symptoms in adrenal insufficiency.
- Improvement in symptoms of ulcerative colitis. Clinical symptoms usually improve in 3–5 days. Mucosal appearance may require 2–3 mo to improve.