General

Pronunciation:
hye-droe-kor-ti-sone

Trade Name(s)

• A-Hydrocort
• Alkindi Sprinkle
• Colocort
• Cortef
• Cortenema
• Solu-CORTEF

Ther. Class.

anti-inflammatories (steroidal)

Pharm. Class.

corticosteroids

Indications

• Adrenocortical insufficiency; chronic use in other situations is limited because of mineralocorticoid activity.

• Used systemically and locally in a wide variety of disorders, including:

  • Inflammatory,
  • Allergic,
  • Hematologic,
  • Neoplastic,
  • Autoimmune disorders,
  • Septic shock.

Action

• 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.

Therapeutic Effect(s):

• Replacement therapy in adrenal insufficiency.
• Suppression of inflammation and modification of the normal immune response.

Pharmacokinetics

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. IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

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)

Contraindication/Precautions

Contraindicated in:

• 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);
• Hypothyroidism;
• Cirrhosis;
• Ulcerative colitis;
• Stress (surgery, infections–supplemental doses may be needed);
• Potential infections may mask signs (fever, inflammation);
• Tumors that have a high proliferative rate, high tumor burden, and high sensitivity to cytotoxic agents (↑ risk for tumor lysis syndrome);
• 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

CV: hypertension

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) , INFECTION, KAPOSI'S SARCOMA

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

• 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.

Route/Dosage

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

Assessment

• Indicated for many conditions. Assess involved systems prior to and periodically during therapy.
• Monitor for signs and symptoms of adrenal insufficiency (fatigue, weakness, nausea and vomiting, low BP); corticosteroid should be tapered more slowly.
• Monitor for signs and symptoms of hypercorticism (moon face, buffalo hump, stretch marks, obesity, bruising, hyperglycemia, elevated BP) every 6 mo; pediatric patients under one yr of age may require more frequent monitoring (every 3–4 mo); temporary discontinuation, dose reduction, or slowed taper may be needed.
• Assess for signs of infection (fever, chills, sore throat, wound that will not heal).
• Assess for signs and symptoms of Kaposi's sarcoma (purple, red, or brown skin blotches on skin or inside the mouth) with long-term use.
• 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.
• Pedi:   Evaluate growth of children periodically during therapy. Monitor linear growth and weight gain. Adjust doses accordingly.
• Rect:  Assess symptoms of ulcerative colitis (diarrhea, bleeding, weight loss, anorexia, fever, leukocytosis) periodically during therapy.

Lab Test Considerations:

Monitor CBC, electrolytes, serum and urine glucose, and lipid panel routinely during therapy. May cause hyperglycemia, especially in persons with diabetes. May cause hypokalemia, hypocalcemia, hypernatremia. May ↓ WBC counts. May ↑ serum cholesterol and lipid values.

• May suppress reactions to allergy skin tests.
• Guaiac test stools. Promptly report presence of guaiac-positive stools.
• May ↓ uptake of thyroid ¹²³ I or ¹³¹ I.
• Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal axis suppression in systemic and chronic topical therapy.

Implementation

• Do not confuse Solu-Cortef with Solu-Medrol.
  • 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; do not administer with grapefruit juice.
  • 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 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 with 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.

Patient/Family Teaching

• Educate patient on reason for  hydrocortisone and side effects. Instruct them to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Do not share medication with others, even if they have similar symptoms; may be harmful. Advise patient to read  Patient Information  before starting and with each Rx refill in case of changes.

  • 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.
  • Stopping the medication 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. Medical ID should be worn in case of emergencies.
  • Advise patient to avoid grapefruit juice during therapy.
  • Advise patient that oral granules may be seen in stool.
  • Advise patient to notify health care professional of signs and symptoms of hypercorticism (acne; thicker or more hair on body and face; bruising easily; fatty pad or hump between shoulders [buffalo hump]; rounding of face [moon face]; pink or purple stretch marks on skin of abdomen, thighs, breasts, and arms; ankle swelling), adrenal suppression (tiredness, weakness, nausea and vomiting, low blood pressure), worsening of allergies (eczema, rhinitis), or infection (fever, chills, pain, feeling tired, aches, nausea and vomiting).
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to inform health care professional promptly if severe abdominal pain or tarry stools occur.
  • Corticosteroids cause immunosuppression and may mask symptoms of infection. May worsen existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Notify health care professional immediately if exposed to chicken pox or measles.
  • Caution patient to avoid vaccinations without first consulting health care professional.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications, especially St. John's wort.
  • Pedi:  Advise parents that use may cause shortened stature.
  • Rep:   Instruct patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Observe infant for signs of hypoadrenalism (poor feeding, irritability, weakness, vomiting).
• 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.

Evaluation/Desired Outcomes

• 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.