Cortenema


Cortenema

 [kort″en´ĕ-mah] trademark for a preparation of enema" >hydrocortisone enema, used in treatment of ulcerative colitis.

hydrocortisone

Ala-Cort, Ala-Scalp, Cetacort, Colocort, Cortef, Cortenema, Hi-Cor, Hycort (CA), Hytone, Stie-Cort, Synacort, Texacort

hydrocortisone acetate

Cortifoam, Hydrocortistab (UK)

hydrocortisone butyrate

Locoid

hydrocortisone sodium succinate

A-hydroCort, Solu-Cortef

hydrocortisone valerate

Westcort

Pharmacologic class: Short-acting corticosteroid

Therapeutic class: Anti-inflammatory (steroidal)

Pregnancy risk category C

Action

Suppresses inflammatory and immune responses, mainly by inhibiting migration of leukocytes and phagocytes and decreasing inflammatory mediators

Availability

Cream, gel, lotion, ointment, solution: various strengths

Injection: 25 mg/ml, 50 mg/ml; 100 mg/vial, 250 mg/vial, 500 mg/vial, 1,000 mg/vial

Intrarectal aerosol foam: 90 mg

Oral suspension: 10 mg/5 ml

Retention enema: 100 mg/60 ml

Spray (topical): 1%

Tablets: 5 mg, 10 mg, 20 mg

Indications and dosages

➣ Replacement therapy in adrenocortical insufficiency; hypercalcemia due to cancer; arthritis; collagen diseases; dermatologic diseases; autoimmune and hematologic disorders; trichinosis; ulcerative colitis; multiple sclerosis; proctitis; nephrotic syndrome; aspiration pneumonia

hydrocortisone, hydrocortisone cypionate-

Adults and children: 20 to 240 mg/day P.O.

hydrocortisone acetate (suspension)-

Adults and children: 5 to 75 mg by intra-articular injection (depending on joint size) q 2 to 3 weeks

hydrocortisone acetate (intrarectal foam)-

Adults and children: One applicatorful of intrarectal foam daily or b.i.d. for 2 to 3 weeks; then one applicatorful every other day

hydrocortisone sodium phosphate-

Adults and children: 15 to 240 mg/day subcutaneously, I.M., or I.V., adjusted according to response

hydrocortisone sodium succinate-

Adults and children: 100 to 500 mg I.M. or I.V.; may repeat at 2-, 4-, or 6-hour intervals, depending on response and condition

hydrocortisone retention enema-

Adults and children: 100 mg P.R. at bedtime for 21 nights or until desired response; patient should retain enema for at least 1 hour.

➣ Itching and inflammation caused by skin conditions

Adults and children: Thin film of topical preparation applied to affected area one to four times daily, depending on drug form and severity of condition

Off-label uses

• Phlebitis

• Stomatitis

Contraindications

• Hypersensitivity to drug, alcohol, bisulfites, or tartrazine (with some products)

• Systemic fungal infections

• Concurrent use of other immunosuppressant corticosteroids

• Concurrent administration of live-virus vaccines

Precautions

Use cautiously in:

• hypertension, osteoporosis, glaucoma, renal or GI disease, hypothyroidism, cirrhosis, thromboembolic disorders, myasthenia gravis, heart failure

• pregnant or breastfeeding patients

• children ages 6 and younger (safety not established).

Administration

• Give oral form with food or milk to avoid GI upset.

• Give I.V. injection of sodium succinate form over 30 seconds to a few minutes.

• Know that drug may be given as intermittent or continuous I.V. infusion. Dilute in normal saline solution, dextrose 5% in water, or dextrose 5% in normal saline solution.

• Inject I.M. deep into gluteal muscle. Rotate injection sites to prevent muscle atrophy.

• Be aware that subcutaneous administration may cause muscle atrophy or sterile abscess.

See Never abruptly discontinue high-dose or long-term systemic therapy.

• Know that systemic forms typically are used for adrenal replacement rather than inflammation.

• Be aware that occlusive dressings, heat, hydration, inflammation, denuding, and thinning of skin increase topical drug absorption.

Adverse reactions

CNS: headache, nervousness, depression, euphoria, personality changes, psychoses, vertigo, paresthesia, insomnia, restlessness, conus medullaris syndrome, meningitis, increased intracranial pressure, seizures

CV: hypotension, hypertension, thrombophlebitis, heart failure, shock, fat embolism, thromboembolism, arrhythmias

EENT: cataracts, glaucoma, increased intraocular pressure, epistaxis, nasal congestion, perforated nasal septum, dysphonia, hoarseness, nasopharyngeal or oropharyngeal fungal infections

GI: nausea, vomiting, esophageal candidiasis or ulcer, abdominal distention, dry mouth, rectal bleeding, peptic ulceration, pancreatitis

Hematologic: purpura

Metabolic: sodium and fluid retention, hypokalemia, hypocalcemia, hyperglycemia, hypercholesterolemia, amenorrhea, growth retardation, diabetes mellitus, cushingoid appearance, hypothalamic-pituitary-adrenal suppression with secondary adrenal insufficiency (with abrupt withdrawal or high-dose, prolonged use)

Musculoskeletal: osteoporosis, aseptic joint necrosis, muscle pain or weakness, steroid myopathy, loss of muscle mass, tendon rupture, spontaneous fractures

Respiratory: cough, wheezing, rebound congestion, bronchospasm

Skin: rash, pruritus, urticaria, contact dermatitis, acne, bruising, hirsutism, petechiae, striae, acneiform lesions, skin fragility and thinness, angioedema

Other: altered taste; anosmia; appetite changes; weight gain; facial edema; increased susceptibility to infection; masking or aggravation of infection; adhesive arachnoiditis; injection site pain, burning, or atrophy; immunosuppression; hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Amphotericin B, loop and thiazide diuretics, mezlocillin, piperacillin, ticarcillin: additive hypokalemia

Fluoroquinolones: increased risk of tendon rupture

Hormonal contraceptives: prolonged half-life and increased effects of hydrocortisone

Insulin, oral hypoglycemics: increased requirements for these drugs

Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse reactions

Nonsteroidal anti-inflammatory drugs: increased risk of adverse GI reactions

Phenobarbital, phenytoin, rifampin: decreased hydrocortisone efficacy

Somatrem: inhibition of growth-promoting effect

Drug-diagnostic tests. Calcium, potassium, thyroxine, triiodothyronine: decreased levels

Cholesterol, glucose: increased levels

Digoxin assays: false elevation (with some test methods)

Nitroblue tetrazolium test: false-negative result

Drug-herbs. Echinacea: increased immunostimulation

Ginseng: potentiation of immunomodulation

Drug-behaviors. Alcohol use: increased risk of gastric irritation and GI ulcers

Patient monitoring

See In high-dose therapy (which should not exceed 48 hours), watch closely for signs and symptoms of depression or psychotic episodes.

• Monitor blood pressure, weight, and electrolyte levels regularly.

• Assess blood glucose levels in diabetic patients. Expect to increase insulin or oral hypoglycemic dosage.

See Monitor patient's response during weaning from drug. Watch for adrenal crisis, which may occur if drug is discontinued too quickly.

Patient teaching

• Instruct patient to take daily P.O. dose with food by 8 A.M.

See Urge patient to immediately report unusual weight gain, face or leg swelling, epigastric burning, vomiting of blood, black tarry stools, irregular menstrual cycles, fever, prolonged sore throat, cold or other infection, or worsening of symptoms.

• Tell patient using topical form not to apply occlusive dressing unless instructed by prescriber.

• Advise patient to discontinue topical drug and notify prescriber if local irritation occurs.

• Instruct patient to eat small, frequent meals and to take antacids as needed to minimize GI upset.

• Tell patient that response to drug will be monitored regularly.

See Caution patient not to stop taking drug abruptly.

• In long-term use, instruct patient to have regular eye exams.

• Instruct patient to wear medical identification stating that he's taking this drug.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

hydrocortisone

(hye-droe-kor-ti-sone) hydrocortisone,

Cortef

(trade name),

Cortenema

(trade name),

Hycort

(trade name),

Solu-CORTEF

(trade name)

Classification

Therapeutic: anti inflammatories steroidal
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

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:
  • 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 effects

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.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)

ROUTEONSETPEAKDURATION
POunknown1–2 hr1.25–1.5 days
IM rapid1 hrvariable
IVrapidunknownunknown

Contraindications/Precautions

Contraindicated in: Active untreated infections (may be used in patients being treated for tuberculous meningitis or septic shock); Lactation: Avoid chronic use; 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); Pediatric: Chronic use will result in ↓ growth; 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); Obstetric: Safety not established.

Adverse Reactions/Side Effects

Adverse reactions/side effects are much more common with high-dose/long-term therapy

Central nervous system

  • depression (most frequent)
  • euphoria (most frequent)
  • headache
  • ↑ intracranial pressure (children only)
  • personality changes
  • psychoses
  • restlessness

Ear, Eye, Nose, Throat

  • cataracts
  • ↑ intraocular pressure

Cardiovascular

  • hypertension (most frequent)

Gastrointestinal

  • peptic ulceration (life-threatening)
  • anorexia (most frequent)
  • nausea (most frequent)
  • vomiting

Dermatologic

  • acne (most frequent)
  • ↓ wound healing (most frequent)
  • ecchymoses (most frequent)
  • fragility (most frequent)
  • hirsutism (most frequent)
  • petechiae (most frequent)

Endocrinologic

  • adrenal suppression (most frequent)
  • hyperglycemia

Fluid and Electrolyte

  • fluid retention (long-term high doses)
  • hypokalemia
  • hypokalemic alkalosis

Hematologic

  • thromboembolism (life-threatening)
  • thrombophlebitis

Metabolic

  • weight gain
  • weight loss

Musculoskeletal

  • muscle wasting (most frequent)
  • osteoporosis (most frequent)
  • avascular necrosis of joints
  • muscle pain

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • cushingoid appearance (moon face, buffalo hump) (most frequent)
  • ↑ susceptibility to infection

Interactions

Drug-Drug interaction

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 (includingaspirin ).At chronic doses that suppress adrenal function, may ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.

Route/Dosage

Oral (Adults and Children > 12 yr) 20–240 mg/day in 1–4 divided doses.Oral (Children) Physiologic replacement—0.5–0.75 mg/kg/day or 20–25 mg/m2/day divided q 6 hr.Anti-inflammatory or immunosuppressive—2.5–10 mg/kg/day or 75–300 mg/m2/dayin 3–4 divided doses.Oral (Neonates) Congenital adrenal hyperplasia—10–20 mg/m2/day in 3 divided doses.Oral Intravenous (Neonates) Refractory hypoglycemia—5 mg/kg/day divided q 8–12 hr or 1–2 mg/kg/dose q 6 hr.Rectal (Adults) Retention enema—100 mg nightly for 21 days or until remission occurs.Intramuscular Intravenous (Adults) 100–500 mg q 2–6 hr (range 100–8000 mg/day).Intramuscular Intravenous (Children and Infants) Adrenocortical insufficiency—1–2 mg/kg/dose bolus, then 25–250 mg/day in divided doses q 6–8 hr. Anti-inflammatory or immunosuppressive— 1–5 mg/kg/day or 30–150 mg/m2/day divided q 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.Intravenous (Neonates) Bronchopulmonary dysplasia prevention in preterm neonates with prenatal inflammatory exposure—1 mg/kg/day divided q 12 hr during the first 2 weeks of life; Refractory hypotension—3 mg/kg/day divided q 8 hr x 5 days.

Availability (generic available)

Tablets: 5 mg, 10 mg, 20 mg Enema: 100 mg/60 mL Powder for injection (sodium succinate): 100 mg/vial, 250 mg/vial, 500 mg/vial, 1 g/vial

Nursing implications

Nursing assessment

  • 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) 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.
  • Children should have periodic evaluations of growth.
  • Rectal: Assess symptoms of ulcerative colitis (diarrhea, bleeding, weight loss, anorexia, fever, leukocytosis) periodically during therapy.
  • Lab Test Considerations: Systemic—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 123I or 131I.
    • 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.

Potential Nursing Diagnoses

Risk for infection (Side Effects)
Disturbed body image (Side Effects)

Implementation

  • Do not confuse hydrocortisone with hydrocodone. 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.
  • Oral: Administer with meals to minimize GI irritation.
    • Tablets may be crushed and administered with food or fluids for patients with difficulty swallowing.
  • Intramuscular: IM doses should not be administered when rapid effect is desirable. Do not dilute with other solution or admix.
  • Intravenous Administration
  • pH: 7.0–8.0.
  • 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: Diluent: 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: acyclovir, alemtuzumab, alfentanil, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amphotericin B cholesteryl, amphotericin B lipid complex, amphotericin B liposome, amsacrine, anidulafungin, argatroban, ascorbic acid, atracurium, atropine, aztreonam, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, carboplatin, carmustine, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftaroline, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, chlorpromazine, cisatracurium, cisplatin, cladribine, clindamycin, cyanocobalamin, cytarabine, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daptomycin, dexamethasone, dexmedetomidine, digoxin, docetaxel, dopamine, doripenem, doxacurium, doxorubicin hydrochloride, doxorubicin liposome, droperidol, edrophonium, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, eptifibitide, ertapenem, erythromycin, etoposide, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, fluorouracil, folic acid, foscarnet, furosemide, gemcitabine, glycopyrrolate, granisetron, heparin, hetastarch, hydromorphone, ifosfamide, imiepnem/cilastatin, indomethacin, insulin, irinotecan, isoproterenol, ketamine, ketorolac, levofloxacin, lidocaine, linezolid, lorazepam, mannitol, mechlorethamine, melphalan, metaraminol, methotrexate, methoxamine, methyldopate, methylergonovine, metoclopramide, metoprolol, metronidazole, milrinone, mitoxantrone, morphine, multivitamins, nafcillin, naloxone, neostigmine, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxacillin, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pantoprazole, pemetrexed, penicillin G, pentobarbital, phenobarbital, phentolamine, phenylephrine, phytonadione, piperacillin/tazobactam, potassium acetate, potassium chloride, procainamide, prochlorperazine, propofol, propranolol, pyridostigmine, ranitidine, remifentanil, rituximab, scopolamine, sodium acetate, sodium bicarbonate, streptokinase, succinylcholine, sufentanil, tacrolimus, telavancin, teniposide, theophylline, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, trastuzumab, trimetaphan, vasopressin, vecuronium, verapamil, vincristine, vinorelbine, voriconazole, zoledronic acid
  • Y-Site Incompatibility: amphotericin B colloidal, azathioprine, calcium chloride, ciprofloxacin, dacarbazine, dantrolene, diazepam, diazoxide, dobutamine, doxycycline, ganciclovir, haloperidol, idarubicin, labetalol, mycophenolate, nalbuphine, pentamidine, phenytoin, protamine, pyridoxime, quinapristin/dalfopristin, rocuronium, sargramostim, thiamine, trimethoprim/sulfamethoxazole
  • Rectal: Position patient on left side and administer nightly for 21 days. Enema should be retained for at least 1 hr and preferrably all night. May use sedatives and antidiarrheals to facilitate retention.

Patient/Family Teaching

  • 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. 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.
    • 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 health care 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.
    • 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 ). Alcohol should be avoided during therapy.
    • If rectal dose used >21 days, decrease to every other night for 2–3 weeks 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.