Full Prescribing Info
Each tablet contains hydrocortisone 10 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate and magnesium stearate.
Pharmacology: Pharmacodynamics: Hydrocortisone is a glucocorticoid secreted by the adrenal cortex. It decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.
Pharmacokinetics: Hydrocortisone is readily absorbed from the GI tract. It is reversibly bound to corticosteroid binding globulin (CBG or transcortin) and corticosteroid binding albumin (CBA). Hydrocortisone is metabolized by the liver which is the rate-limiting step in its clearance. Induction of hepatic enzymes will increase the metabolic clearance of hydrocortisone. About 1% of its usual daily production, or about 200 mcg unchanged hormone is excreted in urine daily. Hydrocortisone is primarily excreted in urine as 17-hydroxysteroids and 17-ketosteroids. Renal clearance is increased when plasma levels are increased. Its half-life elimination is 8-12 hours.
Hydrocortisone is indicated for adrenal replacement therapy, primary adrenocortical insufficiency, congenital adrenal hyperplasia, and Addison's disease.
Dosage/Direction for Use
Dosage in adult: Maintenance dose: 20-30 mg/day divided to more closely mimic normal cortisol secretion. A morning dose is higher than the later doses i.e. twice daily regimens (20 mg in the morning and 10 mg in the evening) and three times daily (10 mg in the morning, 5 mg in the afternoon and 5 mg in the evening).
The daily dose of hydrocortisone should be doubled during periods of minor stress, and the dose needs to be increased to as much as 200 to 300 mg per day during periods of major stress, such as a surgical procedure.
Stress dose: Minor Febrile illness or stress: Increase hydrocortisone dose twofold to threefold for the few days of illness.
Contact physicians if illness worsens or persists for more than 3 days or if vomiting develops.
Moderate illness: Hydrocortisone 50 mg twice a day orally or intravenously. Taper rapidly to maintenance dose as patient recovers.
Severe illness, severe stresses or surgery: Increase hydrocortisone dose up to tenfold but the patients who cannot take oral medications or who experience a significant stress and potential instability should receive intravenous corticosteroid supplementation.
Switch therapy from IV to oral then taper rapidly to maintenance dose.
Dosage in Pregnancy (Category C): Women with primary adrenal insufficiency who become pregnant should be treated with standard replacement therapy. If nausea and vomiting in early pregnancy interfere with oral medication, injections may be necessary.
But daily doses of hydrocortisone are usually increased modestly (5 to 10 mg/day) in the last trimester.
During labor, patients should be well hydrated with a saline drip and receive hydrocortisone at 50 mg intramuscularly every 6 hours until delivery. Thereafter, doses can be rapidly tapered off to usual maintenance regimens.
Dosage in children: Neonate: Maintenance dose: 6-7 mg/m2 every 8 hours, adjusted according to response.
Children 1 month-18 years: Maintenance dose: 5-6.5 mg/m2 every 8 hours, adjusted according to response.
Stress dose: The degree to which doses should be increased varies between 2 and 10 times the maintenance rate depending on the severity of stress.
A common recommendation is to treat most stresses that require increased doses with hydrocortisone 30-50 mg/m2 per day (approximately tripling the daily dose) divided into 3 or 4 doses over the day.
The most severe stresses, such as major surgery or sepsis, are often treated more aggressively, with dose up to 100 mg/m2 per day divided every 6 hours intravenously.
Children who are unable to tolerate oral maintenance or stress doses during an illness require parenteral glucocorticoid administration.
Example of stress condition in Adrenal insufficiency: Minor: Inguinal hernia repair, Colonoscope, Mild febrile illness, Mild-moderate nausea/vomiting, Gastroenteritis.
Moderate: Open cholecystectomy, Hemicolectomy, Significant febrile illness, Pneumonia, Severe gastroenteritis.
Severe: Major cardiothoracic surgery, Whipple procedure, Liver resection, Pancreatitis.
Critically ill: Sepsis-induced hypotension or shock.
No extra supplementation is needed for most uncomplicated, outpatient dental procedures under local anesthesia.
Minor stresses i.e. immunization, uncomplicated viral illnesses and upper respiratory tract infections with sore throat, rhinorrhea and/ or low-grade fever and otitis media may not require use of a stress-dose hydrocortisone if the patient otherwise appears well.
If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
Symptoms: Overdosage may cause nausea and vomiting, sodium and water retention, hyperglycaemia and occasional gastrointestinal bleeding. Treatment need only be symptomatic although cimetidine (200-400 mg by slow intravenous injection every 6 hours) or ranitidine (50 mg by slow intravenous injection every 6 hours) may be administered to prevent gastrointestinal bleeding.
Cushingoid changes: Cushingoid changes from continued use of large doses resulting in moonface, central obesity, striae, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes, hyperlipidemia, peptic ulcer, increased susceptibility to infection and electrolyte and fluid imbalance. Reports of acute toxicity or death are rare.
Hypersensitivity to hydrocortisone, or any component of the formulation; serious infections, except septic shock or tuberculous meningitis; viral, fungal, or tubercular skin lesions.
Patients vaccinated with live vaccines.
Patients with peptic ulcer, intestinal ulcer, diabetes mellitus, tuberculosis or viral infection.
Special Precautions
Use with caution in patients with thyroid disease, hepatic impairment, renal impairment, heart failure, hypertension, diabetes, glaucoma, cataracts, myasthenia gravis, patients at risk for osteoporosis, patients at risk for seizures, or GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk. Use caution following acute MI (corticosteroids have been associated with myocardial rupture). Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration. May affect growth velocity; growth should be routinely monitored in pediatric patients. Withdraw therapy with gradual tapering of dose.
May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisolone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthematic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatinine kinase; recovery may be delayed. Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Pre-existing psychiatric conditions may be exacerbated by corticosteroid use.
Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria or viral hepatitis. Oral steroid treatment is not recommended for the treatment of acute optic neuritis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antitubercolosis treatment). Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be used to manage acute head injury.
Use in Children: Carefully observe growth and development of infants and children on prolonged corticosteroid therapy.
Use In Pregnancy & Lactation
Pregnancy: Category C (Category D if use in the first trimester): The ability of corticosteroids to cross the placenta varies between individual drugs; however, cortisone readily crosses the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intra-uterine growth retardation and affects brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but it is usually resolved spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid states.
Lactation: Corticosteroids are excreted in breast milk, although no data are available for cortisone. Doses of up to 200 mg daily of cortisone are unlikely to cause systemic effects in the infants. Infants of others taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.
Adverse Reactions
Cardiovascular: Arrhythmias, bradycardia, cardiac arrest, cardiomegaly, circulatory collapse, congestive heart failure, edema, fat embolism, hypertension, hypertrophic cardiomyopathy (premature infants), myocardial rupture (post MI), syncope, tachycardia, thromboembolism, vasculitis.
Central nervous system: Delirium, depression, emotional instability, euphoria, hallucinations, headache, insomnia, intracranial pressure increased, malaise, mood swings, nervousness, neuritis, neuropathy, personality changes, pseudotumor cerebri, psychic disorders, psychoses, seizure, vertigo.
Dermatologic: Acne, allergic dermatitis, alopecia, bruising, burning/tingling, dry scaly skin, edema, erythema, hirsutism, hyper-/hypopigmentation, impaired wound healing, petechiae, rash, skin atrophy, skin test reaction impaired, sterile abscess, striae, urticaria.
Endocrine & metabolic: Adrenal suppression, alkalosis, amenorrhea, carbohydrate intolerance increased, Cushing's syndrome, diabetes mellitus, glucose intolerance, growth suppression, hyperglycemia, hyperlipidemia, hypokalemia, hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, pituitary-adrenal axis suppression, potassium loss, protein catabolism, sodium and water retention, sperm motility increased/decreased, spermatogenesis increased/decreased.
Gastrointestinal: Abdominal distention, appetite increased, indigestion, nausea, pancreatitis, peptic ulcer, gastrointestinal perforation, ulcerative esophagitis, vomiting, weight gain.
Hematologic: Leukocytosis (transient).
Hepatic: Hepatomegaly, transaminases increased.
Local: Thrombophlebitis.
Neuromuscular & skeletal: Arthralgia, necrosis (femoral and humoral heads), Charcot-like arthropathy, fractures, muscle mass loss, muscle weakness, myopathy, osteoporosis, tendon rupture, vertebral compression fractures.
Ocular: Cataracts, exophthalmoses, glaucoma, intraocular pressure increased.
Miscellaneous: Abnormal fat deposits, anaphylaxis, avascular necrosis, diaphoresis, hiccups, hypersensitivity reactions, infection, secondary malignancy.
Drug Interactions
Barbiturates: Decreased pharmacologic effects of the corticosteroid may be observed.
Cholestyramine: The hydrocortisone AUC may be decreased.
Oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.
Estrogens: Corticosteroid clearance may be decreased.
Hydantoins: Corticosteroid clearance may be increased, resulting in reduced therapeutic effects.
Ketoconazole: Corticosteroid clearance may be decreased and the AUC increased.
Rifampin: Corticosteroid clearance may be increased, resulting in reduced therapeutic effects.
Anticholinesterases: Anticholinesterase effects may be antagonized in myasthenia gravis.
Oral anticoagulants: Anticoagulant dose requirement may be reduced. Conversely, corticosteroids may oppose the anticoagulant action.
Cyclosporine: Although this combination is therapeutically beneficial for organ transplants, toxicity may be enhanced.
Digitalis glycosides: Coadministration may enhance the possibility of digitalis toxicity associated with hypokalemia.
Isoniazid: Isoniazid serum concentrations may be decreased.
Nondepolarizing muscle relaxants: Corticosteroids may potentiate, counteract, or have no effect on the neuromuscular blocking action.
Potassium-depleting agents (eg, diuretics): Observe patients for hypokalemia.
Salicylates: Corticosteroids will reduce serum salicylate levels and may decrease their effectiveness.
Somatrem: Growth-promoting effect of somatrem may be inhibited.
Theophyllines: Alterations in the pharmacologic activity of either agent may occur.
Macrolide antibiotics eg, erythromycin: Erythromycin may inhibit the metabolism of corticosteroids.
Store below 30°C. Protect from light.
ATC Classification
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Tab 10 mg (off-white, round, compressed tablets, debossed with "CTS 10" on one side and bisected on the other side) x 100's.
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