Adult: For previously diagnosed cases of the mouth whether simple or occurred as a complication in diseases: As hydrocortisone Na succinate buccal tab: Dissolve 1 tab (2.5 mg) slowly in the mouth (placed near the lesions) 4 times daily for 5 days. Do not suck the buccal tab. Child: ≥12 years Same as adult dose.
Adult: As hydrocortisone acetate: 5-50 mg depending on the size of the affected joint via intra-articular or periarticular inj; may be repeated at intervals of 3 weeks. Max: 3 joints treated per day.
Intravenous Supplement in adrenal insufficiency during minor surgery under general anaesthesia
Adult: In patients taking >10 mg daily of oral prednisolone or its equivalent: As hydrocortisone Na succinate: 25-50 mg at induction via inj or infusion. Resume the usual oral corticosteroid dose after surgery.
Intravenous Supplement in adrenal insufficiency during moderate or major surgery
Adult: In patients taking >10 mg daily of oral prednisolone or its equivalent: As hydrocortisone Na succinate: Usual oral corticosteroid dose on the morning of surgery, followed by 25-50 mg at induction via inj or infusion, then 25-50 mg tid via inj for 24 hours after moderate surgery or 48-72 hours after major surgery. Resume the usual oral corticosteroid dose once the injections are stopped.
Ophthalmic Inflammatory eye disorders
Adult: As 1% hydrocortisone acetate ointment: Apply 2-4 times daily. As 1% hydrocortisone acetate drops: Severe inflammation: Instil 1 or 2 drops every 30-60 minutes until satisfactory response occurs. Dosage and treatment duration may vary according to the severity of the condition and patient response.
Oral Anti-inflammatory or immunosuppressive
Adult: Usual range: Initially, 20-240 mg daily. Dosage is individualised and adjusted according to the disease being treated, the severity of the condition, and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Oral Replacement therapy in adrenocortical insufficiency
Adult: Dosage is individualised and adjusted according to patient response. As conventional tab: 20-30 mg daily in 2 divided doses, the larger dose to be given in the morning and the smaller in the evening; may be given together with NaCl or fludrocortisone. As modified-release tab: 20-30 mg once daily in the morning. Child: As conventional tab: 0.4-0.8 mg/kg daily in 2 or 3 divided doses; individualised and adjusted according to patient needs.
Parenteral Acute adrenocortical insufficiency, Adjunct in the emergency treatment of anaphylactic shock, Severe shock, Status asthmaticus
Adult: Adjunct to adrenaline in anaphylactic shock: As hydrocortisone Na phosphate, or Na succinate: 100-500 mg via slow IV inj over 0.5-1 minute, may be repeated 3 or 4 times in 24 hours according to the disease being treated, the severity of the condition, and patient response. Alternatively, doses may be given via IV infusion, or IM inj (response is less rapid). Fluids and electrolytes must be given as needed to correct any metabolic disorder. Child: As hydrocortisone Na phosphate: <1 year 25 mg; 1-5 years 50 mg; 6-12years 100 mg. Doses are given intravenously; may be repeated 3 or 4 times in 24 hours according to the disease being treated, the severity of the condition, and patient response.
Parenteral Anti-inflammatory or immunosuppressive
Adult: As hydrocortisone Na succinate: 100-500 mg via IV inj over 0.5-10 minutes, IV infusion over 20-30 minutes or IM inj; may be repeated at intervals of 2, 4, or 6 hours. Max duration: 48-72 hours. Dosage is individualised and adjusted according to the disease being treated, the severity of the condition, and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations. Child: As hydrocortisone Na succinate: Initially, 0.5-8 mg/kg daily or 20-240 mg/m2 daily in 3 or 4 divided doses. Alternatively, >25 mg daily. Dosage is individualised and adjusted according to the disease being treated, the severity of the condition, and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Parenteral Soft tissue inflammation
Adult: As hydrocortisone Na phosphate: 100-200 mg as local inj into soft tissue lesions; may be repeated on 2 or 3 occasions according to patient response.
Rectal Haemorrhoids
Adult: As hydrocortisone acetate supp: Insert 1 supp (25 mg) bid. Dosage and treatment duration may vary according to the severity of the condition and patient response.
Rectal Ulcerative colitis
Adult: Adjunctive treatment particularly in distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis: As hydrocortisone base 100 mg/60 mL retention enema: 1 enema at night for 3 weeks or until the patient comes into clinical and proctological remission. In patients who cannot retain enemas: As 10% hydrocortisone acetate foam: 90 mg (1 applicatorful) 1 or 2 times daily for 2-3 weeks, then reduced to every other day. Dosage and treatment duration may vary according to the severity of the condition and patient response.
Adult: As 0.1% hydrocortisone base cream, 0.1% hydrocortisone butyrate cream/ointment/scalp lotion, 0.1% hydrocortisone probutate cream, 1% hydrocortisone acetate cream: Apply thinly to affected areas 1 or 2 times daily. As 1-2.5% hydrocortisone base ointment, 0.1% hydrocortisone butyrate solution, 0.2% hydrocortisone valerate cream/ointment: Apply thinly to affected areas 2 or 3 times daily. Dosage and treatment duration may vary according to the severity of the condition and patient response. Child: As 0.1% hydrocortisone base cream: >10 years Same as adult dose. As 1-2.5% hydrocortisone base ointment, 0.1% hydrocortisone butyrate cream/ointment/scalp lotion: Same as adult dose; avoid prolonged treatment if possible. Max treatment duration in infants: 7 days.
Renal Impairment
Oral Replacement therapy in adrenocortical insufficiency:
Severe: As modified-release tab: Dose adjustment may be necessary.
Hepatic Impairment
Oral Replacement therapy in adrenocortical insufficiency:
Severe: As modified-release tab: Dose adjustment may be necessary.
Administration
Should be taken with food.
Reconstitution
As hydrocortisone Na succinate powder for solution: IV/IM inj: Reconstitute a vial labelled as 100 mg with Max 2 mL of sterile water for inj or bacteriostatic NaCl inj, shake gently and withdraw for use. IV infusion: Further add the reconstituted solution to 100-1,000 mL of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution (if the patient is not on Na restriction).
Contraindications
Systemic infections (unless treated with specific anti-infective), cerebral malaria; untreated oral infection (buccal tab). Parenteral: Idiopathic thrombocytopenic purpura (IM); infected joint or surrounding tissues; inj directly into the tendons, spinal or other non-diarthrodial joints (intra-articular/local inj). Rectal: Systemic fungal infections, ileocolostomy during the immediate or postoperative period (enema); abscess, obstruction, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts (foam). Ophthalmic: Herpes simplex or other viral diseases of conjunctiva and cornea; ocular tuberculosis, purulent infections and fungal diseases of the eye, undiagnosed red eye, increased intraocular pressure. Topical: Untreated fungal, bacterial, or viral infections; tubercular or syphilitic lesions, acne vulgaris, peri-oral dermatitis, rosacea; use in widespread plaque psoriasis (as hydrocortisone butyrate). Concomitant use with live or live-attenuated vaccines (immunosuppressive doses).
Special Precautions
Patient with suspected phaeochromocytoma, hypertension, CHF, recent MI; ocular disease (e.g. cataract, glaucoma, ocular herpes simplex), gastrointestinal disease (e.g. diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, non-specific ulcerative colitis), diabetes mellitus, thyroid disease, cirrhosis, myasthenia gravis, systemic sclerosis, previous steroid myopathy, osteoporosis or its risk factors (e.g. postmenopausal women), thromboembolic disorders, predisposition to thrombophlebitis; history of seizure disorder, history of severe affective disorders (particularly steroid psychosis), history of tuberculosis; psoriasis (topical); probability of impending perforation, abscess or other pyogenic infection, obstruction, or extensive fistulas and sinus tracts (rectal enema). Patient subjected to stress conditions (e.g. trauma, surgery, severe infection). Not recommended in patients with increased gastrointestinal motility (modified-release tab). Not indicated for the treatment of cerebral oedema associated with acute head injury or CVA; traumatic brain injury or stroke. Parenteral preparations are not recommended for intrathecal or epidural administration. Avoid abrupt withdrawal (particularly during prolonged use). Renal and hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal suppression (e.g. hypercortisolism, suppression of hypothalamic-pituitary-adrenal [HPA] axis), immunosuppression (prolonged use), Kaposi sarcoma (prolonged use), acute myopathy, myocardial rupture, osteoporosis, growth retardation (in infancy, childhood, and adolescence), visual disturbances (e.g. blurred vision, increased intraocular pressure, glaucoma, posterior subscapular cataract, central serous chorioretinopathy, corneal perforation), scleroderma renal crisis, psychiatric disturbances (e.g. insomnia, euphoria, mood swings, personality changes, severe depression, psychotic manifestations), seizures; venous thromboembolism, epidural lipomatosis (high dose, prolonged use); dermal or subdermal skin depression at inj site. Topical: Allergic contact dermatitis, local sensitisation (e.g. irritation, redness), systemic effects (e.g. Cushing’s syndrome, glucosuria, hyperglycaemia). Rarely, anaphylactoid reactions. Blood and lymphatic system disorders: Leucocytosis. Ear and labyrinth disorders: Vertigo. Eye disorders: Transient burning or stinging sensation; corneal thinning. Gastrointestinal disorders: Diarrhoea, nausea, abdominal pain, dyspepsia, pancreatitis, oesophageal candidiasis; peptic ulceration with perforation and haemorrhage. General disorders and administration site conditions: Fatigue, malaise; inj site reactions (e.g. local pain, swelling); application site reactions (e.g. localised pain, burning sensation, rectal bleeding). Infections and infestations: Secondary infection, folliculitis. Investigations: Increased weight, increased AST/ALT. Metabolism and nutrition disorders: Salt and water retention, hypokalaemia, impaired glucose tolerance, hypokalaemic alkalosis, increased appetite. Musculoskeletal and connective tissue disorders: Arthralgia, tendon rupture, fracture. Nervous system disorders: Headache, paraesthesia. Psychiatric disorders: Anxiety, irritability. Reproductive system and breast disorders: Menstrual irregularity, amenorrhoea. Skin and subcutaneous tissue disorders: Rash, pruritus, acne, dryness, hypertrichosis, acneiform eruption, perioral dermatitis, hypopigmentation, telangiectasia, striae, miliaria. Rarely, skin atrophy. Vascular disorders: Hypertension. Potentially Fatal: Adrenal insufficiency, phaeochromocytoma crisis, adrenal crisis.
Avoid exposure to chickenpox or measles; if exposed, seek immediate medical advice. Ophthalmic: This drug may cause transient blurred vision, if affected, do not drive or operate machinery. Remove soft contact lenses prior to instillation of eye drops and wait at least 15 minutes before reinsertion. Topical: Do not apply on broken skin, anogenital or diaper area, and large surface areas, or use with occlusive dressings (unless instructed by the physician).
Monitoring Parameters
Monitor blood pressure, serum glucose and electrolytes, bone mineral density, weight; growth in children. Perform eye examination regularly (e.g. slit-lamp exam, intraocular pressure for >6 weeks therapy). Assess for signs and symptoms of HPA axis suppression, infection, and ocular changes.
Overdosage
Symptoms: Nausea, vomiting, hyperglycaemia, Na and water retention, gastrointestinal bleeding, hypokalaemia, high blood pressure, excitement, mania or psychosis. Management: Symptomatic and supportive treatment. May administer slow IV inj of cimetidine or ranitidine for gastrointestinal bleeding.
Drug Interactions
Increased risk of hypokalaemia with digoxin, K-depleting agents (e.g. diuretics, amphotericin B, theophylline, carbenoxolone, salbutamol). May cause severe weakness with anticholinesterase agents in myasthenia gravis patients. Increased risk of gastrointestinal bleeding and ulceration with aspirin, NSAIDs. May enhance the metabolism and reduce the therapeutic effects with enzyme inducers (e.g. barbiturates, rifampicin, rifabutin, carbamazepine, primidone, aminoglutethimide). May antagonise the effects of oral hypoglycaemics, insulin, antihypertensive agents. Plasma levels and risk of side effects may be increased by CYP3A4 inhibitors (e.g. erythromycin, ketoconazole, cimetidine) and cobicistat-containing agents. May enhance the efficacy of coumarin anticoagulants. Increased plasma concentrations with estrogens and other oral contraceptives. Plasma levels of hydrocortisone acetate may be increased by ritonavir. May cause convulsions with ciclosporin. Increased risk of haematologic toxicity with methotrexate. Potentially Fatal: May diminish the serum antibody response to live or live attenuated vaccines.
Food Interaction
Enhanced metabolic clearance with St. John’s wort. Increased plasma levels with grapefruit juice.
Lab Interference
Response to skin tests may be suppressed. May cause false-negative result to nitroblue tetrazolium tests for bacterial infections.
Action
Description: Hydrocortisone is a glucocorticoid that reduces inflammation by suppressing the migration of polymorphonuclear leukocytes and reversing the increased capillary permeability. Topically, it has anti-inflammatory, anti-pruritic, and vasoconstrictive effects.
Synonym: cortisol. Onset: IV: 1 hour. Pharmacokinetics: Absorption: Readily absorbed from the gastrointestinal tract; rapidly absorbed after IM inj (Na succinate, Na phosphate); slowly absorbed after intra-articular or soft tissue inj (acetate); partially absorbed after rectal administration; absorbed through the skin. Bioavailability: 96 ± 20%. Time to peak plasma concentration: Approx 1 hour. Distribution: Rapidly distributed to body tissues. Crosses the placenta and enters breast milk (small amounts). Volume of distribution: 27 ± 7 L. Plasma protein binding: >90%, corticosteroid-binding globulin (CBG) and albumin. Metabolism: Metabolised in the liver and most body tissues into hydrogenated and degraded forms (e.g. tetrahydrocortisone, tetrahydrocortisol). Excretion: Via urine (mainly conjugated as glucuronides; small amounts as unchanged drug). Elimination half-life: 1.8 ± 0.5 hour (oral); 2 ± 0.3 hours (IV).
Chemical Structure
Hydrocortisone Source: National Center for Biotechnology Information. PubChem Database. Hydrocortisone, CID=5754, https://pubchem.ncbi.nlm.nih.gov/compound/Hydrocortisone (accessed on Jan. 21, 2020)
Storage
Store between 20-25°C. Parenteral: Protect from light. Do not freeze. Topical/rectal: Protect from heat. Do not freeze.
A01AC03 - hydrocortisone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth. D07AA02 - hydrocortisone ; Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases. C05AA01 - hydrocortisone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures. H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations. S01BA02 - hydrocortisone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. D07XA01 - hydrocortisone ; Belongs to the class of weak (group I) corticosteroids in other combinations. Used in the treatment of dermatological diseases. A07EA02 - hydrocortisone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
References
Anon. Hydrocortisone (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/09/2020.Anon. Hydrocortisone (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/09/2020.Anon. Hydrocortisone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/09/2020.Buckingham R (ed). Hydrocortisone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2020.Cortef Tablet (Pharmacia and Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Cortenema Enema (ANI Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Cortifoam Aerosol Foam (Meda Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Dermacort Hydrocortisone Cream (Marlborough Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Efcortelan Ointment 2.5% (Chemidex Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Efcortesol Injection (Amdipharm UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hc45 Hydrocortisone Cream (Reckitt Benckiser Healthcare [UK] Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hemmorex-HC Suppository (Laser Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Hydrocortisone 10 mg Tablets (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrocortisone 2.5 mg Muco-Adhesive Buccal Tablets (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrocortisone Eye Drops 1% (Martindale Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrocortisone Panpharma 100 mg Powder for Solution for Injection/Infusion (Panpharma). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrocortisone Skin Ointment 1% (Ennogen Healthcare Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrocortisone Valerate Cream and Ointment (Taro Pharmaceuticals U.S.A., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Hydrocortistab Injection (Amdipharm UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Hydrovex 100 mg Powder for Inj (Sannovex Pharmaceuticals). MIMS Philippines. http://www.mims.com/philippines. Accessed 02/09/2020.Joint Formulary Committee. Hydrocortisone Butyrate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2020.Joint Formulary Committee. Hydrocortisone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2020.Locoid Cream (LEO Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Locoid Ointment (LEO Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Locoid Scalp Lotion (LEO Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 02/09/2020.Locoid Solution (Bausch Health US, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Pandel Cream (PharmaDerm a Division of Fougera Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.Plenadren Modified-Release Tablets (Shire Services BVBA). European Medicines Agency [online]. Accessed 02/09/2020.Solu-Cortef Injection, Powder for Solution (Pharmacia and Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/09/2020.
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