Generic Medicine Info
Should be taken with food.
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. Patient Counselling 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.
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.
ROUTE(S) : IM / IV / Rectal: C
ROUTE(S) : Ophth / Otic: C D in 1st trimester.
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.
CIMS Class
Antiasthmatic & COPD Preparations / Corticosteroid Hormones / Eye Corticosteroids / Supportive Care Therapy / Topical Corticosteroids
ATC Classification
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.
A07EA02 - hydrocortisone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
S02BA01 - hydrocortisone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
C05AA01 - hydrocortisone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
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.
S01CB03 - hydrocortisone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
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