SOLUTINA
HYDROCORTISONE SODIUM SUCCINATE · by HORIZON
Composition
Inj 100 mg/250 mg/500 mg: Hydrocortisone (as sodium succinate) 100 mg/250 mg/500 mg; vials. Tab 20 mg: Hydrocortisone (as sodium succinate) 20 mg.
Indications & Dosage
Acute Adrenal insufficiency: BY IV BOLUS: Adult: 100 mg then 300 mg/day in divided doses every 8 hr or as a continuous INF for 48 hr; once patient is stable switch to oral, 50 mg every 8 hr for 6 doses, then taper to 30-50 mg/ day in divided doses. Chronic Adrenal insufficiency: ORAL: A Adult: 15-25 mg/day in 2-3 divided doses, one-half to two-thirds of the daily dose in the morning in order to mimic the physiological cortisol secretion pattern. If the twice-daily regimen is utilized, the second dose should be administered 6-8 hr following the first dose. Anti-inflammatory or immunosuppressive: BY IM OR IV INJ OR ORAL: Adult: 15-25 mg every 12 hr. Status asthmaticus: BY IV INJ: Adult: 1-2 mg/kg/dose every 6 hr for 24 hr, then maintenance of 0.5-1 mg/kg every 6 hr. Stress dosing (in surgery) in patients known to be adrenally-suppressed or on chronic systemic steroids: BY IV INJ: Minor stress (such as inguinal herniorrhaphy): Adult: 25 mg/day for 1 day. Moderate stress (such as joint replacement, cholecystectomy): Adult: 50-75 mg/ day (25 mg every 8-12 hr) for 1-2 days. Major stress (such as pancreatoduodenectomy, oesophagogastrectomy, cardiac surgery): Adult: 100-150 mg/day (50 mg every 8-12 hr) for 2-3 days. Adrenocortical insufficiency: BY IM INJ OR SLOW IV INJ OR IV INF: Adult: 100-500 mg 3-4 times a day or when required. Adrenocortical insufficiency in Addisons disease or following adrenalectomy: ORAL: Adult: 20-30 mg daily in 2 divided doses, the larger dose to be given in the morning and the smaller in the evening, mimicking the normal diurnal rhythm of cortisol secretion, the optimum daily dose is determined on the basis of clinical response. BY IV INJ: Neonate: Initially 10 mg by slow IV injection then 100 mg/ square meter daily by continuous IV INF or in divided doses every 6-8 hr; adjusted according to response; when stable reduce over 4-5 days to oral maintenance dose; 1 month-12 yrs: initially 2-4 mg/kg by slow IV injec-tion or INF then 2-4 mg/kg every 6 hr, adjusted according to response; when stable reduce over 4-5 days to oral maintenance dose; 12-18 yrs:100 mg every 6 to 8 hr by slow IV injection or INF. Adrenal hypoplasia, Addisons disease, chronic maintenance or replacement therapy: Oral: Adult: 20-30 mg once daily, adjusted according to response, dose to be taken in the morning; Neonate: 8-10 mg/ square meter daily in 3 divided doses, higher doses may be needed; 1 month-18 yrs: 8-10mg/ square meter daily in 3 di-vided doses; higher doses may be needed. Give larger doses in the morning and smaller doses in the evening. Severe inflammatory bowel disease: BY SLOW IV INJ, OR BY IV INF: Adult: 100-500 mg 3-4 times a day or when required. BY SLOW IV INJ: Children 2-18 yrs: 2.5 mg/kg (max 100 mg) every 6 hr. BY IV INF: Children 2-18 yrs: 10 mg/kg daily (max 400 mg daily). Thyrotoxic crisis (thyroid storm): BY IV INJ: Adult: 100 mg every 6 hours, to be administered as sodium succinate. Adrenocortical insufficiency resulting from septic shock: BY IV INJ: Adult: 50 mg every 6 hours, given in combination with fludrocortisone. Acute hypersensitivity reactions such as angioedema of the upper respiratory tract and anaphylaxis (adjunct to adrenaline): BY IV INJ: Adult: 100-300 mg, to be administered as sodium succinate BY IM OR IV INJ: Children 6 months: Initially 25 mg 3 times daily, adjusted according to response; 6 months-6 yrs: Initially 50 mg 3 times daily, adjusted according to response; 6-12 yrs: Initially 100 mg 3 times daily, adjusted according to response; 12-18 yrs: Initially 200 mg 3 times daily, adjusted according to response. Hypotension resistant to inotropic treatment and volume replacement: BY IV INJ: Neonate: Initially 2.5 mg/kg repeated if necessary after 4 hr, then 2.5 mg/kg every 6 hr for 48 hr or until blood pressure recovers, then dose reduced gradually over at least 48 hr;1 month-18 yrs: 1 mg/kg (max 100 mg) every 6 hr. Rheumatic disease: BY INTRA-ARTICULAR INJ: (consult product literature for details), Children 1 month-12 yrs: 5-30 mg according to size of child and joint; 12-18 yrs: 5-50 mg according to size of child and joint. Where appropriate may be repeated at intervals of 21 days; not more than 3 joints should be treated on any one day. Severe acute asthma, Life-threatening acute asthma: BY IV INJ: Children 1 month-1 year: 4 mg/kg every 6 hours (max. per dose 100 mg), alternatively 25 mg every 6 hours until conversion to oral prednisolone is possible, dose given, preferably, as sodium succinate; 2-4 years: 4 mg/kg every 6 hours (max. per dose 100 mg), alternatively 50 mg every 6 hours until conversion to oral prednisol one is possible, dose given, preferably, as sodium succinate; 5-17 years: 4 mg/kg every 6 hours (max. per dose 100 mg), alternatively 100 mg every 6 hours until conversion to oral prednisolone is possible, dose given, preferably, as sodium succinate Adult: 100 mg every 6 hours until conversion to oral prednisolone is possible, dose given, preferably, as sodium succinate.
Administration
Hydrocortisone sodium succinate may be administered by IM or IV.IV bolus: Dilute to 50 mg/ml and give over.30 seconds to several min.IV intermittent infusion: Dilute to 1 mg/ml and give over 20-30 min.
Compatibility
Stable in NS, D5W, fat emulsion 10%, LR,1/2NS.
Stability
Store product and solution at 20C-25C (68F-77F). Protect from light. Use solution only if it is clear. Unused solution should be discarded after 3 days.
Contraindications
Systemic fungal infections unless specific anti-infective therapy is used, head injury, stroke.
Precautions
Active infections not controlled by antibiotics, latent or active amoebiasis, history of TB, septicaemia, symptoms may be masked, avoid or maintain extreme cautions in chickenpox, measles, psychiatric disorders, renal impairment, hepatic failure, cirrhosis, active peptic ulcer, myasthenia gravis, previous steroid myopathy, osteoporosis, epilepsy, hypothyroidism, diabetes, adrenal suppression, hypertension, recent MI, congestive heart failure, thromboembolic disorders, glaucoma, corneal perforation. Withdraw gradually, withdrawal symptoms may include fever, myalgia, arthralgia, rhinitis, itchy skin nodules and weight loss.
Interactions
Live vaccines or other vaccines, anticoagulants, hypoglycaemia agents, antihypertensives, diuretics, erythromycin, rifamycin, amphotericin, azole antifungals, ritonavir, cyclosporin, cardiac glycosides, Oestrogens including oral contraceptives, somatropin, Carbamazepine, phenytoin, primicane, barbiturates. Muscle relaxants, NSAIDs, salicylates, sympathomimetics, mifepristone, methotrexate, theophylline, aprepitant.
Pregnancy
Caution advised
Lactation
Caution advised
Side Effects
Endocrine irregularities including menstrual problems, cushingoid state, adrenal suppression, growth suppression in children, increased susceptibility to infection, increased severity of infection, fluid/electrolyte disturbance, hypertension, negative protein, nitrogen andcalcium balance, myopathy, tendon rupture, osteoporosis, osteonecrosis and fractures, impaired wound healing, sweating, hirsutism, striae, telangiectasia, acne, GI disturbance, peptic ulceration, acute pancreatitis, candidiasis, psychiatric effects, neurological effects, insomnia, diabetes, impaired glucose tolerance, weight gain, increased appetite, ocular disturbances including cataracts, raised intraocular pressure, optic nerve damage, corneal changes, glaucoma, thromboembolism, leukocytosis.