Drug Action
Tolvaptan is a vasopressin V2-receptor antagonist.
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Individual generic drug information
Extracted information for Tolvaptan only.
Tolvaptan is a vasopressin V2-receptor antagonist.
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JINARC ® Autosomal dominant polycystic kidney disease in adults with CKD stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (initiated by a specialist) ▶BY MOUTH ▶Adult: Initially 60 mg daily in 2 divided doses for at least a week, 45 mg in the morning before breakfast, and then 15 mg taken 8 hours later; increased to 90 mg daily in 2 divided doses for at least a week, 60 mg in the morning before breakfast, and then 30 mg taken 8 hours later, then increased if tolerated to 120 mg daily in 2 divided doses, 90 mg in the morning before breakfast, and then 30 mg taken 8 hours later, dose titration should be performed cautiously; patients may down-titrate to lower doses based on tolerability
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DUE TO INTERACTIONS ▶For Jinarc ®, manufacturer advises reduce dose with concurrent use of potent CYP3A4 inhibitors—if daily dose 90 mg or 120 mg, reduce to 30 mg once daily (can be further reduced to 15 mg once daily if not tolerated); if daily dose 60 mg, reduce to 15 mg once daily. Manufacturer also advises reduce dose with concurrent use of moderate CYP3A4 inhibitors or ciprofloxacin—if daily dose 120 mg, reduce to 60 mg daily (45 mg in morning and 15 mg taken 8 hours later); if daily dose 90 mg, reduce to 45 mg daily (30 mg in morning and 15 mg taken 8 hours later); if daily dose 60 mg, reduce to 30 mg daily (15 mg in morning and 15 mg taken 8 hours later). SAMSCA ® Hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (initiated in hospital or under specialist supervision) ▶BY MOUTH ▶Adult: Initially 15 mg once daily, increased if necessary up to 60 mg once daily, a reduced starting dose of 7.5 mg once daily should be considered for patients at risk of overly rapid correction of serum-sodium concentration
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Anuria. hypernatraemia. hypovolaemic hyponatraemia. impaired perception of thirst. volume depletion Avoid injections containing benzyl alcohol in neonates. avoid live virus vaccines in those receiving immunosuppressive doses (serum antibody response diminished). systemic infection (unless specific therapy given) CONTRA-INDICATIONS, FURTHER INFORMATION For further information on contra-indications associated with intra- articular, intradermal and intralesional preparations, consult product literature.
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GENERAL CAUTIONS Abnormal liver function tests and/or signs or symptoms of liver injury (do not initiate if the criteria for permanent discontinuation are met—consult product literature). diabetes mellitus. patients at risk of dehydration (ensure adequate fluid intake). urinary outflow obstruction (increased risk of acute retention) SPECIFIC CAUTIONS ▶When used for autosomal dominant polycystic kidney disease serum-sodium abnormalities (correct before treatment initiation) ▶When used for hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion patients at risk of demyelination syndromes (e.g hypoxia, alcoholism and malnutrition) Congestive heart failure. diabetes mellitus (including a family history of). diverticulitis. epilepsy. glaucoma (including a family history of or susceptibility to). history of steroid myopathy. history of tuberculosis or X-ray changes (frequent monitoring required). hypertension. hypothyroidism. infection (particularly untreated). long-term use. myasthenia gravis. ocular herpes simplex (risk of corneal perforation). osteoporosis (in children, post-menopausal women and the elderly at risk). peptic ulcer. psychiatric reactions. recent intestinal anastomoses. recent myocardial infarction (rupture reported). severe affective disorders (particularly if history of steroid-induced psychosis). thromboembolic disorders. ulcerative colitis CAUTIONS, FURTHER INFORMATION For further information on cautions associated with intra-articular, intradermal and intralesional preparations, consult product literature. ▶Elderly Prescription potentially inappropriate (STOPP criteria): . if used instead of inhaled corticosteroids for maintenance therapy in moderate to severe COPD (unnecessary exposure to long-term side-effects) . as long-term (longer than 3 months) monotherapy for rheumatoid arthritis (risk of side-effects) . for treatment of osteoarthritis other than for periodic intra-articular injections for monoarticular pain (risk of side-effects) . with concurrent NSAIDs without proton pump inhibitor prophylaxis (increased risk of peptic ulcer disease) See also Prescribing in the elderly p. 33.
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The manufacturer of Jinarc ® has provided training materials for healthcare professionals to use prior to prescribing tolvaptan in order to minimise the risk of irreversible hepatotoxicity and to highlight the importance of pregnancy prevention.
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NICE decisions Endocrine system ▶Tolvaptan for treating autosomal dominant polycystic kidney disease (October 2015) NICE TA358 Tolvaptan (Jinarc ®) is recommended as an option for the treatment of autosomal dominant polycystic kidney disease in adults if: . the patient has chronic kidney disease stage 2 or 3 at the start of treatment, and . there is evidence of rapidly progressing disease, and . the manufacturer provides tolvaptan with the discount agreed in the patient access scheme. Patients currently receiving tolvaptan (Jinarc ®) whose disease does not meet the above criteria should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta358
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Extracted information for Tolvaptan only.
→Appendix 1: tolvaptan
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▶Common or very common Appetite decreased. asthenia. constipation. dehydration. diarrhoea. dizziness. dry mouth. dyspnoea. gastrointestinal discomfort. gastrooesophageal reflux disease. headache. hepatic disorders. hyperglycaemia. hypernatraemia. hyperuricaemia. insomnia. muscle spasms. palpitations. polydipsia. skin reactions. thirst. urinary disorders. weight decreased ▶Frequency not known Acute hepatic failure (cases requiring liver transplantation reported) SIDE-EFFECTS, FURTHER INFORMATION Interrupt treatment and perform liver-function tests promptly if symptoms of hepatic impairment occur (anorexia, nausea, vomiting, fatigue, abdominal pain, jaundice, dark urine, pruritus)— consult product literature. ▶Common or very common Anxiety. behaviour abnormal. cataract subcapsular. cognitive impairment. Cushing’s syndrome. electrolyte imbalance. fatigue. fluid retention. gastrointestinal discomfort. headache. healing impaired. hirsutism. hypertension. increased risk of infection. menstrual cycle irregularities. mood altered. nausea. Endocrine system osteoporosis. peptic ulcer. psychotic disorder. skin reactions. sleep disorders. weight increased ▶Uncommon Adrenal suppression. alkalosis hypokalaemic. appetite increased. bone fractures. diabetic control impaired. eye disorders. glaucoma. haemorrhage. heart failure. hyperhidrosis. hypotension. leucocytosis. myopathy. osteonecrosis. pancreatitis. papilloedema. seizure. thromboembolism. tuberculosis reactivation. vertigo. vision blurred ▶Rare or very rare Malaise. tendon rupture ▶Frequency not known Chorioretinopathy. growth retardation (very common in children). intracranial pressure increased with papilloedema (usually after withdrawal). telangiectasia SIDE-EFFECTS, FURTHER INFORMATION Adrenal suppression During prolonged therapy with corticosteroids, particularly with systemic use, adrenal atrophy develops and can persist for years after stopping. Abrupt withdrawal after a prolonged period can lead to acute adrenal insufficiency, hypotension, or death. To compensate for a diminished adrenocortical response caused by prolonged corticosteroid treatment, any significant intercurrent illness, trauma, or surgical procedure requires a temporary increase in corticosteroid dose, or if already stopped, a temporary reintroduction of corticosteroid treatment. Patients on long-term corticosteroid treatment should carry a steroid treatment card which gives guidance on minimising risk and provides details of prescriber, drug, dosage and duration of treatment. Infections Prolonged courses of corticosteroids increase susceptibility to infections and severity of infections; clinical presentation of infections may also be atypical. Serious infections e.g. septicaemia and tuberculosis may reach an advanced stage before being recognised, and amoebiasis or strongyloidiasis may be activated or exacerbated (exclude before initiating a corticosteroid in those at risk or with suggestive symptoms). Fungal or viral ocular infections may also be exacerbated. Chickenpox Unless they have had chickenpox, patients receiving oral or parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella–zoster immunoglobulin is needed for exposed non–immune patients receiving systemic corticosteroids or for those who have used them within the previous 3 months. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be increased. Measles Patients taking corticosteroids should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed. Psychiatric reactions Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions including euphoria, insomnia, irritability, mood lability, suicidal thoughts, psychotic reactions, and behavioural disturbances. These reactions frequently subside on reducing the dose or discontinuing the corticosteroid but they may also require specific management. Patients should be advised to seek medical advice if psychiatric symptoms (especially depression and suicidal thoughts) occur and they should also be alert to the rare possibility of such reactions during withdrawal of corticosteroid treatment. Systemic corticosteroids should be prescribed with care in those predisposed to psychiatric reactions, including those who have previously suffered corticosteroid–induced psychosis, or who have a personal or family history of psychiatric disorders.
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Avoid—toxicity in animal studies. The benefit of treatment with corticosteroids during pregnancy outweighs the risk. Corticosteroid cover is required during labour. Following a review of the data on the safety of systemic corticosteroids used in pregnancy and breast-feeding the CSM (May 1998) concluded that corticosteroids vary in their ability to cross the placenta but there is no convincing evidence that systemic corticosteroids increase the incidence of congenital abnormalities such as cleft palate or lip. When administration is prolonged or repeated during pregnancy, systemic corticosteroids increase the risk of intra-uterine growth restriction; there is no evidence of intra-uterine growth restriction following short-term treatment (e.g. prophylactic treatment for neonatal respiratory distress syndrome). Any adrenal suppression in the neonate following prenatal exposure usually resolves spontaneously after birth and is rarely clinically important. Monitoring Pregnant women with fluid retention should be monitored closely when given systemic corticosteroids.
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Avoid—present in milk in animal studies. The benefit of treatment with corticosteroids during breast-feeding outweighs the risk.
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Manufacturer advises caution in severe impairment; avoid if abnormal liver-function tests and/or signs or symptoms of liver injury meet the requirements for permanent discontinuation—consult product literature. In general, manufacturers advise caution (risk of increased exposure).
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No information available in severe impairment. Use by oral and injectable routes should be undertaken with caution.
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▶Manufacturer advises monitor volume, fluid and electrolyte status (risk of dehydration); monitor electrolytes at least every 3 months during long-term therapy. ▶When used for Autosomal dominant polycystic kidney disease Manufacturer advises monitor liver function tests and for symptoms of liver injury. Liver enzymes and bilirubin must be measured and reviewed before treatment initiation, monthly for 18 months, and every 3 months thereafter; interrupt treatment if abnormalities occur— consult product literature for further information including the criteria for permanent discontinuation. Manufacturer advises evaluate uric acid concentration before treatment initiation and as clinically indicated during treatment; monitor urine osmolality periodically. ▶When used for Hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion Manufacturer advises monitor liver function tests and for symptoms of liver injury; interrupt treatment if abnormalities occur. Manufacturer advises monitor serum-sodium concentration no later than 6 hours after treatment initiation, then monitor serum-sodium and volume status at least every 6 hours during the first 1–2 days of treatment and until dose stabilised. If serum-sodium correction exceeds 6 mmol/litre during the first 6 hours or 8 mmol/litre in the first 6–12 hours, frequency of monitoring should be increased; interrupt or discontinue treatment if serum-sodium increases by 12 mmol/litre or greater in 24 hours or 18 mmol/litre or greater in 48 hours. ▶In children The height and weight of children receiving prolonged treatment with corticosteroids should be monitored annually; if growth is slowed, referral to a paediatrician should be considered. l EFFECT ON LABORATORY TESTS May suppress skin test reactions.
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MHRA/CHM ADVICE: CORTICOSTEROIDS: RARE RISK OF CENTRAL SEROUS CHORIORETINOPATHY WITH LOCAL AS WELL AS SYSTEMIC ADMINISTRATION (AUGUST 2017) Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal, epidural, intra-articular, topical dermal, and periocular routes. The MHRA recommends that patients should be advised to report any blurred vision or other visual disturbances with corticosteroid treatment given by any route; consider referral to an ophthalmologist for evaluation of possible causes if a patient presents with vision problems.
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Extracted information for Tolvaptan only.
There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 27 ▶Jinarc (Otsuka Pharmaceuticals (U.K.) Ltd) A Tolvaptan 15 mg Jinarc 15mg tablets | 7 tablet P £302.05 (Hospital only) Tolvaptan 30 mg Jinarc 30mg tablets | 7 tablet P £302.05 (Hospital only) Tolvaptan 45 mg Jinarc 45mg tablets | 7 tablet P s Tolvaptan 60 mg Jinarc 60mg tablets | 7 tablet P s Tolvaptan 90 mg Jinarc 90mg tablets | 7 tablet P s ▶Samsca (Otsuka Pharmaceuticals (U.K.) Ltd) Tolvaptan 15 mg Samsca 15mg tablets | 10 tablet P £746.80 Tolvaptan 30 mg Samsca 30mg tablets | 10 tablet P £746.80 Corticosteroid responsive conditions CORTICOSTEROIDS Corticosteroids, general use Overview Dosages of corticosteroids vary widely in different diseases and in different patients. If the use of a corticosteroid can save or prolong life, as in exfoliative dermatitis, pemphigus, acute leukaemia or acute transplant rejection, high doses may need to be given, because the complications of therapy are likely to be less serious than the effects of the disease itself. When long-term corticosteroid therapy is used in some chronic diseases, the adverse effects of treatment may become greater than the disabilities caused by the disease. To minimise side-effects the maintenance dose should be kept as low as possible. When potentially less harmful measures are ineffective corticosteroids are used topically for the treatment of inflammatory conditions of the skin. Corticosteroids should be avoided or used only under specialist supervision in psoriasis. Corticosteroids are used both topically (by rectum) and systemically (by mouth or intravenously) in the management of ulcerative colitis and Crohn’s disease. They are also included in locally applied creams for haemorrhoids. Use can be made of the mineralocorticoid activity of fludrocortisone acetate p. 713 to treat postural hypotension in autonomic neuropathy. High-dose corticosteroids should be avoided for the management of septic shock. However, there is evidence that administration of lower doses of hydrocortisone p. 713 and fludrocortisone acetate is of benefit in adrenocortical insufficiency resulting from septic shock. Endocrine system Dexamethasone p. 712 and betamethasone p. 711 have little if any mineralocorticoid action and their long duration of action makes them particularly suitable for suppressing corticotropin secretion in congenital adrenal hyperplasia where the dose should be tailored to clinical response and by measurement of adrenal androgens and 17-hydroxyprogesterone. In common with all glucocorticoids their suppressive action on the hypothalamic- pituitary-adrenal axis is greatest and most prolonged when they are given at night. In most individuals a single dose of dexamethasone at night, is sufficient to inhibit corticotropin secretion for 24 hours. This is the basis of the ‘overnight dexamethasone suppression test’ for diagnosing Cushing’s syndrome. Betamethasone and dexamethasone are also appropriate for conditions where water retention would be a disadvantage. A corticosteroid may be used in the management of raised intracranial pressure or cerebral oedema that occurs as a result of malignancy (see Prescribing in palliative care p. 28). However, a corticosteroid should not be used for the management of head injury or stroke because it is unlikely to be of benefit and may even be harmful. In acute hypersensitivity reactions, such as angioedema of the upper respiratory tract and anaphylaxis, corticosteroids are indicated as an adjunct to emergency treatment with adrenaline/epinephrine p. 236. In such cases hydrocortisone (as sodium succinate) by intravenous injection may be required. g Corticosteroids are preferably used by inhalation in the management of asthma and chronic obstructive pulmonary disease (COPD). Systemic therapy along with bronchodilators is required for treatment of acute asthma attacks, in some very severe cases of chronic asthma, and exacerbations of COPD. h Corticosteroids may also be useful in conditions such as autoimmune hepatitis, rheumatoid arthritis and sarcoidosis; they may also lead to remissions of acquired haemolytic anaemia, and some cases of the nephrotic syndrome (particularly in children) and thrombocytopenic purpura. Corticosteroids can improve the prognosis of serious conditions such as systemic lupus erythematosus, temporal arteritis, and polyarteritis nodosa; the effects of the disease process may be suppressed and symptoms relieved, but the underlying condition is not cured, although it may ultimately remit. It is usual to begin therapy in these conditions at fairly high dose, and then to reduce the dose to the lowest commensurate with disease control. For other references to the use of corticosteroids see: Prescribing in Palliative Care, immunosuppression, rheumatic diseases, eye, otitis externa allergic rhinitis, and aphthous ulcers. Side-effects MHRA/CHM advice: Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration (August 2017) Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal, epidural, intra- articular, topical dermal, and periocular routes. The MHRA recommends that patients should be advised to report any blurred vision or other visual disturbances with corticosteroid treatment given by any route; consider referral to an ophthalmologist for evaluation of possible causes if a patient presents with vision problems. Overdosage or prolonged use can exaggerate some of the normal physiological actions of corticosteroids leading to mineralocorticoid and glucocorticoid side-effects. Mineralocorticoid side effects . hypertension . sodium retention . water retention . potassium loss . calcium loss Mineralocorticoid side effects are most marked with fludrocortisone, but are significant with hydrocortisone, corticotropin, and tetracosactide. Mineralocorticoid actions are negligible with the high potency glucocorticoids, betamethasone and dexamethasone, and occur only slightly with methylprednisolone, prednisolone, and triamcinolone. Glucocorticoid side effects . diabetes . osteoporosis, which is a danger, particularly in the elderly, as it can result in osteoporotic fractures for example of the hip or vertebrae; . in addition high doses are associated with avascular necrosis of the femoral head. . muscle wasting (proximal myopathy) can also occur. . corticosteroid therapy is also weakly linked with peptic ulceration and perforation. . psychiatric reactions may also occur. Managing side-effects Side-effects can be minimised by using lowest effective dose for minimum period possible. The suppressive action of a corticosteroid on cortisol secretion is least when it is given as a single dose in the morning. In an attempt to reduce pituitary-adrenal suppression further, the total dose for two days can sometimes be taken as a single dose on alternate days; alternate-day administration has not been very successful in the management of asthma. Pituitary-adrenal suppression can also be reduced by means of intermittent therapy with short courses. In some conditions it may be possible to reduce the dose of corticosteroid by adding a small dose of an immunosuppressive drug. For information on the cessation of oral corticosteroid treatment, see Treatment cessation, for systemic corticosteroids (e.g. prednisolone p. 716). Whenever possible local treatment with creams, intra- articular injections, inhalations, eye-drops, or enemas should be used in preference to systemic treatment. Inhaled corticosteroids have considerably fewer systemic effects than oral corticosteroids, but adverse effects including adrenal suppression have been reported. Use of other corticosteroid therapy (including topical) or concurrent use of drugs which inhibit corticosteroid metabolism should be taken into account when assessing systemic risk. Corticosteroids, replacement therapy Overview The adrenal cortex normally secretes hydrocortisone p. 713 (cortisol) which has glucocorticoid activity and weak mineralocorticoid activity. It also secretes the mineralocorticoid aldosterone. In deficiency states, physiological replacement is best achieved with a combination of hydrocortisone and the mineralocorticoid fludrocortisone acetate p. 713; hydrocortisone alone does not usually provide sufficient mineralocorticoid activity for complete replacement. In Addison’s disease or following adrenalectomy, hydrocortisone by mouth is usually required. This is given in 2 doses, the larger 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. Glucocorticoid therapy is supplemented by fludrocortisone acetate. In acute adrenocortical insufficiency, hydrocortisone is given intravenously (preferably as sodium succinate) every 6 to 8 hours in sodium chloride intravenous infusion 0.9% p. 1101. In hypopituitarism, glucocorticoids should be given as in adrenocortical insufficiency, but since production of aldosterone is also regulated by the renin-angiotensin system a mineralocorticoid is not usually required. Additional replacement therapy with levothyroxine sodium p. 816 and sex hormones should be given as indicated by the pattern of hormone deficiency. Glucocorticoid therapy Glucocorticoid and mineralocorticoid activity In comparing the relative potencies of corticosteroids in terms of their anti-inflammatory (glucocorticoid) effects it should be borne in mind that high glucocorticoid activity in itself is of no advantage unless it is accompanied by relatively low mineralocorticoid activity (see Disadvantages of Corticosteroids). The mineralocorticoid activity of fludrocortisone acetate p. 713 is so high that its anti- inflammatory activity is of no clinical relevance. Equivalent anti-inflammatory doses of corticosteroids This table takes no account of mineralocorticoid effects, nor does it take account of variations in duration of action Prednisolone 5 mg : Betamethasone 750 micrograms : Deflazacort 6 mg : Dexamethasone 750 micrograms : Hydrocortisone 20 mg : Methylprednisolone 4 mg : Prednisone 5 mg : Triamcinolone 4 mg The relatively high mineralocorticoid activity of hydrocortisone p. 713, and the resulting fluid retention, makes it unsuitable for disease suppression on a long-term basis. However, hydrocortisone can be used for adrenal replacement therapy. Hydrocortisone is used on a short-term basis by intravenous injection for the emergency management of some conditions. The relatively moderate anti-inflammatory potency of hydrocortisone also makes it a useful topical corticosteroid for the management of inflammatory skin conditions because side-effects (both topical and systemic) are less marked. Prednisolone p. 716 and prednisone have predominantly glucocorticoid activity. Prednisolone is the corticosteroid most commonly used by mouth for long-term disease suppression. Betamethasone p. 711 and dexamethasone p. 712 have very high glucocorticoid activity in conjunction with insignificant mineralocorticoid activity. This makes them particularly suitable for high-dose therapy in conditions where fluid retention would be a disadvantage. Betamethasone and dexamethasone also have a long duration of action and this, coupled with their lack of mineralocorticoid action makes them particularly suitable for conditions which require suppression of corticotropin (corticotrophin) secretion (e.g. congenital adrenal hyperplasia). Some esters of betamethasone and of beclometasone dipropionate p. 48 (beclomethasone) exert a considerably more marked topical effect (e.g. on the skin or the lungs) than when given by mouth; use is made of this to obtain Endocrine system topical effects whilst minimising systemic side-effects (e.g. for skin applications and asthma inhalations). Deflazacort p. 711 has a high glucocorticoid activity; it is derived from prednisolone. Corticosteroids (systemic) f
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Extracted information for Tolvaptan only.
For Jinarc ®, morning dose to be taken 30 minutes before food, second dose can be taken with or without food. Risk minimisation materials For Jinarc ®, a patient brochure and alert card should be provided. Advice for patients Patients on long-term corticosteroid treatment should carry a Steroid Treatment Card which gives guidance on minimising risk and provides details of prescriber, drug, dosage and duration of treatment. A patient information leaflet should be supplied to every patient when a systemic corticosteroid is prescribed. Patients should especially be advised of the following: . Immunosuppression Prolonged courses of corticosteroids can increase susceptibility to infection and serious infections can go unrecognised. Unless already immune, patients are at risk of severe chickenpox and should avoid close contact with people who have chickenpox or shingles. Similarly, precautions should also be taken against contracting measles; . Adrenal suppression If the corticosteroid is given for longer than 3 weeks, treatment must not be stopped abruptly. Adrenal suppression can last for a year or more after stopping treatment and the patient must mention the course of corticosteroid when receiving treatment for any illness or injury; . Mood and behaviour changes Corticosteroid treatment, especially with high doses, can alter mood and behaviour early in treatment—the patient can become confused, irritable and suffer from delusion and suicidal thoughts. These effects can also occur when corticosteroid treatment is being withdrawn. Medical advice should be sought if worrying psychological changes occur; . Other serious effects Serious gastro-intestinal, musculoskeletal, and ophthalmic effects which require medical help can also occur. Steroid treatment cards Steroid treatment cards should be issued where appropriate. Consider giving a ‘steroid card’ to support communication of the risks associated with treatment, and specific written advice to consider corticosteroid replacement during an episode of stress, such as severe intercurrent illness or an operation, to patients using greater than maximum licensed doses of inhaled corticosteroids. Steroid treatment cards are available for purchase from the NHS Print online ordering portal www.nhsforms.co.uk GP practices can obtain supplies through Primary Care Support England. NHS Trusts can order supplies via the online ordering portal. In Scotland, steroid treatment cards can be obtained from APS Group Scotland by emailing stockorders.dppas@apsgroup.co.uk or by fax on 0131 629 Endocrine system 9967. eiiii F 709
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▶In adults Abrupt withdrawal after a prolonged period can lead to acute adrenal insufficiency, hypotension or death. Withdrawal can also be associated with fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss. The magnitude and speed of dose reduction in corticosteroid withdrawal should be determined on a case-by–case basis, taking into consideration the underlying condition that is being treated, and individual patient factors such as the likelihood of relapse and the duration of corticosteroid treatment. Gradual withdrawal of systemic corticosteroids should be considered in those whose disease is unlikely to relapse and have: . received more than 40 mg prednisolone (or equivalent) daily for more than 1 week; . been given repeat doses in the evening; . received more than 3 weeks’ treatment; . recently received repeated courses (particularly if taken for longer than 3 weeks); . taken a short course within 1 year of stopping long-term therapy; . other possible causes of adrenal suppression. Systemic corticosteroids may be stopped abruptly in those whose disease is unlikely to relapse and who have received treatment for 3 weeks or less and who are not included in the patient groups described above. During corticosteroid withdrawal the dose may be reduced rapidly down to physiological doses (equivalent to prednisolone 7.5 mg daily) and then reduced more slowly. Assessment of the disease may be needed during withdrawal to ensure that relapse does not occur. ▶In children The magnitude and speed of dose reduction in corticosteroid withdrawal should be determined on a case- by–case basis, taking into consideration the underlying condition that is being treated, and individual patient factors such as the likelihood of relapse and the duration of corticosteroid treatment. Gradual withdrawal of systemic corticosteroids should be considered in those whose disease is unlikely to relapse and have: . received more than 40 mg prednisolone (or equivalent) daily for more than 1 week or 2 mg/kg daily for 1 week or 1 mg/kg daily for 1 month; . been given repeat doses in the evening; . received more than 3 weeks’ treatment; . recently received repeated courses (particularly if taken for longer than 3 weeks); . taken a short course within 1 year of stopping long-term therapy; . other possible causes of adrenal suppression. Systemic corticosteroids may be stopped abruptly in those whose disease is unlikely to relapse and who have received treatment for 3 weeks or less and who are not included in the patient groups described above. During corticosteroid withdrawal the dose may be reduced rapidly down to physiological doses (equivalent to prednisolone 2–2.5 mg/m2 daily) and then reduced more slowly. Assessment of the disease may be needed during withdrawal to ensure that relapse does not occur.
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
Initially 60 mg daily in 2 divided doses for at
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 728