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Drug Details

DELTASTAB

• Drug Class Description
  Glucocorticoids (corticosteroids, steroids).
• Generic Name
  Prednisolone
• Presentation
  A white or almost white suspension.
• Description
  Prednisolone Acetate BP 25 mg/ml
• Indications
  Deltastab Injection is indicated for the local treatment, by intra-articular or periarticular injection, of the following conditions: rheumatoid arthritis; osteoarthritis; synovitis not associated with infection; tennis elbow; golfer's elbow, and bursitis. Deltastab Injection is also suitable for administration by the intramuscular route in conditions requiring systemic corticosteroids, e.g. suppression of inflammatory and allergic disorders such as bronchial asthma, anaphylaxis, ulcerative colitis and Crohn's disease.
• Adult Dosage
  

  For intra-articular, periarticular or intramuscular injection.

  For articular use: 5-25 mg depending upon the size of the joint. The injections may be repeated when relapse occurs. No more than three joints should be treated in one day.

  For intramuscular use: Dosage will depend upon the clinical circumstances and the judgement of the physician. The suggested dose is 25-100 mg once or twice weekly.

• Child Dosage
  See data sheet.
• Elderly Dosage
  

  Steroids should be used cautiously in the elderly since adverse effects are enhanced by old age.

  Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose or whenever possible, as a single morning dose on alternate days. Frequent patient review is required to titrate the dose against disease activity.

• Contra Indications
  

  Deltastab Injection is contra-indicated in patients with known hypersensitivity to any of the ingredients. It is also contra-indicated in patients with systemic infections (unless specific anti-infective therapy is employed) and in patients vaccinated with live vaccines.

  Intra-articular and periarticular injections of Deltastab Injection are contra-indicated when the joint or surrounding tissues are infected. The presence of infection also precludes injection into tendon sheaths and bursae. Deltastab Injection must not be injected directly into tendons, nor should it be injected into spinal or other non-diarthrodial joints.

• Special Precautions
  

  A patient information leaflet should be supplied with this product.

  Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

  Adrenal suppression

  Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy, any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy, they may need to be temporarily re-introduced.

  Patients should carry 'Steroid Treatment' cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

  Anti-inflammatory/immunosuppressive effects and infection

  Suppression of inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised. New infections may appear during their use.

  Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobin (VZIG) is needed by exposed, non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

  Patients 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.

  Live vaccines should not be given to individuals with impaired immune responsiveness. Killed vaccines or toxoids may be given though their effects may be attenuated.

  Particular care is required when prescribing systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary:

  (a) Osteoporosis (postmenopausal females are particularly at risk).

  (b) Hypertension or congestive heart failure.

  (c) Existing or previous history of severe affective disorders (especially previous history of steroid psychosis).

  (d) Diabetes mellitus (or a family history of diabetes).

  (e) Previous history of tuberculosis or characteristic appearance on chest X-ray. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy.

  (f) Glaucoma (or a family history of glaucoma).

  (g) Previous corticosteroid-induced myopathy.

  (h) Liver failure.

  (i) Renal insufficiency.

  (j) Epilepsy.

  (k) Peptic ulceration.

  During treatment, the patient should be observed for ophthalmic side effects, psychotic reactions, muscular weakness, electrocardiographic changes, hypertension and untoward hormonal effects.

  Corticosteroids should be used with caution in patients with hypothyroidism.

  Use in children

  Corticosteroids cause growth retardation in infancy, childhood and adolescence; this may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time, in order to minimise suppression of the hypothalamo-pituitary-adrenal (HPA) axis and growth retardation.

  Use in the elderly

  The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

  Withdrawal

  In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5 mg prednisolone or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 7.5 mg of prednisolone is reached, dose reduction should be slower to allow the HPA-axis to recover.

  Abrupt withdrawal of systemic corticosteroid treatment which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses of up to 40 mg daily of prednisolone (or equivalent) for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

  • Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks,

  • When a short course has been prescribed within one year of cessation of long-term therapy (months or years),

  • Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy,

  • Patients receiving doses of systemic corticosteroid greater than 40 mg daily of prednisolone (or equivalent),

  • Patients repeatedly taking doses in the evening.

  Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure, although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most adverse reactions resolve after either dose reduction or withdrawal of the medicine, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

  Particular care is required when considering the use of systemic corticosteroids in patients with existing or a previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

• Interactions
  

  The effectiveness of anticoagulants may be increased or decreased with concurrent corticosteroid therapy, and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.

  Serum levels of salicylates may increase considerably if corticosteroid therapy is withdrawn, possible causing intoxication. Since both salicylates and corticosteroids are ulcerogenic, it is possible that there will be an increased rate of gastrointestinal ulceration. There is an increased risk of gastrointestinal bleeding with aspirin and NSAIDs.

  The desired actions of hypoglycaemic drugs (including insulin), antihypertensives and diuretics will be antagonised by corticosteroids. The growth promoting effect of somatropin may be inhibited by corticosteroids.

  The potassium-depleting effects of amphotericin, carbenoxolone and diuretics (acetazolamide, loop diuretics and thiazides) are enhanced by corticosteroids and signs of hypokalaemia should be looked for during their concurrent use. There is also an increased risk of hypokalaemia with the simultaneous use of theophylline, and if high doses of corticosteroids are given with high doses of bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline.

  The toxicity of cardiac glycosides is increased if hypokalaemia occurs with corticosteroids.

  There is a small amount of evidence that the simultaneous use of corticosteroids and methotrexate may cause increased methotrexate toxicity and possibly death, although this combination of drugs has been used very successfully.

  The metabolism of corticosteroids may be enhanced and the therapeutic effects reduced by certain barbiturates (e.g. phenobarbitone), and by phenytoin, rifampicin, rifabutin, primidone, carbamazepine and aminoglutethimide. The effect of corticosteroids may be reduced for 3-4 days after taking mifepristone.

  Ketoconazole may inhibit the metabolism of corticosteroids.

  The plasma concentration of prednisolone and other corticosteroids may be increased by ritonavir, ciclosporin and oral contraceptives.

• Adverse Drug Reactions
  

  The incidence of predictable undesirable effects, including hypothalamo-pituitary-adrenal suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment.

  The following side effects may be associated with the long-term systemic use of corticosteroids.

  Anti-inflammatory and immunosuppressive effects

  Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.

  Gastrointestinal

  Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, candidiasis, acute pancreatitis.

  Musculoskeletal

  Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture.

  Fluid and electrolyte disturbance

  Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis.

  Dermatological

  Impaired healing, skin atrophy, bruising, striae, acne, telangiectasia.

  Endocrine/Metabolic

  Suppression of the HPA axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, negative protein and calcium balance, increased appetite.

  Neuropsychiatric

  Euphoria, psychological dependence, depression, insomnia and aggravation of schizophrenia. Increased intracranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. Aggravation of epilepsy.

  Ophthalmic

  Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.

  General

  Hypersensitivity, including anaphylaxis, has been reported. Nausea, malaise, leucocytosis, thromboembolism, hiccups, myocardial rupture following recent myocardial infarction.

  Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

  Withdrawal Symptoms

  In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.

  Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema.

  Latent rhinitis or eczema may be unmasked.

  A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.