Prednisolone 5mg Soluble Tablets Summary of Product Characteristics SmPC emc
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prednisoloneAspirin should be used cautiously in conjunction with glucocorticoids in patients with hypoprothrombinaemia. Although concomitant therapy with salicylate and corticosteroids does not appear to increase the incidence or severity of GI ulceration, the possibility of this effect should be considered. Risks may be higher with high doses/systemic exposure (see section 4.5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tampering/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.
Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Patients already receiving Red Medicines in primary care should be handled on a case by case basis with the support of the Medicines Optimisation team. If tablets, soluble tablets and Alkindi not suitable, unlicensed oral suspension is available - recommended strength is 5mg/5mL as per RCPCH guidance.
Suppression of the 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 when corticosteroids, including prednisolone, are used. The immunosuppressive effects of glucocorticoids may result in the activation of latent infection or exacerbation of intercurrent infection.
For all other indications, hydrocortisone sodium succinate powder for injection can be used. These medicines have been evaluated and rejected by MKPAG and are NOT approved for use within MK. They are not recommended for use because of lack of clinical effectiveness, cost effectiveness or safety. This will signify that a product is not recommended for prescribing in both primary and secondary care. All new products are classified as RED-RED pending assessment by PACEF. Alkindi is the only dose appropriate preparation of hydrocortisone licensed for use in cortisol replacement therapy for children with adrenal insufficiency - more information.
Therefore the Clinician should only use a non-formulary drug if this can be justified and it is recommended that all such instances are recorded in the patient record. For doses under 5mg the 5mg/5ml oral solution will be more appropriate. Usually use sodium succinate salt (Solu-Cortef®), but sodium phosphate salt is available for outpatients who may need to self administer (e.g. addisonian crisis). For doses multiple of 5 mg see the entry above on hydrocortisone 10mg tablets. In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.
Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol. Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised. The risk of hypokalaemia also increases 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.
Prophylaxis with intramuscular normal immunoglobulin may be needed. Fractions of the adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year) but clinical factors must be given due weight. Prednisolone 5mg Soluble Tablets are indicated in adults and children.
See here for more info and here for general advice on dispersing tablets. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Impaired carbohydrate intolerance with increased requirement for anti-diabetic therapy, manifestation of latent diabetes mellitus. Significant differences in the pharmacokinetics of prednisolone amongst menopausal women have been described. The postmenopausal women had reduced unbound clearance (30%), reduced total clearance and increased half-life of prednisolone.
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