Loading…
METHYLPREDNISOLONE is a brand name for Methylprednisolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Methylprednisolone sodium succinate is indicated to treat the following conditions: 1. Endocrine diseases Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone are the medicines of choice, however, synthetic analogues can be used in combination with mineralocorticoids; in children, it is of…
Verbatim from this product's MHRA label. Tap a section to expand.
Methylprednisolone may be administered by intravenous (IV) or intramuscular (IM) injection or by intravenous infusion. The preferred method for initial emergency treatment is intravenous injection. Dose adjustments are variable and must be individualized, taking into account the disease to be treated, its severity and the patient's response throughout the duration of the treatment.
A risk/benefit decision must be made in each individual case and continuously. The lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period of time. The proper maintenance dose must be determined by decreasing the initial drug dosage in small amounts and at appropriate time intervals until the lowest dosage, which will maintain an appropriate clinical response, is reached.
4). After the initial emergency period, consideration should be given to using a longer acting injectable preparation or an oral formulation. As a therapeutic adjuvant in life-threatening situations, administer 30 mg/kg of succinate methylprednisolone sodium IV over a minimum period of 30 minutes.
This dose can be repeated every 4 to 6 hours, up to 48 hours. Intermittent IV administration of 250 mg/day or more for a few days (usually ≤ 5 days), may be appropriate in exacerbation phases and situations that do not respond to conventional therapy, such as: rheumatic diseases; systemic lupus erythematosus; oedematous states, such as glomerulonephritis or lupus nephritis.
In multiple sclerosis, in situations that do not respond to conventional therapy (or in exacerbation phases), intermittent administration of 500 mg/day or 1000 mg/day, for 3 days or 5 days, during at least 30 minutes. In adjuvant therapy for other pathologies, the initial dose varies from 10 to 500 mg IV, depending on the clinical situation being treated.
Higher doses may be necessary for short-term treatment of serious acute situations. Initial doses up to 250 mg should be administered by IV route over a minimum period of 5 minutes and higher doses should be administered for at least 30 minutes.
Subsequent doses should be administered by IV or IM route, at intervals dictated by the patients' response and their clinical situation. To administer the medicine intravenously or intramuscularly, the solution should be prepared according to the instructions (see section 6).
The following adverse reactions have been reported with the following contraindicated routes of administration - intrathecal/epidural: arachnoiditis, gastrointestinal disorder functional/ bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures, sensory disturbances.
Within system organ classes, adverse reactions are listed by frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000); not known (cannot be estimated from the available data).
System organ class Frequency Undesirable effect Common Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs). Infections and infestations Not known Opportunistic infections, peritonitis* Blood and lymphatic system disorders Not known Leucocytosis Immune system disorders Not known Hypersensitivity to the drug (anaphylactic reaction and anaphylactoid reaction) Common CushingoidEndocrine disorders Not known Suppression of the hypothalamic-pituitary- adrenal axis, steroid withdrawal syndrome Common Sodium retention, fluid retention Metabolism and nutrition disorders Not known Metabolic acidosis, glucose tolerance decreased, hypokalaemic alkalosis, dyslipidemia, increased insulin requirement (or oral hypoglicemic drugs in diabetics), increased appetite (which can lead to weight increase), epidural lipomatosis Psychiatric disorders Common A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, drug dependence and suicidal thoughts).
4) Ear and labyrinth disorders Not known Vertigo Cardiac disorders Not known Congestive heart failure (in susceptible patients), arrhythmia. Common HypertensionVascular disorders Not known Thrombosis, hypotension, thrombotic events Respiratory, thoracic and mediastinal disorders Not known Pulmonary embolism, hiccups Common Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage) Gastrointestinal disorders Not known Gastric haemorrhage, intestinal perforation, pancreatitis, ulcerative oesophagitis, oesophagitis, abdominal pain, abdominal distension, diarrhoea, dyspepsia, nausea Hepatobiliary disorders Not known Hepatitis, increase of liver enzymes Common Ecchymosis, skin atrophy (thin fragile skin); Acne.
Immunosuppressant effect/Increased susceptibility to infections Corticosteroids may increase susceptibility to infections, may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used.
Pathogenic infections, including viral, bacterial, fungal, protozoan or by helminthic organisms, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular or humoral immunity, or neutrophil function.
These infections may be mild but can become severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Individuals taking medications which suppress the immune system are more susceptible to infections than healthy individuals.
For example, chickenpox and measles can have a more serious, or even fatal, course in non-immune children or adults on corticosteroids. Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines can be decreased. Indicated immunisation procedures may be undertaken in patients receiving non- immunosuppressive doses of corticosteroids.
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Methylprednisolone sodium succinate is contraindicated: - in patients with systemic fungal infections. 1. - for intrathecal administration. - for use by the epidural route of administration. The administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methylprednisolone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
6). Paediatric population The dosage can be reduced for infants and children but should be defined more by the severity of the situation and response to therapy than by the patient's age or weight. 5 mg/kg every 24 hours. Renal insufficiency No dose adjustments are necessary in renal failure.
Methylprednisolone is haemodialysable. Liver failure No dose adjustments are necessary in hepatic failure.
4) Regarding fertility, existing data on animals is insufficient. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Kaposi's sarcoma has been reported in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission. The role of corticosteroids in septic shock has been controversial, with initial studies reporting both beneficial and detrimental effects.
More recently, supplemental corticosteroids have been suggested to be beneficial in patients in established septic shock patients who exhibit adrenal insufficiency. However, their routine use in septic shock is not recommended. A systematic review of short-course, high-dose corticosteroids did not support their use.
However, meta-analyses and a review suggest that longer administrations (5-11 days) of low doses of corticosteroids can reduce mortality. Effects on the immune system Allergic reactions may occur. Due to the fact that, although rarely, cutaneous and anaphylactic/anaphylactoid reactions occur in patients receiving corticosteroid therapy, it is convenient to institute preventive measures before administration, especially in patients with history of allergy to any other drug.
Endocrine effects In patients on corticosteroid therapy subject to unusual stress, increased dosage of fast-acting corticosteroids before, during and after the stressful situation is indicated. Pharmacological doses of corticosteroids administered over prolonged periods of time can result in hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency).
The degree and duration of adrenocortical insufficiency produced are variable between patients and depends on dose, frequency, time of administration and duration of glucocorticoid therapy. This effect can be minimized by use of alternate- day therapy.
Additionally, fatal acute adrenal insufficiency may occur if glucocorticoids are removed abruptly. Drug-induced adrenocortical insufficiency can be minimized by gradually reducing the dose. This type of relative insufficiency can persist for months after therapy withdrawal; therefore, in any stressful situation that occurs during this period, hormone therapy must be reinstituted.
A steroid “withdrawal syndrome” may also occur, apparently not related to adrenal insufficiency, after abrupt interruption of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, peeling, myalgia, weight loss and/or hypotension.
These effects are thought to be due to a sudden change in glucocorticoid concentration and not due to low corticosteroids levels. Glucocorticoids should be avoided in patients with Cushing's disease as they may cause or worsen Cushing's syndrome.
A potentiation of the effect of corticosteroids is observed in patients with hypothyroidism. Metabolism and Nutrition Corticosteroids, including methylprednisolone, can increase blood glucose, worsen pre-existing diabetes, and predispose individuals on long-term corticosteroid therapy to diabetes mellitus.
Psychiatric effects During treatment with corticosteroids, psychiatric changes may occur, ranging from euphoria, insomnia, mood changes, personality changes and severe depression to clearly psychotic manifestations. If there is emotional instability or psychotic tendencies, they can worsen with the use of corticosteroids.
Potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms generally appear within a few days or weeks of starting treatment. Most reactions disappear after dose reduction or withdrawal, although specific treatment may be required.
Psychological effects have been reported after withdrawal of corticosteroids, but its frequency is unknown. Patients/caregivers should be alerted to seek medical assistance if patients develop psychological symptoms, particularly if depressed mood or suicidal ideation are suspected.
Patients/caregivers should be alerted to possible psychiatric disorders that may occur during, or immediately after, dose reduction/withdrawal of systemic steroids. Effects on […]