Brand name: Solu-Medrol
Active ingredient (generic name): Methylperednisolone sodium succinate
Manufacturer: Pfizer
Importer: Behestan Darou
Pharmacotherapeutic group: Glucocorticoid
Pharmaceutical form: 500mg Vials
Medrol is a corticosteroid with an anti-inflammatory activity at least five times that of hydrocortisone. An enhanced separation of glucocorticoid and mineralocorticoid effect results in a reduced incidence of sodium and water retention.
Pharmacokinetic:
Methylprednisolone is extensively bound to plasma proteins, mainly to globulin and less so to albumin. Only unbound corticosteroid has pharmacological effects or is metabolized. Metabolism occurs in the liver and to a lesser extent in the kidney. Metabolites are excreted in the urine.
Mean elimination half-life ranges from 2.4 to 3.5 hours in normal healthy adults and appears to be independent of the route of administration.
Therapeutic indication:
Medrol is indicated to treat any condition in which rapid and intense corticosteroid effect is required such as:
1. Dermatological disease
Severe erythematic multiform (StevensJohnson syndrome)
2. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Angioneurotic oedema
Anaphylaxis
3. Gastrointestinal diseases
Ulcerative colitis
Crohn's disease
4. Respiratory diseases
Aspiration of gastric contents
Fulminating or disseminated tuberculosis (with appropriate antituberculous chemotherapy)
5. Neurological disorders
Cerebral oedema secondary to cerebral tumour
Acute exacerbations of multiple sclerosis superimposed on a relapsing-remitting background.
6. Miscellaneous
T.B. meningitis (with appropriate antituberculous chemotherapy)
Transplantation
Contraindication:
SoluMedrol is contraindicated where there is known hypersensitivity to components, in systemic infection unless specific anti-infective therapy is employed and in cerebral oedema in malaria.
Interaction with other medical products:
1. Convulsions have been reported with concurrent use of methylprednisolone and ciclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.
3. Drugs which inhibit the CYP3A4 enzyme, such as cimetidine, erythromycin, ketoconazole, itraconazole, diltiazem and mibefradil, may decrease the rate of metabolism of corticosteroids and hence increase the serum concentration.
4. Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
5. The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
6. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Salicylates and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium with partial reversal of the neuromuscular block.
Special warnings:
If irritation persists or worsens or headache, eye pain, vision changes or continued redness occurs, discontinue use and consult a physician.
Special precautions:
Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy.
8. Liver failure or cirrhosis.
9. Renal insufficiency.
10. Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Recent myocardial infarction (myocardial rupture has been reported).
21. Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission
22. Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids
Pregnancy and lactation:
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The ability of corticosteroids to cross the placenta varies between individual drugs, however, methylprednisolone does cross the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory , occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk. Side effects: GASTRO-INTESTINAL Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis, perforation of the bowel, gastric haemorrhage. Nausea, vomiting and bad taste in mouth may occur especially with rapid administration. MUSCULOSKELETAL Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture. FLUID AND ELECTROLYTE DISTURBANCE Sodium and water retention, potassium loss, hypertension, hypokalaemic alkalosis, congestive heart failure in susceptible patients. DERMATOLOGICAL Impaired healing, petechiae and ecchymosis, skin atrophy, bruising, striae, telangiectasia, acne. Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission. ENDOCRINE/METABOLIC Suppression of the hypothalamopituitaryadrenal 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 nitrogen and calcium balance. Increased appetite. OPHTHALMIC Increased intraocular pressure, glaucoma, papilloedema with possible damage to the optic nerve, cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease. CARDIOVASCULAR – Myocardial rupture following a myocardial infarction. GENERAL Leucocytosis, hypersensitivity including anaphylaxis, thrombo-embolism, malaise, persistent hiccups with high doses of corticosteroids. |
Storage temperature:
Store below 25°C
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