Methyl Prednisolone Sodium Succinate for Injection USP 500 mg

Usages of Methyl Prednisolone Sodium Succinate for Injection USP 500 mg:

Methyl Prednisolone Sodium Succinate for Injection USP 500 mg is indicated for any condition in which rapid and intense corticosteroid effect is required such as:
Allergic states, for example:
bronchial asthma, angioneurotic oedema, anaphylaxis.
Dermatological conditions
severe erythema multiforme (for example: Stevens‑Johnson syndrome).
Acute adrenal insufficiency with supplemental salt and/or desoxycorticosterone. Dosalon is not first line treatment for acute adrenal insufficiency because it does not possess sufficient mineralocorticoid properties.
Acute systemic lupus erythematosus.
Acute rheumatic carditis.
Suppression of graft rejection reactions following transplantation.
Cerebral oedema secondary to cerebral tumour.
The prevention of nausea and vomiting associated with cancer chemotherapy.
Ulcerative colitis.
Crohn’s disease.
Aspiration of gastric contents.
Acute spinal cord injury. Treatment should begin within eight hours of injury.
The treatment of acute exacerbations of multiple sclerosis superimposed on either a relapsing-remitting or chronic progressive background.

Methyl Prednisolone Sodium Succinate for Injection USP 500 mg may be administered intravenously (injection or infusion) or intramuscularly, the preferred method for emergency use being intravenous injection given over a suitable time interval. When administering Methyl Prednisolone Sodium Succinate for Injection USP 500 mg in high doses intravenously it should be given over a period of at least 30 minutes. Doses up to 250 mg should be given intravenously over a period of at least five minutes.
For intravenous infusion the initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. To avoid compatibility and stability problems with other drugs Methyl Prednisolone Sodium Succinate for Injection USP 500 mg should be administered separately from other drugs whenever possible either as an IV push, through an IV medication chamber, or as an IV “piggy-back” solution and only in the diluents mentioned above.
Parenteral drug products should, wherever possible, be visually inspected for particulate matter and discoloration prior to administration.
Undesirable effects may be minimised by using the lowest effective dose for the minimum period.

Infections and infestations
Opportunistic infections, Infections

Blood and lymphatic system disorders
Leucocytosis

Immune system disorders
Drug hypersensitivity, Anaphylactic reaction

Endocrine disorders
Cushingoid, Hypopituitarism, Steroid withdrawal syndrome

Metabolism and nutrition disorders
Metabolic acidosis, Sodium retention, Epidural lipomatosis, Fluid retention

Psychiatric disorders
Psychotic disorder (including mania, hallucinations, schizophrenia)

Eye disorders
Chorioretinopathy, Cataract, Glaucoma, Blurred vision

Cardiac disorders
Cardiac failure congestive, Arrhythmia

Respiratory, thoracic and mediastinal disorders
Pulmonary embolism, Hiccups

Gastrointestinal disorders
Peptic ulcer, abdominal distension, Oesophagitis, Pancreatitis

Musculo-skeletal and connective tissue disorders
Muscular weakness, Myalgia, Myopathy, Osteoporosis

Reproductive system and breast disorders
Menstruation irregular, Amenorrhoea

Immunosuppressant effects/Increased susceptibility to infections
Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. Chickenpox is of serious concern since this normally minor illness may be fatal in immunosuppressed patients. Measles can have a more serious or even fatal course in immunosuppressed patients. Administration of live or live, attenuated vaccines is contra-indicated 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 may be diminished.

Immune system effects
Allergic reactions may occur. Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any medicinal product.

Nervous system effects
Corticosteroids should be used with caution in patients with seizure disorders and myasthenia gravis. Severe medical events have been reported in association with the intrathecal/epidural routes of administration.

Ocular effects
Visual disturbance may be reported with systemic and topical corticosteroid use. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Prolonged use of corticosteroids may produce posterior subcapsular and nuclear cataracts (particularly in children) and, exophthalmos, or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves. Frequent ophthalmic monitoring is necessary.

Cardiac effects
Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Systemic corticosteroids should be used with caution, and only if strictly necessary, in cases of congestive heart failure. Steroids should be used with caution in patients with hypertension.

Gastrointestinal effects
High doses of corticosteroids may produce acute pancreatitis. Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: Active or latent peptic ulceration, Fresh intestinal anastomoses, Abscess or other pyogenic infections, Ulcerative colitis, Diverticulitis.

Renal and urinary disorders
Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone. Corticosteroids should be used with caution in patients with renal insufficiency.

• Store below 30oC. Protected from light.
• The reconstituted solution to be used immediately.
• Keep the medicine out of reach of children.

• 10 ml Clear tubular Glass Vial with grey bromobutyl rubber stopper, sealed with a yellow flip-off aluminium seal. Methylprednisolone Sodium Succinate for Injection USP 500 mg powder for solution for injection is supplied in glass vial in unit carton with pack insert.