Methyl Prednisolone for Injection USP 500 mg

Therapeutic Class: Pain Management

Dosage Forms: Injectables

Brand Name: Dosalon

Dosalon

How it works?

Uses of Methyl Prednisolone for Injection USP 500 mg

Healthcare providers indicate Methyl Prednisolone Injection for conditions requiring a rapid and intense corticosteroid effect, 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.

Dosages administration of Methyl Prednisolone for Injection USP 500 mg

  • You can administer Methyl Prednisolone Injection USP 500 mg intravenously (injection or infusion) or intramuscularly, with intravenous injection being the preferred method for emergency use. When administering high doses of Methyl Prednisolone Sodium Succinate for Injection USP 500 mg intravenously, give it over a period of at least 30 minutes. For doses up to 250 mg, administer it intravenously over at least five minutes.
  • For intravenous infusion, you can dilute the initially prepared solution with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. To avoid compatibility and stability issues with other drugs, administer Methyl Prednisolone Sodium Succinate for Injection USP 500 mg separately whenever possible, either as an IV push, through an IV medication chamber, or as an IV “piggy-back” solution, and only in the specified diluents.
  • Healthcare providers should visually inspect parenteral drug products for particulate matter and discoloration before administration whenever possible.
  • You can minimize undesirable effects by using the lowest effective dose for the shortest duration.

Side effects of Methyl Prednisolone for Injection USP 500 mg

Under normal circumstances Methyl Prednisolone Injection therapy would be considered as short‑term. However, the possibility of side‑effects attributable to corticosteroid therapy should be recognised, particularly when high‑dose therapy is being used (see section 4.4). Such side-effects include: Very common ≥1/10, (≥10%), Common ≥1/100 and <1/10, (≥1% and <10%), Uncommon ≥1/1000 and <1/100, (≥0.1% and <1%), Rare ≥1/10,000 and <1/1000, (≥0.01% and <0.1%), Very rare <1/10,000, (<0.01%), Not known (cannot be estimated from available data)

 

Frequency: Not Known

 

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

Precautions of Methyl Prednisolone for Injection USP 500 mg

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
High doses and prolonged courses of glucocorticoids may cause adverse effects on the cardiovascular system, such as dyslipidemia and hypertension, which can predispose patients with existing cardiovascular risk factors to additional cardiovascular issues. Use systemic corticosteroids with caution and only when strictly necessary in cases of congestive heart failure. Also, use steroids cautiously in patients with hypertension.

Gastrointestinal effects
High doses of corticosteroids may produce acute pancreatitis.When considering the use of systemic corticosteroids, healthcare providers must take particular care with patients who have the following conditions and should monitor them frequently: active or latent peptic ulceration, fresh intestinal anastomoses, abscesses or other pyogenic infections, ulcerative colitis, and diverticulitis.

Renal and urinary disorders
Providers should exercise caution with patients who have systemic sclerosis because corticosteroids, including methylprednisolone, increase the incidence of scleroderma renal crisis. Additionally, use corticosteroids cautiously in patients with renal insufficiency.

Storage instruction of Methyl Prednisolone for Injection USP 500 mg

  • Store below 30oC. Protected from light.
  • Use the reconstituted solution immediately.
  • Keep the medicine out of reach of children.

Packing details of Methyl Prednisolone for Injection USP 500 mg

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

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