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(Approval lapsed) Solu-Medrone methylprednisolone sodium succinate 125mg powder for injection (Pfizer, UK)

Section 19A approved medicine
(Approval lapsed) Solu-Medrone methylprednisolone sodium succinate 125mg powder for injection (Pfizer, UK)
Section 19A approval holder
Link Medical Products Pty Ltd ABN 73 010 971 516
Phone
1802 181 060
Approved until
Status
Expired
Medicines in short supply/unavailable
SOLU-MEDROL ACT-O-VIAL methylprednisolone (as sodium succinate) 125mg powder for injection and diluent in one vial - ARTG 171992
Indication(s)

When oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, methylprednisolone sodium succinate is indicated only for intravenous or intramuscular use in the following conditions: Endocrine Disorders

  • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
  • Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used).
  • Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.
  • Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.
  • Congenital adrenal hyperplasia
  • Nonsuppurative thyroiditis
  • Hypercalcaemia associated with cancer.

Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Acute and subacute bursitis
  • Epicondylitis
  • Synovitis of osteoarthritis
  • Acute gouty arthritis
  • Acute nonspecific tenosynovitis
  • Post-traumatic osteoarthritis
  • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy).

Collagen Disease During an exacerbation or as maintenance therapy in selected cases of:

  • Systemic lupus erythematosus
  • Systemic dermatomyositis (polymyositis)
  • Acute rheumatic carditis. Dermatological Diseases
  • Bullous dermatitis herpetiformis
  • Pemphigus
  • Severe psoriasis
  • Severe seborrhoeic dermatitis
  • Exfoliative dermatitis
  • Mycosis fungoides
  • Severe erythema multiforme (Stevens-Johnson Syndrome).

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:

  • Bronchial asthma
  • Drug hypersensitivity reactions
  • Contact dermatitis
  • Urticarial transfusion reactions
  • Atopic dermatitis
  • Serum sickness
  • Acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).

Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

  • Allergic corneal marginal ulcers
  • Allergic conjunctivitis
  • Chorioretinitis
  • Anterior segment inflammation
  • Herpes zoster ophthalmicus
  • Iritis, iridocyclitis
  • Diffuse posterior uveitis and choroiditis
  • Keratitis
  • Optic neuritis
  • Sympathetic ophthalmia.

Gastrointestinal Diseases To tide the patient over a critical period of the disease in:

  • Ulcerative colitis (systemic therapy)
  • Regional enteritis (systemic therapy). Respiratory Diseases
  • Symptomatic sarcoidosis
  • Berylliosis
  • Aspiration pneumonitis
  • Loeffler's syndrome not manageable by other means
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Haematologic Disorders
  • Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)
  • Secondary thrombocytopenia in adults
  • Acquired (autoimmune) haemolytic anaemia
  • Erythroblastopenia (RBC anaemia)
  • Congenital (erythroid) hypoplastic anaemia.

Neoplastic Diseases For palliative management of:

  • Leukaemias and lymphomas in adults
  • Acute leukaemia of childhood. Oedematous States
  • To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. Nervous System
  • Acute exacerbations of multiple sclerosis. Miscellaneous
  • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
  • Trichinosis with neurologic or myocardial involvement.
  • methylprednisolone sodium succinate is beneficial as adjunctive therapy in the treatment of acquired immunodeficiency syndrome (AIDS) patients with moderate to severe Pneumocystis jiroveci pneumonia (PCP) when given within the first 72 hours of initial anti-pneumocystis treatment.
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