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CIPLA HYDROCORTISONE, CORTI-H, CORTICIP, HYDROCIP (Cipla Australia Pty Ltd)

Product name
CIPLA HYDROCORTISONE, CORTI-H, CORTICIP, HYDROCIP
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
Hydrocortisone sodium succinate
Registration type
New generic medicine
Indication

When oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, CIPLA HYDROCORTISONE, CORTI-H, CORTICIP, HYDROCIP (powder for injection) is indicated 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 supplements 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:

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

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

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

  • Herpes zoster ophthalmicus
  • Iritis, iridocyclitis
  • Chorioretinitis
  • Diffuse posterior uveitis and choroiditis
  • Optic neuritis
  • Sympathetic ophthalmia
  • Anterior segment inflammation
  • Allergic conjunctivitis
  • Allergic corneal marginal ulcers
  • Keratitis.
  • 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
  • Loeffler’s Syndrome not manageable by other means
  • Berylliosis
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
  • Aspiration pneumonitis.
  • Haematological Disorders
  • Acquired (autoimmune) haemolytic anaemia
  • Erythroblastopenia (RBC anaemia)
  • Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)
  • Secondary thrombocytopenia in adults
  • Congenital (erythroid) hypoplastic anaemia.
  • Neoplastic Diseases

    For palliative management of:

  • Leukaemias and lymphomas in adults
  • Acute leukaemia in 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.
  • Miscellaneous
  • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
  • Trichinosis with neurological or myocardial involvement.
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