HYDROCORTISONE JUNO hydrocortisone (as sodium succinate) 100 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrocortisone hydrogen succinate, Quantity: 127.6 mg (Equivalent: hydrocortisone, Qty 100 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; monobasic sodium phosphate monohydrate; dibasic sodium phosphate

Administration route:

Intravenous, Intramuscular

Units in package:

5 vials, 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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, hydrocortisone powder for ,injection is indicated for intravenous or intramuscular use in the following conditions:,1. 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.,2. 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.,3. Collagen Diseases,During an exacerbation or as maintenance therapy in selected cases of:,? Systemic lupus erythematosus,? Systemic dermatomyositis (polymyositis),? Acute rheumatic carditis.,4. Dermatological Diseases,? Pemphigus,? Severe erythema multiforme (Stevens-Johnson Syndrome),? Exfoliative dermatitis,? Bullous dermatitis herpetiformis,? Severe seborrhoeic dermatitis,? Severe psoriasis,? Mycosis fungoides.,5. 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).,6. 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.,7. Gastrointestinal Diseases,To tide the patient over a critical period of the disease in:,? Ulcerative colitis (systemic therapy),? Regional enteritis (systemic therapy).,8. 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.,9. 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.,10. Neoplastic Diseases,For palliative management of:,? Leukaemias and lymphomas in adults,? Acute leukaemia in childhood.,11. 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.,12. Miscellaneous,? Tuberculous meningitis with subarachnoid block or impending block when used ,concurrently with appropriate antituberculous chemotherapy,? Trichinosis with neurological or myocardial involvement.

Product summary:

Visual Identification: White lyophilized powder in a clear, type I glass vial, stoppered with a (chlorobutyl elastomer) rubber stopper and capped with an aluminium cap.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-03-31

Patient Information leaflet

HYDROCORTISONE JUNO
1
HYDROCORTISONE JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING HYDROCORTISONE JUNO?
HYDROCORTISONE JUNO contains the active ingredient hydrocortisone
sodium succinate. HYDROCORTISONE JUNO is used to
reduce inflammation (pain, swelling, redness and heat).
For more information, see Section 1. Why am I using HYDROCORTISONE
JUNO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYDROCORTISONE JUNO?
Do not use if you have ever had an allergic reaction to hydrocortisone
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
HYDROCORTISONE JUNO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with HYDROCORTISONE JUNO and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE HYDROCORTISONE JUNO?
•
Your doctor will decide the appropriate dose for you.
•
A doctor or nurse will prepare and administer the injection.
•
Follow all instructions given to you by your doctor and pharmacist.
More instructions can be found in Section 4. How do I use
HYDROCORTISONE JUNO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYDROCORTISONE JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
HYDROCORTISONE JUNO.
•
Keep all of your doctor’s appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly unless your doctor tells you.
•
Avoid drinking grapefruit juice while you are being treated with
HYDROCORTISONE JUNO.
•
Do not use diluents containing benzyl alcohol with HYDROCORTISONE JUNO
to treat children.
DRIVING

Summary of Product characteristics

Juno Pharmaceuticals Pty ltd
Australian Product Information
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
HYDROCORTISONE JUNO _(HYDROCORTISONE SODIUM SUCCINATE)_
_ _
1 NAME OF THE MEDICINE
Hydrocortisone sodium succinate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each HYDROCORTISONE JUNO 100 mg vial contains hydrocortisone sodium
succinate
equivalent to 100 mg hydrocortisone.
For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
HYDROCORTISONE JUNO powder for injection: White freeze dried cake
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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, HYDROCORTISONE
JUNO powder for injection is indicated for intravenous or
intramuscular use in the following
conditions:
1.
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.
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode
or exacerbation) in:
Juno Pharmaceuticals Pty ltd
Australian Product Information
Page 2 of 20
•
Post-traumatic osteoarthritis
•
Synovitis of osteoarthritis
•
Rheumatoid arthritis, including juvenile rheumatoid ar