SOLU-CORTEF ACT-O-VIAL 500mg powder for injection and diluent in one vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrocortisone sodium succinate, Quantity: 668.5 mg (Equivalent: hydrocortisone, Qty 500 mg)

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

hydrocortisone sodium succinate

Pharmaceutical form:

Injection, powder for

Composition:

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

Administration route:

Intramuscular, Intravenous

Units in package:

1 X ACT-O-VIAL with powder 500mg, and diluent 4mL in separate chambers

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

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, SOLU-CORTEF 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 freeze dried cake; Container Type: Vial; Container Life Time: 3 Years

Authorization status:

Licence status A

Authorization date:

2010-03-05

Patient Information leaflet

SOLU-CORTEF
®
S
O
L
U
-
C
O
R
T
E
F
®
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 BEING TREATED WITH SOLU-CORTEF?
SOLU-CORTEF contains the active ingredient hydrocortisone sodium
succinate. It belongs to a group of medicines called
corticosteroids. SOLU-CORTEF is used to reduce inflammation (pain,
swelling, redness and heat) in certain glandular disorders,
rheumatic disorders, skin diseases, allergic conditions, inflammation
of the eyes, stomach or gut disorders, respiratory diseases and
blood disorders.
For more information, see Section 1. Why am I being treated with
SOLU-CORTEF? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH SOLU-CORTEF?
Do not use if you have ever had an allergic reaction to hydrocortisone
sodium succinate or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE SEVERE FUNGAL INFECTION, 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
treatment with SOLU-CORTEF? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SOLU-CORTEF 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 IS SOLU-CORTEF GIVEN?
•
SOLU-CORTEF is given as an injection into a muscle, or slowly into a
vein by a doctor or nurse.
•
Your doctor will decide the dose and frequency of SOLU-CORTEF
depending on your condition.
More instructions for the preparation of solutions for the plain vial
(powder only) or ACT-O-VIAL
®
(powder and diluent) system can
be found in Section 4. How is SOLU-CORTEF given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH SOLU-CORTEF?
THINGS YOU
SHOULD DO
•
If you get an infection or suspect an infection during a course of
treatment, tell your doctor as s

Summary of Product characteristics

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Page 1 of 25
AUSTRALIAN
PRODUCT
INFORMATION
-
SOLU-CORTEF

AND
SOLU-CORTEF
®
ACT-O-
VIAL (HYDROCORTISONE SODIUM SUCCINATE)
1. NAME OF THE MEDICINE
Hydrocortisone sodium succinate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SOLU-CORTEF 100 mg plain
vials contains hydrocortisone sodium succinate equivalent
to 100 mg hydrocortisone.
ACT-O-VIAL
®
System Two-Compartment Vial, in three strengths:
100 mg ACT-O-VIAL System: Each 2 mL (when mixed) contains
hydrocortisone sodium
succinate equivalent to 100 mg hydrocortisone.
250 mg ACT-O-VIAL System: Each 2 mL (when mixed) contains
hydrocortisone sodium
succinate equivalent to 250 mg hydrocortisone.
500 mg ACT-O-VIAL System: Each 4 mL (when mixed) contains
hydrocortisone sodium
succinate equivalent to 500 mg hydrocortisone.
For the full list of excipients, see section 6.1, List of excipients.
3. PHARMACEUTICAL FORM
SOLU-CORTEF powder for injection: White freeze dried cake
SOLU-CORTEF ACT-O-VIAL is available in dual chamber vials consisting
of powder for
injection and diluent.
Powder for injection: White freeze dried cake.
Diluent: Clear colourless liquid.
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,
SOLU-CORTEF 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
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Page 2 of 25
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).
•
Pre