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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrocortisone sodium succinate, Quantity: 133.7 mg (Equivalent: hydrocortisone, Qty 100 mg)

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate

Administration route:

Intramuscular, Intravenous

Units in package:

5 x 100 mg powder for injection in glass vials

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, [Invented name] 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 to off-white, lyophilized cake/powder in clear tubular glass vial with lyo rubber stopper and yellow coloured flip-off aluminum seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-06-08

Patient Information leaflet

CIPLA HYDROCORTISONE
1
CIPLA HYDROCORTISONE
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 CIPLA HYDROCORTISONE?
Cipla Hydrocortisone contains the active ingredient hydrocortisone
sodium succinate. It belongs to a group of medicines called
corticosteroids. Cipla Hydrocortisone 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 Cipla
Hydrocortisone? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH CIPLA HYDROCORTISONE?
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 Cipla Hydrocortisone? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Hydrocortisone 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 CIPLA HYDROCORTISONE GIVEN?
•
Cipla Hydrocortisone 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 Cipla Hydrocortisone
depending on your condition.
More instructions for the preparation of solutions for the plain vial
(powder only) can be found in Section 4. How is Cipla
Hydrocortisone given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH CIPLA HYDROCORTISONE?
THINGS
YOU
SHOULD DO
•
If you get an infection or suspe

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CIPLA HYDROCORTISONE
(HYDROCORTISONE SODIUM SUCCINATE) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Hydrocortisone sodium succinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 133.7 mg of hydrocortisone sodium succinate
equivalent to 100 mg of
hydrocortisone.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection
Cipla Hydrocortisone is white to off-white lyophilized cake/powder in
clear tubular glass vial with lyo
rubber stopper and yellow coloured flip-off aluminium seal.
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,
Cipla 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