Consumer medicine information

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.

5. What should I know during treatment with SOLU-CORTEF?

6. Are there any side effects?

Side effects include nausea and vomiting, changes in appetite, weight gain caused by fluid retention, muscle weakness or tenderness, increased sweating, excessive thirst, changes in mood, changes in skin, excessive hairiness, tiredness or drowsiness. Serious side effects are rare and may include sudden signs of allergy, severe stomach pain, vomiting blood, or blood in the stools, convulsions or fits, changes in vision, eye infections, pain and tenderness of the lower leg, ankle and foot, chest pain and breathlessness. Long term treatment with corticosteroids can affect growth and development in children.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of 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

4.9 Overdose

Symptoms and signs. Reports of acute toxicity and metabolic disturbances with glucocorticoids are rare but do occur. There is no clinical syndrome of acute overdosage with hydrocortisone sodium succinate. Acute overdose may possibly aggravate pre-existing disease states such as ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes and oedema.
Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid state. The possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time.
Treatment. In the event of acute overdose, treatment is symptomatic and supportive, including respiratory and cardiovascular function. In chronic toxicity, fluids and electrolytes should be monitored closely. Serum levels are not clinically useful.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Hydrocortisone sodium succinate is a white or nearly white, odourless, hygroscopic, amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone and insoluble in chloroform.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSHYSOSU.gif Non-proprietary name: hydrocortisone sodium succinate.
Molecular weight is 484.52.
CAS number. 125-04-2.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes

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