Solu-Cortef
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
SOLU-CORTEF®
Hydrocortisone sodium succinate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SOLU-CORTEF. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of treating you with SOLU-CORTEF against the benefits they expect it will have for you.
If you have any concerns about being treated with this medicine, ask your doctor or pharmacist.
Keep this leaflet even after your treatment with SOLU-CORTEF is finished.
You may need to read it again.
What SOLU-CORTEF is used for
SOLU-CORTEF acts by reducing inflammation (pain, swelling, redness and heat).
SOLU-CORTEF is an injection. It is used when oral treatment is not possible. Hydrocortisone sodium succinate, the active ingredient in SOLU-CORTEF, belongs to a group of medicines called corticosteroids.
Your doctor has prescribed SOLU-CORTEF for the treatment of one or more of the following:
certain glandular disorders
rheumatic disorders
skin diseases
allergic conditions
inflammation of the eyes
stomach or gut disorders
respiratory diseases
blood disorders
Your doctor may have prescribed SOLU-CORTEF for another reason.
Ask your doctor if you have any questions about why SOLU-CORTEF has been prescribed for you.
SOLU-CORTEF is available only with a doctor’s prescription.
SOLU-CORTEF is not addictive.
Before being treated with SOLU-CORTEF
When SOLU-CORTEF must not be given
SOLU-CORTEF must not be given if you:
are allergic to SOLU-CORTEF, other medicines containing hydrocortisone sodium succinate
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
SOLU-CORTEF must not be given if you have a severe fungal infection
SOLU-CORTEF must not be injected into the spinal cord (intrathecal or epidural) or by any other unapproved route of administration.
SOLU-CORTEF must not be used after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before treatment with SOLU-CORTEF
Tell your doctor if you are allergic to any other medicines, foods, preservatives and dyes.
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of using SOLU-CORTEF when pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Your doctor will discuss the risks and benefits of using SOLU-CORTEF when breastfeeding.
Tell your doctor if you have or have had any of the following medical conditions:
stomach or gut disorders e.g. stomach ulcers
disease of the heart e.g. high blood pressure (hypertension) or congestive heart failure
a problem with blood clots forming in your blood vessels, such as painful inflammation of the veins (thrombophlebitis) or blockage of blood vessels in the legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism)
tuberculosis (TB)
herpes simplex of the eye
chicken pox or measles
mental or mood disorders
thin or weak bones that tend to break easily (osteoporosis)
myasthenia gravis (ongoing chronic fatigue and muscle weakness)
underactive thyroid gland
condition or tumour of the adrenal and/or pituitary glands
kidney or liver disease
recent head injuries
fits or convulsions
ulcerative colitis (disease of the bowel)
diabetes or increased sugar in your blood
blood clots.
Tell your doctor if you plan to have surgery.
The use of SOLU-CORTEF may disguise the signs of infections due to a decrease in the body’s response to the infection. If you are in any doubt please consult your doctor.
If you have not told your doctor about any of the above, tell them before you are treated with SOLU-CORTEF.
Children
Long term treatment with corticosteroids can affect growth and development in children. Other side-effects may occur when given to children. Your doctor will monitor your child closely if your child needs long term treatment with SOLU-CORTEF.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking:
non-steroidal anti-inflammatory medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis e.g. aspirin or salicylates
some antibiotics, e.g. erythromycin, clarithromycin, rifampicin
medicines used to treat TB, e.g. isoniazid
antifungal agents, e.g. ketoconazole, itraconazole
medicines to treat HIV, e.g. indinavir, ritonavir
some medicines used to treat blood pressure and stroke, e.g. digoxin and diltiazem
some diuretics a medicine to help kidneys get rid of salt and water by increasing the amount of urine produced
medicines for nausea e.g. aprepitant, fosaprepitant
oral contraceptives
medicines used for myasthenia gravis, glaucoma
medicines for psychiatric disorders
bronchodilators (a type of medicine that opens up the airways in the lungs) used to treat asthma, bronchitis, emphysema and other lung diseases, e.g. salbutamol
anticonvulsants, e.g. carbamazepine, phenytoin, phenobarbitone
oral medicines to reduce blood clotting, e.g. warfarin
antidiabetic medicines e.g., insulin, glibenclamide and metformin
immunosuppressants, e.g. methotrexate or cyclosporine (a medicine used in kidney transplant patients)
some immunisation, inoculation or vaccinations
medicine used to relieve stomach cramps or spasms, to prevent travel sickness and to treat Parkinson’s disease (anticholinergics)
medicines used to treat breast cancer or hormone disorder
grapefruit juice.
These medicines may be affected by SOLU-CORTEF or may affect how well it works. You may need difference amounts of your medicines, or you may need to take different medicines.
Your doctor or other healthcare professional have more information on medicines to be careful with or avoid while taking this medicine.
How SOLU-CORTEF is given
You will not usually be handling this product directly. It will be given to you as an injection by an experienced health care professional.
SOLU-CORTEF is given as an injection into a muscle or slowly into a vein over a period of 30 seconds to 10 minutes depending on the dose required.
Instructions for the preparation of solutions for the 100 mg vial or the directions for using the Act-O-Vial system are included in the package insert.
How much is given
You may be given a single dose or several doses 2 to 6 hours apart.
The dose and frequency of SOLU-CORTEF that your doctor prescribes for you depends on your medical condition. Your doctor may change the dose and how many times a day you have it, as your condition changes.
Tell your doctor if you have liver disease as your doctor may need to monitor your response and/or adjust your dose.
How long it is given
Your doctor will continue giving you SOLU-CORTEF for as long as your condition requires or before changing to another similar medicine that can be given less frequently or taken orally.
If you are given too much (overdose)
Overdose is unlikely as treatment will be given by your doctor. The possible effects of overdose are the same as those listed under Side Effects.
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency (Casualty) at your nearest hospital if you think that you or anyone else may have been given too much SOLU-CORTEF. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep the telephone numbers for these services handy. Have the SOLU-CORTEF box or this leaflet available to give details if needed.
While being treated with SOLU-CORTEF
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are being treated with SOLU-CORTEF.
If you are about to be given a vaccine or started on any new medicine, tell your doctor, dentist or pharmacist that you are being treated with SOLU-CORTEF.
If you become pregnant while having treatment with SOLU-CORTEF tell your doctor.
SOLU-CORTEF may hide some of the signs of an infection. If you get an infection or suspect an infection during a course of treatment tell your doctor as soon as possible.
If you are a diabetic, your need for insulin or glucose lowering medicines may increase while being treated with SOLU-CORTEF.
Things to be careful of
Avoid drinking grapefruit juice while you are being treated with SOLU-CORTEF.
Grapefruit may interact with SOLU-CORTEF, and affect the way your body uses the medicine.
Be careful when driving or operating machinery until you know how SOLU-CORTEF affects you.
SOLU-CORTEF may cause dizziness, light headedness, visual disturbances, and fatigue in some people.
Do not drive or operate machinery or do anything else that could be dangerous, if you have any of these symptoms.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while being treated with SOLU-CORTEF.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or other health care professional to answer any questions you may have.
Children
Diluents that contain benzyl alcohol should not be used with SOLU-CORTEF to treat children.
Some diluents used with your medicine may contain the preservative benzyl alcohol. Benzyl alcohol has been associated with serious side effects in newborns (especially premature and low weight infants) which can be fatal.
Growth in children may be affected by treatment with SOLU-CORTEF so your doctor may also monitor your child’s height.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
weight gain as a result of fluid retention or increased appetite
muscle weakness or loss of muscle mass
increased sweating
headache, dizziness or, light headedness
effects on your menstrual periods
mood changes and other mental disorders e.g. over-excitement, depression, suicidal thoughts, hallucinations, anxiety, irritability, feeling of confusion, memory loss, reduced perception and problem solving abilities, abnormal behaviour, addiction to drugs or medicines
itchy skin
acne
thin fragile skin, bruising or change in skin colour, redness of the skin, stretch marks, pale areas of the skin
excessive hairiness, particularly in women
excessive thirst, the passing of an increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell
loss of appetite, weight loss, nausea, vomiting, feeling of tiredness, drowsiness or lack of energy, headache, fever, joint pain, peeling skin, aching muscles, muscle tenderness or weakness, not caused by exercise
small lumps under the skin as a result of fat deposits in the tissues
inflammation of the food pipe. You may experience difficulty or pain when swallowing, or heartburn problems with your growth
hiccups
pain, redness at the injection site.
If these effects do not go away or they are worrying to you, tell your doctor.
Tell your doctor immediately if you experience any of the following:
bone fractures or muscle pain
wounds that will not heal
red, purple or brown patches on your skin
problems with your back, including pain or weakness
loss of sensation or problems with your reflexes (slow or too fast)
bouts of anxiety and headaches, sweating, palpitations, dizziness, a feeling of weakness, nausea, vomiting, diarrhoea, dilated pupils and blurred vision, stomach pains, and raised blood pressure. These could be symptoms of a rare tumour of the adrenal gland, which sits near the kidney.
Tell your doctor immediately or go to Emergency at your nearest hospital if you experience any of the following:
allergic reactions, e.g. skin rash, itching, difficulty breathing, wheezing or coughing
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
swelling of hands, ankles or feet
severe stomach pain, nausea and vomiting
vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
convulsions or fits
blurred or distorted vision or loss of vision, eye infections
pain and tenderness in the leg, pain on extending the foot, swelling of the lower leg, ankle and foot
chest pain and breathlessness.
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
SOLU-CORTEF may also cause chemical imbalances in the blood and urine, swelling of the pancreas (pancreatitis), bleeding in the stomach, masking of infections, increased risk of infection, hormone changes, metabolic changes, changes in liver enzymes, increased blood pressure, or increased number of white blood cells (leucocytosis). Some of these side effects can only be found when your doctor does tests to check on your progress.
This is not a complete list of all possible side effects. Some people may get other side effects while being treated with SOLU-CORTEF.
It is very important to tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After treatment with SOLU-CORTEF
Storage
SOLU-CORTEF will normally be stored in a hospital. The undiluted product should be stored below 25°C and should be protected from light (kept in the packaging before use).
The diluted / reconstituted solution should be used as soon as possible and only if it is clear. If storage is necessary, hold reconstituted diluted solutions at 2°C – 8°C for not more than 24 hours. Any solution not used within 24 hours should be discarded.
Product description
What SOLU-CORTEF looks like
SOLU-CORTEF powder for injection is a white, or nearly white powder in a vial. Vials are also available which have separate sections containing the powder and the liquid to dissolve the powder ready for injection (ACT-O-VIAL system).
SOLU-CORTEF 100 mg Plain Vial is supplied in packs of 5 vials. SOLU-CORTEF ACT-O-VIALS 100 mg, 250 mg and 500 mg are supplied in packs of 1 vial.
Identification
SOLU-CORTEF (hydrocortisone sodium succinate) can be identified by an Australian Register Number which is found on the carton.
Plain vial (powder only):
100 mg: AUST R 12264
ACT-O-VIAL® (powder and diluent):
100 mg: AUST R 167893
250 mg: AUST R 167894
500 mg: AUST R 167895.
Ingredients
SOLU-CORTEF contains hydrocortisone sodium succinate as the active ingredient.
Each vial also contains the following inactive ingredients:
monobasic sodium phosphate monohydrate
dibasic sodium phosphate.
The diluent for the ACT-O-VIALs consists of Water for Injections. It does not contain an antimicrobial preservative. Use in one patient on one occasion only.
Supplier
SOLU-CORTEF is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au
This leaflet was revised in September 2019.
® Registered trademark.
© Pfizer Australia Pty Ltd 2017.
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