100 mg, 250 mg, 1g powder, and liquid for injection, solution
hydrocortisone sodium succinate
What Solu-Cortef is and what it is used for
Solu-Cortef contains hydrocortisone sodium succinate and belongs to a group of medicines called corticosteroids. Hydrocortisone is a hormone that occurs naturally in the body, it is normally formed in the adrenal cortex.
Solu-Cortef is used for:
- to replace hydrocortisone when the adrenal cortex for some reason does not produce enough hydrocortisone
- for example during surgery when hydrocortisone reserves are insufficient
- shock treatment together with other treatment
- life-threatening allergic reactions ( anaphylaxis with fever, rash, swelling, and sometimes drop in blood pressure)
- severe hypersensitivity reaction
- severe reactions after insect and snake bites
- severe asthma attacks
- SLE (connective tissue disease)
- congenital enlargement of the adrenal cortex a
- leukemia and malignant lymphoma
The hydrocortisone sodium succinate contained in Solu-Cortef may also be approved to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you are given Solu-Cortef
Do not use Solu-Cortef
- if you are allergic to hydrocortisone sodium succinate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before being given Solu-Cortef if you have any of the following diseases or conditions:
- osteoporosis
- recently undergone intestinal surgery
- mental disorders
- ulcers or other serious stomach or intestinal problems
- tuberculosis
- diabetes
- high blood pressure
- heart failure or another cardiovascular disease
- infection
- tumor of the adrenal medulla ( phaeochromocytoma )
- diseases of the liver, kidneys, and biliary tract
- chicken pox or measles
- underactive thyroid ( hypothyroidism )
- seizures ( epilepsy )
- glaucoma (increased pressure in the eye)
- herpes infection in the eye
- damage to the optic nerve or cataracts (can be seen as vision loss)
- Central serous retinopathy is an eye disease that causes vision loss
- blood clots in blood vessels or have an increased sensitivity to forming blood clots
- a neuromuscular disease called myasthenia gravis, as it can make you more susceptible to acute generalized muscle disease.
Susceptibility to infection
This medicine may increase your susceptibility to infection or mask symptoms of infection. To avoid possible serious consequences due to this, tell your doctor immediately if you develop any symptoms of infection during treatment.
Stress
Talk to your doctor if you are exposed or will be exposed to an unusual amount of stress during treatment. It may be necessary to adjust your treatment.
Mental disorders
Psychiatric disorders, such as elation, insomnia, mood swings, personality changes, deep depression, or overt psychotic symptoms may occur or worsen with the use of this medicine. If you experience similar symptoms, contact your doctor as your treatment may need to be adjusted.
Effects on blood pressure and laboratory values
In rare cases, high doses or long-term use of this medicine can increase blood pressure, increase sodium and water retention in the body (swelling), increase potassium and calcium excretion or increase blood fat values. To manage these side effects, your doctor may ask you to review your diet.
Other
Contact a doctor if you experience blurred vision or other visual disturbances.
High-dose or long-term corticosteroid therapy can cause Kaposi’s sarcoma (a rare tumor disease) or epidural lipomatosis (accumulation of fatty tissue in the area around the spinal canal). You will be monitored for these effects and, if necessary, your doctor will adjust the treatment accordingly. Long-term use of this drug can also impair the body’s adrenal function and cortisol production. To reduce the risk of such symptoms, treatment will be terminated by gradually tapering the dose a.
The doctor may need to monitor your treatment more closely, change the dose or give you a different medicine.
Solu-Cortef should not be used in the treatment of complications after severe head injuries or strokes, as you will probably not benefit from the treatment and it may even be harmful.
Tell the doctor that you have received Solu-Cortef if you are going to undergo a skin test, e.g. prick test for allergy or tuberculin test.
Children
In children, long-term use of high doses of this medicine may cause impaired growth or increased pressure (symptoms: headache, nausea/vomiting, balance disorder, reduced level of consciousness). You should carefully observe your child for signs and symptoms of these conditions.
If hydrocortisone is given to a premature infant, the function and structure of the heart may need to be monitored.
Other medicines and Solu-Cortef
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Tell your doctor if you are simultaneously using:
- drugs that are partly used in the treatment of epilepsy and partly as fast-acting anesthetics ( phenytoin, carbamazepine, and barbiturates such as phenobarbital)
- medicine against bacterial infection (rifampicin).
- certain anti- HIV medicines (cobicistat). Your doctor may want to monitor you closely if you are taking these medicines
- certain antifungal medicines (eg ketoconazole, itraconazole)
- certain antibiotics such as can be used for the treatment of respiratory tract infections or infections in the throat, sinuses and skin, and soft tissues (e.g. clarithromycin)
- blood-thinning medicines taken by mouth to prevent blood clotting (eg warfarin )
- anticholinergics used against, among other things certain eye diseases, asthma, COPD, Parkinson’s disease, and inhibition of mucus formation
- drugs against the neuromuscular disease myasthenia gravis
- medicines used to treat high blood sugar. The doctor may need to adjust the dose
- certain breast cancer medicines (aromatase inhibitors)
- medicines for heart failure and atrial fibrillation ( digoxin )
- drugs for pain ( NSAIDs )
- potassium-lowering agents (eg, diuretics to treat high blood pressure )
Solu-Cortef can be affected by or affect the effect of many other medicines. Treating physicians must therefore be aware of all other medications. This applies to both prescription and non-prescription drugs.
Always tell the doctor who prescribes you another medicine that you are being treated with Solu-Cortef.
Solu-Cortef with food, drink, and alcohol
Avoid drinking grapefruit juice during treatment. Grapefruit juice may increase the side effects of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Pregnancy
There is a risk that the fetus will be affected. With long-term treatment, low birth weight has been seen in infants. Therefore, do not use Solu-Cortef during pregnancy other than on a specific prescription from a doctor.
Solu-Cortef 1 g contains the preservative benzyl alcohol (see “Solu-Cortef 1 g powder and liquid for injection, the solution contains benzyl alcohol”).
Breastfeeding
There is a risk that a child who is breastfed will be affected as small amounts of hydrocortisone pass into breast milk. Therefore, do not use Solu-Cortef during breastfeeding other than on a specific prescription from a doctor.
Solu-Cortef 1 g contains the preservative benzyl alcohol (see “Solu-Cortef 1 g powder and liquid for injection, the solution contains benzyl alcohol”).
Driving ability and use of machinery
Solu-Cortef does not usually affect the ability to drive or use machines. However, you may experience side effects such as dizziness, visual disturbances, and fatigue, which can therefore affect driving ability.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Solu-Cortef 1 g powder and liquid for injection, the solution contains benzyl alcohol
Solu-Cortef 1 g contains 72 mg of benzyl alcohol per 8 ml of solution, which corresponds to 9 mg/ml of benzyl alcohol.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol is associated with the risk of serious side effects such as breathing difficulties in young children. Do not give the medicine to newborns (up to 4 weeks of age) and no longer than 1 week to younger children (younger than 3 years) unless a doctor has prescribed it.
Consult a doctor or pharmacist before using this medicine if you have impaired liver or kidney function or if you are pregnant or breastfeeding. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
Solu-Cortef contains sodium
Solu-Cortef 100 mg contains less than 1 mmol (23 mg) of sodium per bottle, i.e. is second
next to “sodium-free”.
Solu-Cortef 250 mg contains 30 mg of sodium (the main ingredient in common/table salt) per bottle. This corresponds to 1.5% of the maximum recommended daily intake of sodium for adults.
Solu-Cortef 1 g contains 109.3 mg of sodium (the main ingredient in common/table salt) per bottle. This corresponds to 5.5% of the maximum recommended daily intake of sodium for adults.
How Solu-Cortef is given to you
Solu-Cortef is given as an injection. Your doctor will decide where to inject, how much medicine, and how many injections to get, depending on the condition being treated. Your doctor will inject as low a dose for as short a time as possible to effectively relieve your symptoms.
If you are given too much Solu-Cortef
As this medicine will be given to you by your doctor, it is unlikely that you will be given too much medicine.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that can occur with long-term treatment are very rare with short-term treatment.
Among other things, the side effects listed below can occur.
Common (may affect up to 1 in 10 users)
- reduce your resistance to infection or hide or change the signs and symptoms of certain infections which may make them more difficult to detect, as well as activation of infection
- inhibition of the own corticosteroid secretion as well as fat accumulation on the torso and face, skin changes, fluid accumulation in the body (so-called Cushing-like symptoms)
- worsening of diabetes or outbreak of diabetes that has been dormant
- growth retardation in children
- menstrual disorders
- low level of potassium in the blood, impaired excretion of sodium in the urine
- edema, high blood pressure, heart failure
- pinpoint-sized, flat, round, red marks under the skin ( petechiae )
- osteoporosis, muscle wasting (reduction of muscle mass)
Uncommon (may affect up to 1 in 100 users)
- increased risk of blood clots
- the clotting ability of the blood may increase
- allergic or allergy-like reactions with spasms in the trachea
- negative nitrogen balance caused by the breakdown of muscle proteins
- calcium loss from the skeleton
- mental disorders
- increased pressure in the eyes, posterior cataracts with symptoms such as blurred vision and sensitivity to bright light, protruding eyes
- wounds, holes ( perforation ) and possibly bleeding from the gastrointestinal tract, inflammation of the pancreas
- thinned skin, impaired wound healing
- loss of bone and cartilage (aseptic bone necrosis), muscle wasting ( myopathy ), rupture of tendons, spontaneous fractures
Rare (may affect up to 1 in 1,000 users)
- increased pressure in the skull, due to the increased pressure, various side effects can occur such as headaches, vomiting, convulsions, visual disturbances, etc.
Has been reported (occurring in an unknown number of users)
- increased number of white blood cells ( leukocytosis )
- pheochromocytoma-related crisis (symptoms such as palpitations, headache, and sweating)
- dyslipidemia
- increased appetite
- affective disorder (including depression, euphoria, affect lability, drug addiction, suicidal ideation)
- mental disorders (including mania, delusions, hallucinations, and schizophrenia)
- personality change
- sleep disorders
- Mood swings
- confusion
- concern
- abnormal behavior
- irritability accumulation of adipose tissue in isolated places on the body
- memory loss
- deterioration of short-term memory
- dizziness
- headache
- cramps
- an eye disease that causes a distorted field of vision
- blurred vision
- hiccup
- open stomach
- abdominal pain
- diarrhea
- vomiting
- nausea
- increased hair growth in women
- skin redness
- increased sweating
- stretch marks
- rash
- itching
- acne
- pigment spots
- muscle pain
- neuropathic joint disease
- joint pain
- fatigue
- malaise
- injection site reaction
- increase of urea in the blood
- thickening of the heart muscle ( hypertrophic cardiomyopathy ) in premature infants
- weight gain
Liver effects have been seen in connection with corticosteroid treatment. These changes are usually small, with no other symptoms, and that reverse when treatment is stopped.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Solu-Cortef
Keep this medicine out of the sight and reach of children.
Store in the original packaging. Moisture sensitive.
Use before the expiry date which is stated on the carton after EXP.
The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is hydrocortisone sodium succinate. One package contains the equivalent of 100 mg, 250 mg, and 1 g of hydrocortisone sodium succinate.
- Other ingredients are (powder): anhydrous sodium dihydrogen phosphate monohydrate, sodium hydroxide, and sodium phosphate (see section 2 “Solu-Cortef contains sodium”).
Solu-Cortef 100 mg and 250 mg
- Other ingredients are ( diluent ): water for injections.
Solu-Cortef 1 g
- Other ingredients are ( diluent ): benzyl alcohol, water for injections (see section 2 “Solu-Cortef 1 g powder and liquid for injection, the solution contains benzyl alcohol”).
Appearance and package sizes of the medicine
Powder and liquid for injection in combination packaging.
100 mg: 1×100 mg, 25×100 mg, 100×100 mg.
250 mg: 1×250 mg.
1g: 1x1g.
Not all pack sizes and strengths may be marketed.