40 mg, 125 mg, 500 mg, and 1 g powder and liquid for injection, solution
methylprednisolone sodium succinate
What Solu-Medrol is and what it is used for
Solu-Medrol contains methylprednisolone sodium succinate and belongs to a group of medicines called corticosteroids.
Solu-Medrol is used for:
- shock treatment together with other treatment
- severe asthma attacks
- severe allergic reactions
- severe hypersensitivity reaction
- false croup
- severe reactions after insect and snake bites
- brain swelling (which occurs in connection with various types of cancer or cancer treatment).
The methylprednisolone sodium succinate contained in Solu-Medrol may also be approved to treat other conditions not listed in this package insert. 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 using Solu-Medrol
Do not use Solu-Medrol
- if you are allergic to methylprednisolone sodium succinate or any of the other ingredients of this medicine (listed in section 6)
- if you have a fungal infection that affects the whole body.
Talk to your doctor if you have any of the conditions mentioned above.
Warnings and precautions
Talk to your doctor before being given Solu-Medrol if you have any of the following diseases or conditions:
- infection
- osteoporosis
- recently undergone intestinal surgery
- mental disorders
- ulcers or other serious stomach or intestinal problems
- ulcerative colitis (inflammation of the colon)
- hypothyroidism (underactive thyroid gland )
- tuberculosis
- diabetes
- high blood pressure
- heart failure or another cardiovascular disease
- epilepsy (seizures)
- impaired kidney function
- scleroderma (also called systemic sclerosis, an autoimmune disease)
- glaucoma (increased pressure in the eye)
- neuromuscular diseases e.g. Multiple sclerosis (MS) or Parkinson’s disease
- tumor of the adrenal gland ( phaeochromocytoma )
- blood clot or have previously had a blood clot.
The doctor may need to monitor your treatment more closely, change the dose or give you a different medicine.
Solu-Medrol 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-Medrol if you are to be vaccinated or undergo a skin test, e.g. prick test for allergy or tuberculin test.
Children
Use caution when treating children. Solu-Medrol can affect growth in children.
If Solu-Medrol is given to a premature infant, the function and structure of the heart may need to be monitored.
Other medicines and Solu-Medrol
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)
- certain antibiotics for bacterial infections
- certain anti-tuberculosis drugs (rifampicin, isoniazid )
- medicines for fever, pain, and inflammation (eg aspirin, ibuprofen, diclofenac, naproxen )
- medicines to prevent blood clots
- potassium-lowering drugs (e.g. diuretics – fluid-reducing drugs)
- certain anti- HIV medicines (indinavir, ritonavir, and cobicistat). Your doctor may want to monitor you closely if you are taking these medicines.
- certain medicines that are used e.g. in connection with transplantation
- medicines to treat heart problems ( diltiazem )
- medicines used to treat Cushing’s syndrome – a condition in which the body produces an excess of cortisol ( ketoconazole tablets )
- medicine against fungal infection (itraconazole)
- medicines used to prevent nausea (fosaprepitant, aprepitant)
- anticancer drug (cyclophosphamide)
- anticholinesterases (used in the treatment of myasthenia gravis )
- medicines containing xanthan
- medicines for asthma (beta2 agonists )
- medicines used in neuromuscular diseases, e.g. Multiple sclerosis (MS) or Parkinson’s disease
- medicines containing hormones (e.g. contraceptives containing ethinylestradiol, and norethisterone).
Tell the doctor or nurse if you have recently received or are about to receive any vaccination. Certain types of vaccines are not suitable when you are being treated with Solu-Medrol.
Contact a doctor if you experience blurred vision or other visual disturbances.
Solu-Medrol 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 another medicine for you that you are being treated with Solu-Medrol.
Solu-Medrol with food and drink
Intake of grapefruit juice may affect treatment with Solu-Medrol. If you consume grapefruit or grapefruit juice, discuss this with your doctor.
Pregnancy and breastfeeding
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 using 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-Medrol during pregnancy other than on a specific prescription from a doctor.
Solu-Medrol 500 mg and 1 g contain benzyl alcohol (see “
Solu-Medrol contains benzyl alcohol and sodium”).
Breastfeeding
There is a risk that a child who is breastfed will be affected as small amounts of methylprednisolone pass into breast milk. Therefore, do not use Solu-Medrol during breastfeeding other than on a specific prescription from a doctor.
Solu-Medrol 500 mg and 1 g contain benzyl alcohol (see “
Solu-Medrol contains benzyl alcohol and sodium”).
Driving ability and use of machinery
Solu-Medrol 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-Medrol 500 mg and 1 g contain benzyl alcohol
Solu-Medrol 500 mg and 1 g contain 9 mg of benzyl alcohol per 1 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 infants and 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 such as an increased amount of acid in the blood (metabolic acidosis ).
Solu-Medrol contains sodium
Solu-Medrol 40 mg and 125 mg contain less than 1 mmol (23 mg) of sodium per vial, i.e. it is almost “sodium-free”.
Solu-Medrol 500 mg contains 58.3 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 2.92% of the maximum recommended daily intake of sodium for adults.
Solu-Medrol 1 g contains 116.8 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 5.84% of the maximum recommended daily intake of sodium for adults.
How Solu-Medrol is given to you
Solu-Medrol 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. To find the lowest possible maintenance dose that produces the desired effect, your initial dose will be gradually reduced in small steps.
If you are given too much Solu-Medrol
As this medicine will be given to you by your doctor, it is unlikely that you will be given too much medicine.
If you stop using Solu-Medrol
Solu-Medrol should be tapered off gradually during long-term treatment to avoid withdrawal symptoms.
If, after stopping treatment with Solu-Medrol, you develop signs of acute adrenal cortex failure, e.g. fatigue, chills, or dizziness, you should immediately contact a doctor.
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 may occur.
Rare (may affect up to 1 in 1,000 users)
- allergic reaction
- shock (circulatory failure) with symptoms such as palpitations and cold sweats
- irregular heartbeats
- cardiac arrest
- slow heartbeat (occurs at high doses ).
Has been reported (occurring in an unknown number of users)
- increased number of white blood cells ( leukocytosis )
- severe allergic reaction ( anaphylactic reaction
- hypersensitivity to drugs
- pheochromocytoma-related crisis (symptoms such as palpitations, headache, and sweating)
- accumulation of fatty tissue in isolated places on the body
- reduced level of bicarbonate in the blood such as can cause nausea, vomiting, and fatigue (metabolic acidosis )
- the disease of the retina and choroid of the eye, blurred vision
- increased risk of blood clots
- inflammation of the liver, liver damage (increase in liver enzymes)
- increased level of urea in the blood (blood test value)
- fluid accumulation (in ankles, feet, and legs).
After long-term treatment with Solu-Medrol, withdrawal symptoms may occur when treatment is abruptly stopped: decreased appetite, nausea, vomiting, fatigue, headache, fever, pain in the joints or muscles, skin shedding, weight loss, and/or drop in blood pressure.
Talk to your doctor if you experience any of the side effects mentioned or if unusual signs appear during treatment or immediately after it ends.
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-Medrol
Solu-Medrol is stored by healthcare professionals in the hospital or clinic. The storage instructions are as follows, in case you need to know them:
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton after EXP.
- 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.
See “ The following information is intended for healthcare professionals only” for information on shelf life and storage after preparation and dilution.
Contents of the packaging and other information
Contents declaration
- The active substance is methylprednisolone sodium succinate. One vial contains the equivalent of 40 mg, 125 mg, 500 mg, or 1 g of methylprednisolone.
- Other ingredients (powder): anhydrous disodium phosphate, sodium dihydrogen phosphate monohydrate (see section 2 “Solu-Medrol contains sodium”). Solu-Medrol 40 mg also contains sucrose.
- Solu-Medrol 500 mg and 1 g: Other ingredients ( diluent ): benzyl alcohol (see section 2 “Solu-Medrol 500 mg and 1 g contains benzyl alcohol”), water for injections.
- Solu-Medrol 40 mg and 125 mg: Other ingredients ( diluent ): water for injections.
Appearance and package sizes of the medicine
Powder and liquid for injection in combination packaging.