SOLU-CORTEF 100MG
Active substance: HYDROCORTISONE SODIUM SUCCINATE
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PATIENT INFORMATION LEAFLET
Solu-Cortef 100 mg
hydrocortisone sodium succinate
1. What Solu-Cortef is and what it is used for
Solu-Cortef contains Hydrocortisone Sodium Succinate. Hydrocortisone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Solu-Cortef can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufciency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inammatory or allergic conditions affecting the: bowel and gut e.g. Crohns disease (inammation of the gut) or ulcerative colitis (inammation of the lower bowel) lungs e.g. bronchial asthma or inammation caused by breathing in (aspirating) vomit or stomach contents skin e.g. Stevens-Johnson syndrome (an auto-immune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus). Solu-Cortef may be prescribed to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.
You must not have live vaccines while using this medicine. See your doctor immediately if you have any of the above.
Taking other medicines
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Read all of this leaet carefully before you start taking this medicine Keep this leaet. You may need to read it again If you have any further questions please ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it to others. It may harm them even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist In this leaet: 1. What Solu-Cortef is and what it is used for 2. Before you are given Solu-Cortef 3. How Solu-Cortef is given to you 4. Possible side effects 5. How to store Solu-Cortef 6. Further information
2. Before you are given Solu-Cortef
Do not use Solu-Cortef if:
You think you have ever suffered an allergic reaction, or any other type of reaction after being given Solu-Cortef, or any other medicine containing a corticosteroid, or any of the ingredients in this medicine (Section 6 of this leaet contains a list of ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. You have any fungal infection (such as thrush) which is not being treated.
You must tell your doctor before you take this medicine if you have any of the following conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them. Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Solu-Cortef, or having a family history of these illnesses. Diabetes (or if there is a family history of diabetes). Epilepsy. Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. You have recently suffered a heart attack. Heart problems, including heart failure or infections. Hypertension (high blood pressure). Hypothyroidism (an under-active thyroid). Kaposis sarcoma (a type of skin cancer). Kidney or liver disease. Muscle problems (pain or weakness) have happened while taking steroid medicines in the past. Myasthenia gravis (a condition causing tired and weak muscles). Osteoporosis (brittle bones). Skin abscess. Stomach ulcer or other serious stomach or intestinal problems. Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins). Tuberculosis (TB) or if you have suffered tuberculosis in the past. You must tell your doctor before you take this medicine if you have any of the conditions listed above.
Take special care before taking Solu-Cortef:
Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Solu-Cortef with other medicines could be harmful. You should tell your doctor if you are taking any of the following medicines which can affect the way Solu-Cortef or the other medicine works: Acetazolamide - used to treat glaucoma and epilepsy Aminoglutethimide used for treating cancer Anticoagulants - used to thin the blood such as acenocoumarol, phenindione and warfarin Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine Antibiotics (such as erythromycin) Aspirin and non-steroidal antiinammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain Barbiturates, carbamazepine, phenytoin and primidone used to treat epilepsy Carbenoxolone and cimetidine - used for heartburn and acid indigestion Ciclosporin - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant Digoxin - used for heart failure and/or an irregular heart beat Diltiazem or mibefradil used for heart problems or high blood pressure Diuretics sometimes called water tablets Ketoconazole or itraconazole used to treat fungal infections Pancuronium or other medicines called neuromuscular blocking agents which are used in some surgical procedures Rifampicin and rifabutin antibiotics used to treat tuberculosis (TB) Vaccines - tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have live vaccines while using this medicine. Other vaccines may be less effective
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation tell your doctor, dentist or anesthetist that you are taking this medicine. If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Solu-Cortef. This medicine can affect the results of some tests.
medicine, and for 3 months after your last injection. If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.
Dosage information
Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the babys growth. Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.
Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.
Adults
Driving and Using Machines
The effect of this class of medicines on the ability to drive or use machinery has not been studied. There are undesirable effects observed with the use of this medicine such as syncope (fainting), vertigo (sensation of rotation or movement of oneself or the surrounding), and convulsions (seizures). If you are affected by any of them, you should not drive or operate machinery.
Solu-Cortef will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the rst dose is given into a vein, especially in an emergency. It will be given slowly over a period of between 1 10 minutes. Depending on your condition a repeat dose may be injected at intervals of between 2 to 6 hours. Large doses should normally be used for only two to three days. The medicine is rst dissolved in Sterile Water for Injections. If the medicine is to be given by infusion (using a pump or drip) it is then mixed with another suitable uid. No other medicines should be mixed with it.
Elderly
3. How Solu-Cortef is given to you
Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has lled out the details of your medicine, including the dose and how long you will require steroid treatment. You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this
Treatment will normally be the same as for younger adults. However your doctor may want to see you more regularly to check how you are getting on with this medicine.
Steroid Cards
Children
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose (normally not more 25mg a day) that will be effective for your child.
If you are given more Solu-Cortef than you should
If you think you have been given too many injections of this medicine please speak to your doctor immediately.
PHYSICIAN LEAFLET INFORMATION FOR DOCTORS AND PHARMACISTS
Solu-Cortef 100 mg
hydrocortisone sodium succinate
For further information, consult the Summary of Product Characteristics (SPC). Posology and method of administration. Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation. Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patients response and clinical condition.
In general high-dose corticosteroid therapy should be continued only until the patients condition has stabilised - usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufciency. Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy. In patients with liver disease, there may be an increased effect (see section 4.4 of the SPC) and reduced dosing may be considered. Elderly patients: Solu-Cortef is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of
the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use section of the SPC). Children: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight, but should not be less than 25 mg daily (see Special warnings and precautions for use section of the SPC). Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of Sterile Water for Injections to the contents of one vial of Solu-Cortef 100 mg, shake and withdraw for use. For intravenous infusion, rst prepare the solution by adding not more than 2 ml of Sterile Water for Injections to the vial; this solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). When reconstituted as directed the pH of the solution will range from 7.0 to 8.0.
Shelf-life The shelf life is printed on labels and cartons. Do not use Solu-Cortef after this date. After reconstitution with Water for Injections, use immediately, discard any remainder. Storage of the product Store below 25C. Refer to Posology and method of administration section above. Reconstituted solutions should be used immediately. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. This leaet was last revised in July 2012 Ref: SC 6_1
Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you: have been given more than 160 mg of Hydrocortisone, such as Solu-Cortef, for more than 3 weeks, have been given high doses of corticosteroids, such as Solu-Cortef, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less, have already had a course of corticosteroid tablets or injections in the last year, already have problems with your adrenal glands (adrenocortical insufciency) before you started this treatment. You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss. If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.
Stopping/reducing the dose of your Solu-Cortef
4. Possible side effects
Like all steroids this medicine can cause side-effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious. In certain medical conditions medicines like Solu-Cortef (steroids) should not be stopped abruptly, if you suffer from any of the following symptoms seek IMMEDIATE medical attention, your doctor will then decide whether you should continue taking your medicine: Allergic reactions, such as skin rash, swelling of the face or wheezing and difculty breathing. This type of side effect is rare, but can be serious. Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness. Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood. Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a are up of a previous TB infection could be coughing blood or pain in the chest. This medicine may also make you more likely to develop a severe infection. Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood. Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side-effect usually occurs after treatment is stopped. Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difculty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse. Increased numbers of white blood cells (leucocytosis).
Body water and salts
Swelling and high blood pressure, caused by increased levels of water and salt content. Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).
Round or moon-shaped face (Cushingoid facies). Increased appetite and weight gain. Diabetes or worsening of existing diabetes Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months. The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.
Other nervous system side effects may include breathing problems, convulsions, dizziness, drowsiness, difculty breathing, sensation of cold, heat or numbness, tinnitus or unconsciousness.
Marketing Authorisation Holder:
Skin
The company authorised to sell Solu-Cortef is: Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.
Abscess, especially near injection sites. Acne. Poor wound healing. Thinning of skin with stretch marks. Bruising. Small purple/red patches on the skin. Pale or darker patches on your skin, or raised patches which are an unusual color. If you experience any of the side effects listed above tell your doctor straight away.
Manufacturer
Immune system
5. How to store Solu-Cortef
Solu-Cortef must not be used after the expiry date EXP shown on the container. The doctor or pharmacist will keep the medicine in a safe place where children cannot reach or see it. This medicine must be stored below 25C. Once the medicine has been mixed with Sterile Water for Injections the solution should be used straight away. Any unused liquid should be disposed of safely. Your doctor will check that the solution contains no particles and is not discoloured before using it.
Solu-Cortef is made by: Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium, and Laboratoires Pharmacia SAS, Parc Industriel dIncarville, BP 606, 27106 Val De Reuil, Cedex, France.
Company contact address:
Digestive system
Mental health problems can happen while taking steroids like Solu-Cortef (see also section 4, Possible Side Effects). These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment. Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped.
Mental problems while taking Solu-Cortef
Nausea (feeling sick) or vomiting (being sick). Ulcers or thrush in the gullet (discomfort on swallowing). Indigestion. Bloated stomach. Persistent hiccups, especially when high doses are taken.
Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.
Muscles and bones
Eyes
Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches). Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance). Damage to the optic nerve or cataracts (indicated by failing eyesight). Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera). Worsening of viral or fungal eye infections. Protruding of the eyeballs (exophthalmos). Blurred or double vision.
Muscle weakness or wasting. Brittle bones (bones that break easily). Broken bones or fractures. Breakdown of bone due to poor circulation of blood, this causes pain in the hip. Torn muscle tendons causing pain and/or swelling. Muscle cramps or spasms.
For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161. This leaet was last revised in July 2012 Ref: SC 6_1
Nerves and mood issues
Hormones and metabolic system
Slowing of normal growth in infants, children and adolescents which may be permanent. Irregular or no periods in women. Increased hair on the body and face in women (hirsutism).
Steroids, including Solu-Cortef, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Solu-Cortef. Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difculty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
6. Further information
What Solu-Cortef contains:
Each vial of this medicine contains 133.7mg of Hydrocortisone Sodium Succinate (equivalent to 100 mg Hydrocortisone) as the active ingredient. Solu-Cortef also contains sodium biphosphate and sodium phosphate.
What a Solu-Cortef looks like:
Solu-Cortef is a white powder which comes in a clear glass vial tted with a rubber cap and metal seal. Solu-Cortef is available in packs containing 1 or 10 vials.
8R2603
inks on file
structure
PATIENT INFORMATION LEAFLET
Solu-Cortef 100 mg
hydrocortisone sodium succinate
2. Before you are given Solu-Cortef
Do not use Solu-Cortef if:
You think you have ever suffered an allergic reaction, or any other type of reaction after being given Solu-Cortef, or any other medicine containing a corticosteroid, or any of the ingredients in this medicine (Section 6 of this leaet contains a list of ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. You have any fungal infection (such as thrush) which is not being treated. You must not have live vaccines while using this medicine. See your doctor immediately if you have any of the above.
8R2602 615
Myasthenia gravis (a condition causing tired and weak muscles). Osteoporosis (brittle bones). Skin abscess. Stomach ulcer or other serious stomach or intestinal problems. Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins). Tuberculosis (TB) or if you have suffered tuberculosis in the past. You must tell your doctor before you take this medicine if you have any of the conditions listed above. Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Solu-Cortef with other medicines could be harmful. You should tell your doctor if you are taking any of the following medicines which can affect the way Solu-Cortef or the other medicine works: Acetazolamide - used to treat glaucoma and epilepsy Aminoglutethimide used for treating cancer Anticoagulants - used to thin the blood such as acenocoumarol, phenindione and warfarin Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine Antibiotics (such as erythromycin) Aspirin and non-steroidal antiinammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain Barbiturates, carbamazepine, phenytoin and primidone used to treat epilepsy Carbenoxolone and cimetidine used for heartburn and acid indigestion Ciclosporin - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant Digoxin - used for heart failure and/or an irregular heart beat Diltiazem or mibefradil used for heart problems or high blood pressure Diuretics sometimes called water tablets Ketoconazole or itraconazole used to treat fungal infections Pancuronium or other medicines called neuromuscular blocking agents which are used in some surgical procedures Rifampicin and rifabutin antibiotics used to treat tuberculosis (TB)
Vaccines - tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have live vaccines while using this medicine. Other vaccines may be less effective
3. How Solu-Cortef is given to you
Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has lled out the details of your medicine, including the dose and how long you will require steroid treatment. You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this medicine, and for 3 months after your last injection. If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.
Steroid Cards
If you are taking long term medication(s)
Taking other medicines
Read all of this leaet carefully before you start taking this medicine Keep this leaet. You may need to read it again If you have any further questions please ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it to others. It may harm them even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist In this leaet: 1. What Solu-Cortef is and what it is used for 2. Before you are given Solu-Cortef 3. How Solu-Cortef is given to you 4. Possible side effects 5. How to store Solu-Cortef 6. Further information
Solu-Cortef contains Hydrocortisone Sodium Succinate. Hydrocortisone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Solu-Cortef can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufciency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inammatory or allergic conditions affecting the: bowel and gut e.g. Crohns disease (inammation of the gut) or ulcerative colitis (inammation of the lower bowel) lungs e.g. bronchial asthma or inammation caused by breathing in (aspirating) vomit or stomach contents skin e.g. Stevens-Johnson syndrome (an auto-immune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus). Solu-Cortef may be prescribed to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.
1. What Solu-Cortef is and what it is used for
You must tell your doctor before you take this medicine if you have any of the following conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them. Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Solu-Cortef, or having a family history of these illnesses. Diabetes (or if there is a family history of diabetes). Epilepsy. Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. You have recently suffered a heart attack. Heart problems, including heart failure or infections. Hypertension (high blood pressure). Hypothyroidism (an under-active thyroid). Kaposis sarcoma (a type of skin cancer). Kidney or liver disease. Muscle problems (pain or weakness) have happened while taking steroid medicines in the past.
Take special care before taking Solu-Cortef:
If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation tell your doctor, dentist or anesthetist that you are taking this medicine. If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Solu-Cortef. This medicine can affect the results of some tests.
Pregnancy and breast feeding
Dosage information
You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the babys growth. Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.
Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.
Adults
Driving and Using Machines
The effect of this class of medicines on the ability to drive or use machinery has not been studied. There are undesirable effects observed with the use of this medicine such as syncope (fainting), vertigo (sensation of rotation or movement of oneself or the surrounding), and convulsions (seizures). If you are affected by any of them, you should not drive or operate machinery.
Solu-Cortef will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the rst dose is given into a vein, especially in an emergency. It will be given slowly over a period of between 1 10 minutes. Depending on your condition a repeat dose may be injected at intervals of between 2 to 6 hours. Large doses should normally be used for only two to three days. The medicine is rst dissolved in Sterile Water for Injections. If the medicine is to be given by infusion (using a pump or drip) it is then mixed with another suitable uid. No other medicines should be mixed with it.
Elderly
Treatment will normally be the same as for younger adults. However your doctor may want to see you more regularly to check how you are getting on with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose (normally not more 25mg a day) that will be effective for your child.
PHYSICIAN LEAFLET INFORMATION FOR DOCTORS AND PHARMACISTS
Solu-Cortef 100 mg
hydrocortisone sodium succinate
For further information, consult the Summary of Product Characteristics (SPC). Posology and method of administration. Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.
Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patients response and clinical condition. In general high-dose corticosteroid therapy should be continued only until the patients condition has stabilised - usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufciency.
Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy. In patients with liver disease, there may be an increased effect (see section 4.4 of the SPC) and reduced dosing may be considered. Elderly patients: Solu-Cortef is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use section of the SPC). Children: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight, but
If you are given more Solu-Cortef than you should
If you think you have been given too many injections of this medicine please speak to your doctor immediately.
4. Possible side effects
Stopping/reducing the dose of your Solu-Cortef
Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you: have been given more than 160 mg of Hydrocortisone, such as Solu-Cortef, for more than 3 weeks, have been given high doses of corticosteroids, such as Solu-Cortef, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less, have already had a course of corticosteroid tablets or injections in the last year, already have problems with your adrenal glands (adrenocortical insufciency) before you started this treatment. You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss. If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.
Mental problems while taking Solu-Cortef
Mental health problems can happen while taking steroids like Solu-Cortef (see also section 4, Possible Side Effects). These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment. Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped.
Like all steroids this medicine can cause side-effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious. In certain medical conditions medicines like Solu-Cortef (steroids) should not be stopped abruptly, if you suffer from any of the following symptoms seek IMMEDIATE medical attention, your doctor will then decide whether you should continue taking your medicine: Allergic reactions, such as skin rash, swelling of the face or wheezing and difculty breathing. This type of side effect is rare, but can be serious. Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness. Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood. Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a are up of a previous TB infection could be coughing blood or pain in the chest. This medicine may also make you more likely to develop a severe infection. Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood. Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side-effect usually occurs after treatment is stopped. Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difculty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse. Increased numbers of white blood cells (leucocytosis).
The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.
Skin
Immune system
Abscess, especially near injection sites. Acne. Poor wound healing. Thinning of skin with stretch marks. Bruising. Small purple/red patches on the skin. Pale or darker patches on your skin, or raised patches which are an unusual color. If you experience any of the side effects listed above tell your doctor straight away.
6. Further information
What Solu-Cortef contains:
Each vial of this medicine contains 133.7mg of Hydrocortisone Sodium Succinate (equivalent to 100mg Hydrocortisone) as the active ingredient. Solu-Cortef also contains sodium biphosphate and sodium phosphate.
What a Solu-Cortef looks like:
Body water and salts
Swelling and high blood pressure, caused by increased levels of water and salt content. Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).
Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.
5. How to store Solu-Cortef
Solu-Cortef is a white powder which comes in a clear glass vial tted with a rubber cap and metal seal. Solu-Cortef is available in packs containing 1 or 10 vials.
Muscles and bones
Digestive system
Nausea (feeling sick) or vomiting (being sick). Ulcers or thrush in the gullet (discomfort on swallowing). Indigestion. Bloated stomach. Persistent hiccups, especially when high doses are taken.
Muscle weakness or wasting. Brittle bones (bones that break easily). Broken bones or fractures. Breakdown of bone due to poor circulation of blood, this causes pain in the hip. Torn muscle tendons causing pain and/or swelling. Muscle cramps or spasms.
Nerves and mood issues
Eyes
Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches). Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance). Damage to the optic nerve or cataracts (indicated by failing eyesight). Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera). Worsening of viral or fungal eye infections. Protruding of the eyeballs (exophthalmos). Blurred or double vision.
Hormones and metabolic system
Slowing of normal growth in infants, children and adolescents which may be permanent. Irregular or no periods in women. Increased hair on the body and face in women (hirsutism). Round or moon-shaped face (Cushingoid facies). Increased appetite and weight gain. Diabetes or worsening of existing diabetes. Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months.
Steroids, including Solu-Cortef, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Solu-Cortef. Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difculty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone. Other nervous system side effects may include breathing problems, convulsions, dizziness, drowsiness, difculty breathing, sensation of cold, heat or numbness, tinnitus or unconsciousness.
Solu-Cortef must not be used after the expiry date EXP shown on the container. The doctor or pharmacist will keep the medicine in a safe place where children cannot reach or see it. This medicine must be stored below 25C. Once the medicine has been mixed with Sterile Water for Injections the solution should be used straight away. Any unused liquid should be disposed of safely. Your doctor will check that the solution contains no particles and is not discoloured before using it.
Marketing Authorisation Holder:
The company authorised to sell Solu-Cortef is: Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.
Manufacturer
Solu-Cortef is made by: Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium, and Laboratoires Pharmacia SAS, Parc Industriel dIncarville, BP 606, 27106 Val De Reuil, Cedex, France.
Company contact address:
For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161. This leaet was last revised in July 2012 Ref: SC 6_1
should not be less than 25 mg daily (see Special warnings and precautions for use section of the SPC). Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of Sterile Water for Injections to the contents of one vial of Solu-Cortef 100 mg, shake and withdraw for use. For intravenous infusion, rst prepare the solution by adding not more than 2 ml of Sterile Water for Injections to the vial; this solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). When reconstituted as directed the pH of the solution will range from 7.0 to 8.0. Shelf-life The shelf life is printed on labels and cartons. Do not use Solu-Cortef after this date. After reconstitution with Water for Injections, use immediately, discard any remainder.
Storage of the product Store below 25C. Refer to Posology and method of administration section above. Reconstituted solutions should be used immediately. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. This leaet was last revised in July 2012 Ref: SC 6_1
8R2602
Solu-Cortef 100 mg
hydrocortisone sodium succinate
1. What Solu-Cortef is and what it is used for
Solu-Cortef contains Hydrocortisone Sodium Succinate. Hydrocortisone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Solu-Cortef can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufciency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inammatory or allergic conditions affecting the: bowel and gut e.g. Crohns disease (inammation of the gut) or ulcerative colitis (inammation of the lower bowel) lungs e.g. bronchial asthma or inammation caused by breathing in (aspirating) vomit or stomach contents skin e.g. Stevens-Johnson syndrome (an auto-immune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus). Solu-Cortef may be prescribed to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.
You must not have live vaccines while using this medicine. See your doctor immediately if you have any of the above.
Taking other medicines
8R2603 26
Read all of this leaet carefully before you start taking this medicine Keep this leaet. You may need to read it again If you have any further questions please ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it to others. It may harm them even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist In this leaet: 1. What Solu-Cortef is and what it is used for 2. Before you are given Solu-Cortef 3. How Solu-Cortef is given to you 4. Possible side effects 5. How to store Solu-Cortef 6. Further information
2. Before you are given Solu-Cortef
Do not use Solu-Cortef if:
You think you have ever suffered an allergic reaction, or any other type of reaction after being given Solu-Cortef, or any other medicine containing a corticosteroid, or any of the ingredients in this medicine (Section 6 of this leaet contains a list of ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. You have any fungal infection (such as thrush) which is not being treated.
You must tell your doctor before you take this medicine if you have any of the following conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them. Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Solu-Cortef, or having a family history of these illnesses. Diabetes (or if there is a family history of diabetes). Epilepsy. Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. You have recently suffered a heart attack. Heart problems, including heart failure or infections. Hypertension (high blood pressure). Hypothyroidism (an under-active thyroid). Kaposis sarcoma (a type of skin cancer). Kidney or liver disease. Muscle problems (pain or weakness) have happened while taking steroid medicines in the past. Myasthenia gravis (a condition causing tired and weak muscles). Osteoporosis (brittle bones). Skin abscess. Stomach ulcer or other serious stomach or intestinal problems. Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins). Tuberculosis (TB) or if you have suffered tuberculosis in the past. You must tell your doctor before you take this medicine if you have any of the conditions listed above.
Take special care before taking Solu-Cortef:
Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Solu-Cortef with other medicines could be harmful. You should tell your doctor if you are taking any of the following medicines which can affect the way Solu-Cortef or the other medicine works: Acetazolamide - used to treat glaucoma and epilepsy Aminoglutethimide used for treating cancer Anticoagulants - used to thin the blood such as acenocoumarol, phenindione and warfarin Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine Antibiotics (such as erythromycin) Aspirin and non-steroidal antiinammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain Barbiturates, carbamazepine, phenytoin and primidone used to treat epilepsy Carbenoxolone and cimetidine - used for heartburn and acid indigestion Ciclosporin - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant Digoxin - used for heart failure and/or an irregular heart beat Diltiazem or mibefradil used for heart problems or high blood pressure Diuretics sometimes called water tablets Ketoconazole or itraconazole used to treat fungal infections Pancuronium or other medicines called neuromuscular blocking agents which are used in some surgical procedures Rifampicin and rifabutin antibiotics used to treat tuberculosis (TB) Vaccines - tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have live vaccines while using this medicine. Other vaccines may be less effective
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation tell your doctor, dentist or anesthetist that you are taking this medicine. If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Solu-Cortef. This medicine can affect the results of some tests.
medicine, and for 3 months after your last injection. If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.
Dosage information
Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the babys growth. Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.
Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.
Adults
Driving and Using Machines
The effect of this class of medicines on the ability to drive or use machinery has not been studied. There are undesirable effects observed with the use of this medicine such as syncope (fainting), vertigo (sensation of rotation or movement of oneself or the surrounding), and convulsions (seizures). If you are affected by any of them, you should not drive or operate machinery.
Solu-Cortef will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the rst dose is given into a vein, especially in an emergency. It will be given slowly over a period of between 1 10 minutes. Depending on your condition a repeat dose may be injected at intervals of between 2 to 6 hours. Large doses should normally be used for only two to three days. The medicine is rst dissolved in Sterile Water for Injections. If the medicine is to be given by infusion (using a pump or drip) it is then mixed with another suitable uid. No other medicines should be mixed with it.
Elderly
3. How Solu-Cortef is given to you
Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has lled out the details of your medicine, including the dose and how long you will require steroid treatment. You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this
Treatment will normally be the same as for younger adults. However your doctor may want to see you more regularly to check how you are getting on with this medicine.
Steroid Cards
Children
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose (normally not more 25mg a day) that will be effective for your child.
If you are given more Solu-Cortef than you should
If you think you have been given too many injections of this medicine please speak to your doctor immediately.
PHYSICIAN LEAFLET INFORMATION FOR DOCTORS AND PHARMACISTS
Solu-Cortef 100 mg
hydrocortisone sodium succinate
For further information, consult the Summary of Product Characteristics (SPC). Posology and method of administration. Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation. Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patients response and clinical condition.
In general high-dose corticosteroid therapy should be continued only until the patients condition has stabilised - usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufciency. Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy. In patients with liver disease, there may be an increased effect (see section 4.4 of the SPC) and reduced dosing may be considered. Elderly patients: Solu-Cortef is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of
the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use section of the SPC). Children: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight, but should not be less than 25 mg daily (see Special warnings and precautions for use section of the SPC). Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of Sterile Water for Injections to the contents of one vial of Solu-Cortef 100 mg, shake and withdraw for use. For intravenous infusion, rst prepare the solution by adding not more than 2 ml of Sterile Water for Injections to the vial; this solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). When reconstituted as directed the pH of the solution will range from 7.0 to 8.0.
Shelf-life The shelf life is printed on labels and cartons. Do not use Solu-Cortef after this date. After reconstitution with Water for Injections, use immediately, discard any remainder. Storage of the product Store below 25C. Refer to Posology and method of administration section above. Reconstituted solutions should be used immediately. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. This leaet was last revised in July 2012 Ref: SC 6_1
Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you: have been given more than 160 mg of Hydrocortisone, such as Solu-Cortef, for more than 3 weeks, have been given high doses of corticosteroids, such as Solu-Cortef, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less, have already had a course of corticosteroid tablets or injections in the last year, already have problems with your adrenal glands (adrenocortical insufciency) before you started this treatment. You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss. If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.
Stopping/reducing the dose of your Solu-Cortef
4. Possible side effects
Like all steroids this medicine can cause side-effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious. In certain medical conditions medicines like Solu-Cortef (steroids) should not be stopped abruptly, if you suffer from any of the following symptoms seek IMMEDIATE medical attention, your doctor will then decide whether you should continue taking your medicine: Allergic reactions, such as skin rash, swelling of the face or wheezing and difculty breathing. This type of side effect is rare, but can be serious. Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness. Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood. Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a are up of a previous TB infection could be coughing blood or pain in the chest. This medicine may also make you more likely to develop a severe infection. Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood. Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side-effect usually occurs after treatment is stopped. Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difculty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse. Increased numbers of white blood cells (leucocytosis).
Body water and salts
Swelling and high blood pressure, caused by increased levels of water and salt content. Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).
Round or moon-shaped face (Cushingoid facies). Increased appetite and weight gain. Diabetes or worsening of existing diabetes Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months. The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.
Other nervous system side effects may include breathing problems, convulsions, dizziness, drowsiness, difculty breathing, sensation of cold, heat or numbness, tinnitus or unconsciousness.
Marketing Authorisation Holder:
Skin
The company authorised to sell Solu-Cortef is: Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.
Abscess, especially near injection sites. Acne. Poor wound healing. Thinning of skin with stretch marks. Bruising. Small purple/red patches on the skin. Pale or darker patches on your skin, or raised patches which are an unusual color. If you experience any of the side effects listed above tell your doctor straight away.
Manufacturer
Immune system
5. How to store Solu-Cortef
Solu-Cortef must not be used after the expiry date EXP shown on the container. The doctor or pharmacist will keep the medicine in a safe place where children cannot reach or see it. This medicine must be stored below 25C. Once the medicine has been mixed with Sterile Water for Injections the solution should be used straight away. Any unused liquid should be disposed of safely. Your doctor will check that the solution contains no particles and is not discoloured before using it.
Solu-Cortef is made by: Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium, and Laboratoires Pharmacia SAS, Parc Industriel dIncarville, BP 606, 27106 Val De Reuil, Cedex, France.
Company contact address:
Digestive system
Mental health problems can happen while taking steroids like Solu-Cortef (see also section 4, Possible Side Effects). These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment. Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped.
Mental problems while taking Solu-Cortef
Nausea (feeling sick) or vomiting (being sick). Ulcers or thrush in the gullet (discomfort on swallowing). Indigestion. Bloated stomach. Persistent hiccups, especially when high doses are taken.
Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.
Muscles and bones
Eyes
Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches). Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance). Damage to the optic nerve or cataracts (indicated by failing eyesight). Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera). Worsening of viral or fungal eye infections. Protruding of the eyeballs (exophthalmos). Blurred or double vision.
Muscle weakness or wasting. Brittle bones (bones that break easily). Broken bones or fractures. Breakdown of bone due to poor circulation of blood, this causes pain in the hip. Torn muscle tendons causing pain and/or swelling. Muscle cramps or spasms.
For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161. This leaet was last revised in July 2012 Ref: SC 6_1
Nerves and mood issues
Hormones and metabolic system
Slowing of normal growth in infants, children and adolescents which may be permanent. Irregular or no periods in women. Increased hair on the body and face in women (hirsutism).
Steroids, including Solu-Cortef, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Solu-Cortef. Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difculty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
6. Further information
What Solu-Cortef contains:
Each vial of this medicine contains 133.7mg of Hydrocortisone Sodium Succinate (equivalent to 100 mg Hydrocortisone) as the active ingredient. Solu-Cortef also contains sodium biphosphate and sodium phosphate.
What a Solu-Cortef looks like:
Solu-Cortef is a white powder which comes in a clear glass vial tted with a rubber cap and metal seal. Solu-Cortef is available in packs containing 1 or 10 vials.
8R2603
inks on file
structure
PATIENT INFORMATION LEAFLET
Solu-Cortef 100 mg
hydrocortisone sodium succinate
2. Before you are given Solu-Cortef
Do not use Solu-Cortef if:
You think you have ever suffered an allergic reaction, or any other type of reaction after being given Solu-Cortef, or any other medicine containing a corticosteroid, or any of the ingredients in this medicine (Section 6 of this leaet contains a list of ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. You have any fungal infection (such as thrush) which is not being treated. You must not have live vaccines while using this medicine. See your doctor immediately if you have any of the above.
8R2602 615
Myasthenia gravis (a condition causing tired and weak muscles). Osteoporosis (brittle bones). Skin abscess. Stomach ulcer or other serious stomach or intestinal problems. Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins). Tuberculosis (TB) or if you have suffered tuberculosis in the past. You must tell your doctor before you take this medicine if you have any of the conditions listed above. Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Solu-Cortef with other medicines could be harmful. You should tell your doctor if you are taking any of the following medicines which can affect the way Solu-Cortef or the other medicine works: Acetazolamide - used to treat glaucoma and epilepsy Aminoglutethimide used for treating cancer Anticoagulants - used to thin the blood such as acenocoumarol, phenindione and warfarin Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine Antibiotics (such as erythromycin) Aspirin and non-steroidal antiinammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain Barbiturates, carbamazepine, phenytoin and primidone used to treat epilepsy Carbenoxolone and cimetidine used for heartburn and acid indigestion Ciclosporin - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant Digoxin - used for heart failure and/or an irregular heart beat Diltiazem or mibefradil used for heart problems or high blood pressure Diuretics sometimes called water tablets Ketoconazole or itraconazole used to treat fungal infections Pancuronium or other medicines called neuromuscular blocking agents which are used in some surgical procedures Rifampicin and rifabutin antibiotics used to treat tuberculosis (TB)
Vaccines - tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have live vaccines while using this medicine. Other vaccines may be less effective
3. How Solu-Cortef is given to you
Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has lled out the details of your medicine, including the dose and how long you will require steroid treatment. You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this medicine, and for 3 months after your last injection. If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.
Steroid Cards
If you are taking long term medication(s)
Taking other medicines
Read all of this leaet carefully before you start taking this medicine Keep this leaet. You may need to read it again If you have any further questions please ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it to others. It may harm them even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist In this leaet: 1. What Solu-Cortef is and what it is used for 2. Before you are given Solu-Cortef 3. How Solu-Cortef is given to you 4. Possible side effects 5. How to store Solu-Cortef 6. Further information
Solu-Cortef contains Hydrocortisone Sodium Succinate. Hydrocortisone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Solu-Cortef can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufciency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inammatory or allergic conditions affecting the: bowel and gut e.g. Crohns disease (inammation of the gut) or ulcerative colitis (inammation of the lower bowel) lungs e.g. bronchial asthma or inammation caused by breathing in (aspirating) vomit or stomach contents skin e.g. Stevens-Johnson syndrome (an auto-immune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus). Solu-Cortef may be prescribed to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.
1. What Solu-Cortef is and what it is used for
You must tell your doctor before you take this medicine if you have any of the following conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them. Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Solu-Cortef, or having a family history of these illnesses. Diabetes (or if there is a family history of diabetes). Epilepsy. Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. You have recently suffered a heart attack. Heart problems, including heart failure or infections. Hypertension (high blood pressure). Hypothyroidism (an under-active thyroid). Kaposis sarcoma (a type of skin cancer). Kidney or liver disease. Muscle problems (pain or weakness) have happened while taking steroid medicines in the past.
Take special care before taking Solu-Cortef:
If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation tell your doctor, dentist or anesthetist that you are taking this medicine. If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Solu-Cortef. This medicine can affect the results of some tests.
Pregnancy and breast feeding
Dosage information
You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the babys growth. Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.
Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.
Adults
Driving and Using Machines
The effect of this class of medicines on the ability to drive or use machinery has not been studied. There are undesirable effects observed with the use of this medicine such as syncope (fainting), vertigo (sensation of rotation or movement of oneself or the surrounding), and convulsions (seizures). If you are affected by any of them, you should not drive or operate machinery.
Solu-Cortef will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the rst dose is given into a vein, especially in an emergency. It will be given slowly over a period of between 1 10 minutes. Depending on your condition a repeat dose may be injected at intervals of between 2 to 6 hours. Large doses should normally be used for only two to three days. The medicine is rst dissolved in Sterile Water for Injections. If the medicine is to be given by infusion (using a pump or drip) it is then mixed with another suitable uid. No other medicines should be mixed with it.
Elderly
Treatment will normally be the same as for younger adults. However your doctor may want to see you more regularly to check how you are getting on with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose (normally not more 25mg a day) that will be effective for your child.
PHYSICIAN LEAFLET INFORMATION FOR DOCTORS AND PHARMACISTS
Solu-Cortef 100 mg
hydrocortisone sodium succinate
For further information, consult the Summary of Product Characteristics (SPC). Posology and method of administration. Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.
Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patients response and clinical condition. In general high-dose corticosteroid therapy should be continued only until the patients condition has stabilised - usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufciency.
Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy. In patients with liver disease, there may be an increased effect (see section 4.4 of the SPC) and reduced dosing may be considered. Elderly patients: Solu-Cortef is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use section of the SPC). Children: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight, but
If you are given more Solu-Cortef than you should
If you think you have been given too many injections of this medicine please speak to your doctor immediately.
4. Possible side effects
Stopping/reducing the dose of your Solu-Cortef
Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you: have been given more than 160 mg of Hydrocortisone, such as Solu-Cortef, for more than 3 weeks, have been given high doses of corticosteroids, such as Solu-Cortef, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less, have already had a course of corticosteroid tablets or injections in the last year, already have problems with your adrenal glands (adrenocortical insufciency) before you started this treatment. You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss. If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.
Mental problems while taking Solu-Cortef
Mental health problems can happen while taking steroids like Solu-Cortef (see also section 4, Possible Side Effects). These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment. Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped.
Like all steroids this medicine can cause side-effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious. In certain medical conditions medicines like Solu-Cortef (steroids) should not be stopped abruptly, if you suffer from any of the following symptoms seek IMMEDIATE medical attention, your doctor will then decide whether you should continue taking your medicine: Allergic reactions, such as skin rash, swelling of the face or wheezing and difculty breathing. This type of side effect is rare, but can be serious. Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness. Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood. Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a are up of a previous TB infection could be coughing blood or pain in the chest. This medicine may also make you more likely to develop a severe infection. Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood. Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side-effect usually occurs after treatment is stopped. Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difculty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse. Increased numbers of white blood cells (leucocytosis).
The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.
Skin
Immune system
Abscess, especially near injection sites. Acne. Poor wound healing. Thinning of skin with stretch marks. Bruising. Small purple/red patches on the skin. Pale or darker patches on your skin, or raised patches which are an unusual color. If you experience any of the side effects listed above tell your doctor straight away.
6. Further information
What Solu-Cortef contains:
Each vial of this medicine contains 133.7mg of Hydrocortisone Sodium Succinate (equivalent to 100mg Hydrocortisone) as the active ingredient. Solu-Cortef also contains sodium biphosphate and sodium phosphate.
What a Solu-Cortef looks like:
Body water and salts
Swelling and high blood pressure, caused by increased levels of water and salt content. Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).
Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.
5. How to store Solu-Cortef
Solu-Cortef is a white powder which comes in a clear glass vial tted with a rubber cap and metal seal. Solu-Cortef is available in packs containing 1 or 10 vials.
Muscles and bones
Digestive system
Nausea (feeling sick) or vomiting (being sick). Ulcers or thrush in the gullet (discomfort on swallowing). Indigestion. Bloated stomach. Persistent hiccups, especially when high doses are taken.
Muscle weakness or wasting. Brittle bones (bones that break easily). Broken bones or fractures. Breakdown of bone due to poor circulation of blood, this causes pain in the hip. Torn muscle tendons causing pain and/or swelling. Muscle cramps or spasms.
Nerves and mood issues
Eyes
Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches). Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance). Damage to the optic nerve or cataracts (indicated by failing eyesight). Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera). Worsening of viral or fungal eye infections. Protruding of the eyeballs (exophthalmos). Blurred or double vision.
Hormones and metabolic system
Slowing of normal growth in infants, children and adolescents which may be permanent. Irregular or no periods in women. Increased hair on the body and face in women (hirsutism). Round or moon-shaped face (Cushingoid facies). Increased appetite and weight gain. Diabetes or worsening of existing diabetes. Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months.
Steroids, including Solu-Cortef, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Solu-Cortef. Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difculty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone. Other nervous system side effects may include breathing problems, convulsions, dizziness, drowsiness, difculty breathing, sensation of cold, heat or numbness, tinnitus or unconsciousness.
Solu-Cortef must not be used after the expiry date EXP shown on the container. The doctor or pharmacist will keep the medicine in a safe place where children cannot reach or see it. This medicine must be stored below 25C. Once the medicine has been mixed with Sterile Water for Injections the solution should be used straight away. Any unused liquid should be disposed of safely. Your doctor will check that the solution contains no particles and is not discoloured before using it.
Marketing Authorisation Holder:
The company authorised to sell Solu-Cortef is: Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.
Manufacturer
Solu-Cortef is made by: Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium, and Laboratoires Pharmacia SAS, Parc Industriel dIncarville, BP 606, 27106 Val De Reuil, Cedex, France.
Company contact address:
For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161. This leaet was last revised in July 2012 Ref: SC 6_1
should not be less than 25 mg daily (see Special warnings and precautions for use section of the SPC). Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of Sterile Water for Injections to the contents of one vial of Solu-Cortef 100 mg, shake and withdraw for use. For intravenous infusion, rst prepare the solution by adding not more than 2 ml of Sterile Water for Injections to the vial; this solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). When reconstituted as directed the pH of the solution will range from 7.0 to 8.0. Shelf-life The shelf life is printed on labels and cartons. Do not use Solu-Cortef after this date. After reconstitution with Water for Injections, use immediately, discard any remainder.
Storage of the product Store below 25C. Refer to Posology and method of administration section above. Reconstituted solutions should be used immediately. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. This leaet was last revised in July 2012 Ref: SC 6_1
8R2602
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
