Methylprednisolone Sodium Succinate for Injection USP 40mg
Methylprednisolone Sodium Succinate for Injection USP 125mg
Methylprednisolone Sodium Succinate for Injection USP 500mg
Methylprednisolone Sodium Succinate for Injection USP 1g
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Methylprednisolone Sodium Succinate is and what it is used for
- What you need to know before you are given Solu-Madrone
- How Methylprednisolone Sodium Succinate is given to you
- Possible side effects
- How to store Solu-Madrone
- Contents of the pack and other information
- What Methylprednisolone Sodium Succinate is and what it is used for
Methylprednisolone Sodium Succinate contains methylprednisolone sodium succinate. Methylprednisolone belongs to a group of medicines called corticosteroids (steroids). Corticosteroids are produced naturally in your body and are important for many body functions.
Boosting your body with extra corticosteroid such as Methylprednisolone Sodium Succinate can help following surgery (e.g. organ transplants), flare-ups of the symptoms of multiple sclerosis or other stressful conditions.
These include inflammatory or allergic conditions affecting the:
- brain caused
by a tumour or tuberculosis meningitis
- bowel and gut e.g. ?Crohn?s disease? and ?ulcerative colitis?
- lungs caused by asthma, severe allergy or hypersensitivity, tuberculosis or breathing in (aspirating) vomit or stomach contents
- skin e.g. Stevens-Johnson Syndrome.
Methylprednisolone Sodium Succinate may be prescribed to treat conditions other than those listed above.
Talk to your doctor if you are unsure why you have been given this medicine, if you do not feel better or if you feel worse.
2. What you need to know before you are given Methylprednisolone Sodium Succinate
Do not use Solu-Madrone:
- If you think you have ever suffered an allergic reaction, or any other type of reaction after being given Solu-Madrone, or any other medicine containing a corticosteroid or any of the ingredients in this medicine (listed in section 6). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.
- If you have any known or suspected allergy to cow?s milk or its components or other dairy products, tell your doctor before taking this medicine as it may contain trace amounts of milk ingredients.
- If you have a widespread fungal infection (such as thrush) which is not being treated.
- If you have recently had, or are about to have any vaccination.
- If you are suffering from, or receiving treatment for, swelling of the brain, due to malaria.
- If you are suffering from a traumatic brain injury or stroke.
See your doctor immediately if any of the above applies to you. Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions.
Your doctor may 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.
- Worm infestation (e.g. threadworm).
- Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Solu-Madrone or having a family history of these illnesses.
- Diabetes (or if there is a family history of diabetes).
? Epilepsy fits or seizures.
- Glaucoma (increased
pressure in the eye) or if there is a family history of glaucoma.
- Contact your doctor if you experience blurred vision or other visual disturbances.
- You have recently suffered a heart attack.
- Heart problems, including heart failure or infections.
- Hypertension (high blood pressure).
- Hypothyroidism (an under-active thyroid).
? Joint infection.
- Kaposi?s sarcoma (a type of skin cancer).
- Kidney or liver disease.
- Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk of a serious complication called scleroderma renal crisis may be increased.
- 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).
- Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal glands are located above the kidneys).
? Skin abscess.
- Stomach ulcer, diverticulitis (inflammation of the bowel wall) 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.
- Unusual stress.
- Cushing?s disease (a condition caused by an excess of cortisol hormone in your body).
- Acute pancreatitis (inflammation of the pancreas).
Methylprednisolone Sodium Succinate should not be used in the treatment of septic shock.
Methylprednisolone Sodium Succinate 40mg contains cow?s milk proteins
If you are allergic or suspected to be allergic to cow?s milk, you must not be given this medicine as it may contain trace amounts of cow?s milk proteins. Serious allergic reactions have occurred in patients allergic to cow?s milk.
Other medicines and Solu-Madrone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including any you have obtained without a prescription).
This could be harmful or affect the way Methylprednisolone Sodium Succinate or the other medicine works:
- Acetazolamide – used to treat glaucoma and epilepsy
- Aminoglutethimide or Cyclophosphamide ? 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, clarithromycin or troleandomycin)
- Antidiabetics ? medicines used to treat high blood sugar
- Antihypertensives ? medicines used to lower blood pressure
- Aprepitant and Fosaprepitant ? used to prevent nausea and vomiting
- Aspirin and non-steroidal anti-inflammatory 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 heartbeat
- Diltiazem or mibefradil ? used for heart problems or high blood pressure
- Ethinylestradiol and norethisterone ? an oral contraceptive
- Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicistat) used to treat HIV infections
- Isoniazid – used to treat bacterial infections
- Ketoconazole or itraconazole ? used to treat fungal infections
- Mifepristone ? used for the medical termination of a pregnancy
- Pancuronium or vecuronium ? or other medicines called neuromuscular blocking agents which are used in some surgical procedures
- Potassium depleting agents ? such as diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists (e.g. medicines used to treat asthma)
- Rifampicin and rifabutin ? antibiotics used to
treat tuberculosis (TB)
- Tacrolimus ? used following an organ transplant to prevent rejection of the organ
- 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 anaesthetist that you are taking Solu- Madrone.
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-Madrone. This medicine can affect the results of some tests.
Methylprednisolone Sodium Succinate with drink
Do not drink grapefruit juice while taking this medicine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it could slow the baby?s growth. There is a risk of low birth weight of a baby; this risk can be minimised by taking the lowest effective dose of the corticosteroids.
Cataracts have been observed in infants born to mothers undergoing long-term treatment with corticosteroids during pregnancy.
If you are breast-feeding, ask your doctor or pharmacist for advice, as small amounts of corticosteroid medicines may get into breast milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If you are affected do not drive or operate machinery.
- How Methylprednisolone Sodium Succinate is given to you
Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has filled 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 Solu- Madrone. 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
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
Methylprednisolone Sodium Succinate will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually, the first dose is given into a vein, especially in an emergency.
It will be given slowly over at least 5 minutes. For larger doses, this may take 30 minutes or more. Large doses should normally be used for only two to three days.
The medicine is first 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 fluid. 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 and adolescents
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose that will be effective for your child.
If you are given more Methylprednisolone Sodium Succinate than you should
If you think you have been given too many injections of Methylprednisolone Sodium Succinate please speak to your doctor immediately.
Stopping/reducing the dose of your Solu-Madrone
Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you:
- have had repeated doses of corticosteroids for more than 3 weeks
- have been given high doses of Solu-Madrone, over 32 mg 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 had problems with your adrenal glands (adrenocortical insufficiency) 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-Madrone
Mental health problems can happen while taking steroids like Methylprednisolone Sodium Succinate (see section 4).
- 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) shows 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, 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 Methylprednisolone Sodium Succinate (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 difficulty breathing. This type of side effect is rare but can be serious.
- Pancreatitis, stomach pain spreading to your back, possibly accompanied by vomiting, shock and loss of consciousness.
- Burst or bleeding ulcers, symptoms of which are stomach pain (especially if it seems to spread to your back), 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 feel unwell. Symptoms of a flare-up of a previous TB infection could be coughing blood or pain in the chest. Symptoms of previous malaria infection could involve chills and fever. Methylprednisolone Sodium Succinate may also make you more likely to develop a severe infection.
- Pulmonary embolus (blood clots 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 painfully 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.
The side effects may occur with certain frequencies, which are defined as follows:
- rare: may
affect up to 1 in 1,000 people.
- not known: frequency cannot be estimated from the available data.
Blood, heart and circulation
not known
- High blood pressure, symptoms of which are headaches, or generally feeling unwell.
- Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heartbeat) or irregular beating of the heart, irregular or very fast or slow pulse.
- Low blood pressure symptoms may include dizziness, fainting, lightheadedness, blurred vision, a rapid, or irregular heartbeat (palpitations), general weakness.
- Increased numbers of white blood cells (leukocytosis).
Body water and salts
not known
- 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).
Digestive system
not known
- Ulcers.
- Nausea (feeling sick) or vomiting (being sick).
- Diarrhoea.
- Thrush in the gullet (discomfort on swallowing).
- Indigestion.
- Bloated stomach.
- Abdominal pain.
- Hiccups.
Ears
not known
- A feeling of dizziness or spinning (vertigo).
Eyes
rare
- Blurred vision.
not known
- Cataracts
(indicated by failing eyesight).
- Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).
- Swollen optic nerve (papilloedema, indicated by sight disturbance).
- 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 vision (chorioretinopathy).
General disorders
not known
- Poor wound healing.
- Feeling tired or unwell.
- Skin reactions at the site of injection.
Hormones and the metabolic system
not known
- Slowing of normal growth in infants, children and adolescents which may be permanent.
- Round or moon-shaped face (Cushingoid facies).
- Irregular or no periods in women.
- 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 number 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.
- Accumulation of fat tissue on localised parts of the body, manifesting as different presentations for example back pain or weakness (due to epidural lipomatosis).
Immune system
not known
- Increased
susceptibility to infections.
- Suppression of reactions to skin tests, such as that for tuberculosis.
Muscles and bones
not known
- Brittle bones
(bones that break easily).
- Muscle weakness.
- Muscle wasting.
- 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
not known
Steroids including methylprednisolone can cause serious mental health problems.
- Feeling
depressed, including thinking about suicide.
- Feeling high (mania) or moods that go up and down.
- Feeling anxious, having problems sleeping, difficulty 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.
- Fits.
Skin
not known
- Acne.
- Bruising.
- Thinning of skin (skin atrophy).
- Stretch marks (skin striae).
- Small purple/red patches on the skin.
- Pale or darker patches on your skin, or raised patches which are an unusual colour.
- Excessive growth of bodily and facial hair.
- Rash, itching, hives.
- Increased sweating.
Liver disorder
not known
- Methylprednisolone can damage your liver; hepatitis and increase of liver enzymes have been reported.
Vascular disorders
not known
- Increased clotting of the blood.
If you experience any of the side effects listed above tell your doctor straight away. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Solu-Madrone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
1 gram
This medicinal product does not require any special storage conditions.
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.
6. Contents of the pack and other information
What Methylprednisolone Sodium Succinate contains
This medicine contains the following amounts of methylprednisolone sodium succinate as the active ingredient:
1 g vial: 1.326 g methylprednisolone sodium succinate (equivalent to 1 g methylprednisolone)
Methylprednisolone Sodium Succinate also contains the inactive ingredients sodium biphosphate and sodium phosphate.
The 40 mg vial also contains lactose monohydrate produced from cow?s milk (see section 2, Do not use Solu-Madrone).
What Methylprednisolone Sodium Succinate looks like and contents of the pack
Methylprednisolone Sodium Succinate is a powder which comes in a clear glass vial fitted with a rubber stopper. Each pack also contains a vial of Sterile Water for Injections.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)