Methylprednisolone. 10 amp, Amp.15.78 mg
Methylprednisolone. 10 amp, Amp.15.78 mg
WHAT methylprednisolone AND WHAT IT IS USED
Methylprednisolone Sopharma is medicine of the corticosteroid. These are hormones that are normally produced by the adrenal glands. They have strong anti-inflammatory, anti-allergic and immuno-suppressive effect and help the body in harsh conditions associated with inflammation, allergy or other serious illnesses. Sopharma Methylprednisolone is a synthetic analogue of the hormones and have their basic properties and action. Methylprednisolone Sopharma used in endocrine diseases (endocrine) as adjunctive therapy for short periods of time during exacerbation of diseases of the joints and soft tissues around them (rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, psoriatic arthritis, epicondylitis , acute gouty arthritis), systemic lupus erythematosus (disorder of the immune system that causes joint pain, skin rashes and fever), systemic dermatomyositis, acute rheumatic carditis (inflammation of the heart structures due to rheumatism), certain skin diseases like pemphigus, erythema multiforme, Stevens-Johnson syndrome (a severe illness accompanied by blistering of the skin, mouth, eyes and genitals), exfoliative dermatitis, generalized neural dermit, severe psoriasis and severe seborrheic dermatitis unresponsive to another treat diseases such as bronchial asthma, atopic dermatitis, serum sickness, hypersensitivity (allergy) to medication, Quincke's edema, shock (due to hemorrhage, trauma, allergy, infection with severe intoxication), severe acute and chronic allergic and inflammatory processes affecting the eye, severe respiratory diseases, blood disorders, diseases of the digestive system in organ transplantation - to prevent rejection by the body.
BEFORE YOU USE methylprednisolone
Do not use Methylprednisolone Sopharma
if you are allergic (hypersensitive) to methylprednisolone or to any of the ingredients of Methylprednisolone Sopharma;
If you have a systemic fungal infection;
in premature infants.
Take special care with Methylprednisolone
Before starting treatment with methylprednisolone Sopharma, tell your doctor if you have a non-declared or active tuberculosis, mental illness in the past herpes infection, diseases of the cornea (keratitis), stomach or intestinal ulcers, Cushing's syndrome (medical condition that develops due to disease of the adrenal glands), diseases of the gastro - intestinal system (diverticulitis, fresh intestinal anastomoses), osteoporosis, thromboembolic events, renal failure, diabetes, high blood pressure, glaucoma (increased eye pressure), local or general infections conditions of suppressed immunity (AIDS, chickenpox), myasthenia gravis (a disease marked by muscle weakness).
Tell your doctor if you are or have recently received a vaccination you (including vaccination against varicella).
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you take:
barbiturates (sleeping pills), rifampicin (a medicine used to treat tuberculosis) and phenytoin (an antiepileptic drug);
cardiac glycosides (medicines to treat heart failure);
salidiuretitsi (water resources);
antidiabetic medicines taken by mouth;
aspirin and NSAIDs.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant, treatment with methylprednisolone Sopharma only be given under medical supervision. During the first three months of pregnancy should avoid its use except in exceptional testimony.
Corticosteroids pass into breast milk and may affect a nursing infant, so when the need for treatment with methylprednisolone breastfeeding should be discontinued.
Driving and operating machinery
Methylprednisolone Sopharma not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Methylprednisolone Sopharma
This product contains sodium, less than 1 mmol (23 mg) per dose, ie essentially sodium.
HOW TO USE methylprednisolone
Sopharma Methylprednisolone is administered by qualified medical personnel. If you have any questions, consult your doctor.
The dose is determined by the treating physician and depends on the severity of your condition.
The usual starting dose ranges from 10 mg to 500 mg daily.
During prolonged treatment with methylprednisolone Sopharma discontinuation of treatment should be done by gradually reducing the dose.
In children, treatment doses were 0.8 to 1.5 mg / kg body weight per day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Sopharma Methylprednisolone can cause side effects, although not everybody gets them.
When treated with the product may be impaired water and electrolyte balance, which is manifested by fluid retention in the body, sodium retention and enhanced urinary potassium excretion. In predisposed patients may cause weakness of the heart muscle (heart failure).
Rarely can cause muscle weakness, tendon rupture, pathological fractures of bones.
In some patients it is possible exacerbation of peptic ulcer, ulcerative colitis (inflammation of the colon), pancreatitis (inflammation of the pancreas), inflammation of the esophagus. Sopharma Methylprednisolone can cause increased levels of certain abnormalities in the blood (ALT, SGPT, AST, SGOT, alkaline phosphatase).
Other possible side effects include: bleeding skin spotting, bleeding spots, rash, contact dermatitis, steroid acne, abnormal skin color, hair, slow wound healing, depression, anxiety, irritability, insomnia, euphoria, convulsions in children, mental violations, steroid diabetes, menstrual irregularities (amenorrhea), impotence, suppression of growth in children, proteinuria (excretion of protein in urine), hematuria (blood in urine), lymphopenia (reduction of lymphocytes in the blood), shortening of the clotting , cataract (clouding of the lens of the eye, cataract), increased intraocular pressure, ekzoftalm (bulging eyes), hypersensitivity reactions, including anaphylaxis.
Sopharma administration of methylprednisolone may mask signs of infection in the body or exacerbate latent infection occurs. The site of application may develop sterile abscesses, infection failing to adhere to sterile injection.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE methylprednisolone
In original packaging, protected from light place, at temperatures below 25 ° C.
Do not freeze!
Keep out of reach of children.
Do not use Methylprednisolone Sopharma after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Methylprednisolone Sopharma
The active substance is sodium succinate metilprednizolonov corresponding to 6.31 mg Methylprednisolone, 15.78 mg, 40 mg, 125 mg, 250 mg.
The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate.
Each ampoule of solvent Sterilised water for injections containing 1 ml, 2 ml and 5 ml of water for injections.
Methylprednisolone Sopharma looks like and contents of pack
White to off-white powder lyophilic.
The pack contains colorless glass ampoules powder for injection with solvent ampoules in a cardboard box and leaflet.
6.31 mg Methylprednisolone - 5 and 10 ampoules powder for solution for injection 1 ml in blister PVC foil;
15.78 mg Methylprednisolone - 5 and 10 ampoules powder for solution for injection 1 ml in blister PVC foil;
Methylprednisolone 40 mg - 10 ampoules powder for solution for injection 1 ml in blister PVC foil;
Methylprednisolone 125 mg - 5 ampoules of powder and solvent for solution for injection 2 ml in blister PVC foil;
Methylprednisolone 250 mg - 5 ampoules of powder and solvent for solution for injection 5 ml in blister PVC foil.
The following information is intended for healthcare professionals only:
Method of application:
Intravenously administered intravenously as an infusion and intramuscular. Preferred method for initial emergency use is intravenous injection conditions.
Preparation of the solution:
As ampoule powder for injection is added optional second solvent ampoule. If the product is applied infusion so reconstituted solution is added to different amounts of infusion - 5% dextrose, isotonic saline or 5% dextrose in isotonic saline solution.
Should not be mixed with other drugs in a syringe! Before applying the product to check the color and clarity of the solution for parenteral use!
The starting dose ranges from 10 mg to 500 mg daily depending on the severity of the condition and response. Higher doses (250 mg) should be administered very slowly for at least 30 minutes. In emergencies recommended intravenous product in high doses for short periods of time. After stabilizing the patient dose is reduced and switched to treatment with oral medications.
During prolonged treatment with methylprednisolone discontinuation of therapy should be performed with a gradual reduction in dose.
In pulse therapy, high doses (more than 1 g per day) for 3 days.
Shock - 125 mg every 2-6 hours or 250 mg every 4-6 hours. You can also apply a 30 mg / kg body weight every 24 hours.
Apply intravenous infusion of no less than 10 to 30 minutes. High doses should be administered over 48 to 72 hours, provided that the patient's condition did not improve.
For immunosuppression - to prevent organ rejection in organ transplants (especially kidney) Methylprednisolone was administered at doses of 0.5 g to 2 g intravenously every 24 to 48 hours.
In cerebral edema - a 40-125 mg every 4 to 6 hours intravenously or intramuscularly for 4 to 7 days (to stabilize the patient's condition).
In other states - Sopharma Methylprednisolone is used as adjunctive therapy in the treatment of patients with ulcerative colitis at 20 to 40 mg given by continuous infusion of 3 to 7 times per week for 2 weeks or more.
Children: Children curative doses are 0.8 to 1.5 mg / kg body weight per day.
Discontinuation of therapy
The sharp decrease in dose or abrupt withdrawal of corticosteroids after prolonged treatment can lead to acute adrenal insufficiency. This insufficiency can last months after discontinuation of use, so if you experience stress during this period (trauma, surgery, serious illness), corticosteroid therapy should be re-appointed or may have increased the dose. Cessation of therapy with corticosteroids, especially after prolonged therapy should be slowly tapering off.
Overdose of corticosteroids are almost always due to their application in high doses to patients with normal physiological needs. Treatment is symptomatic. Treatment with corticosteroids was gradually discontinued. In case of overdose There is no specific antidote.