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METHYLPREDNISOLONE SODIUM SUCCINATE FOR is a brand name for Methylprednisolone, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intravenous administration of Methylprednisolone Sodium Succinate for Injection, USP (methylprednisolone sodium succinate) is indicated in situations in which a rapid and intense hormonal effect is required. Methylprednisolone Sodium Succinate for Injection, USP is indicated for: • Hypersensitivity and dermatologic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
• The lowest possible dose of corticosteroid should be used to control the condition under treatment. • Patients should be advised to inform subsequent health professionals of the prior use of Methylprednisolone Sodium Succinate for Injection, USP.
• The existence of diabetes, osteoporosis, renal insufficiency, chronic psychosis, cardiovascular disease, myasthenia gravis or predisposition to thrombophlebitis requires that Methylprednisolone Sodium Succinate for Injection, USP be administered with extreme caution.
• Dosage adjustments may be required based on the following: - during remission - exacerbation of the disease process - the patient’s individual response to therapy - upon exposure of the patient to emotional or physical stress such as serious infection, surgery or injury.
Methylprednisolone Sodium Succinate for Injection, USP dosage may need to be increased during and after the stressful situation. • Geriatrics: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Caution is recommended with prolonged corticosteroid treatment in the elderly due to a potential increased risk for osteoporosis, as well as increased risk for fluid retention with possible resultant hypertension. 3 Pediatrics). 2 Recommended Dose and Dosage Adjustment • Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy.
, shock states), the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg per kg, given intravenously over Methylprednisolone Sodium Succinate for Injection, USP Page 7 of 42 a period of at least 30 minutes.
This large dose may be repeated every 4- 6 hours for up to 48 hours. • In other indications, initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated. Larger doses may be required for short-term management of severe, acute conditions.
1 Adverse Reaction Overview The following Adverse Reactions have been reported with the systemic use of Methylprednisolone Sodium Succinate and other corticosteroid preparations. Methylprednisolone Sodium Succinate for Injection, USP Page 18 of 42 MedDRA (v15) System Organ Class Undesirable Effect Blood and lymphatic system disorders Leukocytosis Infections and infestations Infection; opportunistic infection; injection site infections following non-sterile administration; decreased resistance to infection Immune system disorders Drug hypersensitivity; (anaphylactoid reaction; anaphylactic reaction (with or without circulatory collapse)) Endocrine disorders Cushingoid; hypothalamic pituitary adrenal axis suppression; steroid withdrawal syndrome; moon face; abnormal fat deposits; glycosuria; hypertrichosis; secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of glucocorticoids.
This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Metabolism and nutrition disorders Lipomatosis; sodium retention; sodium excretion; fluid retention; alkalosis hypokalemic; dyslipidaemia; metabolic acidosis; glucose tolerance impaired; increased requirement for insulin (or oral hypoglycemic agents in diabetics); nitrogen balance negative (due to protein catabolism); blood urea increased; increased appetite (which may result in weight increased); diuresis Psychiatric disorders Affective disorder (including affect lability, depressed mood, euphoric mood, drug dependence, suicidal ideation); psychotic disorder (including mania, delusion, hallucination, schizophrenia [aggravation of]); mental disorder; insomnia; mood swings; personality change; confusional state; abnormal behavior; anxiety; irritability; emotional instability Nervous system disorders Epidural lipomatosis; intracranial pressure increased (with papilledema [idiopathic intracranial hypertension] usually following discontinuation of treatment); convulsion; amnesia; cognitive disorder; dizziness; headache; seizures; neuritis; neuropathy; paresthesia Eye disorders Central serous chorioretinopathy; cataract; glaucoma; exophthalmos; rare instances of blindness associated with periocular injections.
3 Pediatrics). 2 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 2 CONTRAINDICATIONS Methylprednisolone Sodium Succinate for Injection, USP is contraindicated: • in patients with known hypersensitivity to the ingredients.
• for systemic fungal infections • in patients administered with live or live, attenuated vaccines while receiving immunosuppressive doses of corticosteroids. • for intrathecal or epidural administration. Reports of serious medical events have been associated with these routes of administration.
• for use in premature infants, if the sterile Bacteriostatic Water for Injection is used for reconstituting Methylprednisolone Sodium Succinate for Injection, USP products (as sterile Bacteriostatic Water for Injection contains benzyl alcohol).
3 Pediatrics. • for intramuscular administration in idiopathic thrombocytopenic purpura. 1 Dosing Considerations • Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
• The lowest possible dose of corticosteroid should be used to control the condition under treatment. • Patients should be advised to inform subsequent health professionals of the prior use of Methylprednisolone Sodium Succinate for Injection, USP.
• The existence of diabetes, osteoporosis, renal insufficiency, chronic psychosis, cardiovascular disease, myasthenia gravis or predisposition to thrombophlebitis requires that Methylprednisolone Sodium Succinate for Injection, USP be administered with extreme caution.
• Dosage adjustments may be required based on the following: - during remission - exacerbation of the disease process - the patient’s individual response to therapy - upon exposure of the patient to emotional or physical stress such as serious infection, surgery or injury.
3 Pediatrics). 2 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 2 CONTRAINDICATIONS Methylprednisolone Sodium Succinate for Injection, USP is contraindicated: • in patients with known hypersensitivity to the ingredients.
• for systemic fungal infections • in patients administered with live or live, attenuated vaccines while receiving immunosuppressive doses of corticosteroids. • for intrathecal or epidural administration. Reports of serious medical events have been associated with these routes of administration.
• for use in premature infants, if the sterile Bacteriostatic Water for Injection is used for reconstituting Methylprednisolone Sodium Succinate for Injection, USP products (as sterile Bacteriostatic Water for Injection contains benzyl alcohol).
3 Pediatrics. • for intramuscular administration in idiopathic thrombocytopenic purpura. Except for short-term emergency therapy, Methylprednisolone Sodium Succinate for Injection, USP is contraindicated in patients with: • arrested tuberculosis • herpes simplex keratitis • acute psychoses • Cushing's syndrome • peptic ulcer Methylprednisolone Sodium Succinate for Injection, USP Page 6 of 42 • markedly elevated serum creatinine • vaccinia and varicella
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, doses greater than 250 mg). Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. • Methylprednisolone Sodium Succinate in doses of 40 to 120 mg administered as retention enemas or by continuous drip three to seven times weekly for periods of two or more weeks have been shown to be a useful adjunct in the treatment of some patients with ulcerative colitis.
Many patients can be controlled with 40 mg of Methylprednisolone Sodium Succinate for Injection, USP administered in from 1 to 10 fluid ounces of water depending on the degree of involvement of the inflamed colonic mucosa. Other accepted therapeutic measures should, of course, be instituted.
3 Reconstitution Parenteral Products: DIRECTIONS FOR RECONSTITUTION USING THE FLIP-OFF VIALS 1. Remove the protective plastic flip-off seal. 2. Swab the rubber stopper with an antiseptic solution and introduce the required quantity of the diluent by means of a syringe into the vial.
3. Shake the vial thoroughly to dissolve the powder content. 4. Withdraw the dose in the usual manner with the help of a syringe Reconstitute with Sterile Water for Injection, or, if required, sterile Bacteriostatic Water for Injection as follows: Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
5 mg/mL Compatibility The compatibility and stability of Methylprednisolone Sodium Succinate for Injection, USP , in solutions and with other drugs in intravenous admixtures is dependent on admixture pH, concentration, time, temperature, and the ability of methylprednisolone to solubilize itself.
V. V. V. "piggy-back" solution. 9% sodium chloride. The resulting solutions are physically and chemically stable for 48 hours. 4 Administration Methylprednisolone Sodium Succinate for Injection, USP may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection.
To administer Methylprednisolone Sodium Succinate for Injection, USP, reconstitute the vial as per instructions. Store reconstituted solution at room temperature (between 15 and 30°C). Use reconstituted solution within 48 hours. Methylprednisolone Sodium Succinate for Injection, USP vials are single dose vials.
Discard unused portion. Reconstituted Methylprednisolone Sodium Succinate for Injection, USP products can be used directly […]
Ear and labyrinth disorders Vertigo Cardiac disorders Cardiac failure congestive (in susceptible patients); arrhythmia; cardiac arrest; bradycardia; tachycardia; cardiac enlargement; circulatory collapse; hypertrophic cardiomyopathy in premature infants; myocardial rupture following recent myocardial infarction; pulmonary oedema; syncope Methylprednisolone Sodium Succinate for Injection, USP Page 19 of 42 MedDRA (v15) System Organ Class Undesirable Effect Vascular disorders Hypertension; hypotension; flushing; thromboembolism; thrombophlebitis, thrombosis, vasculitis Respiratory, thoracic and mediastinal disorders Hiccups; bronchospasm, pulmonary embolism Gastrointestinal disorders Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage); intestinal perforation; gastric haemorrhage; pancreatitis; esophagitis ulcerative; oesophagitis; abdominal distension; abdominal pain; diarrhoea; dyspepsia; nausea; vomiting; dysgeusia; peritonitis (peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis) Hepatic disorders Hepatomegaly, hepatitis, drug-induced liver injury, liver failure Skin and subcutaneous disorders Angioedema; hirsutism; petechiae; ecchymoses; skin atrophy; erythema; hyperhidrosis; skin striae; rash; pruritus; urticaria; acne; panniculitis; skin hypopigmentation; skin hyperpigmentation; allergic dermatitis; burning or tingling (especially in the perineal area after intravenous injection); cutaneous and subcutaneous atrophy; dry scaly skin; sterile abscess; thinning scalp hair; Kaposi’s sarcoma Musculoskeletal and connective tissue disorders Muscular weakness; myalgia; myopathy; rhabdomyolysis; muscle atrophy; osteoporosis; osteonecrosis; pathological; post-injection flare (following intra-articular use); fracture; neuropathic arthropathy; arthralgia; growth retardation Reproductive system and breast disorders Menstruation irregular; increased or decreased motility and number of spermatozoa.
General disorders and administration site conditions Impaired healing; fatigue; malaise; injection site reaction; oedema peripheral Investigations Urine calcium increased; blood potassium decreased; Carbohydrate tolerance decreased; intraocular pressure increased; aminotransferase increased; aspartate aminotransferase increased; blood alkaline phosphatase increased; suppression of reactions to skin tests; blood urea increased Injury, poisoning and procedural complications Spinal compression fracture; tendon rupture (particularly of the Achilles tendon)
Methylprednisolone Sodium Succinate for Injection, USP dosage may need to be increased during and after the stressful situation. • Geriatrics: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Caution is recommended with prolonged corticosteroid treatment in the elderly due to a potential increased risk for osteoporosis, as well as increased risk for fluid retention with possible resultant hypertension. 3 Pediatrics). 2 Recommended Dose and Dosage Adjustment • Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy.
, shock states), the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg per kg, given intravenously over Methylprednisolone Sodium Succinate for Injection, USP Page 7 of 42 a period of at least 30 minutes.
This large dose may be repeated every 4- 6 hours for up to 48 hours. • In other indications, initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated. Larger doses may be required for short-term management of severe, acute conditions.
, doses greater than 250 mg). Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. • Methylprednisolone Sodium Succinate in doses of 40 to 120 mg administered as retention enemas or by continuous drip three to seven times weekly for periods of two or more weeks have been shown to be a useful adjunct in the treatment of some patients with ulcerative colitis.
Many patients can be controlled with 40 mg of Methylprednisolone Sodium Succinate for Injection, USP administered in from 1 to 10 fluid ounces of water depending on the degree of involvement of the inflamed colonic mucosa. Other accepted therapeutic measures should, of course, be instituted.
3 Reconstitution Parenteral Products: DIRECTIONS FOR RECONSTITUTION USING THE FLIP-OFF VIALS 1. Remove the protective plastic flip-off seal. 2. Swab the rubber stopper with an antiseptic solution and introduce the required quantity of the diluent by means of a syringe into the vial.
3. Shake the vial thoroughly to dissolve the powder content. 4. Withdraw the dose in the usual manner with the help of a syringe Reconstitute with Sterile Water for Injection, or, if required, sterile Bacteriostatic Water for Injection as follows: Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
5 mg/mL Compatibility The compatibility and stability of Methylprednisolone Sodium Succinate for Injection, USP , in solutions and with other drugs in intravenous […]