M-prednisolone

M-prednisolone

methylprednisolone

Manufacturer:

Able Medical

Distributor:

Universal Medical Industry

Marketer:

Able Medical
Concise Prescribing Info
Contents
Methylprednisolone Na succinate
Indications/Uses
Primary or secondary adrenocortical insufficiency; acute adrenocortical insufficiency; shock secondary to adrenocortical insufficiency, or shock unresponsive to conventional therapy; pre-op or in serious trauma or illness; congenital adrenal hyperplasia; non-suppurative thyroiditis; hypercalcemia associated w/ cancer. Adjunctive therapy for short-term administration in management of acute episode or exacerbation of rheumatic disorders. Collagen & immune complex diseases or as maintenance therapy in selected cases eg, SLE; acute rheumatic carditis; polymyositis. Dermatologic diseases eg, pemphigus; Stevens-Johnson syndrome; exfoliative dermatitis; severe psoriasis; bullous dermatitis herpetiformis; severe seborrheic dermatitis; mycosis fungoides. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Severe acute & chronic allergic & inflammatory processes involving the eye. Management of ulcerative colitis, regional enteritis. Symptomatic sarcoidosis; berylliosis; fulminating or disseminated TB when used concurrently w/ appropriate antituberculous chemotherapy; Loeffler's syndrome unmanageable by other means; aspiration pneumonitis; adjunctive therapy to moderate to severe Pneumocystis jiroveci pneumonia in AIDS patients when given w/in 1st 72 hr of anti-pneumocystis treatment. Acquired hemolytic anemia; idiopathic thrombocytopenic purpura & secondary thrombocytopenia in adults; erythroblastopenia; congenital hypoplastic anemia. Palliative management of leukemias & lymphomas in adults; acute leukemia of childhood. Induce diuresis or remission of proteinuria in nephrotic syndrome, w/o uremia in edematous states. Acute exacerbations of multiple sclerosis. Tuberculous meningitis w/ subarachnoid or impending block when used concurrently w/ appropriate chemotherapy; trichinosis w/ neurologic or myocardial involvement.
Dosage/Direction for Use
IV/IM Adjunctive therapy in life-threatening conditions 30 mg/kg IV over a period of at least 30 min. May be repeated every 4-6 hr for up to 48 hr. Rheumatic disorders unresponsive to standard therapy (or during exacerbation) 1 g daily for 1-4 days, or 1 g mthly for 6 mth as IV pulse dosing over at least 30 min. SLE unresponsive to standard therapy (or during exacerbation) 1 g daily for 3 days as IV pulse dosing over at least 30 min. May be repeated if no improvement w/in 1 wk after therapy. Multiple sclerosis unresponsive to standard therapy (or during exacerbation) 1 g daily for 3 or 5 days as IV pulse dosing over at least 30 min. May be repeated if no improvement w/in 1 wk after therapy. Edematous states eg, glomerulonephritis or lupus nephritis, unresponsive to standard therapy (or during exacerbation) 30 mg/kg every other day for 4 days, or 1 g daily for 3, 5 or 7 days as IV pulse dosing over at least 30 min. May be repeated if no improvement w/in 1 wk after therapy. Terminal cancer (to improve quality of life) 125 mg daily IV for up to 8 wk. Prevention of nausea & vomiting associated w/ cancer chemotherapy for mild to moderately emetogenic chemotherapy 250 mg IV over at least 5 min 1 hr before start of chemotherapy. Repeat dose at initiation of chemotherapy & at time of discharge. May use in combination w/ chlorinated phenothiazine at 1st dose; severely emetogenic chemotherapy 250 mg IV over at least 5 min in combination w/ metoclopramide or butyrophenone 1 hr before start of chemotherapy. Repeat dose at initiation of chemotherapy & at time of discharge. Acute spinal cord injury Initiate treatment w/in 8 hr of injury. Patient initiated on treatment w/in 3 hr of injury 30 mg/kg as IV bolus over 15-min period followed by 45-min pause, then continuous IV infusion of 5.4 mg/kg/hr for 23 hr; patient initiated on treatment w/in 3-8 hr of injury 30 mg/kg as IV bolus over 15-min period followed by 45-min pause, then continuous IV infusion of 5.4 mg/kg/hr for 47 hr. Pneumocystis jiroveci pneumonia in patient w/ AIDS Initiate therapy w/in 72 hr of initial anti-pneumocystis treatment. Administer 40 mg IV every 6-12 hr w/ gradual tapering over max of 21 days or until end of pneumocystis therapy. Adjunctive therapy Initially 10-500 mg IV, depending on clinical condition. Initiate up to 250 mg IV over at least 5-min period, or 30-min period for larger doses, then subsequent dose may administer IV or IM at intervals depending on patient's response. Ped Not <0.5 mg/kg every 24 hr.
Contraindications
Hypersensitivity. Patients w/ systemic fungal infections. Intrathecal & epidural route of administration. Live or live attenuated vaccines.
Special Precautions
Not to be administered large doses IV push. Not to be used in patient w/ GI disease, diabetes, TB & viral infection; for traumatic brain injury. Skin reactions & anaphylactic/anaphylactoid reaction; history of allergy to any drug. Discontinue use if acute pancreatitis occurs. Not to administer live or live attenuated vaccines in patients receiving immunosuppressive dose of corticosteroids. Increased susceptibility to infection. Reactivation of latent TB or tuberculin reactivity; hypothalamic-pituitary suppression; increased blood glucose; worsened preexisting diabetes & predisposed to DM; epidural lipomatosis; acute myopathy during prolonged therapy & high doses. Active, fulminating or disseminated TB; Kaposi's sarcoma. Osteoporosis associated w/ long-term use of large dose of glucocorticoid. Pheochromocytoma crisis. May mask signs of infection; peptic ulcer symptoms. Not recommended in septic shock. Patients w/ Cushing's disease; hypothyroidism; seizure disorders; myasthenia gravis; ocular herpes simplex; existing CV risk factors; HTN; non-specific ulcerative colitis. Cardiac arrhythmias, circulatory collapse, cardiac arrest; bradycardia; CHF; thrombosis including venous thromboembolism. Psychic derangements. Retinal detachment. Increased creatine kinase; Ca & K excretion. Elevated BP, salt & water retention. W/drawal syndrome. Avoid abrupt w/drawal. Combination w/ other immunosuppressive agents; aspirin & NSAIDs. Concomitant use w/ anticholinergics eg, pancuronium. May affect ability to drive & use machines. Renal insufficiency. Pregnancy & lactation. Premature & low birth wt infants. Increased risk of intracranial pressure in infants & childn on prolonged therapy; pancreatitis on high doses. Gasping syndrome in childn. Childn <2 yr.
Adverse Reactions
Opportunistic infection, infection; leukocytosis; drug hypersensitivity including anaphylactic & anaphylactoid reaction; Cushingoid, hypopituitarism, steroids w/drawal syndrome; lipomatosis, Na & fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance; increased oral hypoglycemics in diabetics, negative nitrogen balance; increased blood urea & appetite; affective, psychotic & mental disorder, personality change, confusional state, anxiety, mood swings, abnormal behaviour, insomnia, irritability; epidural lipomatosis, increased intracranial pressure w/ papilloedema, convulsion, amnesia, cognitive disorder, dizziness, headache; central serous chorioretinopathy, cataract, glaucoma, exophthalmos; vertigo; congestive cardiac failure, arrhythmia; thrombosis, HTN, hypotension; pulmonary embolism, hiccups; peptic ulcer w/ possible perforation & haemorrhage, intestinal perforation, gastric haemorrhage, pancreatitis, peritonitis, ulcerative oesophagitis, oesophagitis, abdominal distention & pain, diarrhoea, dyspepsia, nausea; hepatitis; angioderma, peripheral oedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae, rash, pruritus, urticaria, acne, skin hypopigmentation; muscle weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fractures, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; impaired healing, fatigue, malaise, inj site reaction; increased urine Ca, IOP, ALT, AST & blood alkaline phosphatase, decreased blood K & carbohydrate tolerance, skin tests suppression; spinal compression fracture, tendon rupture.
Drug Interactions
Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors. Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers. Affected hepatic clearance w/ another CYP3A4 substrate. Increased acetylation rate & clearance of INH. Enhanced or diminished effects of anticoagulants. Concomitant use w/ anticholinergics eg, neuromuscular blockers. Antagonism of neuromuscular blocking effects of pancuronium & vecuronium. Reduced effects of acetylcholinesterase. Increased blood glucose conc w/ antidiabetics. Increased plasma conc w/ PIs eg, indinavir, ritonavir. Reduced plasma conc of HIV-PIs. Exacerbated endocrine changes w/ aminoglutethimide. Increased plasma conc; convulsions w/ cyclosporine. Increased incidence of GI bleeding & ulceration w/ NSAIDs. Increased clearance of high-dose aspirin. Increased risk of hypokalemia w/ diuretics, amphotericin B, xanthenes, or β2 agonist.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
M-prednisolone powd for soln for inj 1 g
Packing/Price
1's
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/thailand/image/info/m-prednisolone powd for soln for inj 1 g/15-6 ml?id=ab200f64-39e9-4153-9bab-adc200fbf601
Form
M-prednisolone powd for soln for inj 2 g
Packing/Price
1's
/thailand/image/info/m-prednisolone powd for soln for inj 2 g/2 g-vial?id=17014372-4224-43b4-b475-adc6009490fb
/thailand/image/info/m-prednisolone powd for soln for inj 2 g/31-2 ml?id=0c5ac153-e90c-476c-9579-adc6009490fb
Form
M-prednisolone powd for soln for inj 500 mg
Packing/Price
1's
/thailand/image/info/m-prednisolone powd for soln for inj 500 mg/7-8 ml?id=844aad23-890d-4da6-8ab5-adc200fbf642
/thailand/image/info/m-prednisolone powd for soln for inj 500 mg/500 mg-vial?id=b8c210ca-c431-4efb-ac31-adc200fbf642
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