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Solu-Medrol

Solu-Medrol

methylprednisolone

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Methylprednisolone Na succinate
Indications/Uses
Adjunct therapy for short-term management of acute episode or exacerbation of post-traumatic OA, synovitis of OA, RA (eg, juvenile RA), acute & subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty & psoriatic arthritis, ankylosing spondylitis. Exacerbation or maintenance therapy of SLE & lupus nephritis, acute rheumatic carditis, systemic dermatomyositis (polymyositis), polyarteritis nodosa, Goodpasture's syndrome. Dermatologic, ophth, GI (management of critical disease periods), resp & neoplastic (palliative management) diseases; allergic & edematous states; endocrine, hematologic & nervous system disorders. TB meningitis w/ subarachnoid block or impending block (when used concurrently w/ appropriate anti-TB chemotherapy); trichinosis w/ neurologic or myocardial involvement; organ transplantation. Prevention of nausea & vomiting associated w/ cancer chemotherapy.
Dosage/Direction for Use
IV inj or infusion/IM Individualized dosage. Adjunctive therapy in life-threatening conditions 30 mg/kg IV over at least 30 min, may be repeated 4-6 hrly for up to 48 hr. Exacerbation episodes or conditions unresponsive to standard therapy eg, rheumatic disorders, SLE, edematous states (eg, glomerulonephritis or lupus nephritis) ≥250 mg IV pulses daily for a few days, usually ≤5 days. Multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes) 500 mg or 1 g daily for 3 or 5 days as IV pulse over 30 min. Adjunctive therapy in other conditions Initially 10-500 mg IV depending on clinical condition. Administer initial doses up to 250 mg over at least 5 min & larger doses over at least 30 min. May administer subsequent doses at intervals according to patient's response & clinical condition. Ped Not <0.5 mg/kg 24 hrly.
Contraindications
Hypersensitivity to methylprednisolone or cow's milk. Systemic fungal infections. Intrathecal & epidural route. Co-administration w/ live or live attenuated vaccines.
Special Precautions
Allergic reactions may occur. Discontinue use if Kaposi's sarcoma is suspected. Not to be used in patients w/ spreading fungal infection unless necessary; to treat traumatic brain injury. Not recommended in septic shock. Avoid use in patients w/ Cushing's syndrome. Restrict use in cases of fulminating or disseminated TB. Severe medical events w/ intrathecal/epidural administration. Unusual stress; psychiatric effects; acute pancreatitis; osteoporosis; BP elevation; pheochromocytoma crisis. Increased susceptibility to infection; Ca excretion; blood glucose, worsen pre-existing diabetes, & predispose those on long-term corticosteroid therapy to DM. Hypothalamic-pituitary adrenal axis suppression (secondary adrenocortical insufficiency) w/ prolonged use. Epidural lipomatosis w/ long-term use at high doses. May mask some signs of infections, exacerbate existing infection & increase the risk of reactivation or exacerbation of latent & new infections; symptoms of peptic ulcer, peritonitis, or GI disorders (eg, perforation, obstruction, pancreatitis). Tumor lysis syndrome in patients w/ malignancies, including hematological malignancies & solid tumors following use of systemic corticosteroids alone or in combination w/ other chemotherapeutics. Acute myopathy w/ high doses in patients w/ neuromuscular transmission disorders (eg, myasthenia gravis) or those on anticholinergics eg, neuromuscular blockers (eg, pancuronium). Cases of rhabdomyolysis. Patients w/ hypothyroidism; seizure disorders; myasthenia gravis; ocular herpes simplex (due to possible corneal perforation); posterior subcapsular & nuclear cataracts (particularly in childn), exophthalmos or increased IOP; central serous chorioretinopathy; existing CV risk factors, CHF; thromboembolic disorders, HTN; non-specific ulcerative colitis; systemic sclerosis; peptic or intestinal ulcer, diabetes, TB, viral infection. Monitor for development of infection & consider w/drawal of therapy or dose reduction. Closely observe patients w/ latent TB or tuberculin reactivity for possible reactivation. Dietary salt restriction & K supplementation may be necessary. Avoid abrupt w/drawal. Not to be used w/ live or live, attenuated vaccines. Concomitant use w/ aspirin & NSAIDs; neuromuscular-blocking drugs eg, pancuronium. May affect ability to drive & use machines. Renal insufficiency. Hepatobiliary effects. May impair fertility. Pregnancy & lactation. Not to be used in childn <2 yr (due to benzyl alcohol content). High doses may produce pancreatitis in childn. Premature & low-birth wt infants, growth suppression in childn.
Adverse Reactions
Oportunistic infection, peritonitis (may be the primary sign or symptom of GI disorder eg, perforation, obstruction or pancreatitis); leukocytosis; drug hypersensitivity, anaphylactic & anaphylactoid reaction; cushingoid, hypothalamic pituitary adrenal axis suppression, steroid w/drawal syndrome; metabolic acidosis, Na & fluid retention, hypokalaemic alkalosis, dyslipidaemia, impaired glucose tolerance, increased insulin requirement (or oral hypoglycemics in diabetics), lipomatosis, increased appetite (may result in increased wt); affective (eg, depressed & euphoric mood, affect lability, drug dependence, suicidal ideation), psychotic (eg, mania, delusion, hallucination, & schizophrenia), mental & cognitive disorder, personality change, confusional state, anxiety, mood swings, abnormal behaviour, insomnia, irritability; epidural lipomatosis, increased ICP [w/ papilloedema (benign intracranial HTN)], seizure, amnesia, dizziness, headache; chorioretinopathy, cataract, glaucoma, exophthalmos; vertigo; congestive cardiac failure in susceptible patients, arrhythmia; thrombosis, HTN, hypotension, flushing; pulmonary embolism, hiccups; peptic ulcer (w/ possible perforation & haemorrhage), intestinal perforation, gastric haemorrhage, pancreatitis, ulcerative oesophagitis, oesophagitis, abdominal distention & pain, diarrhoea, dyspepsia, nausea; hepatitis (w/ IV administration); angioedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae, rash, pruritus, urticaria, acne, skin hypopigmentation, panniculitis; muscular weakness, myalgia, myopathy, rhabdomyolysis, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; impaired wound healing, peripheral oedema, fatigue, malaise, inj site reaction; increased IOP, urine Ca, ALT, AST, blood alkaline phosphatase & urea; decreased carbohydrate tolerance, blood K; suppression of reactions to skin tests; spinal compression & tendon rupture.
Drug Interactions
Altered glucocorticoid metabolism by induction (upregulation) or inhibition of CYP3A4 enzyme. Decreased hepatic clearance w/ CYP3A4 inhibitor. Increased hepatic clearance by CYP3A4 inducers. Increased acetylation rate & clearance of INH. Diminished or enhanced effects of oral anticoagulants. Antagonised neuromuscular blocking effects of pancuronium, vecuronium. Reduced effects of anticholinesterases in myasthenia gravis. Increased blood glucose conc w/ antidiabetics. Increased plasma conc by PIs. Induced metabolism of HIV PIs. Exacerbated endocrine changes w/ aminoglutethimide w/ prolonged use. Convulsions w/ cyclosporine. Increased GI bleeding & ulceration w/ NSAIDs. Increased high-dose aspirin clearance. Increased risk of hypokalemia w/ K-depleting agents. Incompatibility w/ allopurinol Na, doxapram HCl, tigecycline, diltiazem HCl, Ca gluconate, vecuronium Br, rocuronium Br, cisatracurium besylate, glycopyrrolate, propofol.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
D07AA01 - methylprednisolone ; Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Form
Solu-Medrol Act-O-Vial 125 mg/2 mL
Packing/Price
1's
Form
Solu-Medrol Act-O-Vial 40 mg/mL
Packing/Price
1's
Form
Solu-Medrol powd for inj 1000 mg/16 mL
Packing/Price
1's
Form
Solu-Medrol powd for inj 500 mg/8 mL
Packing/Price
1's
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