Vaxcel Methylprednisolone

Vaxcel Methylprednisolone



Kotra Pharma


Kotra Pharma
Concise Prescribing Info
Methylprednisolone Na succinate
Adjunctive therapy for short-term management of post-traumatic OA, synovitis or OA, RA (eg, juvenile RA), acute & subacute bursitis, epicondylitis, acute nonspecific tenosynovitis & gouty arthritis, psoriatic arthritis, ankylosing spondylitis. Exacerbation or maintenance therapy of SLE, acute rheumatic carditis, systemic dermatomyositis, polyarteritis nodosa, Goodpasture syndrome. Dermatologic, ophth, GI & resp diseases; allergic, edematous & shock states; hematologic, endocrine disorders & nervous system disorders. Palliative management of oncological diseases. Immunosuppressive treatment in organ transplantation.
Dosage/Direction for Use
Adjunctive therapy in life-threatening conditions 30 mg/kg IV over at least 30 min, may be repeated every 4-6 hr up to 48 hr. Unresponsive rheumatic disorders or during exacerbation episodes 1 g daily for 1-4 days or 1 g mthly for 6 mth as IV pulse dosing over at least 30 min. Unresponsive SLE or during exacerbation episodes 1 g daily for 3 days as IV pulse dosing over at least 30 min. Unresponsive multiple sclerosis or during exacerbation episodes 1 g daily for 3 or 5 days as IV pulse dosing over at least 30 min. Prevention of chemotherapy-associated nausea & vomiting 250 mg IV over at least 5 min 1 hr prior to, during initiation & after chemotherapy. Mild to moderately emetogenic chemotherapy 1st dose may be used w/ chlorinated phenothiazine for increased effect. Severely emetogenic chemotherapy May be given w/ metoclopramide or butyrophenone. Acute spinal cord injury 30 mg/kg as IV bolus over 15-min followed by 45-min pause & continuous IV infusion of 5.4 mg/kg/hr for 23 hr w/in 3 hr of injury & for 47 hr w/in 3-8 hr of injury. Adjunctive therapy in other indications Initially 10-500 mg IV depending on clinical condition. Initial doses up to 250 mg should be administered over at least 5 min; larger doses should be administered over at least 30 min. Childn Not <0.5 mg/kg every 24 hr.
Hypersensitivity. Intrathecal route. Systemic fungal infections, cerebral edema in malaria. Concomitant use w/ live or live, attenuated vaccines.
Special Precautions
Allergic reactions. Not to be used for management of head injury or stroke & in septic syndrome or shock. Avoid use in patients w/ Cushing's disease & exposure to measles or close personal contact w/ chickenpox or herpes zoster. Known or suspected parasitic infections eg, Strongyloides (threadworm) infestation; latent TB or tuberculin reactivity; Kaposi's sarcoma; hypothalamic-pituitary adrenal suppression; unusual stress; acute pancreatitis; osteoporosis (particularly postmenopausal females). Patients w/ hypothyroidism; DM; existing or previous history of severe affective disorder; seizure disorders, epilepsy, myasthenia gravis; glaucoma, ocular herpes simplex; existing CV risk factors, CHF or recent MI; HTN; ulcerative colitis, perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses. Menstrual irregularities. May mask signs of infections & symptoms of peptic ulcer. Dietary salt restriction & K supplement. High-dose & long-term use. Avoid abrupt w/drawal. Concomitant use w/ aspirin & NSAIDs; digoxin. May affect ability to drive & use machines. Renal insufficiency. Pregnancy & lactation. Monitor growth & development of infants & childn. Elderly.
Adverse Reactions
Infection; Cushingoid; Na & fluid retention; psychiatric disorders; posterior subcapsular cataracts; HTN; peptic ulcer; peripheral oedema, ecchymosis, skin atrophy, acne; growth retardation (in childn), osteoporosis, muscular weakness; impaired wound healing; decreased blood K.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, troleandomycin, INH, grapefruit juice, PIs eg, indinavir, ritonavir. Decreased plasma conc w/ CYP3A4 inducers eg, rifampin, phenobarb, phenytoin. Increased/decreased plasma conc w/ CYP3A4 inihibitors (eg, aprepitant, fosaprepitant, itraconazole, ketoconazole, diltiazem, OCs, clarithromycin, erythromycin), inducers (eg, carbamazepine), substrates (eg, cyclosphosphamide, tacrolimus). Convulsions w/ ciclosporin. Enhanced/diminished effects of oral anticoagulants. Increased incidence of GI bleeding & ulceration w/ NSAIDs. Increased clearance of high-dose aspirin. Acute myopathy w/ high-dose anticholinergics eg, neuromuscular-blocking drugs. Antagonised neuromuscular-blocking effects of pancuronium & vecuronium. Increased blood glucose conc w/ antidiabetics. Hypokalemia w/ K-depleting agents eg, diuretics, amphotericin B, β2-agonists, xanthenes; cardiac glycosides. Antagonized effects of diuretics, antihypertensives. Reduced effects by mifepristone. Incompatibility w/ allopurinol Na, doxapram HCl, tigecycline, Ca gluconate, 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.
Vaxcel Methylprednisolone powd for inj 1 g
10 × 1's
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