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Camelon 4/Camelon 8

Camelon 4/Camelon 8

methylprednisolone

Manufacturer:

Caprifarmindo

Marketer:

Caprifarmindo
Concise Prescribing Info
Contents
Methylprednisolone
Indications/Uses
Camelon 4 Endocrine, rheumatic, hematologic disorders; collagen, dermatologic, ophth, resp, neoplastic, GI diseases; allergic & edematous states; acute exacerbation of multiple sclerosis; TB meningitis w/ subarachnoid block, trichinosis w/ neurologic or myocardial involvement. Camelon 8 Bronchial asthma, allergic rhinitis, urticaria, eczema or dermatitis, acute rheumatic fever, RA, acquired (autoimmune) hemolytic anemia, ITP in adults, myeloblastosis, lymphogranulomatosis, ulcerative colitis, nephrotic syndrome, skin diseases, lupus erythematosus, dermatomyositis. Suppression of the immune response after transplantations. Adjuvant in treatment w/ cytostatic agents or in RT. Substitution in primary adrenocortical insufficiency & after adrenalectomy.
Dosage/Direction for Use
Camelon 4 Individualized dosage. Initial dose: 4-48 mg daily, depending on the specific disease. Multiple sclerosis 160 mg daily for a wk followed by 64 mg every other day for 1 mth. Alternate day therapy: Twice the usual daily dose every other morning. Camelon 8 Adult Initial dose: 4-80 mg daily. Maintenance dose: 4-8 mg daily, may be increased up to 16 mg daily. Childn Initial dose: 0.8-1.1 mg/kg. Maintenance dose: 2-4 mg daily, may be increased up to 8 mg daily. Adjuvant to mineralocorticoid therapy in Addison's disease Substitution dose: 4-8 mg in stressful situation, up to 16 mg daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to methylprednisolone or other glucocorticoids. Camelon 4 Systemic fungal infections. Administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. Camelon 8 Gastric ulcers, osteoporosis, psychiatric disorders, amebiasis, systemic mycosis infection, poliomyelitis, narrow or open-angle glaucoma & viral diseases.
Special Precautions
May produce subcapsular cataracts, glaucoma & enhance the establishment of fungi or virus infections. May mask signs of infection. Not to be discontinued abruptly but gradually. Increase dosage in patients w/ stressful situation. Patients should not receive smallpox or other high-dose vaccines. Monitor carefully patients w/ TB-latent or tuberculine reactivity. May inhibit growth & development w/ prolonged use in childn. Camelon 4 Allergic reactions (eg, angioedema) may occur. May increase susceptibility to infection, & new infections may appear during use. Hypothalamic-pituitary-adrenal suppression may occur in prolonged periods. Acute adrenal insufficiency may occur if w/drawn abruptly. W/drawal syndrome may occur following abrupt discontinuation. Avoid in patients w/ Cushing's disease. Increased blood glucose, worsen preexisting diabetes, & predispose to DM in those on long-term therapy. Psychic derangements may appear & may aggravate existing emotional instability or psychotic tendencies. Psychological symptoms may develop, especially if depressed mood or suicidal ideation is suspected; possible psychiatric disturbances may occur during or immediately after dose tapering or w/drawal. Seizure disorders; myasthenia gravis; corneal perforation in patients w/ ocular herpes simplex; CHF; thrombosis including VTE, HTN; non-specific ulcerative colitis; systemic sclerosis; suspected or identified pheochromocytoma. Epidural lipomatosis w/ long-term use at high doses. Central serous chorioretinopathy leading to retinal detachment. May predispose patients w/ existing CV risk factors to additional CV effects w/ high doses & prolonged courses. Acute pancreatitis w/ high doses. May mask the symptoms of peptic ulcer (perforation or hemorrhage may occur w/o significant pain); peritonitis or other signs or symptoms associated w/ GI disorders eg, perforation, obstruction or pancreatitis. Hepatobiliary disorders. Acute myopathy (w/ high doses) in patients w/ neuromuscular transmission disorders or those receiving concomitant therapy w/ anticholinergics. Creatine kinase elevations may occur. Elevation of BP, salt & water retention, & increased K excretion w/ large doses. Dietary salt restriction & K supplementation may be necessary. Increased Ca excretion. Not indicated for treatment of traumatic brain injury. Combination w/ aspirin & NSAIDs. May affect ability to drive & use machines. Renal insufficiency. May impair fertility. Risk of nuclear cataracts; raised intracranial pressure in infants & childn. Camelon 8 Patients w/ severe HTN & cardiac insufficiency. Carry out ophth control every 3 mth in long-term treatment. Re-examine blood & urine sugar values in diabetic patients. May potentiate glucocorticoid effects in patients w/ hypothyroid or hepatic cirrhosis. Not recommended for pregnant women & nursing mothers.
Adverse Reactions
Camelon 8 Moon face, trunk obesity, muscular weakness, HTN, osteoporosis, reduced glucose tolerance, DM, sex hormone secretion disorder, peptic ulcer, Ab response impairment, growth retardation in childn, glaucoma, cataract, thrombosis, pancreatitis; headache, vertigo, increased ICP w/ papilledema; electrolyte disturbance, fluid retention; dermatologic & immunologic disturbance.
Drug Interactions
Decreased clearance w/ ketoconazole & troleandomycin. Convulsions w/ cyclosporin. Camelon 4 Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors eg, antibacterial (INH), grapefruit juice, Ca antagonist (mibefradil), histamine H2 receptor antagonist (cimetidine), antiemetic (aprepitant, fosaprepitant), antifungal (itraconazole), Ca channel blocker (diltiazem), OCs (ethinylestradiol/norethindrone), immunosuppressants (ciclosporin, cyclophosphamide, tacrolimus), macrolide antibacterial (clarithromycin, erythromycin), antivirals (HIV-PIs). Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers eg, antitubercular antibiotic (rifampin, rifabutin), anticonvulsants (phenobarb, phenytoin, primidone, carbamazepine). May affect hepatic clearance w/ another CYP3A4 substrates eg, immunosuppressant (cyclophosphamide, tacrolimus). Potentially increased acetylation rate & clearance of INH. May reduce the effects of anticholinesterases in myasthenia gravis. May increase blood glucose conc of antidiabetic agents. May increase plasma conc w/ PIs (eg, indinavir, ritonavir). May induce metabolism of HIV-PIs. May exacerbate endocrine changes w/ aminoglutethimide-induced adrenal suppression. Increased incidence of GI bleeding & ulceration w/ NSAIDs. Decreased salicylate serum levels w/ high-dose aspirin. Acute myopathy w/ anticholinergics (eg, neuromuscular blocking drugs). Antagonism of the neuromuscular blocking effects of pancuronium & vecuronium. Enhanced efficacy of coumarin anticoagulants. Increased risk of hypokalemia w/ K-depleting agents (eg, diuretics), amphotericin B, xanthines, or β2 agonists. Camelon 8 May potentiate/increase glycoside effect w/ cardiac glycosides. May potentiate/increase K-depleting effect w/ diuretics. Reduced hypoglycaemic effect of antidiabetic agents & anticoagulant effect of coumarin derivatives. Reduced corticosteroid effect w/ rifampicin, phenytoin or barbiturates. May potentiate/increase clearance of chronic high-dose acetosal.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Camelon 4 tab 4 mg
Packing/Price
10 × 10's
Form
Camelon 8 tab 8 mg
Packing/Price
10 × 10's (Rp330,000/boks)
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