ContentSIMDROL - 4 Tablet : Each tablet contains Methylprednisolone 4 mg.
SIMDROL - 125 Injection : Each vial contains Methylprednisolone sodium succinate 179 mg sterile buffer equivalent to Methylprednisolone 125 mg.
Indication- Collagen disease: Systemic Lupus Erythematosus (SLE), acute cardiac rheumatism, systemic dermatomyositis (polymyositis)
- Allergic diseases: annual or seasonal allergic rhinitis, contact dermatitis, atopic dermatitis, bronchial asthma.
- Certain skin disorders: exfoliative dermatitis, bullous herpetiform dermatitis, severe inflammatory dermatitis, Stevens-Johnson syndrome, psoriasis.
- Certain endocrine disorders: adrenocortical insufficiency (combined with mineralocorticoids).
- Rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, acute or sub-acute bursitis, acute gouty arthritis, post-traumatic osteoarthritis.
- Acute and chronic inflammation: Allergic conjunctivitis, keratitis, optic neuritis, corloretinitis, iridocyclitis, sympathetic ophthalmia, posterior uveitis difussion, posterior choloiditis diffusion.
- Haematological abnormalities: hemolytic anemia (autoimmune), congenital hipoplastic anemia (erythroid), red blood cell anemia (erythoblastopenia), secondary trombocytopenia (in adults), idiopathic purpurea thrombocytopenia in adults (i.v, contraindicated if i.m)
- Ulcerative colitis and regional enteritis (Crohn's disease).
- Leukemia and lymphoma in adult patients; acute leukemia in children.
- Nephrotic syndrome.
- Organ transplant rejection
Contra IndicationHypersensitivity, Tberculosis, systemic fungal infections, vaccinia or varicella, herpes simplex keratitis, peptic ulcer, Cushing's syndrome, acute psychosis, recent vaccination.
ADULT: 4-48 mg/day depending on the type and severity of the illness and response of the patient. Multiple sclerosis 160 mg/day for 1 week, with 64 mg/day for 1 month.
ADULT: i.m or i.v 10-40 mg (base) is repeated as needed.
- For high doses (pulse therapy): i.v 30 (base) mg/kgBB is given at least 30 minutes. Dosage can be repeated every 4-6 hours as needed.
- For acute exacerbations in multiple sclerosis: i.m or i.v 160 mg (base) mg/day for 1 week followed 64 mg/day for 1 month.
- For treatment of acute spinal injury: i.v 30 (base) mg/kgBB administered for 15 minutes followed 45 minute infusion, 5.4 mg/kgBW/hour for 23 hours.
- For additional treatment of AIDS associated with pneumocystis carinii: i.v 30 mg (base) twice a day from first day until fifth day, 30 mg once daily on day six to ten, 15 mg once daily on day eleven to twenty one.
BABY AND CHILDREN
- Adrenocortical insufficiency: i.m 117 μg (0.117 mg) (base) /kgBB or 3.33 mg (base) /m2 daily body surface (in divided three doses ) every third day or 39 - 58.5 μg (0.039 - 0,0585 mg) (base) /kgBB or 1.11 - 1.66 mg (base) /m2 body surface once daily.
- For treatment of acute spinal injury: i.v 30 mg (base) /kgBB administered for 15 minutes, followed for 45 minutes with infusion 5.4 mg/kgBW/hour, for 23 hours.
- Other indications: i.m 139 - 835 μg (0.139 - 0.835 mg) (base) /kgBB or 4.16 - 25 mg (base) /m2 body surface every 12 - 24 hours.
- For additional treatment of AIDS associated with pneumocystis carinii: Children <13 years old : dose not yet determined. Children >13 years old: same as adult dose.
AttentionShould be taken with food
Special Precaution- Patients receiving corticosteroid therapy or in stressful conditions.
- May mask any signs of infections.
- Avoid vaccination during treatment.
- Prolonged use.
- Avoid abrupt withdrawal.
- Infants, children.
- Pregnancy & lactation.
Adverse ReactionProlonged use may cause moon face, fatty deposits in some body parts, muscle weakness, hipertension, osteoporosis, reduced glucose tolerance, impaired sex hormone secretion, striae, petechiae, acne, edema, hypokalemia, atrophy of adrenal cortex, vasculitis, peptic ulcer, reduced body immunity, delayed wound healing, growth retardation in children, glaucoma, cataract, thrombosis, psychosis, allergic reactions, congestive heart failure, Natrium retention.
Drug InteractionCardiac glycosides, cyclosporine, phenobarbital, phenytoin, rifampicin, troleandomycin, ketoconazole, anticoagulant, asetosal, neuromuscular blocking agent (pancuronium), insulin, antihypertensives, diuretic antagonist, acetazolamide, loop & thiazide diuretic, carbenoxolone.
Presentation/PackingSIMDROL - 4 mg Tablet : Box, 10 strip @10 tablet.
SIMDROL - 125 mg Injection : Box, 1 vial @125 mg methylprednisolone (dry) and 1 ampul @2 ml solvent.