SOLOMED
METHYLPREDNISOLONE SODIUM SUCCINATE · by PHARMASOL
Composition
Inj 40 mg/125 mg/500 mg/1 gm: Methylprednisolone (as sodium succinate) 40 mg/12 5 mg/500 mg/ 1 gm; powder in vials, and solvent.
Indications & Dosage
Suppression of inflammatory and allergic disorders, Cerebral oedema associated with malignancy: BY IM INJ, OR BY SLOWIV INF: Adult: Initially 10-500 mg; Children1 month-18 yrs: 0.5-1.7 mg/kg daily in 2-4 divided doses depending on condition and response. Treatment of graft rejection reactions: BY IV INF: Adult: Up to 1 g daily for up to 3 days. BY IV INJ: Children: 1 month -18 yrs:10-20 mg/kg or 400-600 mg/square meter (max. 1 gm), once daily for 3 days. Anti-inflammatory or allergic disorder, Immunosuppressive: BY IM inj: Adult: 10-80 mg/ day once daily. BY IV inj: Adult: 10-40 mg over a period of several minutes and repeated IV or IM at intervals depending on clinical response; when high dosages are needed, give 30 mg/kg over a period 30 minutes or more and may be repeated every 4-6 hr for 48 hr. Asthma exacerbations, including status asthmaticus: BY IV INJ: Adult: 40-80 mg/day in 1- 2 divided doses until peak expiratory flow is 70% of predicted or personal best. Dermatomyositis, Polymyositis: BY IV INJ: Adult: 1 gm/day for 3-5 days for severe muscle weakness, followed by conversion to oral prednisone. Lupus nephritis: BY IV INJ: Adult: 0.5-1 gm/day for 3 days. Pneumocystis pneumonia in AIDS patients: BY IV INJ: Adult: 30 mg twice daily for 5 days, then 30 mg once daily for 5 days, then 15 mg once daily for 11 days. Severe erythema multiforme, lupus nephritis, systemic onset juvenile idiopathic arthritis: BY IV INJ: Children: 1 month -18 yrs:10-30 mg/kg (max 1 gm) once daily or on alternate days for up to 3 doses.
Administration
Only sodium succinate may be given IV. Methylprednisolone sodium succinate is highly soluble and has a rapid effect by IM and IV routes. Methylprednisolone sodium succinate may be administered IM or IV Inject IM form deep into gluteal muscle.
Compatibility
Stable in D5W, NS, incompatible with D51/2NS. .
Stability
Intact vials should be stored at controlled room temperature. Reconstituted solution- should be stored at room temperature and use within 48 hours. Stability of par-enteral admixture at room temperature and at refrigeration temperature is 48 hours.
Contraindications
Systemic fungal infections unless specific anti-infective therapy is used, head injury, stroke.
Precautions
Active infections not controlled by antibiotics, latent or active amoebiasis, history of TB, septicaemia, symptoms may be masked, avoid or maintain extreme cautions in chickenpox, measles, psychiatric disorders, renal impairment, hepatic failure, cirrhosis, active peptic ulcer, myasthenia gravis, previous steroid myopathy, osteoporosis, epilepsy, hypothyroidism, diabetes, adrenal suppres-sion, hypertension, recent MI, congestive heart failure, thromboembolic disorders, glaucoma, corneal perforation. Withdraw gradually, withdrawal symp-toms may include fever, myalgia, arthralgia, rhinitis, itchy skin nodules and weight loss.
Interactions
Live vaccines or other vaccines, anticoagulants, hypoglycaemia agents, antihypertensives, diuretics, erythromycin, rifamycin, amphotericin, azole antifungals, ritonavir, cyclosporin, cardiac glycosides, Oestrogens including oral contraceptives, somatropin, Carbamazepine, phenytoin, primicane, barbiturates. Muscle relaxants, NSAIDs, salicylates, sympathomimetics, mifepristone, methotrexate, theophylline, aprepitant.
Pregnancy
Caution advised
Lactation
Caution advised
Side Effects
Endocrine irregularities including menstrual problems, cushingoid state, adrenal suppression, growth suppression in children, increased susceptibility to infection, increased severity of infection, fluid/electrolyte disturbance, hypertension, negative protein, nitrogen and calcium balance, myopathy, tendon rupture, osteoporosis, osteonecrosis and fractures, impaired wound healing, sweating, hirsutism, striae, telangiectasia, acne, GI disturbance, peptic ulceration, acute pancreatitis, candidiasis, psychiatric effects, neurological effects, insomnia, diabetes, impaired glucose tolerance, weight gain, increased appetite, ocular disturbances including cataracts, raised in-traocular pressure, optic nerve damage, corneal changes, glaucoma, thromboembolism, leukocytosis.