COMPOSITIONS :
Methylprednisolone Sodium Succinate 125 mg Powder for Injection, each vial contains : Methylprednisolone sodium succinate equivalent to Methylprednisolone 125 mg.
DESCRIPTION :
Methylprednisolone Sodium Succinate with Methylprednisolone sodium succinate (equivalent to Methyprednisolone) as active ingredient is available in 125 mg and 500 mg powder for injection.
INDICATIONS :
- Endocrine disorders : Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency.
- Rheumatic disorders : As adjunctive therapy for short – term administration in : Post traumatic osteoarthritis, synovitis osteoarthritis, rheumatoid arthritis, acute and sub-acute bursitis; epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriasis arthritis and ankylosing spondylitis.
- Collagen diseases : During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematous, systemic dermatomyositis and acute rheumatic carditis.
- Dermatologic disease : Pemphigus, severe erythema multiform, exfoliate dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis and mycosis fungoides.
- Allergic states : Bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions.
- Gastrointestinal disease : To tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis.
- Neoplastic disease : For palliative management of leukemia and lymphomas in adults and acute leukemia of childhood.
- Edematous states : To induce diuresis or remission of proteinuria in the nephritic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
- Nervous system : Acute exacerbation of multiple sclerosis.
DOSAGE AND ADMINISTRATIONS :
Adult :
Administered by IM/IV : 10 – 40 mg (base), repeated as needed.
- For pulse therapy (large doses) : IV 30 mg (base)/kgBW administered minimum within 30 minutes. Doses can be repeated every 4 – 6 hours as needed.
- For acute exacerbation at double sclerosis : IM/IV : 160 mg (base) per day during a week. Followed by 64 mg everyday during a month.
- For acute vertebrae injury : IV 30 mg (base)/kgBW administered within 15 minutes, followed by 45 minutes infuse, 5.4 mg/kgBW/hour, during 23 hours.
- Additional therapy for patient with AIDS related to pneumocystis carinii : IV 30 mg (base) twice a day from first to fifth day, 30 mg once a day from sixth to tenth day, 15 mg once a day from eleventh to twenty first day.
Baby and children :
- Adrenocortical insufficiency : IM 117 mcg (0.117 mg) (base)/kgBW or 3.33 mg (base)/m2 body surface per day (in three divided dose) every third day or 39 – 58.5 mcg (0.039 – 0,0585 mg) (base) per kgBW or 1.11 – 1.66 mg (base)/m2 body surface once a day.
- For acute vertebrae injury : IV 30 mg (base)/kgBW administered within 15 minutes, followed by 45 minutes infuse 5.4 mg/kgBW/hour during 23 hours.
- Other indications : IM 139 – 835 mcg (0.139 – 0.835 mg) (base)/kgBW or 4.16 – 25 mg (base)/m2 body surface every 12 – 24 hours.
- Additional therapy for AIDS related to Pneumocystis carinii :
- Children age ≤ 13 years : No certain dose determined.
- Children > 13 years : Same with adult’s doses.
Reconstitution procedure of Methylprednisolone Sodium Succinate Powder for Injection :
Reconstitute powder by adding solvent (containing benzyl alcohol 0,9%), mix homogeneously. Direct IV can be given at least 1 min. After reconstitution, Methylprednisolone Sodium Succinate can be stored for up to 48 hours at temperature below 30ºC.
CONTRAINDICATIONS :
- Systemic fungal infection.
- Patients with known hypersensitivity to the product and the constituents.
- Premature babies : Providing long term in patients with duodenal ulcer, severe osteoporosis, patient with a history of psychosis, herpes, patient who were immunized.
WARNINGS AND PRECAUTIONS :
- Corticosteroids may mask some signs of infections, and new infections may appear during their use. The infection may be mild, but can be severe and at the time fatal.
- Prolonged use of corticosteroids may produce posterior sub capsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
- While on corticosteroids therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of the possible hazards of neurological complications and a lack of antibody response.
- Use in pregnancy : Since there is inadequate evidence of safety in human pregnancy, Methylprednisolone should be used in pregnancy only if clearly needed.
- There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
- Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
- Large doses of Methylprednisolone can cause elevation of blood pressure, water and salt retention, increasing of potassium and calcium excretion, and reducing body immune against fungal, bacterial, and viral infection.
DRUG INTERACTIONS :
- Mutual inhibition of metabolism and convulsion occurs with concurrent use of Cyclosporin and Methylprednisolone.
- Methylprednisolone may increase the clearance of chronic high dose Aspirin.
- Drugs that induce hepatic enzymes such as Phenobarbital, Phenytoin and Rifampicin may increase the clearance of Methylprednisolone and may require increase in Methylprednisolone dose to achieve the desire response.
- Drug such as Troleandomycin and Ketoconazole may inhibit the metabolism of Methylprednisolone and thus decrease it clearance.
- Patients who are on immunosuppressant of corticosteroids should be warned to avoid exposure be advised that if they are exposed, medical adviced should be sought without delay.
- Concomitant administration with Acetosal for hypoprothrombin patients should be monitored.
- Methylprednisolone effect to anticoagulant is various, usually is reducing anticoagulant effect.
- Have ever been reported the interaction with neuromuscular blocking agents such as: pancuronium which has partial reversible from neuromuscular block.
- Steroid can reduce anticolinesterase effect in myasthenia gravis. Increasing effect of hypoglycemic (included Insulin), anti hypertension, and diuretic antagonist. Increasing hypopotassemia of Acetazolamide, loop diuretic, thiazide diuretic, and Carbenoxolone.
- Vaccine and toxoid : Because of antibody response inhibition, this drug can cause reducing of toxoid response and inactivation vaccine (life vaccine).
- Anticholinesterase substance.
ADVERSE REACTIONS :
- Fluid and electrolyte disturbance : Sodium retention, fluid retention, congestive heart failure, potassium loss, hypopotassium alkalosis, hypertension.
- Musculoskeletal : Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, aseptic necrosis.
- Gastrointestinal : Abdominal distention, ulcerative esophagitis, peptic ulcer with possible perforation and hemorrhage, pancreatitis.
- Dermatologic : Impaired wound healing, thin fragile skin, facial erythema, increased sweating.
- Neurological : Increased intracranial pressure, convulsions, vertigo and headache.
- Endocrine : Menstrual irregularities, development of Cushingoid state, suppression of growth in children, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus and increased requirements for Insulin or oral hypoglycemic agents in diabetics.
- Ophthalmic : Posterior sub capsular cataracts, increased intraocular pressure, glaucoma and exophthalmoses.
- Metabolic : Negative nitrogen balance due to protein catabolism.
- Immune system : Injury covering, latent infection become active, opportunistic infection, hypersensitive reaction included anaphylaxis, can suppress reaction of skin test.
PRESENTATIONS :
Methylprednisolone Sodium Succinate Powder for Injection 125 mg
Box, 1 vial @ 125 mg + 1 ampoule solvent @ 2 ml Reg. No. GKL0902341744B1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
After reconstitution, Methylprednisolone Sodium Succinate can be stored for up to 48 hours at temperature below 30°C.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
