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Sunday, February 7, 2016
When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, A-Methapred (methylprednisolone sodium succinate) sterile powder is indicated for intravenous or intramuscular use in the following conditions:
- Endocrine Disorders
- Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance)
- Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)
- Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful
- Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected
- Congenital adrenal hyperplasia
- Hypercalcemia associated with cancer
- Nonsuppurative thyroiditis
- Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:- Post-traumatic osteoarthritis
- Synovitis of osteoarthritis
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
- Acute and subacute bursitis
- Epicondylitis
- Acute nonspecific tenosynovitis
- Acute gouty arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:- Systemic lupus erythematosus
- Systemic dermatomyositis (polymyositis)
- Acute rheumatic carditis
- Dermatologic Diseases
- Pemphigus
- Severe erythema multi-forme (Stevens-Johnson syndrome)
- Exfoliative dermatitis
- Bullous dermatitis herpetiformis
- Severe seborrheic dermatitis
- Severe psoriasis
- Mycosis fungoides
- Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:- Bronchial asthma
- Contact dermatitis
- Atopic dermatitis
- Serum sickness
- Seasonal or perennial allergic rhinitis
- Drug hypersensitivity reactions
- Urticarial transfusion reactions
- Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)
- Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:- Herpes zoster ophthalmicus
- Iritis, iridocyclitis
- Chorioretinitis
- Diffuse posterior uveitis and choroiditis
- Optic neuritis
- Sympathetic ophthalmia
- Anterior segment inflammation
- Allergic conjunctivitis
- Allergic corneal marginal ulcers
- Keratitis
- Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:- Ulcerative colitis (systemic therapy)
- Regional enteritis (systemic therapy)
- Respiratory Diseases
- Symptomatic sarcoidosis
- Berylliosis
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
- Loeffler's syndrome not manageable by other means
- Aspiration pneumonitis
- Hematologic Disorders
- Acquired (autoimmune) hemolytic anemia
- Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)
- Secondary thrombocytopenia in adults
- Erythroblastopenia (RBC anemia)
- Congenital (erythroid) hypoplastic anemia
- Neoplastic Diseases
For palliative management of:- Leukemias and lymphomas in adults
- Acute leukemia of childhood
- Edematous States
- To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupuserythematosus
- Nervous System
- Acute exacerbations of multiple sclerosis
- Miscellaneous
- Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
- Trichinosis with neurologic or myocardial involvement
A-Methapred (methylprednisolone sodium succinate for injection, USP) sterile powder contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble inacetone.
The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxo-propoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6a, 11ß), and the molecular weight is 496.53.
The structural formula is represented below:
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Methylprednisolone sodium succinate is so extremely soluble in water that it may be administered in a small volume of diluent and is especially well suited for intravenous use in situations in which high blood levels of methylprednisolone are required rapidly.
A-Methapred (methylprednisolone sodium succinate) is available in several strengths and packages for intravenous or intramuscular administration.
40 mg Single-Dose Vial- Each mL (when mixed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate anhydrous; 25 mg lactose anhydrous; 8.8 mg benzyl alcohol added as preservative.
125 mg Single-Dose Vial- Each 2 mL (when mixed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate anhydrous; 17.6 mg benzyl alcohol added as preservative.
When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL, 0.40 osmolar; (Isotonic saline = 0.28 osmolar).
IMPORTANT- Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting A-Methapred (methylprednisolone sodium succinate)
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