"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
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
- Acute nonspecific tenosynovitis
- Acute gouty arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
- Dermatologic Diseases
- Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
- Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
- Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
- Respiratory Diseases
- Hematologic Disorders
- 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 lupus erythematosus
- Acute exacerbations of multiple sclerosis
DOSAGE AND ADMINISTRATION
When high dose therapy is desired, the recommended dose of A-Methapred (methylprednisolone sodium succinate) sterile powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.
In other indications initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.
Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg/kg every 24 hours.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
A-Methapred (methylprednisolone sodium succinate) may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes.
To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution.
In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).
Directions for Reconstitution
- Remove protective cap.
- Cleanse stopper with suitable germicide.
- Aseptically add 1 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 40 mg vial or 2 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 125 mg vial.
- Agitate to effect solution.
- Invert vial. Insert needle through target area of stopper until tip is just visible. Withdraw dose.
Protect from light.
Store unreconstituted product at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Store solution at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Use solution within 48 hours after mixing.
A-Methapred (methylprednisolone sodium succinate) sterile powder is available in the following packages:
|3217||Single-Dose Vial||40 mg/vial|
|3218||Single-Dose Vial||125 mg/vial|
Rev: October, 2005. Hospira Inc., Lake Forest, IL 60045, USA. FDA rev date: 11/25/2008
Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional A-Methapred Information
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