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ACTAVIS PHARMA/
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00591079001

methylprednisolone 4 mg tablet

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Uses

Methylprednisolone and its derivatives are used principally as anti-inflammatory or immunosuppressant agents. Because methylprednisolone has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If methylprednisolone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid also is required.

Dosage and Administration

Administration

The route of administration and dosage of methylprednisolone and its derivatives depend on the condition being treated and the response of the patient. IM or IV therapy is generally reserved for patients who are unable to take the drug orally or for use in emergency situations. After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered.

Dosage

Dosage for infants and children should be based on the severity of the disease and the response of the patient rather than on strict adherence to dosage indicated by age, body weight, or body surface area. After a satisfactory response is obtained, dosage should be decreased in small decrements to the lowest level that maintains an adequate clinical response. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma). When long-term oral methylprednisolone therapy is necessary, an alternate-day dosage regimen should be considered. Following long-term therapy, methylprednisolone should be withdrawn gradually.

Methylprednisolone

Methylprednisolone is administered orally. The initial adult dosage may range from 2-60 mg daily, depending on the disease being treated, and is usually administered in 4 divided doses. Some clinicians state that children may be given a dosage of 0.117-1.66 mg/kg daily or 3.3-50 mg/m daily, administered in 3 or 4 divided doses.

For certain allergic conditions (e.g., contact dermatitis including poison ivy), methylprednisolone may be administered for short-term use (e.g., 6 days) using 4-mg tablets; the recommended initial dosage is 24 mg (6 tablets) for the first day, which is then tapered by 4 mg daily until 21 tablets have been administered. On the first day, 8 mg (2 tablets) is administered twice daily (before breakfast and at bedtime) and 4 mg (1 tablet) is administered twice daily (after lunch and dinner). On the second day, 4 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and after dinner) and 8 mg (2 tablets) is administered at bedtime. On the third day, 4 mg (1 tablet) is administered 4 times daily (before breakfast, after lunch, after dinner, and at bedtime). On the fourth day, 4 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and at bedtime). On the fifth day, 4 mg (1 tablet) is administered twice daily (before breakfast and at bedtime). On the sixth day, 4 mg (1 tablet) is administered before breakfast. Some clinicians state that tapering the dosage of the drug over a longer period (e.g., 12 days instead of 6 days) may be associated with a lower incidence of flare-up of the dermatitis than that associated with 6-day therapy.

To gain prompt control of asthma in infants and children 4 years of age or younger with very poorly controlled, moderate-to-severe asthma (i.e., more than 3 exacerbations per year requiring oral corticosteroids) and in children 5-11 years of age with asthma of comparable control and severity (i.e., at least 2 exacerbations per year requiring oral corticosteroids), methylprednisolone 1-2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy. In adults and adolescents with very poorly controlled, moderate-to-severe asthma (i.e., at least 2 exacerbations per year requiring oral corticosteroids), methylprednisolone 40-60 mg daily as a single dose or in 2 divided doses may be added to low-to-high maintenance dosages of the inhaled corticosteroid and a long-acting inhaled β2-agonist bronchodilator. A short course (usually 3-10 days) of oral corticosteroid therapy should be continued until the patient achieves a peak expiratory flow (PEF) of 80% of his or her personal best and until symptoms resolve. However, a longer duration of treatment may be needed in some patients. There is no evidence that tapering the dosage after improvement will prevent a relapse.

Methylprednisolone 7.5-60 mg daily in the morning or every other day is suggested in adults and adolescents with severe asthma who are inadequately controlled with a high-dose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled β2-agonist bronchodilator, based on consensus and clinical experience. A short course (2 weeks) of oral corticosteroids may be considered to confirm clinical response prior to implementing long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated, the lowest possible effective dosage (i.e., alternate-day or once-daily administration) should be used and the patient should be monitored carefully for adverse effects. Once asthma is well controlled, repeated attempts should be made to reduce the oral corticosteroid dosage.

For emergency department treatment of moderate-to-severe acute asthma exacerbations not controlled with an inhaled β2-adrenergic agonist in children 11 years of age or younger, methylprednisolone 1-2 mg/kg daily in 2 divided doses (maximum 60 mg daily) can be added. For treatment of such exacerbations in adults and adolescents, methylprednisolone 40-80 mg daily as a single dose or in 2 divided doses can be added to an inhaled β2-adrenergic agonist. Treatment should be continued until the patient achieves a PEF of 70% of predicted or personal best. For additional information on the stepped-care approach to drug therapy in asthma, .

Methylprednisolone Acetate

Methylprednisolone acetate may be administered by IM, intra-articular, intralesional, intrasynovial, or soft tissue injection. The manufacturer of Depo-Medrol states that this formulation of methylprednisolone acetate should not be administered intrathecally because of reports of severe adverse events with such use. Because it is slowly absorbed, IM administration of methylprednisolone acetate suspension is not indicated when an immediate effect of short duration is required. The usual adult IM dose of methylprednisolone acetate is 10-80 mg. When methylprednisolone acetate suspension is given as a temporary substitute for oral therapy, the dose of the suspension should be equal to the total daily oral dose of methylprednisolone and should be administered IM once daily. If a prolonged effect is desired, a dose of methylprednisolone acetate equal to 7 times the daily oral dose of methylprednisolone may be administered IM once weekly. For maintenance therapy in patients with rheumatoid arthritis, 40-120 mg may be administered IM weekly. In patients with congenital adrenogenital syndrome, 40 mg of methylprednisolone acetate administered IM every 2 weeks may be adequate.

For intra-articular, intralesional, or soft tissue injection, the dosage of methylprednisolone acetate varies with the degree of inflammation and the size and location of the affected area. A local anesthetic such as 1% procaine hydrochloride may be infiltrated into the tissue surrounding the joint before administration of methylprednisolone acetate. For large joints such as the knee, 20-80 mg of methylprednisolone acetate may be used. For smaller joints, 4-40 mg may be adequate. The dose for bursae, ganglia, and soft tissue infiltration is 4-30 mg. Methylprednisolone acetate in a dosage of 20-60 mg may be administered intralesionally. Absorption of methylprednisolone acetate from intra-articular injection sites is usually very slow and continues for about 7 days. Intra-articular, intralesional, intrasynovial, and soft tissue injections may be repeated every 1-5 weeks depending on the response of the patient.

For control of severe or incapacitating allergic conditions (e.g., bronchial asthma, seasonal or perennial allergic rhinitis) intractable to adequate trials of conventional therapy, the usual IM dose of methylprednisolone acetate is 80-120 mg in adults. For pediatric patients with such conditions, the American Academy of Pediatrics (AAP) recommends an initial IM methylprednisolone acetate dose of 1-2 mg/kg. A single methylprednisolone acetate IM injection of 7.5 mg/kg or 240 mg is recommended by the National Asthma Education and Prevention Program (NAEPP) in infants and children 4 years of age or younger or adults and children 5 years of age or older, respectively, with very poorly-controlled, moderate-to-severe asthma as an alternative to a short course of an oral corticosteroid to gain prompt control of asthma in those who are vomiting or noncompliant with oral corticosteroid therapy. Relief of asthma symptoms should occur within 6-48 hours and persist for several days to 2 weeks. Relief of coryzal symptoms of allergic rhinitis should occur within 6 hours and persist for several days to 3 weeks.

Methylprednisolone Sodium Succinate

Methylprednisolone sodium succinate may be administered by IM or IV injection or by IV infusion; absorption from IM injection sites is rapid. Methylprednisolone sodium succinate is reconstituted for IM or IV injection with bacteriostatic water for injection containing 0.9% benzyl alcohol according to the manufacturer's instructions. When the drug is administered by direct IV injection it should be administered over a period of at least 1 minute. For IV infusion, the reconstituted methylprednisolone sodium succinate should be further diluted with 5% dextrose, 0.9% sodium chloride, 5% dextrose in 0.9% sodium chloride injection, or other compatible IV solution.

Dosage of methylprednisolone sodium succinate is expressed in terms of methylprednisolone. IM or IV dosage of methylprednisolone as the sodium succinate may range from 10 mg to 1.5 g daily; however, much higher IV dosages have been used in the management of life-threatening shock. The usual adult dosage is 10-250 mg IM or IV and may be repeated up to 6 times daily. Some clinicians state that children may be given 0.03-0.2 mg/kg or 1-6.25 mg/m IM 1-2 times daily.

For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment, such as bronchial asthma in pediatric patients, the AAP recommends an initial IV methylprednisolone dose of 1-2 mg/kg.

In adults and adolescents older than 13 years of age with acquired immunodeficiency syndrome (AIDS) who require parenteral glucocorticoid therapy as an adjunct to anti-infective treatment of moderate to severe Pneumocystis carinii pneumonia, an IV methylprednisolone regimen of 30 mg twice daily for 5 days, followed by 30 mg once daily for 5 days, and then 15 mg once daily for 11 days (or until completion of the anti-infective regimen) currently is recommended. Such adjunctive glucocorticoid therapy preferably should be initiated within 24-72 hours of initial antipneumocystis therapy. However, it should be recognized that this recommendation is based on limited data and may not represent the optimum dosage and schedule. Therefore, clinicians should consult published protocols and the most current clinical guidelines. Shorter courses of glucocorticoid therapy would be desirable, but rebound deterioration in pulmonary function has occurred in some patients following discontinuance of glucocorticoid therapy, and some clinicians discourage the use of shorter treatment courses.

In life-threatening shock, massive IV doses of methylprednisolone as the sodium succinate (such as 30 mg/kg initially and repeated every 4-6 hours if needed or 100-250 mg initially and repeated at 2- to 6-hour intervals as required) have been recommended. In such cases, the drug is administered by direct IV injection over a period of 3-15 minutes. Alternatively, following the initial dose by direct IV injection, additional doses of 30 mg/kg may be administered by slow continuous IV infusion every 12 hours for 24-48 hours. High-dose therapy should be continued only until the patient's condition has stabilized and usually should not be continued beyond 48-72 hours.

When used to treat motor and/or sensory deficits and potentially minimize disability in patients with acute spinal cord injury, an initial dose of 30 mg/kg of methylprednisolone given by rapid IV injection over 15 minutes, followed in 45 minutes by IV infusion of 5.4 mg/kg per hour for 23 hours (total dose administered over 24 hours), has been recommended. Other glucocorticoids and other methylprednisolone dosage regimens have not been shown to be effective in humans to date, and glucocorticoid therapy should be initiated as early as possible after spinal cord injury since appreciable benefit has been observed only when methylprednisolone therapy was initiated within 8 hours of injury.

In the successful management of severe lupus nephritis, methylprednisolone as the sodium succinate has been administered by so-called ''pulse'' therapy. In adults, a daily dose of 1 g has been given IV over a 1-hour period for 3 consecutive days; children have been given 30 mg/kg IV every other day for 6 doses. ''Pulse'' therapy with methylprednisolone sodium succinate has been followed by long-term oral prednisone or prednisolone therapy (0.5-1 mg/kg daily).

For the management of croup in pediatric patients, AAP recommends an initial IV methylprednisolone dose of 1-2 mg/kg.

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