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ACTAVIS PHARMA/
SKU
00591544210

prednisone 10 mg tablet

Generic
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Uses

Prednisone is usually considered the oral glucocorticoid of choice for anti-inflammatory or immunosuppressant effects. Because it has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If prednisone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid is also required.

Dosage and Administration

Administration

Prednisone is administered orally. For patients unable to swallow tablets, prednisone may be administered orally as a commercially available solution, concentrate solution, or an extemporaneously prepared suspension. The oral concentrate may be diluted in juice or other flavored diluent or in semisolid food (e.g., applesauce) prior to administration.

An extemporaneous prednisone suspension containing 10 mg/mL can be prepared in the following manner. First, 5 g of prednisone as tablets is mixed with 200 mL of 0.1% sodium benzoate solution; 100 mL of an aqueous suspension containing 3% tragacanth, 3% acacia, and 0.1% sodium benzoate is then added, and the mixture is stirred until homogeneous. When the prednisone suspension is diluted to 500 mL with a mixture of 67% simple syrup and 33% cherry syrup, it contains prednisone 10 mg/mL and is apparently stable for 2 months at 2-8°C. (4 L of the tragacanth-acacia suspension may be prepared in a container that can be closed for vigorous agitation. Initially, 4 g of sodium benzoate is dissolved in 2 L of purified water. Then 120 g of powdered tragacanth and 120 g of acacia are added in that order and the container shaken vigorously. Additional water is added gradually over 24-48 hours with agitation at regular intervals until a volume of 4 L and a smooth suspension results. To mask the odor, 1 mL of anise oil may be added.)

Dosage

Dosage of prednisone depends on the condition being treated and the response of the patient. 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. The drug should be discontinued as soon as possible. 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 prednisone therapy is necessary, an alternate-day dosage regimen should be considered. Following long-term therapy, prednisone should be withdrawn gradually.

The initial adult dosage of prednisone may range from 5-60 mg daily, depending on the disease being treated, and is usually administered in 2-4 divided doses. Some clinicians state that children may be given a dosage of 0.14-2 mg/kg daily or 4-60 mg/m daily, administered in 4 divided doses.

Pneumocystis carinii Pneumonia

For use as an adjunct to anti-infective therapy in the treatment of moderate to severe Pneumocystis carinii pneumonia in adults and adolescents older than 13 years of age with acquired immunodeficiency syndrome (AIDS), an oral prednisone regimen of 40 mg twice daily for 5 days, followed by 40 mg once daily for 5 days, and then 20 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 therapy would be desirable, but rebound deterioration in pulmonary function has occurred in some patients following discontinuance of glucocortical therapy, and some clinicians discourage the use of shorter treatment courses.

Allergic Conditions

For certain allergic conditions (e.g., contact dermatitis including poison ivy), prednisone may be administered for short-term use (e.g., 6 days) using 5-mg tablets; the recommended initial dosage is 30 mg (6 tablets) for the first day, which is then tapered by 5 mg daily until 21 tablets have been administered. On the first day, 10 mg (2 tablets) is administered twice daily (before breakfast and at bedtime) and 5 mg (1 tablet) is administered twice daily (after lunch and dinner). On the second day, 5 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and after dinner) and 10 mg (2 tablets) is administered at bedtime. On the third day, 5 mg (1 tablet) is administered 4 times daily (before breakfast, after lunch, after dinner, and at bedtime). On the fourth day, 5 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and at bedtime). On the fifth day, 5 mg (1 tablet) is administered twice daily (before breakfast and at bedtime). On the sixth day, 5 mg (1 tablet) is administered before breakfast.

Asthma

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), prednisone 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), prednisone 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 of oral corticosteroid therapy (usually 3-10 days) should be continued until the patient achieves a peak expiratory flow (PEF) of at least 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.

For the treatment of moderate-to-severe exacerbations of asthma associated with a viral respiratory infection in infants and children 4 years of age or younger with intermittent asthma, prednisone 1 mg/kg daily for 3-10 days or equivalent daily dosage should be considered. For those with a history of viral-associated severe asthma exacerbations, initiation of oral corticosteroids should be considered at the first sign of infection.

For the treatment of acute asthma exacerbations in the community setting, 0.5-1 mg/kg of prednisone or equivalent during a 24-hour period is recommended to quickly resolve all but the mildest exacerbations of asthma, especially in patients whose response to a short-acting inhaled β2-agonist is not prompt or sustained. 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, prednisone 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, prednisone 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, .

Advanced Pulmonary or Extrapulmonary Tuberculosis

For enhancing resolution of severe systemic and respiratory complications of advanced pulmonary tuberculosis, corticosteroid dosages equivalent to 40-60 mg daily of prednisone, tapered over 4-8 weeks, have been used. A prednisone dosage of 1 mg/kg daily for 30 days, followed by gradual tapering of the dosage over a period of weeks, has been suggested in patients with tuberculous meningitis. Tuberculous pericarditis has been treated with prednisone (or prednisolone) dosages of 60 mg daily tapered over 6-12 weeks. For the treatment of pain, dyspnea, and fever associated with tuberculous pleurisy, corticosteroid dosages equivalent to 20-40 mg daily of prednisone tapered over 4-8 weeks have been suggested. Prednisone 2-5 mg/kg per day (or equivalent), with dosage reduction to 1 mg/kg per day over the first week and tapered over the next 5 weeks, has been used to hasten resolution of mediastinal lymphadenopathy associated with primary intrathoracic tuberculosis.

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