"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
(Generic versions may still be available.)
1. Endocrine disorders.
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
2. Rheumatic disorders.
Acute nonspecific tenosynovitis
Acute gouty arthritis
Synovitis of osteoarthritis
3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:
Acute rheumatic carditis
4. Dermatologic diseases
Severe seborrheic dermatitis
5. Allergic states.
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
6. Ophthalmic diseases.
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
7. Respiratory diseases
Loeffler's syndrome not manageable by other means
8. Hematologic disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Congenital (erythroid) hypoplastic anemia
9. Neoplastic diseases. For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous states.
11. Gastrointestinal diseases. To tide the patient over a critical period of the disease in:
12. Nervous system. Acute exacerbations of multiple sclerosis
Tuberculous meningitis with sub-arachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
DOSAGE AND ADMINISTRATION
The initial dosage of prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) tablets may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Alternate-Day Therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 p.m. to a peak level about 6 a.m. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 a.m. and 8 a.m. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day, the lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during the long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) , are considered to be short acting (producing adrenocortical suppression for 1 1/4 days to 1 ½ days following a single dose) and thus are recommended for alternate-day therapy.
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate-day therapy should not encourage the indiscriminate use of steroids.
- Alternate-day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated,
it may be possible to initiate treatment with alternate-day therapy. More
severe disease states usually will require daily divided high dose therapy
for initial control of the disease process. The initial suppressive dose level
should be continued until satisfactory clinical response is obtained, usually
four to ten days in the case of many allergic and collagen diseases. It is
important to keep the period of initial suppressive dose as brief as possible
particularly when subsequent use of alternate-day therapy is intended.
Once control has been established, two courses are available: (a) change to alternate-day therapy and then gradually reduce the amount of corticoid given every other day, or (b) following control of the disease process, reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate-day schedule. Theoretically, course (a) may be preferable.
- Because of the advantages of alternate-day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate-day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
- As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate-day therapy (e.g., dexamethasone and betamethasone).
- The maximal activity of the adrenal cortex is between 2 a.m. and 8 a.m., and it is minimal between 4 p.m. and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (a.m.).
- In using alternate-day therapy it is important, as in all therapeutic situations, to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate-day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
- In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established, alternate-day therapy may be reinstituted.
- Although many of the undesirable features of corticosteroid therapy can be minimized by alternate-day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient with whom corticoid therapy is being considered.
Prednisolone (prednisolone (prednisolone (prednisolone tablets) tablets) tablets) Tablets USP 5 mg are scored, round, peach tablets imprinted DAN DAN 5059 supplied in bottles of 100, and 1000.
Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Watson Laboratories, Inc., Corona, CA 92880 USA. Revised: June 2006. FDA revision date: 9/16/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/29/2016
Additional Prednisolone Information
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