"The US Food and Drug Administration (FDA) has approved adalimumab-atto (Amjevita, Amgen, Inc), a biosimilar to adalimumab (Humira, AbbVie, Inc; approved in December 2002), for the treatment of multiple inflammatory diseases."...
(Generic versions may still be available.)
DELTASONE (prednisone) Tablets are indicated in the following conditions:
- 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)
Congenital adrenal hyperplasia
Hypercalcernia associated with cancer
- Rheumatic Disorders
As adjunctive therapy for short-term administration
(to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-dose maintenance therapy)
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Synovitis of osteoarthritis
- Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
- Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme
Severe seborrheic dermatitis
- Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
- Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic cornea marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Iritis and iridocyclitis
- Respiratory Diseases
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
- Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
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 a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
- Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
- Nervous System
Acute exacerbations of multiple sclerosis
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
DOSAGE AND ADMINISTRATION
The initial dosage of DELTASONE Tablets may vary from 5 mg to 60 mg of prednisone 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, DELTASONE (prednisone) 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 decrements 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 DELTASONE (prednisone) 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.
In the 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. (Dosage range is the same for prednisone and prednisolone.)
ADT® (Alternate Day Therapy)
ADT 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 pm to a peak level about 6 am. Increasing levels of ACTH
stimulate adrenocortical activity resulting in a rise in plasma cortisol with
maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens
ACTH production and in turn adrenocortical activity. There is a gradual fall
in plasma corticoids during the day with 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 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 (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 rnethylprednisolone,
hydrocortisone, pednisone and prednisolone, are considered to be short acting
(producing adrenocortical suppression for 1 1/4 to 1 1/2 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 ADT should not encourage the indiscriminate use of steroids.
- ADT 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 ADT. 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 ADT 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 ADT, it may be desirable to try patients on
this form of therapy who have been on daily corticoids for long periods of
time (eg, patients with rheumatoid arthritis). Since these patients may already
have a suppressed HPA axis, establishing them on ADT 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 (eg, dexamethasone and betamethasone).
- The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
- In using ADT 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 ADT 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 re- instituted.
- Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
DELTASONE (prednisone) Tablets are available in the following strengths and package sizes:
2.5 mg (pink, round, scored, imprinted DELTASONE (prednisone) 2.5)
Bottles of 100 NDC 0009-0032-01
5 mg (white, round, scored, imprinted DELTASONE (prednisone) 5)
Bottles of 100 NDC 0009-0045-01
Bottles of 500 NDC 0009-0045-02
Bottles of 1000 NDC 0009-0045-16
DOSEPAK™ Unit-of-Use (21 tablets)
Unit Dose Packages (100) NDC 0009-0045-05
10 mg (white, round, scored, imprinted DELTASONE (prednisone) 10)
Bottles of 100 NDC 0009-0193-01
Bottles of 500 NDC 0009-0193-02
Unit Dose Packages (100) NDC 0009-0193-03
20 mg (peach, round, scored, imprinted DELTASONE (prednisone) 20)
Bottles of 100 NDC 0009-0165-01
Bottles of 500 NDC 0009-0165-02
Unit Dose Packages (100) NDC 0009-0165-03
50 mg (white, round, scored, imprinted DELTASONE (prednisone) 50)
Bottles of 100 NDC 0009-0388-01
Store at controlled room temperature 15º to 30ºC (59º to 86º F).
Caution: Federal law prohibits dispensing without prescription.
The Upjohn Company
Kalamazoo, MI 49001, USA
Revised September 1995
FDA rev date: 12/28/1993
Last reviewed on RxList: 1/24/2017
Additional Deltasone Information
- Deltasone Drug Interactions Center: prednisone oral
- Deltasone Side Effects Center
- Deltasone Overview including Precautions
- Deltasone FDA Approved Prescribing Information including Dosage
Deltasone - User Reviews
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