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Millipred™ Tablets
8. Hematologic disorders
Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adults Millipred™ DP - 6-Day Tablet Dose Pack
Millipred™ DP - 12-Day Tablet Dose Pack
Congenital (erythroid) hypoplastic anemia
9. Neoplastic diseases. For palliative management of:
10. Edematous states. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without
DESCRIPTION
uremia, of the idiopathic type or that due to lupus erythematosus.
Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily 11. Gastrointestinal diseases.
absorbed from the gastrointestinal tract. Prednisolone is a white crystalline powder, very slightly soluble in To tide the patient over a critical period of the disease in: water. It is designated chemically as pregna-1,4-diene-3,20-ione,11,17,21-trihydroxy-, (11␤)-. The structural 12. Nervous system. Acute exacerbations of multiple sclerosis.
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appro- Trichinosis with neurologic or myocardial involvement
CONTRAINDICATIONS
WARNINGS
Persons who are on drugs which suppress the immune system are more susceptible to infections than
Millipred and Millipred DP Tablets contain the following inactive ingredients: anhydrous lactose, colloidal Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune chil- silicon dioxide, crospovidone, D&C Yellow No. 10, docusate sodium, FD&C Yellow No. 6, magnesium dren or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.
CLINICAL PHARMACOLOGY
How the dose, route and duration of corticosteroid administration affects the risk of developing a dissemi- Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining proper- nated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treat- ties, are used as replacement therapy in adrenocortical deficiency states.
Prednisolone is primarily used for its potent anti-inflammatory effects in disorders of many organ systems.
If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If Glucocorticoids cause profound and varied metabolic effects.
exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See In addition, they modify the body's immune responses to diverse stimuli.
the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, INDICATIONS AND USAGE
treatment with antiviral agents may be considered.
1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is
In patients on corticosteroid therapy subjected to unusual stress increased dosage of rapidly acting corti- the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in costeroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some infancy mineralocorticoid supplementation is of particular importance).
signs of infection, and new infections may appear during their use. There may be decreased resistance and Congenital adrenal hyperplasia Nonsuppurative thyroiditis inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the 2. Rheumatic disorders. As adjunctive therapy for short term administration (to tide the patient over an
establishment of secondary ocular infections due to fungi or viruses.
Usage in Pregnancy
Since adequate human reproduction studies have not been done with corticosteroids, the use of these Rheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible bene- fits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants bornof mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic 3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:
derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Systemic dermatomyositis (poly-myositis).
While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immuniza-
4. Dermatologic diseases
tion procedures should not be undertaken in patients who are on corticosteroids, especially on high
dose, because of possible hazards of neurological complications and a lack of antibody response.
Severe erythema multiforme (Stevens-Johnson syndrome); The use of prednisolone in active tuberculosis should be restricted to those cases of fulminating or dissem- inated tuberculosis in which the corticosteroid is used for the management of the disease in conjunctionwith an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation 5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of
is necessary as reactivation of the disease may occur.
During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Seasonal or perennial allergic rhinitisSerum sickness PRECAUTIONS
Information for Patients
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to
6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye
chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralo- Diffuse posterior uveitis and choroiditis corticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
7. Respiratory diseases
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible Loeffler's syndrome not manageable by other means The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangements may appear Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antitubercu- when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic ten-dencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
noted during the long-term pharmacologic dose corticoid therapy administered in conventional daily divid- Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending ed doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corti- perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent coid values during the night may play a significant role in the development of undesirable corticoid effects.
peptic ulcer; renal insufficiency; hypertension; osteoporosis and myasthenia gravis.
Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in Growth and development of infants and children on prolonged corticosteroid therapy should be carefully protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subse-quent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of variable depending upon the dose and duration of treatment.
acute exacerbations of multiple sclerosis they do not show that they affect the ultimate outcome or naturalhistory of the disease. The studies do show that relatively high doses of corticosteroids are necessary to During this time the patient is vulnerable to any stressful situation.
demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION section.)
Although it has been shown that there is considerably less adrenal suppression following a single morning Since complications of treatment with glucocorticoids are dependent on the size of the dose and the dura- dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evi- tion of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of dence that some suppressive effect on adrenal activity may be carried over into the following day when treatment and as to whether daily or intermittent therapy should be used.
pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids willproduce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, ADVERSE REACTIONS
hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical Fluid and Electrolyte Disturbances Sodium retention. Fluid retention. Congestive heart failure in suscepti-
suppression for 1 1/4 days to 1 1/2 days following a single dose) and thus are recommended for alternate- ble patients. Potassium loss. Hypokalemic alkalosis. Hypertension.
Musculoskeletal
The following should be kept in mind when considering alternate-day therapy: Muscle weakness. Steroid myopathy. Loss of muscle mass. Osteoporosis. Vertebral compression fractures.
1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate-day Aseptic necrosis of femoral and humeral heads. Pathologic fracture of long bones.
therapy should not encourage the indiscriminate use of steroids.
Gastrointestinal
2. Alternate-day therapy is a therapeutic technique primarily designed for patients in whom long-term phar- Peptic ulcer with possible perforation and hemorrhage. Pancreatitis. Abdominal distention. Ulcerative macologic corticoid therapy is anticipated.
3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate Dermatologic
treatment with alternate-day therapy. More severe disease states usually will require daily divided high dose Impaired wound healing. Thin fragile skin. Petechiae and ecchymoses. Facial erythema. Increased sweat- therapy for initial control of the disease process. The initial suppressive dose level should be continued until ing. May suppress reactions to skin tests.
satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen Neurological
diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when Convulsions. Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treat- 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 Endocrine
gradually reduce the amount of corticoid given every other day, or (b) following control of the disease Menstrual irregularities. Development of Cushingoid state. Suppression of growth in children. Secondary process, reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or ill- change over to an alternate-day schedule. Theoretically, course (a) may be preferable.
ness. Decreased carbohydrate tolerance. Manifestations of latent diabetes mellitus. Increased requirements 4. Because of the advantages of alternate-day therapy, it may be desirable to try patients on this form of for insulin or oral hypoglycemic agents in diabetics.
therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthri- Ophthalmic
tis). Since these patients may already have a suppressed HPA axis, establishing them on alternate-day ther- Posterior subcapsular cataracts. Increased intraocular pressure. Glaucoma. Exophthalmos.
apy may be difficult and not always successful. However, it is recommended that regular attempts be made Metabolic
to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and admin- Negative nitrogen balance due to protein catabolism.
ister this every other day rather than just doubling the daily dose if difficulty is encountered. Once thepatient is again controlled, an attempt should be made to reduce this dose to a minimum. DOSAGE AND ADMINISTRATION
5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal The initial dosage of Millipred and Millipred DP Tablets may vary from 5 mg to 60 mg per day depending activity, are not recommended for alternate-day therapy (e.g., dexamethasone and betamethasone).
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 6. The maximal activity of the adrenal cortex is between 2 a.m. and 8 a.m., and it is minimal between 4 p.m.
adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satis- and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time factory clinical response, prednisolone should be discontinued and the patient transferred to other appro- 7. In using alternate-day therapy it is important, as in all therapeutic situations, to individualize and tailor IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDU-
the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explana- ALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
tion of the benefits of alternate-day therapy will help the patient to understand and tolerate the possibleflare-up in symptoms which may occur in the latter part of the off-steroid day. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing Other symptomatic therapy may be added or increased at this time if needed.
the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which willmaintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is 8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppres- needed in regard to drug dosage. Included in the situations which may make dosage adjustments neces- sive daily divided corticoid dose for control. Once control is again established, alternate-day therapy may sary 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 9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate-day directly related to the disease entity under treatment; in this latter situation it may be necessary to increase therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each the dosage of prednisolone for a period of time consistent with the patient's condition. If after long-term patient with whom corticoid therapy is being considered.
therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
HOW SUPPLIED
Alternate-Day Therapy
Millipred and Millipred DP Tablets (prednisolone tablets USP, 5 mg) are scored, round, peach tablets Alternate-Day Therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is imprinted DAN DAN 5059 supplied in bottles of 100 (NDC 16477-505-01), a unit of use Blister Pack of 21 administered every other morning. The purpose of this mode of therapy is to provide the patient requiring tablets (NDC 16477-505-21) and a unit of use Blister Pack of 48 tablets (NDC 16477-0507-48) respectively.
long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain Dispense in a well-closed container with child-resistant closure.
undesirable effects, including pituitaryadrenal suppression, the Cushingoid state, corticoid withdrawal Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or ther- Watson Pharma Private Limited
apeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) admin- istration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypo-thalamic- 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 Laser Pharmaceuticals, LLC
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 sys- tem is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10p.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 damp- ens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids duringthe day, the lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing'sdisease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribu-tion, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent dia-betes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be

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