Prednisone (Prednisone)

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Trade Name: Prednisone

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 5 mg/1

Storage and handling

PREDNISONE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
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Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-
The structural formula is represented below:
Molecular weight: 358.44
Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%.

ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Prednisone Tablets, USP are indicated in the following conditions:
1. n n n n
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 hyperplasian n n Nonsuppurative thyroiditisn nn
2. n n n n
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritisn n n Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)n n n Ankylosing spondylitisn n n Acute and subacute bursitisn n n Acute nonspecific tenosynovitis n n n Acute gouty arthritisn n n Post-traumatic osteoarthritis n n n Synovitis of osteoarthritisn n n Epicondylitis.n nn
3. n n n n
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosusn n n Systemic derznatomyositis (polymyositis)n n n Acute rheumatic carditisn nn
4. n n n n
Pemphigusn n n Bullous dermatitis herpetiformisn n n Severe erythema multiforme (Stevens-Johnson syndrome)n n n Exfoliative dermatitisn n n Mycosis fungoidesn n n Severe psoriasisn n n Severe seborrheic dermatitisn nn
5. n n n n
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitisn n n Bronchial asthman n n Contact dermatitisn n n Atopic dermatitisu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Serum sicknessu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Drug hypersensitivity reactionsn nn
6. n n n n
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcersn n n Herpes zoster ophthalmicusn n n Anterior segment inflammationn n n Diffuse posterior uveitis and choroiditisn n n Sympathetic ophthalmian n n Allergic conjunctivitisn n n Keratitisn n n Chorioretinitisn n n Optic neuritisn n n Iritis and iridocyclitisn nn
7. n n n n
Symptomatic sarcoidosisn n n Loeffleru2019s syndrome not manageable by other meansn n n Berylliosisn n n Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.n n n Aspiration pneumonitisn nn
8. n n n n
Idiopathic thrombocytopenic purpura in adultsn n n Secondary thrombocytopenia in adultsn n n Acquired (autoimmune) hemolytic anemian n n Erythroblastopenia (RBC anemia)n n n Congenital (erythroid) hypoplastic anemian nn
9. n n n n
For palliative management of:
Leukemias and lymphomas in adultsn n n Acute leukemia of childhoodn nn
10. n n n n
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
11. n n n n
To tide the patient over a critical period of the disease in:
Ulcerative colitisn n n Regional enteritisn nn
12. n n n n
Acute exacerbations of multiple sclerosis
13. n n n n
Tuberculous meningitis with subarachnoid block or, impending block when used concurrentlyu00a0 with appropriate antituberculous chemotherapyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Trichinosis with neurologic or myocardial involvementn nn

Systemic fungal infections and known hypersensitivity to components.

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and 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 establishment of secondary ocular infections due to fungi or viruses.
Usage in pregnancy:
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 the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization 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.
The use of Prednisone Tablets, USP in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

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Fluid and Electrolyte Disturbances
Sodium retentionu00a0u00a0u00a0 n n n Fluid retentionu00a0u00a0u00a0 n n n Congestive heart failure in susceptible patientsu00a0u00a0u00a0 n n n Potassium lossu00a0u00a0u00a0 n n n Hypokalemic alkalosisu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Hypertensionn nn
Musculoskeletal
Muscle weaknessu00a0u00a0u00a0 n n n Steroid myopathyu00a0u00a0u00a0 n n n Loss of muscle massu00a0u00a0u00a0 n n n Osteoporosisu00a0u00a0u00a0 n n n Vertebral compression fracturesu00a0u00a0u00a0 n n n Aseptic necrosis of femoral and humeral headsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Pathologic fracture of long bonesn nn
Gastrointestinal
Peptic ulcer with possible perforation and hemorrhageu00a0u00a0u00a0 n n n Pancreatitisu00a0u00a0u00a0 n n n Abdominal distentionu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Ulcerative esophagitisn nn
Dermatologic
Impaired wound healingu00a0u00a0u00a0 n n n Thin fragile skinu00a0u00a0u00a0 n n n Petechiae and ecchymosesn n n u00a0u00a0u00a0 n n n Facial erythemau00a0u00a0u00a0 n n n Increased sweatingu00a0u00a0u00a0 n n n May suppress reactions to skin testsn nn
Metabolic
Negative nitrogen balance due to protein catabolism
Neurological
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatmentu00a0u00a0 n n n Convulsionsu00a0u00a0u00a0 n n n Vertigou00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Headachen nn
Endocrine
Menstrual irregularitiesu00a0u00a0u00a0 n n n Development of Cushingoid stateu00a0u00a0u00a0 n n n Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illnessn n n Suppression of growth in childrenu00a0u00a0u00a0 n n n Decreased carbohydrate toleranceu00a0u00a0u00a0 n n n Manifestations of latent diabetes melliltusu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Increased requirements for insulin or oral hypoglycemic agents in diabeticsn nn
Ophthalmic
Posterior subcapsular cataracts u00a0u00a0u00a0 n n n Increased intraocular pressure u00a0u00a0u00a0 n n n Glaucomau00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n Exophthalmosn nn
Additional Reactions
Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

The initial dosage of prednisone Tablets, USP may vary from 5 mg to 60 mg 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, Prednisone should be discontinued and the patient transferred to other appropriate therapy. n n n 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 patientu2019s 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 Prednisone for a period of time consistent with the patientu2019s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.n nn
Multiple Sclerosis
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 u00ae (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 andu00a0 (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 Cushingu2019s 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 methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1u00a0u00bc to 1u00a0u00bd 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:
1)u00a0Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.n n n n 2)u00a0ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic n n n corticoid therapy is anticipated.n n n n 3)u00a0u00a0 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. n n n n 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 n n n (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.n n n n 4)u00a0Because 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.n n n n 5)u00a0As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg; dexamethasone and betamethasone).n n n n 6)u00a0The 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).n n n n 7) 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 symptomsu00a0 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.n n n n 8) 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.n n n n 9) 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.n nn

20mg (peach, round, scored, imprinted with TL175)n nNDC 66267-172-10 BOTTLES OF 10n
NDC 66267-172-15 BOTTLES OF 15
NDC 66267-172-20 BOTTLES OF 20
NDC 66267-172-21 BOTTLES OF 21
NDC 66267-172-30 BOTTLES OF 30
NDC 66267-172-40 BOTTLES OF 40
Store at 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F) [See USP Room Temperature].
Manufactured By:n n nJubilant Cadista Pharmaceuticals Inc.n n nSalisbury, MD 21801, USA.n
Revised 03/11

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Prednisone (Prednisone) which is also known as Prednisone and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 5 mg/1.

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