DESCRIPTION

Prednisone is a glucocorticoid. Glucocorticoids room adrenocortical steroids, both normally occurring and synthetic, that space readily took in from the gastrointestinal tract. The formula for prednisone is C21H26O5. Chemically, that is 17,21-dihydroxypregna-1, 4-diene-3,11, 20-trione and has the complying with structural formula:


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Prednisone is a white to virtually white, odorless, crystalline powder and also has a molecular load of 358.43. It melts at around 230°C through some decomposition. Prednisone is an extremely slightly dissolve in water, slightly dissolve in alcohol, chloroform, dioxane, and methanol.

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Each tablet, for dental administration, contains 5 mg, 10 mg, and also 20 mg prednisone.

Inactive ingredients room as follows:

 5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. 10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, salt starch glycolate, and talc. 20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and also sodium strength glycolate.

CLINICAL PHARMACOLOGY

Naturally occurring glucocorticoids (hydrocortisone and also cortisone), which likewise have salt-retaining properties, are provided as replacement treatment in adrenocortical deficiency states. Their synthetic analogs, such as prednisone, are mostly used for your potent antiinflammatory results in obstacle of countless organ systems.

Glucocorticoids, such as prednisone, reason profound and also varied metabolic effects. In addition, they modify the body\"s immune solution to varied stimuli.


INDICATIONS and USAGE

Prednisone tablets are shown in the following conditions:

Endocrine disorders: major or second adrenocortical insufficiency (hydrocortisone or cortisone is the an initial choice; man-made analogs may be provided in conjunction with mineralocorticoids wherein applicable; in infancy mineralocorticoid supplementation is of specific importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia linked with cancer.

Rheumatic disorders: together adjunctive therapy for short-term administration (to birds the patient end an acute episode or exacerbation) in; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected instances may need low-dose maintain therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis that osteoarthritis; epicondylitis.

Collagen diseases: throughout an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis.

Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, serious seborrheic dermatitis.

Allergic states: manage of serious or incapacitating allergic problems intractable to sufficient trials of standard treatment: seasonal or perennial allergy rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dematitis, drug hypersensitivity reactions.

Ophthalmic diseases: serious acute and chronic allergic and also inflammatory processes involving the eye and also its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffusive posterior uveitis and choroiditis, optic neuritis, sorry ophthalmia.

Respiratory diseases: symptomatic sarcoidosis, Loeffler\"s syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when supplied concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.

Hematologic disorders: Idiopathic thrombocytopenic purpura in adults, second thrombocytopenia in adults, obtained (autoimmune) hemolytic anemia, eythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.

Neoplastic diseases: for palliative monitoring of: leukemias and lymphomas in adults, acute leukemia of childhood.

Edematous states: to induce a diuresis or remission the proteinuria in the nephrotic syndrome, there is no uremia, of the idiopathic kind or that due to lupus erythematosus.

Gastrointestinal diseases: to tide the patient over a vital period that the an illness in: ulcerative colitis, regional enteritis.

Miscellaneous: tuberculous meningitis v subarachnoid block or brewing block when used concurrently with suitable antituberculous chemotherapy, trichinosis v neurologic or myocardial involvement.

In addition to the over indications, prednisone tablets are shown for systemic dermatomyositis (polymyositis).


WARNINGS

In patients on corticosteroid therapy subjected to unusual stress, boosted dosage of rapidly acting corticosteroids before, during and also after the stressful situation is indicated.

Corticosteroids may mask some signs of epidemic and new infections may show up during your use. There may be diminished resistance and also inability to localize infection when corticosteroids space used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may boost the facility of an additional ocular infections as result of fungi or viruses.

Average and huge doses that hydrocortisone or cortisone can reason elevation of blood pressure, salt and water retention, and also increased excretion that potassium. These results are less likely to take place with the man-made derivatives except when offered in huge doses. Diet salt restriction and potassium supplementation might be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy, patients must not it is in vaccinated against smallpox. Other immunization actions should not be undertaken in patient who room on corticosteroids, specifically on high doses, since of feasible hazards of neurological complications and also a lack of antibody response.

Persons who space on drugs the suppress the immune device are an ext susceptible to infections than healthy individuals. Chickenpox and also measles, for example, can have a more serious or also fatal course in non-immune youngsters or adults on corticosteroids. In such youngsters or adults who have not had actually these diseases, certain care have to be taken to stop exposure. Just how the dose, route, and also duration that corticosteroid management affects the risk of developing a disseminated epidemic is no known. The donation of the underlying condition and/or former corticosteroid treatment to the danger is likewise not known. If exposed come chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis v pooled intravenous immunoglobulin (IG) might be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment through antiviral agents may be considered.

The usage of prednisone tablets in active tuberculosis have to be restricted to those situations of fulminating or disseminated tuberculosis in i m sorry the corticosteroid is provided for the monitoring of the an illness in conjunction v an appropriate antituberculous regimen.

If corticosteroids are suggested in patients through latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the an illness may occur. During an extensive corticosteroid therapy, this patients must receive chemoprophylaxis.


Usage in Pregnancy: because adequate human being reproduction studies have not to be done v corticosteroids, the use of these drugs in pregnancy, nursing mothers or ladies of childbearing potential calls for that the feasible benefits the the drug be weighed against the potential risks to the mother and also embryo or fetus. Babies born of mothers who have actually received considerable doses the corticosteroids throughout pregnancy should be carefully observed for indicators of hypoadrenalism.


General: Drug-induced, second adrenocortical insufficiency might be minimized by steady reduction of dosage. This kind of family member insufficiency might persist for months after discontinuation of therapy; therefore, in any kind of situation that stress occurring during that period, hormone therapy need to be reinstituted. Due to the fact that mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid need to be administered concurrently.

There is an magnified effect of corticosteroids ~ above patients with hypothyroidism and in those v cirrhosis.

Corticosteroids need to be provided cautiously in patients through ocular herpes simplex due to the fact that of possible corneal perforation.

The lowest feasible dose that corticosteroid must be supplied to regulate the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.

Psychic derangements may show up when corticosteroids space used, ranging from euphoria, insomnia, atmosphere swings, personality changes, and also severe depression, to frank psychotic manifestations. Also, existing emotionally instability or psychotic tendencies may be aggravated through corticosteroids.

Aspirin have to be offered cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids need to be used with fist in: nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; new intestinal anastomosis; energetic or implicit peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and advancement of infants and also children on prolonged corticosteroid therapy need to be very closely observed.


Information for Patients: people who room on immunosuppressant doses of corticosteroids need to be warned to avoid exposure to chickenpox or measles. Patients should likewise be advised that if they room exposed, medical advice should be sought without delay.


ADVERSE REACTIONS

Fluid and also electrolyte disturbances: salt retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.

Musculoskeletal: muscle weakness, steroid myopathy, ns of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and also humeral heads, pathological fracture of long bones.

Gastrointestinal: peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal muscle distention, ulcerative esophagitis.

Dermatologic: impaired wound healing, thin vulnerable skin, petechiae and also ecchymoses, face erythema, boosted sweating, may suppress reactions to skin tests.

Neurological: convulsions, boosted intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache.

Endocrine: menstrual irregularities; development of cushingoid state; suppression of expansion in children; an additional adrenocortical and pituitary unresponsiveness, an especially in time of stress, as in trauma, surgery or illness; reduced carbohydrate tolerance; manifestations of implicit diabetes mellitus; boosted requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.

Metabolic: an unfavorable nitrogen balance because of protein catabolism.


DOSAGE and ADMINISTRATION

Dosage that prednisone tablets must be individualized follow to the severity that the an illness and the response of the patient. Because that infants and also children, the recommended dosage have to be governed by the exact same considerations fairly than strictly adherence come the ratio shown by age or human body weight.

Hormone therapy is an adjunct to, and also not a replacement for traditional therapy.

Dosage must be diminished or discontinued slowly when the drug has been administered for much more than a few days.

The severity, prognosis, meant duration of the disease, and the reaction that the patience to medication are primary determinants in identify dosage.

If a duration of spontaneous remission wake up in a chronic condition, treatment need to be discontinued.

Blood pressure, human body weight, regime laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be derived at continuous intervals during lengthy therapy. Top Gl X-rays are preferable in patient with recognized or doubt peptic ulcer disease.

The initial dosage the prednisone might vary native 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of much less severity lower doses will typically suffice, when in selected patients higher initial doses may be required. The initial dosage need to be kept or changed until a satisfactory solution is noted. If ~ a reasonable period of time over there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other proper therapy. IT need to BE EMPHASIZED the DOSAGE requirements ARE VARIABLE and MUST be INDIVIDUALIZED top top THE communication OF THE condition UNDER TREATMENT and THE an answer OF THE PATIENT. ~ a favorable solution is noted, the ideal maintenance dosage need to be identified by to decrease the initial drug dosage in tiny decrements at appropriate time intervals till the lowest dosage which will keep an enough clinical solution is reached. It must be kept in mind that constant monitoring is needed in for to medicine dosage. Had in the instances which might make dosage adjustment vital are changes in clinical status second to remissions or exacerbations in the condition process, the patient\"s individual medicine responsiveness, and the result of patience exposure come stressful instances not straight related to the disease entity under treatment; in this latter case it might be important to rise the dosage of prednisone for a duration of time continuous with the patient\"s condition. If after permanent therapy the medicine is to be stopped, the is recommended that it it is in withdrawn progressively rather 보다 abruptly.


HOW SUPPLIED

Prednisone tablets USP, 5 mg: White, round tablets, score on one side and \"West-ward 475\" debossed top top the other side. Each tablet contains 5 mg that prednisone for oral administration.

Prednisone tablets USP, 10 mg: White, round tablets, score on one side and \"West-ward 473\" debossed top top the various other side. Each tablet contains 10 mg the prednisone for dental administration.

Prednisone tablet computers USP, 20 mg: Peach colored, ring tablets, scored on one side and \"Westward 477\" debossed on the various other side. Each tablet computer contains 20 mg the prednisone for dental administration.

They are supplied by Keltman Pharmaceuticals Inc. As follows:

NDCStrengthQuantity/FormColorSource Prod. Code
68387-240-1020 mg10 tablets in a Plastic BottleORANGE0143-1477
68387-240-2520 mg25 tablet computers in a Plastic BottleORANGE0143-1477
68387-241-1510 mg15 tablets in a Plastic BottleWHITE0143-1473

Store in ~ 20°-25°C (68°-77°F) . Safeguard from light and also moisture.

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Dispense in a tight, light-resistant container as identified in the USP utilizing a child-resistant closure.

Manufactured for:West-ward medicine Corp.Eatontown. NJ 07724

This Product was Repackaged by Sandhills Packaging for:

Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, ms 39232 united States


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