DESCRIPTION

Prednisone is a glucocorticoid. Glucocorticoids space adrenocortical steroids, both naturally occurring and synthetic, that are readily soaked up from the cradle tract. The formula because that 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 practically white, odorless, crystalline powder and has a molecular weight of 358.43. That melts at about 230°C through some decomposition. Prednisone is really slightly soluble in water, slightly soluble in alcohol, chloroform, dioxane, and also methanol.

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Each tablet, for oral administration, consists of 5 mg, 10 mg, and also 20 mg prednisone.

Inactive ingredients space as follows:

 5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, salt starch glycolate, and also 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 sodium starch glycolate.

CLINICAL PHARMACOLOGY

Naturally arising glucocorticoids (hydrocortisone and also cortisone), which likewise have salt-retaining properties, are supplied as replacement treatment in adrenocortical deficiency states. Their synthetic analogs, such as prednisone, are generally used for their potent antiinflammatory effects in obstacle of many organ systems.

Glucocorticoids, such as prednisone, reason profound and also varied metabolic effects. In addition, they change the body"s immune an answer to varied stimuli.


INDICATIONS and also USAGE

Prednisone tablet computers are suggested in the following conditions:

Endocrine disorders: major or second adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs might be provided in conjunction v mineralocorticoids whereby applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.

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

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

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

Allergic states: control of major or incapacitating allergic conditions intractable to adequate trials of typical treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dematitis, drug hypersensitivity reactions.

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

Respiratory diseases: symptomatic sarcoidosis, Loeffler"s syndrome not controlled by various other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when offered 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 administration of: leukemias and also lymphomas in adults, acute leukemia of childhood.

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

Gastrointestinal diseases: to tide the patient over a an important period of the disease in: ulcerative colitis, regional enteritis.

Miscellaneous: tuberculous meningitis with subarachnoid block or unavoidable block when provided concurrently with suitable antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.

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


WARNINGS

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

Corticosteroids might mask some indications of epidemic and brand-new infections may appear during your use. There may be reduced resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may develop posterior subcapsular cataracts, glaucoma with possible damage come the optic nerves, and may enhance the establishment of an additional ocular infections due to fungi or viruses.

Average and big doses that hydrocortisone or cortisone can cause elevation that blood pressure, salt and also water retention, and also increased excretion of potassium. These effects are less likely to happen with the man-made derivatives except when used in large doses. Diet salt restriction and also potassium supplementation might be necessary. Every corticosteroids increase calcium excretion.

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

Persons who space on drugs the suppress the immune mechanism are more susceptible to epidemic than healthy individuals. Chickenpox and measles, because that example, can have a much more serious or even fatal course in non-immune youngsters or adults on corticosteroids. In such children or adult who have not had actually these diseases, details care should be take away to avoid exposure. Exactly how the dose, route, and also duration of corticosteroid administration affects the risk of developing a disseminated infection is no known. The contribution of the underlying disease and/or prior corticosteroid therapy to the hazard is also not known. If exposed to chickenpox, prophylaxis through varicella-zoster immune globulin (VZIG) might be indicated. If exposed come measles, prophylaxis with pooled intravenous immunoglobulin (IG) might be indicated. (See the respective package inserts for complete VZIG and also IG prescribing information.) If chickenpox develops, treatment through antiviral agents might be considered.

The use of prednisone tablet computers in active tuberculosis should be minimal to those instances of fulminating or disseminated tuberculosis in i beg your pardon the corticosteroid is supplied for the monitoring of the an illness in conjunction through an proper antituberculous regimen.

If corticosteroids are shown in patients with latent tuberculosis or tuberculin reactivity, close monitoring is crucial as reactivation that the an illness may occur. During prolonged corticosteroid therapy, this patients have to receive chemoprophylaxis.


Usage in Pregnancy: due to the fact that adequate human being reproduction studies have actually not been done v corticosteroids, the use of this drugs in pregnancy, nursing mother or women of childbearing potential needs that the feasible benefits the the drug be weighed versus the potential hazards to the mother and embryo or fetus. Babies born of mothers who have received comprehensive doses that corticosteroids throughout pregnancy must be very closely observed for indications of hypoadrenalism.


General: Drug-induced, secondary adrenocortical insufficiency might be lessened by progressive reduction the dosage. This type of loved one insufficiency may persist because that months after discontinuation that therapy; therefore, in any type of situation of stress arising during the period, hormone therapy have to be reinstituted. Due to the fact that mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid have to be administered concurrently.

There is an enhanced effect of corticosteroids top top patients with hypothyroidism and also in those with cirrhosis.

Corticosteroids must be used cautiously in patients with ocular herpes simplex since of feasible corneal perforation.

The lowest possible dose that corticosteroid must be provided to manage the problem under treatment, and when palliation in dosage is possible, the reduction have to be gradual.

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

Aspirin have to be used cautiously in conjunction through corticosteroids in hypoprothrombinemia.

Steroids must be offered with fist in: nonspecific ulcerative colitis, if over there is a probability of imminent perforation, abscess or various other pyogenic infection; diverticulitis; new intestinal anastomosis; energetic or implicitly peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and breakthrough of infants and children on prolonged corticosteroid therapy need to be carefully observed.


Information for Patients: persons who are on immunosuppressant sheep of corticosteroids need to be warned to stop exposure to chickenpox or measles. Patient should also be advised that if they space exposed, medical advice need to be sought there is no delay.


ADVERSE REACTIONS

Fluid and electrolyte disturbances: salt retention, fluid retention, congestive heart failure in at risk 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 distention, ulcerative esophagitis.

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

Neurological: convulsions, enhanced intracranial press with papilledema (pseudotumor cerebri) generally after treatment, vertigo, headache.

Endocrine: menstrual irregularities; breakthrough of cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, specifically in times of stress, together in trauma, surgical procedure or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; raised requirements for insulin or dental hypoglycemic agents in diabetics.

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

Metabolic: negative nitrogen balance as result of protein catabolism.


DOSAGE and ADMINISTRATION

Dosage that prednisone tablets must be individualized follow to the severity that the condition and the an answer of the patient. Because that infants and also children, the encourage dosage must be administrate by the same considerations quite than strictly adherence to the ratio shown by age or body weight.

Hormone treatment is an adjunct to, and also not a instead of for conventional therapy.

Dosage need to be diminished or discontinued gradually when the drug has actually been administered for more than a couple of days.

The severity, prognosis, supposed duration of the disease, and also the reaction that the patient to medication space primary determinants in identify dosage.

If a period of spontaneous remission wake up in a chronic condition, treatment should be discontinued.

Blood pressure, body weight, program laboratory studies, consisting of two-hour postprandial blood glucose and also serum potassium, and a chest X-ray need to be obtained at constant intervals during lengthy therapy. Upper Gl X-rays are desirable in patients with known or suspected peptic ulcer disease.

The initial dosage of prednisone may vary native 5 mg to 60 mg per day, depending on the specific condition entity gift treated. In instances of much less severity lower doses will usually suffice, while in selected patients higher initial doses may be required. The early stage dosage need to be preserved or changed until a satisfactory solution is noted. If after ~ a reasonable period of time over there is a absence of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other suitable therapy. IT have to BE EMPHASIZED that DOSAGE demands ARE VARIABLE and MUST be INDIVIDUALIZED top top THE basis OF THE condition UNDER TREATMENT and also THE an answer OF THE PATIENT. ~ a favorable an answer is noted, the suitable maintenance dosage must be figured out by decreasing the initial drug dosage in little decrements at ideal time intervals until the shortest dosage i beg your pardon will preserve an enough clinical solution is reached. It must be kept in mind that constant monitoring is needed in regard to medicine dosage. Consisted of in the cases which might make dosage adjustment important are transforms in clinical status second to remissions or exacerbations in the condition process, the patient"s individual drug responsiveness, and the effect of patient exposure come stressful cases not directly related come the an illness entity under treatment; in this latter situation it may be crucial to rise the dosage the prednisone for a duration of time continual with the patient"s condition. If after irreversible therapy the drug is to it is in stopped, the is recommended the it it is in withdrawn slowly rather than abruptly.


HOW SUPPLIED

Prednisone tablet computers USP, 5 mg: White, ring tablets, scored on one side and also "West-ward 475" debossed ~ above the other side. Each tablet computer contains 5 mg of prednisone for dental administration.

Prednisone tablets USP, 10 mg: White, ring tablets, score on one side and also "West-ward 473" debossed ~ above the various other side. Each tablet computer contains 10 mg that prednisone for oral administration.

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

They are supplied by Keltman Pharmaceuticals Inc. As follows:

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

Store at 20°-25°C (68°-77°F) . Protect from light and also moisture.

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Dispense in a tight, light-resistant container as characterized 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, multiple sclerosis 39232 united States


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