Product Elements:
Prednisone prednisone prednisone prednisone lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate type a potato starch, corn stearic acid pd4
Indications and Usage:
Indications 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, nonsuppurative thyroiditis, hypercalcemia associated with cancer. rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis
Read more.... dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (stevens-johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. ophthalmic diseases: severe 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 iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. respiratory diseases: symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. 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: ulcerative colitis, regional enteritis. miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement. in addition to the above indications, prednisone tablets, usp are indicated for systemic dermatomyositis (polymyositis).
Warnings:
Warnings 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 since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. infants born of mothers who have received substantial doses of corticosteroids
Read more... 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 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 doses, because of possible hazards of neurological complications and a lack of antibody response. 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. 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 antituberculous 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.
Dosage and Administration:
Dosage and administration dosage of prednisone tablets, usp should be individualized according to the severity of the disease and the response of the patient. for infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight. hormone therapy is an adjunct to, and not a replacement for, conventional therapy. dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days. the severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. if a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest x-ray should be obtained at regular intervals during prolonged therapy. upper gi x-rays
Read more... are desirable in patients with known or suspected peptic ulcer disease. the initial dosage of prednisone may vary from 5 mg to 60 mg 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. 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 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.
Contraindications:
Contraindications prednisone tablets, usp are contraindicated in systemic fungal infections.
Adverse Reactions:
Adverse reactions fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension. musculoskeletal: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones. gastrointestinal: peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis. dermatologic: impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests. neurological: convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache. endocrine: menstrual irregularities; development of cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularl
Read more...y in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements of insulin or oral hypoglycemic agents in diabetics. ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos. metabolic: negative nitrogen balance due to protein catabolism.
Description:
Description glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. the formula for prednisone is c 21 h 26 o 5 . chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure: prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. it melts at about 230°c with some decomposition. prednisone is very slightly soluble in water, slightly soluble in alcohol, chloroform, dioxane, and methanol. prednisone tablets, usp contain 1 mg prednisone, usp. the inactive ingredients for prednisone tablets, usp include: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, sodium starch glycolate and magnesium stearate. prednisone structure
How Supplied:
How supplied 1 mg (white, round, scored, imprinted pd4) bottles of 100 ndc 0527-2930-37 bottles of 1000 ndc 0527-2930-43 store at 20°c to 25°c (68°f to 77°f) [see usp controlled room temperature]. protect from moisture. dispense in a tight, child-resistant container as defined in the usp/nf. bottles of 1000 tablets are not for household use.
Package Label Principal Display Panel:
Package/label principal display panel ndc 0527- 2930 -37 prednisone tablets, usp 1 mg rx only 100 tablets lannett 100 count
Package/label principal display panel ndc 0527- 2930 -43 prednisone tablets, usp 1 mg rx only 1000 tablets lannett 1000 count