DESCRIPTION

Prednisone is a glucocorticoid. Glucocorticoids room adrenocortical steroids, both normally occurring and also synthetic, that are readily absorbed from the cradle tract. The formula for prednisone is C21H26O5. Chemically, that is 17,21-dihydroxypregna-1, 4-diene-3,11, 20-trione and has the adhering to structural formula:


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

You are watching: West ward 473 round white pill

Each tablet, for oral administration, consists of 5 mg, 10 mg, and 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, sodium starch glycolate, and also 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 cortisone), which likewise have salt-retaining properties, are provided as replacement therapy in adrenocortical deficiency states. Their artificial analogs, such together prednisone, are primarily used for your potent antiinflammatory impacts in obstacle of countless organ systems.

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


INDICATIONS and also USAGE

Prednisone tablet computers are indicated in the complying with conditions:

Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the an initial choice; synthetic analogs might be used in conjunction v mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of details importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.

Rheumatic disorders: together adjunctive treatment for short-term management (to tide the patient end an acute episode or exacerbation) in; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected instances may call for low-dose maintenance therapy); ankylosing spondylitis; acute and 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 instances of: systemic lupus erythematosus, acute rheumatic carditis.

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

Allergic states: manage of significant or incapacitating allergic problems intractable to enough trials of typical treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, call dermatitis, atopic dematitis, drug hypersensitivity reactions.

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

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

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

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

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

Gastrointestinal diseases: to birds the patient over a vital period the the disease in: ulcerative colitis, regional enteritis.

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

In addition to the above indications, prednisone tablets are indicated 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 instance is indicated.

Corticosteroids may mask some indications of infection and new infections may show up during your use. There may be lessened resistance and inability to localize infection as soon as corticosteroids room used.

Prolonged usage of corticosteroids may develop posterior subcapsular cataracts, glaucoma with feasible damage to the optic nerves, and also may enhance the facility of second ocular infections because of fungi or viruses.

Average and huge doses that hydrocortisone or cortisone can cause elevation that blood pressure, salt and also water retention, and increased excretion of potassium. These impacts are much less likely to occur with the synthetic derivatives except when supplied in large doses. Diet salt restriction and potassium supplementation might be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy, patients need to not it is in vaccinated versus smallpox. Various other immunization procedures should no be undertaken in patients who room on corticosteroids, particularly on high doses, due to the fact that of feasible hazards the neurological complications and a absence of antibody response.

Persons who are on drugs that suppress the immune device are much more susceptible to epidemic than healthy and balanced individuals. Chickenpox and measles, because that example, deserve to have a more serious or even fatal food in non-immune children or adult on corticosteroids. In such kids or adults who have actually not had actually these diseases, certain care should be bring away to avoid exposure. Exactly how the dose, route, and also duration of corticosteroid administration affects the hazard of developing a disseminated epidemic is not known. The donation of the underlying condition and/or former corticosteroid therapy to the danger is additionally not known. If exposed come chickenpox, prophylaxis v varicella-zoster immune globulin (VZIG) might be indicated. If exposed to measles, prophylaxis v pooled intravenous immunoglobulin (IG) may be indicated. (See the particular package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

The usage of prednisone tablets in active tuberculosis should be minimal to those situations of fulminating or disseminated tuberculosis in which the corticosteroid is offered for the monitoring of the an illness in conjunction through an suitable antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close monitoring is important as reactivation of the condition may occur. During lengthy corticosteroid therapy, this patients need to receive chemoprophylaxis.


Usage in Pregnancy: since adequate human reproduction studies have actually not been done with corticosteroids, the use of these drugs in pregnancy, nursing mother or women of childbearing potential calls for that the possible benefits of the drug be weighed versus the potential perils to the mother and also embryo or fetus. Infants born of mothers who have actually received comprehensive doses the corticosteroids throughout pregnancy must be very closely observed for indications of hypoadrenalism.


General: Drug-induced, an additional adrenocortical insufficiency might be reduced by gradual reduction of dosage. This form of relative insufficiency may persist for months after ~ discontinuation that therapy; therefore, in any kind of situation the stress arising during that period, hormone therapy have to be reinstituted. Since mineralocorticoid secretion might be impaired, salt and/or a mineralocorticoid have to be administered concurrently.

There is an magnified effect the corticosteroids on patients v hypothyroidism and in those through cirrhosis.

Corticosteroids need to be used cautiously in patients v ocular herpes simplex because of feasible corneal perforation.

The lowest feasible dose that corticosteroid should be provided to regulate the problem under treatment, and also when reduction in dosage is possible, the reduction must be gradual.

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

Aspirin need to be provided cautiously in conjunction through corticosteroids in hypoprothrombinemia.

Steroids should be provided with fist in: nonspecific ulcerative colitis, if there is a probability of imminent perforation, abscess or various other pyogenic infection; diverticulitis; fresh intestinal anastomosis; energetic or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and also myasthenia gravis.

Growth and development of infants and children on lengthy corticosteroid therapy should be carefully observed.


Information because that Patients: people who space on immunosuppressant sheep of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patient should likewise be advised that if they space exposed, clinical advice should be sought there is no delay.


ADVERSE REACTIONS

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

Musculoskeletal: muscle weakness, steroid myopathy, lose of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis that femoral and humeral heads, pathological fracture of lengthy bones.

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

Dermatologic: impaired wound healing, thin breakable skin, petechiae and also ecchymoses, face erythema, raised sweating, may suppress reaction to skin tests.

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

Endocrine: expression irregularities; advance of cushingoid state; suppression of growth in children; an additional adrenocortical and pituitary unresponsiveness, specifically in times of stress, as in trauma, surgery or illness; diminished carbohydrate tolerance; manifestations of implicitly diabetes mellitus; enhanced requirements because that insulin or oral hypoglycemic agents in diabetics.

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

Metabolic: an unfavorable nitrogen balance due to protein catabolism.


DOSAGE and ADMINISTRATION

Dosage that prednisone tablets need to be individualized follow to the severity the the condition and the response of the patient. For infants and also children, the encourage dosage should be governed by the same considerations quite than strict adherence come the ratio suggested by period or human body weight.

Hormone therapy is one adjunct to, and also not a instead of for standard therapy.

Dosage should be decreased or discontinued progressively when the drug has been administered for much more than a couple of days.

The severity, prognosis, meant duration of the disease, and also the reaction of the patient to medication space primary factors in determining dosage.

If a duration of voluntary remission wake up in a chronic condition, treatment should be discontinued.

Blood pressure, body weight, regime laboratory studies, including two-hour postprandial blood glucose and also serum potassium, and also a chest X-ray need to be acquired at regular intervals during an extensive therapy. Upper Gl X-rays are preferable in patient with well-known or suspected peptic ulcer disease.

The initial dosage the prednisone may vary native 5 mg come 60 mg every day, relying on the specific disease entity gift treated. In instances of less severity reduced doses will usually suffice, if in selected patients greater initial doses may be required. The early dosage should be preserved or adjusted until a satisfactory an answer is noted. If after a reasonable duration of time there is a lack of satisfactory clinical response, prednisone need to be discontinued and also the patient moved to other ideal therapy. IT have to BE EMPHASIZED the DOSAGE demands ARE VARIABLE and MUST it is in INDIVIDUALIZED ~ above THE basis OF THE disease UNDER TREATMENT and also THE an answer OF THE PATIENT. ~ a favorable solution is noted, the suitable maintenance dosage have to be established by diminish the initial drug dosage in small decrements at suitable time intervals until the shortest dosage i beg your pardon will preserve an sufficient clinical solution is reached. It have to be retained in mental that continuous monitoring is required in to the to medicine dosage. Consisted of in the cases which may make dosage adjustment essential are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient"s individual medicine responsiveness, and the impact of patient exposure to stressful instances not directly related to the disease entity under treatment; in this latter instance it might be crucial to increase the dosage of prednisone for a duration of time consistent with the patient"s condition. If after long-term therapy the drug is to it is in stopped, it is recommended the it be withdrawn progressively rather than abruptly.


HOW SUPPLIED

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

Prednisone tablets USP, 10 mg: White, ring tablets, scored on one side and "West-ward 473" debossed top top the other side. Each tablet computer contains 10 mg the prednisone for oral administration.

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

They are offered 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 in ~ 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 pharmaceutical 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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