DESCRIPTION

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


*

Prednisone is a white to almost white, odorless, crystalline powder and has a molecular weight of 358.43. It melts at around 230°C through some decomposition. Prednisone is very slightly dissolve in water, slightly soluble in alcohol, chloroform, dioxane, and methanol.

You are watching: West world 475

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

Inactive ingredients are as follows:

 5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and also talc. 10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, salt 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 also sodium strength glycolate.

CLINICAL PHARMACOLOGY

Naturally developing glucocorticoids (hydrocortisone and cortisone), which likewise have salt-retaining properties, are supplied as replacement therapy in adrenocortical deficiency states. Their man-made analogs, such as prednisone, are mostly used for your potent antiinflammatory effects in obstacle of plenty of organ systems.

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


INDICATIONS and also USAGE

Prednisone tablets are suggested in the complying with conditions:

Endocrine disorders: main or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the very first choice; man-made analogs may be provided in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of certain importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.

Rheumatic disorders: as adjunctive therapy for short-term administration (to birds the patient over an acute episode or exacerbation) in; psoriatic arthritis; rheumatoid arthritis, consisting of juvenile rheumatoid arthritis (selected cases may call for low-dose maintain 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 together maintenance treatment in selected cases of: systemic lupus erythematosus, acute rheumatic carditis.

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

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

Ophthalmic diseases: major acute and also chronic allergic and inflammatory processes entailing 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, diffuse posterior uveitis and also choroiditis, optic neuritis, sympathetic ophthalmia.

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

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

Neoplastic diseases: because that palliative administration of: leukemias and also lymphomas in adults, acute leukemia of childhood.

Edematous states: come induce a diuresis or remission that proteinuria in the nephrotic syndrome, without uremia, the the idiopathic type or that due to lupus erythematosus.

Gastrointestinal diseases: to birds the patient over a vital period the the an illness in: ulcerative colitis, local enteritis.

Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when supplied concurrently with proper antituberculous chemotherapy, trichinosis v neurologic or myocardial involvement.

In addition to the over indications, prednisone tablet computers are suggested for systemic dermatomyositis (polymyositis).


WARNINGS

In patient on corticosteroid therapy based on unusual stress, enhanced dosage of promptly acting corticosteroids before, during and also after the stressful instance is indicated.

Corticosteroids might mask some signs of infection and brand-new infections may show up during your use. There might be diminished resistance and also inability come localize infection once corticosteroids are used.

Prolonged usage of corticosteroids may create posterior subcapsular cataracts, glaucoma with possible damage come the optic nerves, and may boost the facility of secondary ocular infections because of fungi or viruses.

Average and huge doses of hydrocortisone or cortisone can cause elevation the blood pressure, salt and water retention, and also increased excretion of potassium. These effects are less likely to occur with the fabricated derivatives except when supplied in huge doses. Dietary salt restriction and potassium supplementation might be necessary. Every corticosteroids boost calcium excretion.

While top top corticosteroid therapy, patients have to not be vaccinated versus smallpox. Other immunization procedures should no be undertaken in patient who space on corticosteroids, especially on high doses, due to the fact that of possible hazards the neurological complications and also a lack of antibody response.

Persons who room on drugs the suppress the immune device are more susceptible to infections than healthy individuals. Chickenpox and also measles, for example, have the right to have a more serious or even fatal food in non-immune kids or adults on corticosteroids. In such children or adult who have actually not had actually these diseases, specific care must be taken to stop exposure. How the dose, route, and duration the corticosteroid management affects the risk of occurring a disseminated epidemic is no known. The contribution of the underlying condition and/or front corticosteroid treatment to the risk is additionally not known. If exposed to chickenpox, prophylaxis v varicella-zoster immune globulin (VZIG) might be indicated. If exposed come measles, prophylaxis v pooled intravenous immunoglobulin (IG) may be indicated. (See the respective package inserts for finish VZIG and IG prescribing information.) If chickenpox develops, treatment through antiviral agents may be considered.

The use of prednisone tablet computers in energetic tuberculosis have to be restricted to those situations of fulminating or disseminated tuberculosis in i m sorry the corticosteroid is offered for the management of the condition in conjunction with an ideal antituberculous regimen.

If corticosteroids are shown in patients through latent tuberculosis or tuberculin reactivity, close observation is crucial as reactivation that the an illness may occur. During lengthy corticosteroid therapy, this patients should receive chemoprophylaxis.


Usage in Pregnancy: due to the fact that adequate person reproduction studies have not to be done with corticosteroids, the use of these drugs in pregnancy, nursing mother or females of childbearing potential needs that the possible benefits the the drug be weighed versus the potential hazards to the mother and embryo or fetus. Babies born of mothers who have received substantial doses that corticosteroids throughout pregnancy need to be carefully observed for signs of hypoadrenalism.


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

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

Corticosteroids must be offered cautiously in patients with ocular herpes simplex because of possible corneal perforation.

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

Psychic derangements may show up when corticosteroids room used, varying from euphoria, insomnia, the atmosphere swings, personality changes, and severe depression, come frank psychotic manifestations. Also, existing emotionally instability or psychotic tendencies might be aggravated by corticosteroids.

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

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

Growth and advancement of infants and children on an extensive corticosteroid therapy should be closely observed.


Information because that Patients: persons who are on immunosuppressant sheep of corticosteroids have to be warned to protect against exposure come chickenpox or measles. Patient should also be advised the if they are exposed, medical advice should be sought without delay.


ADVERSE REACTIONS

Fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart fail 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 feasible perforation and hemorrhage, pancreatitis, abdominal muscle distention, ulcerative esophagitis.

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

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

Endocrine: term irregularities; breakthrough of cushingoid state; suppression of expansion in children; secondary adrenocortical and pituitary unresponsiveness, an especially in time of stress, together in trauma, surgery or illness; reduced carbohydrate tolerance; manifestations of latent diabetes mellitus; boosted requirements for insulin or oral hypoglycemic agents in diabetics.

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

Metabolic: negative nitrogen balance due to protein catabolism.


DOSAGE and also ADMINISTRATION

Dosage the prednisone tablets should be individualized according to the severity the the an illness and the an answer of the patient. For infants and children, the recommended dosage must be administer by the exact same considerations rather than strict adherence come the ratio shown by age or human body weight.

Hormone treatment is one adjunct to, and not a replacement for conventional therapy.

Dosage have to be decreased or discontinued gradually when the drug has actually been administered for much more than a few days.

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

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

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

The initial dosage of prednisone might vary native 5 mg come 60 mg per day, depending on the specific an illness entity gift treated. In instances of much less severity reduced doses will normally suffice, if in selected patients greater initial doses may be required. The early stage dosage must be preserved or adjusted until a satisfactory solution is noted. If after a reasonable duration of time there is a lack of satisfactory clinical response, prednisone should be discontinued and also the patient transferred to other appropriate therapy. IT must BE EMPHASIZED that DOSAGE needs ARE VARIABLE and MUST be INDIVIDUALIZED on THE basis OF THE condition UNDER TREATMENT and also THE solution OF THE PATIENT. After a favorable solution is noted, the appropriate maintenance dosage must be figured out by to decrease the initial drug dosage in tiny decrements at appropriate time intervals till the shortest dosage i beg your pardon will maintain an sufficient clinical response is reached. It should be maintained in mind that continuous monitoring is needed in regard to drug dosage. Consisted of in the situations which may make dosage adjustment vital are alters in clinical status secondary to remissions or exacerbations in the disease process, the patient"s individual drug responsiveness, and also the result of patience exposure to stressful instances not directly related come the disease entity under treatment; in this latter situation it might be essential to rise the dosage that prednisone because that a period of time continual with the patient"s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn progressively rather 보다 abruptly.


HOW SUPPLIED

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

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

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

They are offered 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 tablet computers in a Plastic BottleWHITE0143-1473

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

See more: Call Of Duty Black Ops 3 Split Screen Setup For Xbox One, Is Black Ops 3 Split Screen

Dispense in a tight, light-resistant container as characterized in the USP using 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 joined States


*

*