PREDNISONE (Page 2 of 2)

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, particularly 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.

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 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.

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.

Rx only

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

Manufactured by:
Tianjin Tianyao Pharmaceuticals Co., Ltd
Tianjin China 300457

L6972 Revised 04-2019-00

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0527-2930 -37

Prednisone Tablets, USP

1 mg

Rx Only 100 TABLETS

Lannett

100 count
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0527-2930 -43

Prednisone Tablets, USP

1 mg

Rx Only 1000 TABLETS

Lannett

1000 count
(click image for full-size original)
PREDNISONE
prednisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2930
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISONE (PREDNISONE) PREDNISONE 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code PD4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-2930-37 100 TABLET in 1 BOTTLE None
2 NDC:0527-2930-43 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211496 12/28/2018
Labeler — Lannett Company, Inc. (002277481)

Revised: 04/2019 Lannett Company, Inc.

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