PrednisoLONE (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 (pseudo-tumor cerebri) usually after treatment
Vertigo
Headache

Endocrine
Menstrual irregularities
Development of Cushingoid state
Suppression of growth in pediatric patients
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 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 ADMINISTRATION

Dosage of PrednisoLONE Syrup (PrednisoLONE Oral Solution 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 PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) 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, PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) 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 PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) 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

PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) is a berry-flavored, red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied in 8 fl oz bottles (NDC 0121- 0687-08), 16 fl oz bottles (NDC 0121- 0687-16) and 5 mL unit dose cups packaged in trays of 10 (NDC 0121-0687-05).

Pharmacist: Dispense with a suitable calibrated measuring device to assure proper measuring of dose. Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF.

Dose/Volume Chart

15 mg prednisolone = 1 teaspoon

10 mg prednisolone = 2/3 teaspoon

7.5 mg prednisolone = 1/2 teaspoon

5 mg prednisolone = 1/3 teaspoon

Store at controlled room temperature, 20°-25°C (68°-77° F). [See USP] DO NOT REFRIGERATE.

R11/06

Pharmaceutical
Associates, Inc. Greenville, SC 29605

PREDNISOLONE prednisolone solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0687
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prednisolone (Prednisolone) Prednisolone 15 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate
Alcohol
Artificial Berry Flavor
Citric Acid Anhydrous
Edetate Disodium
FD&C Blue No. 1
FD&C Red No. 40
Glycerin
Propylene Glycol
Water
Sodium Saccharin
Sucrose
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-0687-08 236 mL (236 MILLILITER) in 1 BOTTLE None
2 NDC:0121-0687-16 473 mL (473 MILLILITER) in 1 BOTTLE None
3 NDC:0121-0687-05 10 CUP, UNIT-DOSE (10 CUP) in 1 TRAY contains a CUP, UNIT-DOSE
3 5 mL (5 MILLILITER) in 1 CUP, UNIT-DOSE This package is contained within the TRAY (0121-0687-05)
Labeler — Pharmaceutical Associates, Inc.

Revised: 08/2007 Pharmaceutical Associates, Inc.

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