Prednisolone Oral Solution USP contains prednisolone which is a glucocorticoid.  Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. 

Prednisolone is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

The chemical name for prednisolone is Pregna-1,4-diene-3,20-dione,11,17,21-trihydroxy-,(11β)-. 

C21H28O5                                                                                                              M.W. 360.45

Prednisolone Oral Solution USP, 15 mg/5 mL contains 15 mg of prednisolone in each 5 mL.  Benzoic acid, 0.1% is added as a preservative.  It also contains alcohol 5%, citric acid (anhydrous), edetate disodium, glycerin, propylene glycol, purified water, saccharin sodium, sucrose, FD&C blue #1 and FD&C red #40.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.  Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids such as prednisolone cause profound and varied metabolic effects.  In addition, they modify the body’s immune responses to diverse stimuli.

Prednisolone Oral Solution USP is indicated in the following conditions:

1. 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

2. 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

3. Collagen Diseases

      During an exacerbation or as maintenance therapy in selected cases of:

            Systemic lupus erythematosus

            Acute rheumatic carditis

4. Dermatologic Diseases

            Pemphigus

            Bullous dermatitis herpetiformis

            Severe erythema multiforme (Stevens-Johnson syndrome)

            Exfoliative dermatitis

            Mycosis fungoides

            Severe psoriasis

            Severe seborrheic dermatitis

5. Allergic States

      Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

            Seasonal or perennial allergic rhinitis

            Bronchial asthma

            Contact dermatitis

            Atopic dermatitis

            Serum sickness

            Drug hypersensitivity reactions

6. Ophthalmic Diseases

      Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

            Allergic corneal marginal ulcers

            Herpes zoster ophthalmicus

            Anterior segment inflammation

            Diffuse posterior uveitis and choroiditis

            Sympathetic ophthalmia

            Allergic conjunctivitis

            Keratitis

            Chorioretinitis

            Optic neuritis

            Iritis and Iridocyclitis

7. Respiratory Disorders

            Symptomatic sarcoidosis

            Loeffler’s syndrome not manageable by other means

            Berylliosis

            Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy

            Aspiration pneumonitis

8. Hematologic Disorders

            Idiopathic thrombocytopenic purpura in adults

            Secondary thrombocytopenia in adults

            Acquired (autoimmune) hemolytic anemia

            Erythroblastopenia (RBC anemia)

            Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases

      For palliative management of:

            Leukemias and lymphomas in adults

            Acute leukemia of childhood

10. 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.

11. Gastrointestinal Diseases

      To tide the patient over a critical period of the disease in:

            Ulcerative colitis

            Regional enteritis

12. Miscellaneous

      Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.  Trichinosis with neurologic or myocardial involvement.

In addition to the above indications, Prednisolone Oral Solution USP is indicated for systemic dermatomyositis (polymyositis).

Systemic fungal infections.

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.

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 dose, 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 prednisolone oral solution 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.

Use 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 during pregnancy should be carefully observed for signs of hypoadrenalism.

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

To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage of prednisolone oral solution 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 oral solution 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 oral solution 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 oral solution 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.

Product: 50090-7115

NDC: 50090-7115-0 120 mL in a BOTTLE, DISPENSING / 240 in a BOTTLE

NDC: 50090-7115-1 60 mL in a BOTTLE, DISPENSING / 240 in a BOTTLE

NDC: 50090-7115-2 240 mL in a BOTTLE

 Manufactured by:

Greenville, SC 29605

R06/23