Prednisolone

Prednisolone Syrup (Prednisolone Oral Solution, USP) is indicated in the following conditions:

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

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

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

     Systemic lupus erythematosus

     Acute rheumatic carditis

     Pemphigus

     Bullous dermatitis herpetiformis

     Severe erythema multiforme (Stevens-Johnson syndrome)

     Exfoliative dermatitis

     Mycosis fungoides

     Severe psoriasis

     Severe seborrheic dermatitis

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

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

Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means

     Berylliosis

     Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy

     Aspiration pneumonitis

Idiopathic thrombocytopenic purpura in adults

Secondary thrombocytopenia in adults

Acquired (autoimmune) hemolytic anemia

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

For palliative management of:

     Leukemias and lymphomas in adults

     Acute leukemia of childhood

To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

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

     Ulcerative colitis

     Regional enteritis

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 Syrup (Prednisolone Oral Solution, USP) is indicated for systemic dermatomyositis (polymyositis).

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.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Prednisolone Syrup (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).

Prednisolone Syrup (Prednisolone Oral Solution, USP) contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5% v/v, cherry flavor, citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose. Prednisolone Syrup (Prednisolone Oral Solution, USP) may contain sodium citrate for pH adjustment.

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.