Label: PREDNISOLONE solution

  • NDC Code(s): 0121-0885-08, 0121-0885-16
  • Packager: PAI Holdings, LLC
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 12, 2023

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    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 Structure

    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


    3. Collagen Diseases

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

                Systemic lupus erythematosus

                Acute rheumatic carditis

    4. Dermatologic Diseases


                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



                Optic neuritis

                Iritis and Iridocyclitis

    7. Respiratory Disorders

                Symptomatic sarcoidosis

                Loeffler’s syndrome not manageable by other means


                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.



    Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.  This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. 

    Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

    There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

    Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

    The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

    Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.  Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

    Information for Patients:

    Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles.  Patients should also be advised that if they are exposed, medical advice should be sought without delay.


    Fluid and Electrolyte Disturbances

          Sodium retention

          Fluid retention

          Congestive heart failure in susceptible patients

          Potassium loss

          Hypokalemic alkalosis



          Muscle weakness

          Steroid myopathy

          Loss of muscle mass


          Vertebral compression fractures

          Aseptic necrosis of femoral and humeral heads

          Pathologic fracture of long bones


          Peptic ulcer with possible perforation and hemorrhage


          Abdominal distention

          Ulcerative esophagitis


          Impaired wound healing

          Thin fragile skin

          Petechiae and ecchymoses

          Facial erythema

          Increased sweating

          May suppress reactions to skin tests



          Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after





          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


          Posterior subcapsular cataracts

          Increased intraocular pressure




    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


    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.


    Prednisolone Oral Solution USP, 15 mg/5 mL is a clear, pink to red liquid containing 15 mg of Prednisolone in each 5 mL (teaspoonful) and is supplied as

    NDC 0121-0885-08:  240 mL bottles

    NDC 0121-0885-16:  480 mL bottles

    Pharmacist:  Dispense Prednisolone Oral Solution USP, 15 mg/5 mL with a suitable calibrated measuring device to assure proper measuring of dose.

    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

    Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF.

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT REFRIGERATE.


     Manufactured by:

     PAI Pharma Logo

    Greenville, SC 29605



    NDC 0121-0885-08


    Oral Solution, USP

    15 mg / 5 mL

    Rx Only

    240 mL

    PAI Pharma

    Bottle Label - 240 mL

    NDC 0121-0885-16


    Oral Solution, USP

    15 mg / 5 mL

    Rx Only

    480 mL

    PAI Pharma

    Bottle Label - 480 mL
    prednisolone solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0121-0885
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorpink (clear pink to red) Score    
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0885-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2023
    2NDC:0121-0885-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - PAI Holdings, LLC (044940096)
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma044940096analysis(0121-0885) , label(0121-0885) , manufacture(0121-0885) , pack(0121-0885)