Label: PREDNISOLONE solution

  • NDC Code(s): 50383-042-24, 50383-042-48
  • Packager: Hi-Tech Pharmacal Co., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 5, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Rx only

  • DESCRIPTION

    Prednisolone Oral Solution 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). Its molecular weight is 360.45. The molecular formula is C21H28O5 and the structural formula is:

    Chemical Structure

    Prednisolone Oral Solution 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, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.

  • CLINICAL PHARMACOLOGY

    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.

  • INDICATIONS AND USAGE

    PREDNISOLONE Oral Solution 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 Diseases

    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:

     
    Acute leukemia of childhood
     
    Leukemias and lymphomas in adults

    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 is indicated for systemic dermatomyositis (polymyositis).

  • CONTRAINDICATIONS

    Systemic fungal infections.

  • WARNINGS

    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.

  • PRECAUTIONS

    General

    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.

  • 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 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 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 Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    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 Gl 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.

  • HOW SUPPLIED

    Prednisolone Oral Solution containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles and 480 mL bottles.

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

    Dosing chart

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

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

    HI-TECH PHARMACAL CO., INC.

    Amityville, NY 11701

    Rev.042:05 01/17

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Display panel

    AKORN

    50383-042-48

    PrednisoLONE Oral Solution, USP

    15 mg per 5 mL

    Rx only

    480 mL

    USUAL DOSAGE: See accompanying circular.

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

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

    PHARMACIST: Dispense with a suitable Calibrated Measuring Device.

    For your convenience, calibrated teaspoons are enclosed.

    DESCRIPTION: PREDISOLONE ORAL SOLUTION, USP contains 15 mg of PREDNISOLONE in each 5 mL (teaspoonful and alcohol 5% (v/v). Benzoic acid 0.1% added as a preservative.

    Alcohol 5% (v/v)

    HI-TECH PHARMACAL CO., INC.

    Amityville, NY 11701

    MADE IN U.S.A.

  • INGREDIENTS AND APPEARANCE
    PREDNISOLONE 
    prednisolone solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50383-042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CHERRY (UNII: BUC5I9595W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50383-042-481 in 1 CARTON02/27/2003
    1480 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50383-042-241 in 1 CARTON02/27/2003
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04040102/27/2003
    Labeler - Hi-Tech Pharmacal Co., Inc. (117696873)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.117696873MANUFACTURE(50383-042)