Label: PREDNISOLONE syrup

  • NDC Code(s): 0527-5406-68, 0527-5406-70
  • Packager: Lannett Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION

    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)-.

    This is an image of the structural formula of Prednisolone.

    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.

  • 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 Syrup (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 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:

    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 Syrup (Prednisolone Oral Solution, USP) 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 Syrup (Prednisolone Oral Solution, USP) 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 Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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 cherry flavored red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied as follows:

    NDC 0527-5406-68                   240 mL

    NDC 0527-5406-70                   480 mL

    Pharmacist:

    Dispense 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.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Lannett Company, Inc.
    Philadelphia, PA 19136

    10-1211
    Rev. 02/19

  • PRINCIPAL DISPLAY PANEL

    NDC 0527-5406-70

    PrednisoLONE
    Syrup
    (PrednisoLONE
    Oral Solution, USP)

    15 mg per 5 mL

    Rx Only
    480 mL

    Lannett

    480 mL bottle label

  • INGREDIENTS AND APPEARANCE
    PREDNISOLONE 
    prednisolone syrup
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0527-5406
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0527-5406-68240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    2NDC:0527-5406-70480 mL in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04077509/21/2007
    Labeler - Lannett Company, Inc. (002277481)